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The Nautilus VF ECMO Oxygenator with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor modules.

The Nautilus™ ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.

The Nautilus™ VF ECMO Oxygenator device contains integrated sensors that connects to the VitalFlow Console (K230364) for the display of measured parameters. The following measured parameters are measured: inlet pressure, inlet oxygen saturation, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, is calculated. The device is intended to be interconnected with a VitalFlow Console device that receives digital data from the oxygenator.

The oxygenator devices are single-use, nontoxic, non-pyrogenic, and not made from natural latex rubber materials.

The provided FDA 510(k) summary for the Nautilus VF ECMO Oxygenator describes the device and its substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria within the context of AI/ML-powered medical devices.

This document is for a medical device (an oxygenator) and its associated monitoring components, not an AI/ML diagnostic or prognostic algorithm. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI vs. without AI, ground truth establishment for training sets, number of experts for ground truth, etc.) are not applicable in this context.

Here's an analysis of the information that is present or can be inferred, formatted to address your questions where possible, and noting where information is missing or irrelevant to this type of device:

Device Acceptance Criteria and Performance

The document describes "Performance Evaluations" and "Special Controls" that were met to demonstrate substantial equivalence to the predicate device (Nautilus™ Smart ECMO Module (K191935) and Nautilus™ ECMO Oxygenator (K191935)). These act as the acceptance criteria for the device clearance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document mentions "bench studies" for performance evaluations, and "in vivo evaluation" using a "biologic test system" and a "summary... described the initial real-world clinical experience... into the ELSO registry."

• Sample Size for Bench Studies: Not specified. Bench studies typically involve a set number of device units for various tests (e.g., electrical, mechanical, software).
• Sample Size for In Vivo Evaluation: Not specified, but refers to a "biologic test system" and "initial real-world clinical experience with the first records of clinical ECMO cases entered sequentially into the ELSO registry." The exact number of cases or subjects is not provided in this summary.
• Data Provenance: The "ELSO registry" implies multi-center, international data, but the specific country of origin or whether it's retrospective/prospective is not detailed for the "real-world clinical experience" summary. The "biologic test system" would be a controlled lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided for this type of medical device. The evaluation of an oxygenator focuses on its physical, chemical, electrical, and biological performance characteristics, not on diagnostic accuracy requiring expert interpretation or "ground truth" establishment in the way an AI algorithm for image analysis would.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving interpretation (e.g., by radiologists) where there might be disagreements, which is not the case for an oxygenator's performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this is not an AI/ML-driven diagnostic or assistive device requiring human reader interaction.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is not an AI/ML-driven device. The device has integrated sensors and connects to a console for display, so there's a human-in-the-loop for monitoring parameters, but it's not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an oxygenator, "ground truth" would refer to established scientific and engineering principles, validated measurement techniques, and regulatory standards. For example:

• Biocompatibility: Established by adherence to ISO 10993 standards.
• Sterility: Validated sterilization methods and testing.
• Performance (e.g., gas exchange, heat exchange): Measured against validated laboratory methods and established clinical ranges for physiological parameters (e.g., blood oxygenation, CO2 removal).
• Safety (Electrical/EMC): Adherence to relevant IEC standards.
• In vivo: Performance in a "biologic test system" and "real-world clinical experience" as mentioned, assessed against physiological outcomes.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML-driven device with a "training set" in the machine learning sense. The device is hardware with integrated sensors and software components that are validated, not trained.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as #8.

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The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain.

The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.

The provided text describes the Nautilus, an image intensified fluoroscopic x-ray system. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The "Performance Data" section primarily addresses adherence to electrical safety and electromagnetic compatibility (EMC) standards, and software verification and validation. These are crucial for the safety and basic functionality of the device, but they are not the typical performance metrics associated with demonstrating the clinical efficacy or diagnostic accuracy of an imaging system compared to a ground truth or a human reader.

Here's a breakdown of what is and isn't present, based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria Mentioned: The text implicitly states acceptance criteria by listing the standards that the Nautilus was tested against (e.g., IEC 60601-1, IEC 60601-1-2). The "Performance Data" states that "Performance testing confirmed that the Nautilus met the requirements of the following standards."
• Reported Device Performance: The document only reports conformance to these safety and software standards, not specific performance metrics in terms of image quality, diagnostic accuracy, or clinical outcomes. There are no numerical results (e.g., contrast-to-noise ratio, spatial resolution, diagnostic sensitivity/specificity) provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No clinical or diagnostic performance test set is described. The testing mentioned is for electrical safety, EMC, and software, which typically involves engineering tests, not patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment for diagnostic performance is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No diagnostic performance test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states: "Clinical testing is not necessary for the subject system Nautilus, based on the same basic technology as the predicate device and based on existing minor differences." This indicates that an MRMC study or any clinical effectiveness study was not performed or deemed necessary for this 510(k) submission. There is no AI assistance mentioned, so no effect size for human readers with AI vs. without AI assistance can be provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is an imaging system (fluoroscopic x-ray system) and not an AI algorithm. Its performance is evaluated fundamentally in conjunction with a human operator / clinician interpreting the images. No standalone algorithm performance is applicable or discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No diagnostic ground truth is mentioned. The "ground truth" for the non-clinical tests would be the requirements defined by the referenced international standards for electrical safety, EMC, and software quality.

8. The sample size for the training set

• Not Applicable. As no AI algorithm or diagnostic performance study is described, there's no training set for such a purpose.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Summary of Device Acceptance and Study as Described in the Document:

The Nautilus device's acceptance is based on its substantial equivalence to a predicate device (Dornier Genesis K151485) and its demonstrated conformance to established international standards for:

• Electrical Safety: IEC 60601-1, EN 60601-1-6, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54
• Electromagnetic Compatibility (EMC): IEC 60601-1-2
• Usability: EN 60601-1-6, IEC 62366-2
• Software Verification and Validation: Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern).

The study that "proves the device meets the acceptance criteria" is non-clinical testing (bench testing) against these referenced standards. No clinical studies, human reader studies, or diagnostic performance studies with explicit acceptance criteria (e.g., sensitivity/specificity thresholds) and corresponding test results are provided in this submission document. The rationale provided for not conducting clinical testing is that the device uses "the same basic technology as the predicate device and based on existing minor differences."

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The Nautilus(tm) Smart ECMO Module with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor modules and display.

The Nautilus(tm) ECMO Oxygenator with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use.

The Nautilus™ ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.

The Nautilus™ Smart ECMO Module device contains integrated sensors with an electronic touch screen display. The following measured parameters are visible on the electronic display: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, delta pressure, is calculated and also displayed on the screen. The touchscreen display allows users to set alarm limits for all measured parameters. The Nautilus™ Smart ECMO Module will alarm visually and audibly when the limits are exceeded.

The devices are single-use, nontoxic, non-pyrogenic, and not made from natural latex rubber materials.

The provided text describes performance evaluations for the MC3 Nautilus Smart ECMO Module and Nautilus ECMO Oxygenator. However, it does not explicitly state "acceptance criteria" in a tabulated format and then directly link each criterion to "reported device performance" in a separate column. Instead, it presents various performance evaluations and their findings.

Based on the information provided, here's a structured summary attempting to address your request as closely as possible:

1. Table of acceptance criteria and the reported device performance

While explicit acceptance criteria are not tabulated with specific numerical targets, the document implies that the device is considered acceptable if its performance is "comparable or better" than a state-of-the-art device and meets the "special controls" and standards.

• "The most common complication reported was circuit exchange in twenty percent of patients..."
• "Ten percent of patients had reports of blood infections on ECMO, which is similar to the rate of infections (11%) previously reported by others."
• "One patient suffered a CNS infarction event (5%), and another patient, a CNS hemorrhage." |
  | Compatibility with other circuit devices | Technological Characteristics: "The subject device is designed to be compatible with other extracorporeal circuit devices and accessories." |

The studies collectively show that the Nautilus device meets performance expectations by being comparable to or better than predicate/reference devices and established clinical norms, and by demonstrating safety and efficacy in various testing environments.

2. Sample size used for the test set and the data provenance

• Long-term Bench Gas Exchange testing: The sample size isn't explicitly stated as a number of devices, but it refers to "MC3 Nautilus oxygenators from accelerated age populations" and "competitive heparin coated oxygenators."
  • Provenance: In vitro, conducted according to ISO 7199:2016, using bovine blood/plasma.
• In-Vivo Study in Sheep:
  • Sample size: A total of 15 sheep. Specifically, 10 sheep were used to evaluate the Nautilus device (at either 2 or 5 L/min), and 5 control animals were studied with a state-of-the-art heparin-coated device (at 2 L/min).
  • Provenance: Prospective animal study.
• Clinical information (Real World Evidence):
  • Sample size: Not explicitly stated as a number of patients, but data were collected from patients at 7 centers in 4 countries. The average duration of ECMO support was 378.5 hours (15.8 days), with a range of 17 to 1271 hours (52.9 days). Given these durations, it implies a significant number of patient-hours of use.
  • Provenance: Retrospective, voluntarily entered into the ELSO registry from initial real-world clinical experience. Data from 7 centers in 4 countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. The studies described are performance-based (bench, in-vivo) and real-world data collection, rather than studies requiring expert adjudication of device performance in a diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the text. The studies described (bench, animal, real-world registry data) do not appear to involve a human adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might be evaluated.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human readers improving with AI assistance. The device is an ECMO module/oxygenator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable. The device (ECMO module/oxygenator) is a medical device that physically interacts with a patient's blood, not an algorithm. The "Smart Module" has integrated sensors and an electronic display, which would operate in a "standalone" algorithmic sense for its sensor functions, but its primary function as an ECMO device is not an algorithm. The sensor accuracy was evaluated as part of "Smart Module Testing."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Long-term Bench Gas Exchange testing: Ground truth for gas exchange and pressure drop was established by measurements according to the ISO 7199:2016 standard using bovine blood, providing objective scientific measurements.
• In-Vivo Study in Sheep: Ground truth for clotting was established by direct observation ("no clots in any location") and confirmation of oxygenator functionality in the animal model.
• Clinical information (Real World Evidence): Ground truth for complications and device performance in a clinical setting was derived from clinical observation and patient outcomes data voluntarily entered into the ELSO registry by clinicians at the participating centers.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical medical device, not a machine learning algorithm that requires a "training set" for its operation in the way an AI diagnostic tool would.

9. How the ground truth for the training set was established

This information is not applicable/provided, as the concept of a "training set" does not apply to this type of device.

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The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cvcle. The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders.

As described above, the BrainPulse, Model 1100 (BrainPulse) is designed to measure skull motion caused by pulsatile blood flow. The BrainPulse measures these cranial pulsatile movements via an array of accelerometers placed on the scalp. The system consists of three main components: a headset, data collector, and computer.

The headset contains a forehead photoplethysmograph (PPG) sensor that measures the patient's pulse rate, a Sound Pressure Level (SPL) sensor for detecting ambient environment noise, and six accelerometers to detect the acceleration of the skull at six selected locations. These acceleration measurements typically fall in the range of 0.001 - 0.03 g.

The data collector converts the analog signals from the headset sensors and provides a digital data stream via Ethernet cable to the computer. The computer is loaded with software that allows for the user to initiate and end recordings and to manage saved data files. The BrainPulse software is not capable of displaying the recorded data from the headset; rather the data are saved in multiple file formats that can be readily displayed using other third-party software for post-hoc review.

Here's an analysis of the acceptance criteria and the study that proves the BrainPulse, Model 1100 meets these criteria, based on the provided text.

Based on the provided text, the BrainPulse, Model 1100 is a Class II device intended to non-invasively detect, amplify, and capture skull motion caused by pulsatile flow from the cardiac cycle. It is not intended for diagnostic purposes. Therefore, the "acceptance criteria" for this device are primarily focused on its ability to accurately, precisely, stably, and repeatably measure cranial motion, and its safety, rather than diagnostic performance metrics like sensitivity, specificity, or AUC.

The information provided describes the assessment of the device against a set of standards and performance expectations, rather than a single "study" with a specific test set, ground truth, and expert adjudication as might be seen for a diagnostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a measurement tool, not a diagnostic one), the "acceptance criteria" are derived from the "Special Controls" and the objectives of the various non-clinical and clinical performance tests.

2. Sample Size Used for the Test Set and Data Provenance

As this device is a measurement tool and not a diagnostic AI, there isn't a dedicated "test set" in the sense of a validation dataset for a diagnostic algorithm. Instead, its performance was assessed through various bench and clinical evaluations.

• Clinical Performance Data: 616 successful recordings from 273 patients across six clinical studies.
• Data Provenance: Studies were conducted "both at centers within and outside the United States." The text also mentions that summaries of these studies were "supplied to support a determination of a reasonable assurance of the safety and effectiveness." It is not specified whether these were specifically prospective or retrospective studies for the purpose of regulatory submission, but rather they appear to be existing clinical studies from which data was leveraged.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For a device like BrainPulse, which measures a physical phenomenon (skull motion due to pulsatile flow), the concept of "ground truth" for a diagnostic outcome established by human experts is not directly applicable.

• Ground Truth for Measurement Performance: The "ground truth" for evaluating the measurement capabilities of the accelerometers and PPG sensor would have been established by:

  • Reference Measurement Devices: For accelerometer resolution and SPL sensor accuracy tests, comparison to "reference measurement device" was used.
  • Known Physical Inputs/Conditions: Accelerometer stability/repeatability and hardware verification would likely involve known mechanical inputs or environmental conditions to test the device's output.
  • Physiological Correlation: For the PPG sensor, performance was evaluated by "visual comparison to concurrent SpO2 (blood oxygen saturation) sensor recordings." The "ground truth" here is the expected physiological correlation between blood flow and pulse.
  • Clinical Correlation: In clinical studies, the "ground truth" for the device's intended function was the correlation of measured skull motion with a regular pulse related to the cardiac cycle. This is an observable physiological phenomenon.

• Experts: No specific number or qualifications of "experts" are mentioned for establishing this type of ground truth, as it relies on physical and physiological principles and comparisons to established reference measurements.

4. Adjudication Method for the Test Set

Not applicable in the context of this device's performance evaluation. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human experts are making qualitative or subjective assessments that need to be aggregated into a "ground truth" for a diagnostic label. Here, the performance is based on quantifiable physical measurements and their correlation with physiological events.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted and was not necessary for this device.

• Reasoning: An MRMC study assesses the impact of AI assistance on human reader performance, typically for diagnostic tasks (e.g., radiologists reading images with or without AI). The BrainPulse is a measurement device, not a diagnostic aid that assists a human reader in interpreting complex clinical data. Its output (skull motion data) is intended to be incorporated into a clinician's overall assessment paradigm, but the device itself doesn't offer a diagnostic interpretation or classification that a human "reader" would be evaluating. The submission explicitly states: "Consequently, a demonstration of clinical diagnostic utility in specific patient populations was not required."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the core of the performance evaluation for BrainPulse, Model 1100, is essentially its standalone (algorithm/hardware-only) performance in measuring cranial motion.

• Measurement Accuracy and Reliability: The bench performance tests (accelerometer stability, repeatability, resolution, PPG accuracy, hardware verification) evaluate the device's ability to accurately and reliably capture the intended data independently.
• Clinical Correlation: The clinical studies confirmed that the device's measurements (algorithm's output) correlated with the cardiac cycle, which is its primary intended function. While clinicians use the data, the device is evaluated on its ability to produce the measurement correctly, not on a human's ability to interpret that measurement for a specific diagnostic outcome.

7. The Type of Ground Truth Used

The "ground truth" for the BrainPulse's evaluation was primarily:

• Physical/Engineering Specifications: For bench testing, this often meant comparing the device's output to known physical inputs or outputs from calibrated reference instruments (e.g., "reference measurement device" for SPL sensor, "accelerometer specifications" for resolution).
• Physiological Correlation: For the PPG sensor, the ground truth was the expected physiological correlation with SpO2 readings (though "visual comparison" suggests a qualitative assessment of this correlation rather than quantitative comparison to a gold standard).
• Observable Physiological Events: In clinical studies, the ground truth for validating the device's intended use was the "regular pulse related to the cardiac cycle," an established physiological event which the device's skull motion measurements were expected to correlate with.
• Absence of Adverse Events: Safety ground truth relied on patient reporting of discomfort or adverse events.

This is distinct from "expert consensus" or "pathology" which are typically ground truths for diagnostic tasks. Outcomes data might be relevant for clinical utility, which was explicitly not assessed.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning (ML) or Artificial Intelligence (AI) model that would require a distinct training set. The device appears to be based on direct physical measurements using accelerometers and a PPG sensor. Its "software" is described as managing recordings and saving data, consistent with traditional software, not an ML/AI algorithm that learns from data.

If there were internal algorithms for signal processing or noise reduction, the document does not specify if these were "trained" on data or if they were designed based on known physics and engineering principles. Given the de novo nature from 2014, it's highly likely that any signal processing would be deterministic rather than AI/ML-based.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or specific ML/AI model is described.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The NAUTILUS Thoracolumbar Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Thoracolumbar Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the NAUTILUS Thoracolumbar Spinal System 5.5 rod system may be connected to the Solstice-OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

The purpose of this submission is to add new screw iterations to the Nautilus Spinal System.

This document pertains to the Nautilus Spinal System, a medical device intended for spinal fixation, and is a 510(k) premarket notification. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.Acceptance Criteria and Device Performance for Nautilus Spinal System (K151196)

This 510(k) submission for the Nautilus Spinal System does not describe an AI/algorithm-based device and therefore does not have acceptance criteria or a study proving that an algorithm meets such criteria. Instead, it is for a physical medical device (spinal fixation system) and relies on mechanical testing to demonstrate substantial equivalence to predicate devices.

However, based on the provided text, we can extrapolate the performance data mentioned for the physical device as meeting implied acceptance criteria related to mechanical integrity and safety.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices or iterations. The testing involved various "screw iterations" and system components. The tests (static/dynamic compression, torsion, axial grip, torsional grip, moment bending) would have been performed on a sufficient number of samples of the Nautilus Spinal System components to satisfy the requirements of ASTM F1717 and ASTM F1798.
• Data Provenance: The document does not specify the origin (e.g., country) of the data, but it would have been generated in a controlled laboratory setting (likely in the US or a country with recognized testing standards). The study is prospective in the sense that the testing was conducted specifically for this submission to demonstrate the performance of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable as the Nautilus Spinal System is a physical medical device, not an AI/algorithm. "Ground truth" in this context would refer to the physical and mechanical properties being measured by established testing methodologies rather than expert consensus on data interpretation. The "experts" involved would be engineers and lab technicians conducting the mechanical tests according to ASTM standards.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, torque) against pre-defined engineering standards (ASTM F1717, ASTM F1798), not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• This question is not applicable. An MRMC study is relevant for diagnostic imaging AI algorithms where human readers interpret medical images. This submission is for a physical spinal implant system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• This question is not applicable. There is no algorithm described in this submission.

7. The type of ground truth used

• The "ground truth" for the performance of the Nautilus Spinal System is its mechanical properties as measured by standardized engineering tests (ASTM F1717 and ASTM F1798). These standards define the methods and expected performance characteristics for spinal implant devices. The "truth" is whether the device meets or exceeds the mechanical performance requirements outlined by these standards, indicating its structural integrity and comparability to predicate devices.

8. The sample size for the training set

• This question is not applicable. There is no algorithm or "training set" in the context of this device submission.

9. How the ground truth for the training set was established

• This question is not applicable. There is no algorithm or "training set" in the context of this device submission.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (8) spondylolisthesis.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

The purpose of this submission is to add an additional cross connector component.

Based on the provided text, the document is a 510(k) premarket notification for the Nautilus Spinal System. The text describes the device, its intended use, and states that it has been determined to be substantially equivalent to predicate devices. However, the document does not contain any information about a study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or F1 score, nor does it discuss AI or algorithm performance data.

The "Performance Data" section in the 510(k) Summary only states: "Engineering analysis was presented to demonstrate the substantial equivalency of the Nautilus Spinal System." This indicates that the performance data submitted for this device relates to its mechanical performance and substantial equivalence, not to the type of statistical performance metrics typically associated with AI/ML devices.

Therefore, for your request, I cannot provide the detailed information about acceptance criteria and a study proving device performance as it pertains to AI/ML devices, because the document describes a traditional medical device (a spinal implant system) and uses a "substantial equivalence" pathway for clearance, not a pathway that would involve performance metrics like sensitivity or specificity.

I cannot create the requested table or answer most of the questions because the provided text is for a physical medical device (spinal system) and does not discuss AI/ML device performance, acceptance criteria in the context of diagnostic accuracy, or studies involving test sets, ground truth, or expert review for AI algorithms.

The document states that the device is "substantially equivalent" to predicate devices based on design, materials, indications for use, sizing, and mechanical performance (engineering analysis). This is a different type of assessment than what is typically performed for AI/ML devices where specific performance metrics like sensitivity and specificity against a ground truth would be established.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor. (5) failed previous fusion (6) pseudarthrosis. (7) spondylolisthesis.

Solstice OCT System:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks, rods, and connectors are also intended to provide stabilization to promote fusion of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Solstice OCT system can also be linked to the Conquest, Pilot, and Nautilus Spinal Systems through the use of transitional rods and rod connectors.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps, connectors and breakaways.

The purpose of this submission is to add transition connectors to both the Nautilus and Solstice Systems.

This document pertains to a 510(k) premarket notification for the Nautilus Spinal System and the Solstice OCT System, both spinal fixation devices. The submission focuses on adding transition connectors to these systems. The FDA letter confirms the substantial equivalence of the devices to legally marketed predicates.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for performance in a table format with corresponding reported device performance values against those criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. This means that the new device (Nautilus Spinal System and Solstice OCT System with added transition connectors) performs comparably to devices already cleared by the FDA.

The "Performance Data" section states:

• "Mechanical testing was included to demonstrate the substantial equivalency of the Nautilus Spinal System and the Solstice OCT System."
• "The testing included static and dynamic compression and static torsion testing per ASTM F1717, static axial and torsional grip per ASTM F1798."

This implies that the acceptance criteria for these tests were that the performance of the Nautilus and Solstice systems (with the new connectors) had to be equivalent or superior to that of the predicate devices or meet the general requirements of the ASTM standards for spinal implant systems. However, specific numerical thresholds for these criteria are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing." This typically refers to laboratory testing of physical samples of the devices, not clinical data from human subjects. Therefore, the concept of "sample size for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) is not applicable here. For mechanical testing, the "samples" would be the physical devices tested according to the ASTM standards. The exact number of device samples tested is not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this document. The device in question is a spinal implant system, and the "study" described is mechanical testing in a laboratory setting, not a study involving human interpretation of medical images or clinical outcomes that would require expert consensus for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 refer to processes used in clinical studies, particularly for interpreting ambiguous findings, typically by multiple experts. The study mentioned here is mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable to this document. The device is a spinal implant system, not a diagnostic or AI-powered imaging device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to this document. This question relates to AI algorithms operating independently, which is not relevant to a physical spinal implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This question is not applicable in the traditional sense for a medical device that undergoes mechanical testing. For mechanical testing, the "ground truth" is defined by the physical properties and performance characteristics measured by standardized test methods (ASTM F1717, ASTM F1798). The goal is to demonstrate that the device meets the performance requirements (e.g., strength, durability) as defined by these standards and is comparable to predicate devices.

8. The sample size for the training set

This question is not applicable to this document. "Training set" refers to data used to train machine learning models. This document describes mechanical testing of a physical medical device, not an AI or software device.

9. How the ground truth for the training set was established

This question is not applicable to this document for the same reasons as #8.

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Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Nautilus Delta can be used with PICCs and with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Nautilus Delta can be used with CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use. Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Nautilus Delta™ system consists of the following elements: single use sterile ECG extension cable (also known as Nautilus Electrical Adaptor also known as NautilusE), non-sterile ECG cable, patient module (ECG data acquisition and processing and integrated remote control), and mobile medical application running on any mobile platform which complies with the minimum requirements. Nautilus Delta™ provides real-time catheter tip location information by using the patient's cardiac electrical activity (ECG). This information can be used to position any central venous access devices (CVADs) at or around the cavo-atrial junction (CAJ). Nautilus Delta supports navigation of central venous catheters from the vascular access point towards the CAJ by computing and displaying a navigation signal. Nautilus Delta also displays on its graphical user interface the surface (skin) ECG signal, a marker identifying the R-peak, and the patient's heart rate. In order to obtain intravascular ECG information at the tip (distal end) of a catheter, a stylet or a guidewire inserted in the catheter can be connected to Nautilus Delta patient module via the sterile Nautilus Delta ECG extension cable. Nautilus Delta and NautilusE do not have any direct or indirect contact with the patient.

The provided text is a 510(k) Summary for the Nautilus Delta™ device, which is an accessory to percutaneous, implanted, long-term intravascular catheters. Its intended use is to support navigation and tip positioning of central venous access devices (CVADs) by using the patient's cardiac electrical activity (intracardiac ECG) as an alternative to chest X-ray and fluoroscopy for CVAD tip placement confirmation.

The document states that Romedex International SRL submitted this 510(k) after obtaining CE mark approval, and that the device "was successfully used in Europe in hundreds of patients in several hospitals in several countries by many different users of different backgrounds and experience levels. No adverse events were reported. Side-by-side comparisons with legally marketed similar devices, including the predicate devices, were performed in clinical settings to demonstrated substantial equivalence of Nautilus Delta with the predicate devices."

However, the document does NOT contain explicit acceptance criteria (e.g., target accuracy, sensitivity, specificity values) for device performance, nor does it detail a specific study proving the device meets quantified acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices (Epidural Catheter Connector K973371 and Sherlock 3CG Tip Confirmation System K113808) through a comparison of technological characteristics, performance testing against various standards (ES60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 62304, IEC 62366, ISO 11737-1, ISO 11135-1, ISO 11135-2, EN 55022, and EN 300328), and post-market clinical experience from Europe.

Since the input document does not contain the specific information requested, I will state that the information is not provided.

Here's a breakdown of the requested information based on the provided text:

• A table of acceptance criteria and the reported device performance:
  • Not provided. The document states that "Romedex has performed extensive testing in order to demonstrate that the new characteristics do not affect safety and effectiveness when compared to the predicate devices and to demonstrate compliance with the following standards: ES60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 62304, IEC 62366, ISO 11737-1, ISO 11135-1, ISO 11135-2, EN 55022, and EN 300328." It does not, however, list specific performance metrics (e.g., accuracy, sensitivity, specificity for tip placement) or their corresponding acceptance thresholds.
• Sample size used for the test set and the data provenance:
  • The document states: "Since obtaining the CE mark, Nautilus Delta also known as Handy Nautilus was successfully used in Europe in hundreds of patients in several hospitals in several countries..." This indicates a retrospective collection of real-world use data from Europe. A precise sample size for a formal "test set" demonstrating performance is not explicitly provided, beyond "hundreds of patients."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • Not provided. The document mentions "many different users of different backgrounds and experience levels" using the device, but it does not specify how ground truth was established for these "hundreds of patients" for comparison purposes (e.g., if chest X-ray or fluoroscopy was used as ground truth for tip placement confirmation and adjudicated by experts).
• Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
  • Not provided. The device is not an AI/ML algorithm that assists human readers; it's a device that provides real-time catheter tip location information using cardiac electrical activity as an alternative method to chest X-ray and fluoroscopy. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in the typical sense for this device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • The device provides real-time information to a human operator. The document describes it as a system with a patient module, cables, and a mobile application for display. Performance would inherently involve the device generating a "navigation signal" and displaying information for a human to interpret and act upon. The text does not describe a "standalone algorithm-only" performance evaluation independent of human interaction or interpretation of the displayed information for tip placement confirmation.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Not explicitly stated for the "hundreds of patients" data. For CVAD tip placement, the common ground truth methods are chest X-ray or fluoroscopy. The device is indicated as an alternative to these. While "side-by-side comparisons with legally marketed similar devices" (which would presumably use standard confirmation methods) were performed, the specific type of ground truth used to validate the Nautilus Delta's performance in terms of tip placement accuracy is not detailed.
• The sample size for the training set:
  • Not applicable / Not provided. The Nautilus Delta as described is a medical device that measures and processes ECG signals to determine catheter tip location using established physiological principles. It is not an AI/ML device that requires a "training set" in the context of machine learning model development.
• How the ground truth for the training set was established:
  • Not applicable / Not provided. As it's not an AI/ML device in the sense of needing a training set, the methodology for establishing ground truth for a training set is not pertinent here.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NAUTILUS Spinal System:

The provided text does not contain information about acceptance criteria or a study with performance metrics in the way one would typically find for an AI/ML medical device. This document is a 510(k) summary for a traditional medical device (spinal implant system).

Therefore, I cannot populate most of the requested fields as they pertain to the performance evaluation of an AI/ML device. I will indicate where the information is not applicable (N/A) or not found (N/F) based on the context of this traditional device submission.

Acceptance Criteria and Study for NAUTILUS Spinal System

This 510(k) submission for the NAUTILUS Spinal System demonstrates substantial equivalence to a predicate device (NAUTILUS Spinal System K133564) primarily through performance testing based on established industry standards and engineering analysis. It is for a physical medical implant, not an AI/ML diagnostic or prognostic device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a "sample size" in the context of test subjects or data points for an algorithm. For a physical device like this, testing typically involves a set number of implants or components subjected to mechanical tests. The exact number of test articles is not provided in this summary.
• Data Provenance: N/A for AI/ML context. For mechanical testing, the "data" is generated in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This is a physical device, and "ground truth" for its performance is established by objective mechanical testing according to recognized standards (ASTM F1717), not by expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• N/A. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert review of images/data, which is not the nature of this device's performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• N/A. This is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• N/A. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For this device, "ground truth" for performance relates to objective mechanical properties and structural integrity as measured by standardized engineering tests (e.g., fatigue strength, static load capacity, pull-out strength). The "truth" is whether the device meets the physical requirements outlined in the ASTM standard, demonstrating equivalence to the predicate.

8. The sample size for the training set:

• N/A. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• N/A. There is no "training set."

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

This document describes a spinal system called the NAUTILUS Spinal System and details its substantial equivalence to predicate devices, which is the basis for its 510(k) clearance. Because this is a spinal implant and not an AI/ML device, the typical AI/ML-focused acceptance criteria and study components requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, training set details) are not applicable.

Here's a breakdown of the information provided in the context of the prompt:

1. A table of acceptance criteria and the reported device performance

• Study that proves the device meets the acceptance criteria: The device's compliance with acceptance criteria is established through a substantial equivalence determination to predicate devices (NAUTILUS Spinal System K132760 and CD Horizon Spinal System K132471). This is supported by performance data from static, torsional, and dynamic compression testing per ASTM F1717, as well as axial grip, torsional grip, and moment bending testing per ASTM F1798. These tests demonstrate that the NAUTILUS Spinal System performs comparably to the predicate devices in terms of mechanical properties.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A). This is a submission for a medical device (spinal implant) based on substantial equivalence, not an AI/ML diagnostic or predictive device. There is no "test set" in the context of medical images or patient data to evaluate an algorithm. The "test set" here refers to the mechanical tests performed on the physical device components. The document does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance beyond stating the tests performed to demonstrate substantial equivalency.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable (N/A). As this is a mechanical device, ground truth is established by engineering standards and test results, not by expert medical review of images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable (N/A). Adjudication methods are relevant for subjective interpretations (e.g., image reading) by multiple experts. For mechanical testing, the results are objectively measured against established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable (N/A). This study is irrelevant for a spinal implant device. MRMC studies are used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable (N/A). This study is irrelevant for a spinal implant device. "Standalone" performance refers to the accuracy of an AI algorithm without human input, which does not apply here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device is based on established engineering standards and material specifications (e.g., ASTM F136, ASTM 1537, ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties and safety are equivalent to those already accepted.

8. The sample size for the training set

• Not Applicable (N/A). This concept applies to AI/ML algorithms, not to the mechanical testing of a medical implant.

9. How the ground truth for the training set was established

• Not Applicable (N/A). This concept applies to AI/ML algorithms.

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