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Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece. The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Strauss Surgical Cystoscopes & Hysteroscopes." This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the newly cleared device itself.

Crucially, the document explicitly states under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section that:

"The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance."

This means that a study proving the device meets individual acceptance criteria, as typically understood for new device performance validation, was not performed or not deemed necessary by the FDA for this 510(k) clearance due to the identical technological characteristics with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and the study that proves the device meets them because the document clearly states such testing was not performed for this clearance.

However, I can still address some of your points based on the information provided, even if it's to state the absence of the requested detail:

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

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

• Sample Size for Test Set: Not applicable, as no performance testing was conducted.
• Data Provenance: Not applicable, as no performance testing was conducted.

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, as no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

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. This device is a rigid endoscope for visualization, not an AI-powered diagnostic tool. Furthermore, no performance testing was conducted.

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

• Not applicable. This device is a rigid endoscope, not an algorithm. Furthermore, no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

8. The sample size for the training set

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

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

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

Summary of Document's Key Information regarding Performance:

The FDA clearance for the Strauss Surgical Cystoscopes & Hysteroscopes (K251652) was based on substantial equivalence to existing predicate devices (K150158 Schoelly Cystoscopes/Hysteroscopes and accessories). The manufacturer asserted, and the FDA accepted, that the subject device and the predicate device have identical technological characteristics. Therefore, no new performance testing (non-clinical or clinical) was deemed necessary or performed to demonstrate safety and effectiveness for this specific 510(k) submission. The clearance relies on the established safety and performance of the predicate device.

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Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders.

Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson.

The recorded data will be made available to the healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

The device is not a life supporting physiological monitor.

Onera Sleep Test System 2 (Onera STS 2) is a hardware, wearable system for measuring physiological signals during a sleep study. The device can be used in the home (Home Healthcare Environment) as well as in Professional Healthcare Facilities.

The device measures EEG, EOG, EMG, ECG, respiratory signals, cannula based respiratory flow, oxygen saturation, activity, position, ambient light level and sound pressure level.

The ECG signal is not intended for diagnosis of cardiac disorders, except for the manual determination of arrhythmia during polysomnography studies.

The Onera STS 2 does not provide any automated output like heart rate, assessments of arrhythmia, heart rate variability, or other related heart rate measurement functions.

Onera STS 2 consists of five Sensors applied on the forehead, upper chest area, abdomen and lower leg area (both left and right leg).

The Sensors should be placed on intact skin. During the night measurement it is not needed to inspect the application sites. The Sensors encrypt the recorded signals and upload the measurement data during the night to the Patient App installed on the patient's phone via Bluetooth. The Patient App securely transfers the data to the cloud interface for further processing once all data has been uploaded. The output of the system is represented by a file in EDF format which contains the recorded (physiological) signals. EDF files can be read by any application software that accepts such files as input.

It is not possible to relocate the Sensors during a sleep study since the Sensor is single-use and for one sleep study only.

Here's a summary of the acceptance criteria and study information for the Onera STS 2, based on the provided FDA 510(k) clearance letter:

Onera STS 2: Acceptance Criteria and Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on the SpO2 measurement accuracy as a key performance metric with specific acceptance criteria.

Note: While other parameters are listed as "Identical" to the predicate, specific numerical acceptance criteria for those parameters are not explicitly stated in this document beyond their qualitative equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 12 healthy subjects
  • 9 male, 3 female
  • Aged between 23 and 46 years old
• Data Provenance: The study was conducted in an "independent research laboratory." The country of origin is not explicitly stated in the provided text. The study involved "induced hypoxia," indicating a prospective, controlled experimental design.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish ground truth for the SpO2 accuracy test.
• The ground truth for SpO2 was established by "laboratory co-oximeter" measurements of arterial hemoglobin oxygen (SaO2) values from blood samples.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. The SpO2 accuracy was determined by direct comparison of the device's SpO2 measurements to SaO2 values from a laboratory co-oximeter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The device primarily measures physiological parameters, and the study focused on the accuracy of these measurements rather than human reader interpretation with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted for SpO2 measurement accuracy. The device's SpO2 readings were directly compared to reference SaO2 values without human intervention in the SpO2 measurement process itself. The Onera STS 2 is described as measuring and recording parameters, with the output as an EDF file to be read by other software. The SpO2 accuracy assessment is specifically for the device's measurement capability.

7. Type of Ground Truth Used

• Objective Measurement (Laboratory Co-oximeter): For SpO2 accuracy, the ground truth was established by arterial hemoglobin oxygen (SaO2) values determined from blood samples using a laboratory co-oximeter, which is considered a gold standard for blood oxygen saturation.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size for a training set. This is likely because the performance study described (SpO2 accuracy) is a validation of the device's sensor capabilities, not an evaluation of a machine learning algorithm that would typically require a training set. The device outputs raw physiological signals in EDF format for clinicians to interpret, rather than providing automated diagnoses based on an internal algorithm.

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

• As no training set is mentioned or implied for the device's core functionality (measuring and recording parameters for clinician interpretation), this information is not applicable and not provided in the document.

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The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.

The provided text is a 510(k) summary for the STS device, a pulmonary function data calculator. While it mentions a clinical study, the details provided are limited and do not fully address all requested points regarding acceptance criteria and study specifics for proving the device meets those criteria.

Based on the provided document, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria values for performance. However, an implicit acceptance criterion is a "high correlation" and specific statistical thresholds mentioned in the clinical study summary.

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

• Sample Size: 161 subjects (61 females, 100 males, implicitly). This test set was used for the clinical study comparing STS to Body Plethysmography.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects were "enrolled" and "tested by both STS and BP," suggesting data was collected specifically for this study.

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

• The document states that Body Plethysmography (BP) is considered the "gold standard" for measuring lung volumes. Therefore, the BP measurements served as the ground truth.
• It does not specify the number of experts or their qualifications involved in performing or interpreting the Body Plethysmography tests. It's implied that standard clinical practice for BP was followed, which would involve trained medical professionals, but this is not detailed.

4. Adjudication method for the test set:

• No information on adjudication methods is provided. The comparison is directly between the STS device measurements and the "gold standard" Body Plethysmography measurements.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported. This device is a pulmonary function data calculator and not an AI-assisted diagnostic imaging tool where human reader performance with and without AI assistance would typically be evaluated. The study focuses on the device's accuracy in measuring physiological parameters when compared to a gold standard.

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

• The clinical study described evaluates the "performance of STS technique in calculating resistance and compliance parameters" by comparing it with Body Plethysmography.
• The STS device itself is a "pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters." This implies a standalone performance evaluation of the device's measurements against the gold standard. However, the device "is to be used by either a physician, respiratory therapist, or technician" and its results are "displayed on the physician's computer via the STS software/App," indicating there's a human-in-the-loop for operation and interpretation. The study evaluates the measurement accuracy, which can be seen as a form of standalone performance for the measurement part of the device.

7. The type of ground truth used:

• The ground truth used was "gold standard" Body Plethysmography (BP) measurements of lung volumes. While BP is a clinical measurement, it serves as the established reference standard in this context.

8. The sample size for the training set:

• The document does not provide any information about the sample size used for the training set. This is a 510(k) submission, and often, proprietary training data details are not included in the public summary.

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

• The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

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Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.

Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson. The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.

Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.

The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.

The study preparation and data retrieval are done in a professional/clinical environment by the trained operator. The device is provided to the user by the trained operator.

The device is not a life supporting physiological monitor.

The provided text is a 510(k) summary for the Onera Sleep Test System (Onera STS). It details the device, its intended use, and a comparison to a previously cleared predicate device (K210593). The primary change in this submission (K223573) is an extension of the device's use time from 8 hours to 16 hours.

It's crucial to understand that this document is a premarket notification asserting substantial equivalence, not a detailed clinical study report proving performance against specific acceptance criteria for diagnostic accuracy. The FDA's review for a 510(k) focuses on safety and effectiveness in comparison to a predicate device, rather than requiring new, full-scale clinical trials for every parameter.

Therefore, the information regarding acceptance criteria and performance studies within this document is limited to demonstrating that the change (extended wear time) does not introduce new safety or effectiveness concerns, and that the device still meets regulatory standards. There is no information provided about a study that assesses the device's diagnostic accuracy or performance against specific, quantifiable "acceptance criteria" for detecting sleep disorders. The device is described as measuring and recording parameters for clinicians to use, not as an automated diagnostic tool itself.

Given this context, I will address your points based on the available information in the provided text.

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

The FDA 510(k) summary primarily focuses on demonstrating that the modified device (Onera STS with 16-hour wear time) is substantially equivalent to its predicate device (Onera STS with 8-hour wear time) and that the change does not introduce new safety or effectiveness concerns. There are no explicit "acceptance criteria" for diagnostic accuracy or performance of the device in the context of detecting sleep disorders presented in this document. The "performance testing" mentioned is related to meeting general safety and performance standards, and verifying that the extended wear time does not degrade existing performance or safety.

Table of Comparison (Not "Acceptance Criteria" for Diagnostic Performance):

The table below summarizes the comparison between the proposed device and the predicate, highlighting the only stated difference: extended use time. This is a demonstration of substantial equivalence rather than meeting specific diagnostic acceptance criteria.

Study Details (Based on provided 510(k) Summary)

The provided document describes a 510(k) "premarket notification" which asserts substantial equivalence, not a dedicated clinical study for diagnostic accuracy. Therefore, information related to diagnostic performance studies, AI algorithms, human readers, or specific "acceptance criteria" for disease diagnosis is largely absent.

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

   • As explained above, the "acceptance criteria" discussed are for substantial equivalence and compliance with general safety and performance standards for a medical device (e.g., biocompatibility for extended wear, electrical safety, EMC).
   • The reported performance for the primary change (extended wear time) is implied by the statement: "The extension is supported by new skin irritation testing and 16-hour wear time testing as part of design verification and validation activities." This testing demonstrated that the device performs safely and effectively for the increased duration. No quantitative performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for detecting specific sleep disorders) are provided, as the device records data for clinicians to use for diagnosis, it does not autonomously diagnose.

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

   • The document states: "No clinical data was required to support equivalence." This means a dedicated clinical test set for diagnostic accuracy was not part of this 510(k) submission.
   • The extended wear time and skin irritation testing would have involved engineering and biocompatibility testing, likely using a limited number of human subjects or in-vitro/in-vivo models. Specific sample sizes and provenance for these verification/validation activities are not detailed in this summary.

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/Not provided. Since "No clinical data was required," there was no clinical test set for which ground truth needed to be established by experts for diagnostic performance.

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

   • Not applicable/Not provided.

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. The document does not describe the device as incorporating AI for automated diagnosis or interpretation to assist human readers. The device records physiological parameters for clinicians to interpret.

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

   • Not applicable. The device's stated function is to "measure and record multiple physiological parameters... which are used by clinicians to make a decision on the diagnosis of sleep disorders." It is not presented as a standalone diagnostic algorithm.

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

   • Not applicable for diagnostic ground truth. The "ground truth" for this 510(k) was the predicate device's cleared performance and safety standards, combined with verification and validation of the extended wear time not introducing new risks.

8. The sample size for the training set:

   • Not applicable. This device is not described as involving machine learning or AI that would require a "training set" for diagnostic functions.

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

   • Not applicable.

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Onera STS measures and records multiple physiological parameters from a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.

Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson.

The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.

Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.

The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.

The study preparation and data retrieval are done in a professional/clinical environment by a dedicated trained operator.

The device is not a life supporting physiological monitor

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the Onera Sleep Test System (K210593):

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" in a quantitative table format for all parameters. However, we can infer some key performance metrics and their proven results:

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

• SpO2 Accuracy Validation:
  • Sample Size: 10 healthy volunteers.
  • Data Provenance: Not explicitly stated regarding country of origin, but described as a controlled study meeting ISO standards. It is a prospective study as it involved active data collection from subjects for the purpose of validating the device.
• Comparative Sleep Study Testing (Primary Clinical Test Set):
  • Sample Size: 32 patients.
  • Data Provenance: Not explicitly stated regarding country of origin or if it was retrospective or prospective. However, the description states "concurrently applied to 32 patients undergoing a routine sleep study," which implies a prospective, clinical data collection for the validation purpose.

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

• SpO2 Accuracy Validation: The ground truth for SpO2 accuracy is typically established using a reference oximeter that has been calibrated and validated according to specific standards (e.g., arterial blood gas measurements). The document does not specify the number or qualifications of experts involved in the direct "ground truth" establishment, as it's a technical parameter validated against a standard reference.
• Comparative Sleep Study Testing:
  • Number of Experts: Not explicitly stated. The document mentions "Studies were scored blinded by a qualified sleep professional." This phrasing suggests at least one, but possibly more, qualified sleep professionals were involved.
  • Qualifications: "Qualified sleep professional." Specific details like years of experience or board certification (e.g., diplomate of the American Board of Sleep Medicine) are not provided.

4. Adjudication Method for the Test Set

• SpO2 Accuracy Validation: No explicit adjudication method is mentioned, as SpO2 validation against a reference is a direct measurement comparison.
• Comparative Sleep Study Testing: The scoring was done "blinded" by a qualified sleep professional. It's not explicitly stated if multiple professionals scored and then adjudicated differences (e.g., 2+1, 3+1). The wording "a qualified sleep professional" might suggest single-reader scoring relative to the predicate device, or it might be a simplification of a more complex process. More specific adjudication methods (e.g., consensus, expert panel review) are not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

• No explicit MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was described. This study is focused on the device's ability to record and process physiological parameters similarly to a predicate device, and the sleep staging/scoring is done by a human professional based on the device's output. The device itself is not described as providing AI-assisted interpretations that then improve human reader performance. Its purpose is to provide the raw data for such interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The study is essentially a standalone performance evaluation of the device's data collection and preliminary processing capabilities, compared against a predicate device. The "scoring" is done by a human, but the device provides the signals for that scoring. Therefore, the device's performance in generating these signals is evaluated independently of a human's final diagnostic decision. The agreement metrics (Cohen's kappa, accuracy, sensitivity, specificity, correlation) reflect the device's ability to produce data that leads to similar scores as the predicate device.

7. Type of Ground Truth Used

• SpO2 Accuracy Validation: The ground truth for SpO2 was based on a reference standard (likely a co-oximeter or another highly accurate method) as per ISO 80601-2-61:2019, generally derived from arterial blood gas measurements.
• Comparative Sleep Study Testing: The ground truth was established by comparing the Onera STS data to the data from the predicate device (Embletta MPR), with both sets of data scored by a "qualified sleep professional." This means the ground truth for sleep staging and physiological scoring is expert scoring of data from a legally marketed device. It is not stated to be pathology or direct outcomes data, but rather a comparative performance to a widely accepted clinical standard.

8. Sample Size for the Training Set

• The provided document does not mention a specific "training set" or its size for the Onera STS device. This implies that the device's underlying algorithms (if any, separate from standard signal processing) were not developed using a distinct, large, and formally defined training dataset in the way a deep learning AI model would be. The focus is on the device's performance in measuring and recording parameters, and the comparison to an existing predicate device.

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

• Since a dedicated "training set" is not described, the method for establishing its ground truth is also not applicable or not provided in this document. The device appears to rely on established physiological measurement principles and signal processing, validated against a predicate device and relevant standards.

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The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequelae. The TalarLift STS is intended for the following pathological conditions resulting from disease, injury, or other trauma:
• Hypermobile pes valgus;
• Posterior tibial tendon dysfunction;
• Severe pronation;
• Subtalar instability;
• Hypermobile flexible congenital flat foot.

The TalarLift STS consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The system consists of three configurations, conical, cylindrical, and anatomic. All three devices are manufactured from titanium alloy (Ti-6Al-4V) complying with ASTM F136.

The provided document is a 510(k) Premarket Notification for the TalarLift STS device, which is a subtalar spacer. It describes the device, its intended use, and claims substantial equivalence to predicate devices. This document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves an AI/ML device meets those criteria based on the provided text. The document primarily focuses on non-clinical testing for mechanical properties and pyrogenicity of a physical implant. It explicitly states, "No clinical studies were performed."

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The Anterior Spine Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

This document describes a 510(k) premarket notification for a medical device called the "Anterior Spine Truss System (STS) Interbody Fusion Device." This device is an intervertebral body fusion device made from Ti6Al4V alloy, designed with an open architecture truss to support bone growth and fusion. It's intended for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, and must be used with supplemental fixation and bone graft.

Based on the provided text, the document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance testing (mechanical, MR compatibility). It does NOT describe a clinical study involving human patients, nor a study on an Artificial Intelligence (AI) device.

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/Machine Learning device's performance against human readers or standalone performance, expert ground truth establishment, or sample sizes for training/test sets in the context of an AI study.

The acceptance criteria and "study" described in this document are related to the physical properties and mechanical performance of the implied medical device itself, not an AI component.

Here's what can be inferred about the "acceptance criteria" and "study" from the provided text, related to the physical device:

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

The document doesn't provide a direct table of specific acceptance limits alongside the exact numerical results for each test. Instead, it lists the performance standards that the device was tested against. The "reported device performance" is implicitly that the device met these standards, allowing for a finding of substantial equivalence.

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

• Sample size: Not applicable in the context of a clinical study or AI model test set. For mechanical and MR testing, "samples" would refer to the number of physical devices tested to statistically demonstrate compliance with the standards. This specific number is not provided in the document, but it's typically a small number of devices (e.g., 5-10 per test) as per the individual ASTM standards.
• Data provenance: Not applicable. These are engineering tests performed on the device itself, not on patient data.

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

This is not applicable as there is no "ground truth" in the context of a clinical or AI study. The "ground truth" for the device's performance is established by the engineering standards themselves and the results of the physical tests.

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

This is not applicable as there are no expert readers or interpretations to adjudicate in these engineering and MR compatibility tests.

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 is not applicable. This document describes an interbody fusion device, not an AI or imaging diagnostic device that would involve human readers.

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

This is not applicable. This document describes a physical medical implant, not an algorithm.

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

The "ground truth" for this device's performance is compliance with established engineering and material standards (ASTM standards), demonstrated through physical testing of the device.

8. The sample size for the training set:

This is not applicable as there is no training set mentioned for an AI model.

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

This is not applicable as there is no training set mentioned for an AI model.

In summary, this document is a 510(k) submission for a physical medical device (an interbody fusion device) and does not involve AI or machine learning technology, nor does it describe a clinical study with human patients in the typical sense of evaluating diagnostic or treatment effectiveness through patient outcomes. The "study" refers to the engineering performance testing to demonstrate the device meets predefined physical and material requirements.

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The STS screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.

• Severely pronated foot;
• Walking intemperance;
• Calcaneal stance position greater than 50;
• Manually correctable deformities;
• Mid-tarsal breech (arch pain);
• Forefoot varus greater than 10°.

The Subtalar Spacer System (STS) a threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint. It is manufactured from Ti-6A1-4V per ASTM F136 and is available in 6 sizes. STS has a center cannula design for use with a guide wire to facilitate proper placement.

This FDA 510(k) summary (K150213) is for a medical device called the Subtalar Spacer System (STS). Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria in the typical format of a table with quantitative metrics (e.g., sensitivity, specificity, accuracy, or specific mechanical performance thresholds).

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the primary "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device. The performance is assessed by comparing the new device's technological characteristics and showing no new questions of safety or effectiveness are raised.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This submission does not detail a "test set" in the sense of a clinical trial or a performance study with a specific number of cases/patients. Instead, it relies on non-clinical (bench) testing and comparison to predicate devices.
• Data Provenance: The data provenance is primarily from non-clinical evidence (bench testing and technical characteristic analysis) supporting the comparison to predicate devices. No human data (clinical or retrospective/prospective study) is described.

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

Not applicable. As no clinical "test set" with ground truth determination is described, there's no mention of experts for this purpose.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication is described.

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

No. This document explicitly states "N/A" under "Substantial Equivalence - Clinical Evidence," indicating that a clinical study, including an MRMC study, was not performed or deemed necessary for this 510(k) submission.

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

Not applicable. This device is a physical implant (Subtalar Spacer System), not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes data). For a 510(k) based on substantial equivalence, the "ground truth" is established through:

• Predicate Device Performance: The safety and effectiveness profile of the legally marketed predicate devices.
• Engineering/Bench Test Data: Non-clinical testing data to ensure mechanical integrity and comparable performance to the predicate, often against established standards (e.g., ASTM F136 for material).

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable. No training set is involved.

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The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) consists of a series of titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy. The device is available in multiple sizes to accommodate varied patient's anatomy.

This document is focused on the regulatory clearance of a medical device, specifically a Spine Truss System, based on substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the requested information on acceptance criteria and studies proving an AI device meets those criteria, as well as details like sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable and cannot be extracted from the provided text.

The document discusses preclinical testing for mechanical performance of the spine truss system, which is different from validating an AI algorithm's performance.

Here's what can be extracted related to the device and its assessment, framed as closely as possible to your request, but highlighting the difference in context:

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

Important Note: These are mechanical performance criteria for an implantable device, not performance metrics for an AI algorithm. The reporting states the devices "performed as intended, demonstrating substantial equivalence," which is the regulatory standard for this type of device, implying the test results fell within acceptable ranges defined by the ASTM standards for equivalence. Specific numerical performance values are not provided in this summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI device. For the mechanical testing of the Spine Truss System, the sample size (number of devices tested) for each specific test (static axial compression, dynamic axial compression, etc.) is not explicitly stated in this summary.
• Data Provenance: Not applicable in the context of an AI device. The tests are preclinical mechanical tests performed on physical devices, not clinical data sets from patients of a specific country.

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 is not applicable as the device is a spinal implant, not an AI diagnostic tool. Ground truth in this context refers to the defined parameters of the ASTM mechanical tests.

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

• Not applicable as this is not an AI diagnostic study requiring expert adjudication.

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. This device is a physical medical implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This is not an algorithm.

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

• For the preclinical mechanical testing, the "ground truth" is defined by the objective quantitative measurements and pass/fail criteria established by the ASTM standards (e.g., ASTM F2077, ASTM F2267-04) for intervertebral body fusion devices.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

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REVOIS PRO Implant System is an implant system recommended for surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges, or dentures.

The titanium implant can be applied either in a one-stage surgical procedure with immediate loading (with good primary stability and appropriate occlusal loading) or in a two-stage surgical procedure (after osseointegration of the implant).

The REVOIS® PRO Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures.

The REVOIS® PRO Implant System is composed of a titanium screw type cylindrical implant. It is a screw form implant with cylindrical thread and a progressive thread near the apex. The double thread of the implant body is contiguous with the triple thread (fine thread) at the implant neck. Together with the conical implant body of the REVOIS®: PRO implant, the progressive thread makes sure that the implant is well anchored in the host bone of the alveolar crest. The incremental pitch of the thread upwards evenly distributes the forces so that implants heal well and can be loaded immediately.

The implant system is delivered in a sterile insert blister and comprises an implant, an impression abutment, an impression screw and a cover screw (sterile packed as a set in a blister packaging). The impression screw serves as a connector between impression abutment and implant so that the pre-assembled parts fit tightly into the inlay for sterility reasons. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). For ease of identification the implants are color coded according to diameter.

The dental abutment portions of the REVOIS® : PRO implant system include several abutments described subsequently:

• Healing Abutments of diameter 4.4 mm and 5.2 mm in height 2 mm, 3mm and 5 mm each, made of Titanium Grade 5
• Standard abutment (incl. retaining screw) of diameter 4,4 mm in height 5 mm and 7 mm each, made of Titanium Grade 5
• Individual aesthetic abutment of diameter 4,4 mm, made of CERAMICOR®, a gold- platinium alloy
• Impression abutment, multi (pre-mounted with impression screw) made of Titanium Grade 5
• Impression abutment open tray of diameter 4.4 mm, made of Titanium Grade 5
• Locator* abutment, made of Titanium Grade 5
• Locatore Replacement set, consists of several components made of plastic and Titanium Grade 5
• Locator® impression coping, made of the Aluminium Alloy 6061
• Dalbot ball attachment of diameter 4.4 mm and in height 3 mm and 5mm, made of Titanium Grade 5

The REVOIS® PRO Implant System is provided with a variety of prosthetic components and tool which are definitely 510(K)-exempt or still cleared by the submission K063106.

The main components of the implant system are made of Grade V Titanium (implant, abutment). The materials comply with the ASTM standards ASTM F067 (implant) and ASTM F0136-2a (abutment). The implant surface is blasted with luminium oxide particles (Corundum) and then acid-etched for micro-roughness.

The REVOIS® PRO titanium implant is sterile packed for single use only. The sterility is indicated by the color on the sterility indicator attached to the inner Tyvek® foil.

The acceptance criteria and study proving the device meets them are not explicitly detailed in the provided text in the format typically expected for AI/medical device performance evaluation reports (e.g., sensitivity, specificity, accuracy against a gold standard).

This document is a 510(k) summary for a dental implant system (REVOIS® PRO Implant System), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on presenting novel performance study results for a new AI algorithm.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices in:

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

• Sample Size: Not applicable in the context of this 510(k) summary for a dental implant. The "test set" here refers to non-clinical performance testing of mechanical properties:
  • Fatigue Testing was done according to ISO 14801. The standard specifies the number of samples required for fatigue testing, which typically involves a set number of test pieces (e.g., 5-10 samples per condition) to establish fatigue limits. The exact number of implants tested is not specified in the summary but would follow the ISO standard.
  • Bench Testing with Animal Model was also performed. The summary does not specify the number of animals or implants used in this animal model bench test.
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical tests' data, nor whether it was retrospective or prospective. Given that RIEMSER Arzneimittel AG is a German company, it's highly probable the testing was conducted in Germany or Europe. Non-clinical tests like fatigue testing are inherently prospective at the time of execution.

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

This question is not applicable to this 510(k) summary. The "ground truth" for a dental implant system like this is established through objective engineering and biological testing (mechanical fatigue, biocompatibility, and animal/human clinical studies for osseointegration and loading), not expert consensus on image interpretation or diagnostic accuracy. The listed studies (e.g., FRIATEC, 1998; Cia et al., 2003) are scientific publications and clinical trials, where the "ground truth" for success or failure would be determined by clinical outcomes, radiographic assessment, or histological analysis, as defined by the methodologies of those studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. This is not a study assessing diagnostic accuracy requiring expert adjudication.

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. This device is a dental implant, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a dental implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the REVOIS® PRO Implant System, the "ground truth" for its performance and safety is derived from:

• Mechanical Integrity/Fatigue Testing: Compliance with ISO 14801 standards, which inherently defines "ground truth" for mechanical performance.
• Biocompatibility: Conformance to ASTM material standards (ASTM F067, ASTM F0136-2a).
• Bench Testing with Animal Models: Histological and biomechanical outcomes observed in animal models (e.g., osseointegration, bone-implant contact) serve as a form of "ground truth" for biological response before human trials.
• Clinical Outcomes Data (from referenced studies): The numerous referenced studies (e.g., Cia et al., 2003; Striezel et al., 1998) would have established their "ground truth" through clinical success rates, survival rates, bone loss measurements, clinical evaluations by dentists/surgeons, and patient outcomes over time.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical dental implant, not an AI algorithm requiring a training set.

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

Not applicable.

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