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Ask a specific question about this device

Ask a specific question about this device

The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The RAUMEDIC® NEUROMONITORING-SYSTEM consists of several different models of probes and probe catheters capable of performing one or several different functions:

• Models with a dedicated lumen can be used for drainage of cerebrospinal fluid (CSF).
• Models equipped with ICP sensors can determine the level and change in intracranial pressure (ICP).
• Models equipped with temperature thermistors can monitor intracranial temperature.
• Models equipped with fiber optic sensors can monitor partial tissue oxygen pressure (ptiO2).

The RAUMEDIC® NEUROMONITORING-SYSTEM is intended to be used in conjunction with previously cleared RAUMEDIC® EASY logO Monitor (K130529), RAUMEDIC® MPR2 logO DATALOGGER (K171666), RAUMEDIC® NPS3 (K103206) or RAUMEDIC® NPS2 X (Brand name for NPS2 cleared in K103206).

The RAUMEDIC® NEUROMONITORING-SYSTEM includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

The RAUMEDIC® NEUROMONITORING-SYSTEM can be used in MR environment under specific constraints (MR conditional). Those constraints vary by device type, implantation method (bolting or tunneling), and magnetic field strength (1.5 or 3.0 Tesla).

The provided FDA 510(k) clearance letter for NEUROVENT Devices does not contain the specific details required to describe the acceptance criteria and the study that proves the device meets those criteria, particularly for performance metrics.

The document primarily focuses on:

• Device Identification: Listing all device names, regulation numbers, classification, and product codes.
• Regulatory Equivalence: Stating that the device is substantially equivalent to previously cleared predicate devices based on intended use, indications for use, and technological characteristics.
• Intended Use/Indications for Use: Detailed descriptions of what each NEUROVENT component is used for (e.g., ICP monitoring, CSF drainage, brain temperature, tissue oxygen partial pressure).
• MR Safety Testing: A list of ASTM and ISO/TS standards used to confirm the device's MR conditional status, along with the specific tests performed (magnetically induced displacement force, torque, image artifacts, heating, malfunction for various fields).

Crucially, the document explicitly states: "Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that: - The devices have the same intended use and indication for use. - Performance characteristics are suitable for designated indications for use."

However, it does NOT provide:

• A table of specific numerical acceptance criteria (e.g., ICP accuracy within X mmHg, temperature accuracy within Y °C, ptiO2 accuracy within Z mmHg).
• The reported device performance metrics against those criteria.
• Details about the "performance testing" beyond the MR safety tests. This implies that the performance characteristics (accuracy, precision, etc., for measuring ICP, temperature, ptiO2) were either derived from the predicate devices, established using bench testing, or considered suitable without presenting detailed clinical performance data in this 510(k) summary. Given the device type, it's highly likely a combination of bench and possibly animal/cadaveric testing, as well as reliance on the long-established performance of similar predicate devices, was used.
• Information about clinical study design. There is no mention of human subject data, test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies. The phrases "anticipated clinical performance" and "does not raise new issues of safety or effectiveness" suggest reliance on the substantial equivalence principle rather than novel clinical trial data.

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and the study proving the device meets them, beyond the MR safety aspects.

I will indicate "Not provided in the document" for sections where the information is missing.

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

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 provided in the document. The document primarily refers to "performance testing" and "MR safety requirements" being "tested and confirmed" to meet standards, rather than a clinical test set from human subjects.
• Data provenance: Not provided. The MR safety tests are likely laboratory-based.

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. The document does not describe a study involving expert-established ground truth for performance evaluation of vital sign monitoring. The evaluation methodology focuses on substantial equivalence and laboratory testing for MR compatibility.

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. This device is a monitoring system and a kit for surgical access, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The performance evaluation discussed pertains to the physical and functional aspects of the hardware (catheters, sensors, and their compatibility with MR environments), not a standalone algorithm.

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

• For the MR safety testing, the "ground truth" would be established by the specifications and measurement techniques defined in the referenced ASTM and ISO/TS standards.
• For the core physiological measurements (ICP, temp, ptiO2), the "ground truth" would typically refer to the accuracy of the sensors against calibrated reference standards in laboratory or animal models. This specific detail is not provided, but it's implied compliance with recognized industry standards or internal validation that is deemed "suitable for designated indications for use" and "equivalent."

8. The sample size for the training set

• Not applicable. The document does not describe the use of machine learning or AI, and therefore, no "training set."

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

• Not applicable.

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This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

RadiForce GX570 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

The Digital Uniformity Equalizer function compensates luminance non-uniformity, one of the inherent characteristics of LCD panel modules, to the levels required by various QC standards and guidelines.

The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).

There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.

Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce GX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX570.

RadiCS is of Basic Documentation Level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce GX570 and it's not a medical imaging software.

The provided FDA 510(k) clearance letter and summary are for a medical display monitor (RadiForce GX570), not an AI device or a diagnostic algorithm. Therefore, the information requested regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document discusses the technical performance of a display monitor, such as:

• Spatial resolution (MTF)
• Pixel defects
• Luminance and chromaticity (including DICOM GSDF conformance)
• Temporal response
• Noise (NPS)
• Display reflections
• Small-spot contrast ratio

These are physical and optical performance characteristics of a display hardware, not the diagnostic performance of a software algorithm.

Therefore, I cannot populate the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment, as this information is not relevant to a medical display monitor clearance.

The document does state that the device is intended for use with "clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners." However, the studies described are bench tests to assure the display hardware meets performance standards for displaying these images, not for interpreting them with AI.

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The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.

Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.

The Portable Oxygen Concentrator is a Class II, low-risk medical device designed to provide a high-concentration oxygen supply (87%-95.5%) to adult patients requiring supplemental oxygen therapy as prescribed by a healthcare professional. It is intended for use at home, in institution, vehicle, train, airplane, boats and other transport modalities and complies with FAA regulations for in-flight use. The device is not intended for life-support or life-sustaining purposes.

The Portable Oxygen Concentrator utilizes Pressure Swing Adsorption (PSA) technology, which extracts oxygen from ambient air by selectively adsorbing nitrogen through molecular sieve beds. Oxygen is delivered through a pulse dose mechanism, synchronizing oxygen release with the patient's inhalation cycle to optimize efficiency and minimize waste.

The series consists of four models, each offering different pulse dose settings:

• W-R1 (MAX): 1, 2, 3, 4, 5, 6, S
• W-R1: 1, 2, 3, 4, 5, 6
• W-R2: 1, 2, 3, 4, 5
• W-R2 (Lite): 1, 2, 3, 4

The device operates in pulse flow mode and supports multiple power sources, including 100–240V AC (50–60Hz) and a rechargeable lithium-ion battery (14.4V / 6500mAh). While the hardware supports 13.0–16.8V DC input, DC operation is not currently supported, as no DC accessories are provided or authorized. A single battery charge provides up to 4.5 hours of continuous use, ensuring flexibility across various environments.

Designed for portability and efficiency, the W-R Series features a lightweight build (1.8 kg), low noise operation, and an intuitive LCD display. Its ergonomic and user-friendly design has been internationally recognized with six global design awards, including iF, Red Dot, and IDEA, for its usability, portability, and patient-centered innovation.

The device is suitable for operation within a temperature range of -5°C to 40°C (23°F to 104°F), humidity levels of 5% to 90% (non-condensing), and atmospheric pressure from 54kPa to 106kPa. It can function at altitudes up to 5,000 meters (16,400 feet).

The Portable Oxygen Concentrator consists of a casing, compressor, molecular sieve system, solenoid valve, battery, cooling fan, control board, and display screen.

Note: The device does not include a nasal cannula; patients should purchase one separately. The oxygen outlet follows international standards, and recommended cannula specifications can be found in Section 2.12: Cannula Use of the user manual.

The provided FDA 510(k) clearance letter is for a Portable Oxygen Concentrator. This device is not an AI/ML-enabled device. The information requested in the prompt (acceptance criteria, study details, sample size, ground truth, expert adjudication, MRMC studies, etc.) is typically associated with the rigorous evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices, especially those using diagnostic imaging.

Medical devices like portable oxygen concentrators are evaluated primarily on their physical performance characteristics, safety standards, and conformity to established regulations for mechanical and electrical safety. The clearance letter outlines the non-clinical tests performed (safety and performance testing, biocompatibility testing, electrical safety and EMC testing, battery safety testing, and software verification/validation), but these are not the types of studies that involve expert readers, ground truth consensus, or MRMC comparative effectiveness specific to AI diagnostics.

Therefore, I cannot extract the requested information (acceptance criteria in the context of an AI study, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document, as it pertains to a different type of medical device evaluation.

To directly answer your request based on the provided document, which is for a Portable Oxygen Concentrator (not an AI/ML diagnostic device):

The FDA 510(k) Clearance Letter for the Portable Oxygen Concentrator focuses on demonstrating substantial equivalence to a predicate device through:

• Same Intended Use: Providing supplemental oxygen to adult patients on a prescriptive basis for respiratory therapy.
• Similar Technological Characteristics: Utilizing breath detection, molecular sieve/pressure swing adsorption, and a pulse dose mechanism.
• Performance Data: Presenting specifications like oxygen concentration, pulse volumes, sound levels, and mechanical/electrical safety.
• Compliance with Recognized Standards: Adhering to various international IEC and ISO standards for medical electrical equipment, biocompatibility, and oxygen concentrators.

The "acceptance criteria" for a device of this type are generally meeting the performance specifications and safety standards outlined in the non-clinical testing section, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's a breakdown of the closest equivalents to your requested categories, given the nature of the device and the document:

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

For a portable oxygen concentrator, acceptance criteria are generally related to its physical and performance specifications like oxygen purity, flow rates, noise levels, and battery life, rather than diagnostic accuracy metrics.

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The NeuroOne OneRF® Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

OneRF® Ablation System for Trigeminal Nerve (TN) Ablation uses radiofrequency (RF) ablation to create lesion(s) in an area of nerve tissue that the surgeon has identified for ablation. The ablation site may be identified by diagnostic stimulation of the trigeminal nerve using the Trigeminal Nerve Radiofrequency (TN-RF) Probe to accurately locate the target area for ablation.

The subject device is identical to the sEEG-RF Probe cleared after FDA review of K231675. In K231675, the FDA reviewed and cleared the sEEG-RF Probe when used with the NeuroOne OneRF® Generator to form the OneRF® Ablation System. The OneRF® Ablation System is indicated to create radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

In this new 510(k), we propose to market the identical sEEG-RF Probes to create lesion(s) in the trigeminal nerve "for the treatment of pain." This use for treatment of facial pain requires new accessories (Cannula and Tuohy Borst Adapter) for insertion/placement of the sEEG-RF Probe. When the sEEG-RF Probe is used to create lesion(s) in the trigeminal nerve, it will be marketed as the Trigeminal Nerve Radiofrequency (TN-RF) Probe. The TN-RF Probe and new accessories, when combined with the cleared (K231675) NeuroOne OneRF® Generator and accessories, will be referred to as the OneRF® Trigeminal Nerve Ablation System.

The OneRF® for TN Ablation System components/accessories consist of the following:

1. TN-RF Probe (with Stylet)
   • 16mm x 5 Contact TN-RF Probe Kit
   • 26.5mm x 8 Contact TN-RF Probe Kit
2. Insertion Components
   i. Insulated Cannula w/Stylet
   ii. Tuohy Borst Adapter (Adapter)
3. Stimulation Components
   i. Cable Assembly (5 or 8 connector pins) (CA)
4. Ablation Components
   i. Stylet
   ii. Temperature Accessory (TA)
   iii. Spacer Tubes
   iv. Radiofrequency Connector Box (RFCB)
   v. Equipment
   1. Generator
   2. Generator Interface Cable (GIC)
   3. Cart
   4. Foot Pedal (optional)
   5. Ground Pad

The provided document is a 510(k) Clearance Letter for a medical device. It does not describe a study that uses a test set, training set, or ground truth to evaluate algorithm performance. The clearance is based on the substantial equivalence of the "NeuroOne OneRF Trigeminal Nerve Radiofrequency Probes" to existing predicate devices, supported by non-clinical performance tests and biocompatibility assessments.

Therefore, I cannot provide the requested information in a table format as there are no relevant acceptance criteria or reported device performance metrics for an AI/algorithm-based study within the document.

Here's why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document focuses on performance testing related to mechanical, dimensional, packaging integrity, and sterilization aspects of the physical device, not an AI algorithm's performance. The "Lesion Size Testing" states "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate," but it doesn't provide specific quantitative acceptance criteria or detailed numerical results beyond this qualitative statement.
2. Sample size used for the test set and the data provenance: Not applicable. The studies are non-clinical, involving physical device testing, not data analysis on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for a test set in these non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance testing:

The document outlines a series of non-clinical performance tests to support the substantial equivalence claim. These tests primarily verify the physical and functional integrity of the device and its components.

• Lesion Size Testing:
  • Overview: Measured lesion size as a function of temperature and time, for monopolar and bipolar configurations, and temperature control/manual modes.
  • Results: "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate." (No specific numerical data or explicit acceptance criteria provided in the summary).
• Dimensional Verification of the Cannula:
  • Overview: Evaluated dimensional characteristics and compatibility between components.
  • Results: "Pass – The test results indicate that the Cannula meet the dimensional requirements."
• Mechanical Performance:
  • Overview: Verified specifications related to mechanical interaction between the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass – The test results indicate that the TN-RF Probe, Cannula, Tuohy Borst Adapter designs meet the mechanical performance requirements."
• Mechanical Integrity:
  • Overview: Evaluated mechanical integrity of the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass - The test results indicate that the TN-RF Probe, Cannula and Tuohy Borst Adapter designs meet the mechanical integrity requirements."
• TN-RF Probe Kit Package Integrity:
  • Overview: Tested the packaged device and labeling against conditions of packaging, shelf life, and distribution per ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980, ASTM F2096, ASTM F88.
  • Results: "Pass - The test results indicate that the TN-RF Probe Kit (...) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility)."
• Sterilization:
  • Overview: Validated ethylene oxide sterilization process to achieve a minimum SAL of 10⁻⁶ per ISO 11135.
  • Results: "Pass – All criteria passed and the new product/package configuration was adopted into the validated sterilization cycle."
• Usability – Summative Validation:
  • Overview: Performed in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices," February 3, 2016.
  • Results: "Pass – The NeuroOne OneRF® TN-RF Ablation System has been found to be safe and effective for the intended users, uses, and use environments."
• Biocompatibility:
  • Overview: Tested sEEG-RF Probe for prolonged contact and Cannula w/stylet, Tuohy Borst Adapter for limited contact.
  • Results: "Passed" for all tested components. No testing for Temperature Accessory/Spacer Tubes/Stylet and Radio Frequency Connector Box as there is no direct or indirect patient contact.

The provided document specifically clarifies that the device is substantially equivalent, and the "conclusions drawn from the nonclinical testing demonstrate the device is as safe, as effective, and performs as well as the legally marketed device predicates, per 21 CFR 807.92(b)(3)." This is a traditional medical device clearance, not an AI/ML-driven software clearance.

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The Tyber Medical Distal Radius Plating System includes Distal Radius, Forearm, and Fragment-Specific Plates, which are indicated for fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The Tyber Medical Distal Radius Plating System is not for spinal use.

This traditional 510K is a line extension to the Tyber Medical Distal Radius Plating System, previously cleared under K232693. The extension includes additional plates, screws, pegs, cases and trays, and instrumentation.

The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The implants – delivered sterile or non-sterile – are:

• Various bone plates of different shapes and hole configurations.
• Variable angle locking and non-locking screws in various lengths and diameters.

The implants are manufactured from Stainless Steel per ASTM F138, from Titanium alloy per ASTM F136, or Commercially Pure Titanium grade 4 per ASTM F67.

The instruments – delivered sterile and non-sterile – are intended to support the implantation of the Tyber Medical Distal Radius Plating System implants. Specialized cases/trays are available specific to the Tyber Medical Distal Radius Plating System. Other ancillary instrumentation is available but not specific to the Tyber Medical Distal Radius Plating System.

The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.

The provided document is an FDA 510(k) clearance letter for the "Tyber Medical Distal Radius Plating System." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed acceptance criteria or a study proving the device meets said criteria in the way one would expect for a diagnostic or AI-driven medical device.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical trials as is the case for premarket approval (PMA).

However, I can extract the information that is present concerning device performance and testing.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state acceptance criteria in an "acceptance criteria" column and then "reported performance" against it for parameters like sensitivity, specificity, AUC, etc., as would be expected for a diagnostic device. Instead, it describes what mechanical tests were performed and what was concluded.

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

• Test Set Sample Size: Not specified. The testing mentioned is mechanical and engineering analysis, not clinical testing with human subjects. The phrase "subject plate designs" and "subject devices" refers to the new devices being submitted for clearance.
• Data Provenance: Not applicable for mechanical and engineering analysis. These are laboratory tests and simulations. No country of origin for patient data is mentioned as no patient data was used.
• Retrospective or Prospective: Not applicable as no clinical data was used.

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. This device is a bone fixation system (hardware), not a diagnostic tool requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for mechanical properties is established by engineering standards and measurements.

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

Not applicable. No human adjudication was involved in the mechanical testing or engineering analysis 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 MRMC study was done. This is a physical medical device (bone plating system), not an AI-driven diagnostic or image analysis tool.

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

This refers to AI or software performance. Not applicable to this physical device.

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

The "ground truth" for the mechanical testing would be defined by the specifications and tolerances established by the relevant ASTM standards (ASTM F543) and engineering principles for material strength and bending resistance.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or data training sets.

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

Not applicable.

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LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.

LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.

The LUMINOS Q.namix T is an under-table fluoroscopy system and the LUMINOS Q.namix R is an over-table fluoroscopy system. Both systems are multifunctional, general R/F systems, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. They are designed as modular systems with components such as main fluoro table including fixed fluoroscopy detector and X-ray tube, a ceiling suspension with X-ray tube, Bucky wall stand, X-ray generator, monitors, a bucky tray in the table as well as portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.

This FDA 510(k) clearance letter and summary discuss the LUMINOS Q.namix T and LUMINOS Q.namix R X-ray systems. The provided documentation does not include specific acceptance criteria (e.g., numerical thresholds for image quality, diagnostic accuracy, or performance metrics) in the same way an AI/ML device often would. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.

The study presented focuses primarily on image quality evaluation for the new detectors (X.fluoro and X.wi-D24) for diagnostic acceptability, rather than establishing acceptance criteria for the entire system's overall performance.

Here's an attempt to extract and present the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria for the overall device performance are not stated in the provided 510(k) summary, this section will reflect the available qualitative performance assessment for the new detectors. The primary "acceptance criterion" implied for the overall device is substantial equivalence to predicate devices and acceptability for diagnostic use.

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

• Test Set Description: "expert evaluations" for the new detectors X.fluoro and X.wi-D24.
• Sample Size: The exact number of images or fluorography studies evaluated is not specified. The document mentions "multiple images and fluorography studies from different body regions" for the US board-certified radiologist's evaluation.
• Data Provenance:
  • Countries of Origin: Germany (University Hospital Augsburg, Klinikum rechts der Isar Munich, Herz-Jesu-Krankenhaus Münster/Hiltrup) and Belgium (ZAS Jan Palfijn Hospital of Merksem).
  • Retrospective or Prospective: Not explicitly stated, but clinical image quality evaluations often involve prospective data collection or a mix with retrospective cases. Given they are evaluating "new detectors" and "clinical image quality evaluation", it implies real or simulated clinical scenarios.

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

• Number of Experts:
  • Initial Evaluations: Multiple "expert evaluations" (implies more than one) were conducted across the listed hospitals. The exact number of individual experts is not specified.
  • Specific Evaluation: One "US board-certified radiologist" performed a dedicated clinical image quality evaluation.
• Qualifications of Experts:
  • For the general "expert evaluations": Not specified beyond being "experts."
  • For the specific evaluation: "US board-certified radiologist." No mention of years of experience is provided.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1 consensus voting) for establishing ground truth or evaluating the image quality. The evaluations appear to be individual or group assessments leading to a conclusion of "acceptability for diagnostic use."

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

• Was an MRMC study done? The document does not describe a formal MRMC comparative effectiveness study designed to quantify the improvement of human readers with AI vs. without AI assistance.
• Effect Size of Human Reader Improvement: Therefore, no effect size is reported.
  • Note: While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the study described is an evaluation of the detectors' image quality and the overall system's substantial equivalence, not the clinical impact of these specific AI features on human reader performance.

6. Standalone Performance Study (Algorithm Only)

• The document primarily describes an evaluation of the new detectors within the LUMINOS Q.namix T/R systems and the overall system's substantial equivalence.
• While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the document does not report on a standalone performance study specifically for these AI algorithms in isolation from the human-in-the-loop system. The AI features are listed as technological characteristics that contribute to the device's overall updated design.

7. Type of Ground Truth Used

For the detector image quality evaluation, the ground truth was based on expert assessment ("qualified for proper diagnosis"). This falls under expert consensus or expert judgment regarding diagnostic acceptability.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for any AI components. The focus of this 510(k) summary is on substantiating equivalence and safety/effectiveness of the entire X-ray system, not on the development of individual AI algorithms within it.

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

Since no information is provided about a training set, the method for establishing its ground truth is not mentioned in the document.

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The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media.

The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.

The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft.

The subject device is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.

The outer surface of the long sheath is coated with a hydrophilic polymer and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices.

The dilator consists of two parts: (1) a shaft and (2) a connector.

The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.

The provided FDA 510(k) Clearance Letter for the FUBUKI XF-R Neurovascular Long Sheath describes the device and its demonstrated substantial equivalence to a predicate device. However, it does not contain information about a study involving an AI/algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested details regarding acceptance criteria, ground truth, expert opinions, and sample sizes for AI/algorithm performance studies cannot be extracted from this document because such a study was not conducted or reported for this submission. This is a medical device, specifically a catheter, not an AI/software device.

I will provide the information that is available in the document, framed as if it were a typical medical device clearance, rather than an AI/ML clearance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study for FUBUKI XF-R Neurovascular Long Sheath

This clearance pertains to a physical medical device (a neurovascular long sheath), not an AI/software device. Therefore, the "acceptance criteria" and "study" refer to non-clinical bench testing and biocompatibility testing to demonstrate the device's physical performance, safety, and substantial equivalence to a predicate device. There is no AI component involved in this device or its clearance documentation.

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

The document states that the device met all acceptance criteria, but it does not specify the numerical acceptance criteria for each test. Instead, it lists the types of tests performed and the conclusions.

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

• Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench or biocompatibility test. It only states that testing was "performed." For biocompatibility, it refers to standard ISO test methods (e.g., "Rabbit Pyrogen Test" implies a certain number of rabbits, but the exact count isn't given).
• Data Provenance: Not explicitly stated, but typically, non-clinical lab testing data would originate from the manufacturer's own testing facilities or contract research organizations. No geographic origin is mentioned for the data, nor is it specified if the tests were retrospective or prospective; however, given that these are physical device tests for a 510(k) submission, they would inherently be prospective (i.e., new tests conducted specifically for this submission).

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 to this type of device clearance. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically reserved for diagnostic devices, particularly those involving image interpretation or clinical decision support, or AI/ML-driven devices. For a physical medical device like a catheter, "ground truth" is established through standardized engineering and biological tests (e.g., tensile strength, fluid flow, material composition, biological response), rather than expert clinical interpretation of data.

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

This is not applicable. Adjudication methods are relevant for clinical trials or multi-reader studies where there might be disagreement in expert assessment (e.g., image interpretation). For bench and biocompatibility testing, results are quantitative or qualitative based on predefined scientific standards and validated test methods.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic devices, especially those that involve human interpretation assisted by algorithms (AI). This submission is for a physical percutaneous catheter, not a diagnostic or AI-assisted device. Therefore, a discussion of human reader improvement with AI assistance is not relevant to this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

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

The "ground truth" for this medical device is based on:

• Predefined engineering specifications and performance standards (e.g., dimensions, strength, lubricity).
• Validated test methods outlined in ISO standards (e.g., ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
• Chemical and material analysis.
• Biological responses observed in animal models (for biocompatibility).

This is fundamentally different from a ground truth established by expert clinical consensus, pathology, or outcomes data for diagnostic devices.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or "ground truth for a training set" as this is not an AI/ML device.

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