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The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.

The Synthes Graphic Case & Tray System is a medical device intended for storing, organizing, and transporting orthopedic instruments and implants during sterilization and surgical procedures. It is designed to be used with an FDA-cleared sterile barrier. The device's performance was evaluated through non-clinical testing.

Here's a breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance:

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SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient.

SynthVISION is a medical imaging viewing software used with off-the-shelf workstation hardware and web browsers for the 2D & 3D diagnostic visualization of DICOM and non-DICOM medical images by intended users such as trained radiologists, technologists and all others involved in the patient's care.

SynthVISION consists of configurable software-only modules that display and process DICOM and non-DICOM images and associated medical information to aid in the day-to-day operations and workflow of imaging healthcare professionals, clinicians and other healthcare practitioners.

SynthVISION has the following primary features and functions -

• Zero-footprint medical image upload, transfer, and display of medical images between facilities
• Easy access to images for all participants in the healthcare process, including radiologists, physicians, nurses and others who participate in patient care
• Serves as information and data management system for DICOM and non-DICOM medical images
• Industry-standard tools for image manipulation, annotation and measurement ●
• Metadata information and orientation labels display
• . Advanced image manipulation functions like view synchronization across series, MIP and MPR
• Advanced image processing filters
• Encrypted transmission of medical images through secured networks
• Encrypted storage of medical images
• . HIPAA-compliant data management, including centralized storage of user activities via audit trails.

The provided text, a 510(k) summary for Synthesis Health Intelligence Inc.'s SynthVISION 1.0.0, does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in the manner typically expected for medical device performance evaluation.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (eUnity) through non-clinical testing. It explicitly states that clinical tests were not conducted.

Therefore, many of the requested information points cannot be extracted from this document, as they pertain to clinical performance studies.

However, I can extract information regarding the non-clinical tests performed and their general conclusions which serve as a form of acceptance criteria for software functionality and equivalence.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Since no specific numerical performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document as acceptance criteria, the "acceptance criteria" here are inferred from the stated purpose and conclusions of the non-clinical tests, which aim to demonstrate functional equivalence and safety.

Study Details from the Provided Text:

1. A table of acceptance criteria and the reported device performance: (See above table.)

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

   • Test Set Sample Size: Not specified. The document refers to "key software components," "user interfaces," "image quality assessments," and "tool tests" without quantifying the number of elements or cases involved.
   • Data Provenance: Not specified. Given that clinical tests were not performed, the "data" for these non-clinical tests would likely refer to synthetic data, representative DICOM/non-DICOM images, and interactive user scenarios. No country of origin is mentioned. The tests are described as non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Since these were non-clinical software tests aimed at functionality and usability equivalence, not diagnostic accuracy, there is no mention of "ground truth" adjudicated by medical experts for diagnostic purposes. Usability testing would involve users, but the number and qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There was no diagnostic test set requiring adjudication in this technical documentation.

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 explicitly states "Clinical tests: Not Applicable." SynthVISION is primarily a medical image viewing software, not an AI diagnostic aid requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a viewer, designed for human use. The performance tests ("Image quality assessments, tool tests, display requirements") represent standalone software capabilities validation, but not in the diagnostic sense often implied by this question for AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic "ground truth." The "ground truth" for the non-clinical tests would be the expected software behavior and output based on design specifications and the predicate device's functionality. For example:

   • Software Verification: Specifications compliance.
   • Usability Testing: User feedback, task completion rates, error rates (compared to predicate).
   • Performance Testing: Expected image display accuracy, measurement accuracy, tool functionality (compared to predicate).

8. The sample size for the training set: Not applicable. This document does not describe the development or testing of an AI algorithm that would require a training set. SynthVISION is described as a "medical image management and processing system" and a "software application" for viewing, manipulation, and display of images.

9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set or AI model.

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The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

• Supracondylar fractures, including those with intra-articular extension
• Combination of ipsilateral condylar and diaphyseal fractures
• Ipsilateral femur/tibia fractures
• Femoral fractures in multiple trauma patients
• Periprosthetic fractures
• Fractures in the morbidly obese
• Fractures in osteoporotic bone
• Impending pathologic fractures
• Malunions and nonunions

The DePuy Synthes Retrograde Femoral Nail Advanced System was developed to address challenges associated with treating distal femur fractures with intramedullary nails. The modular system incorporates several components to a variety of fracture patterns including those in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two distal bend configurations which enable standard and periprosthetic entry points for the insertion of the femur. The nailing system implants are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (DePuy Synthes Retrograde Femoral Nail Advanced System). It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as implied by the structure of your request.

This document describes a traditional medical device (an intramedullary nail for fracture stabilization) and its substantial equivalence to a predicate device. The "tests results meet established acceptance criteria" mentioned in the non-clinical and/or clinical tests summary section refers to mechanical and material performance tests for the physical implant, not the performance of an AI/ML system.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on the provided text. The document does not describe:

• A table of acceptance criteria for an AI/ML device or its reported performance.
• Sample sizes for AI/ML test sets or data provenance.
• Number/qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML test sets.
• MRMC comparative effectiveness studies.
• Standalone AI algorithm performance.
• Types of ground truth for AI/ML.
• Training set sample sizes for AI/ML.
• Ground truth establishment for AI/ML training sets.

The text focuses on the device's indications for use, its mechanical properties, and its substantial equivalence to existing devices based on physical design changes (specifically, the option to remove an "inlay" from the nail).

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Robotic Integration Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which:

· the use of EXPEDIUM. VIPER. TriALTIS and SYMPHONY OCT is indicated.

• · the use of stereotactic surgery may be appropriate, and
  · reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (eg. CT or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.

Robotic Integration Instruments are reusable instruments used for the preparation and placement of DePuy Synthes screws (EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT), in either open or percutaneous procedures. The Robotic Integration instruments consist of a collection of Array Sleeves. Access Guides, Drills, Taps and Screwdrivers as well as various accessories and are designed for robotic assisted, navigated and nonnavigated use. They can be operated manually or under power. Navigation and Robotic Guidance of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine and associated and compatible VELYS Spine Instrument Arrays. The Core Instrument is a Navigation Ready Instrument, navigation of this instrument is achieved using a Universal Navigation Adaptor Set (UNAS) Navigation Ring and compatible VELYS Spine Instrument Arrays.

This FDA 510(k) summary for the Robotic Integration Instruments (K233256) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document states:

• "The performance data for the subject devices consists of the following evaluations: . Accuracy Verification through engineering analysis, . Fulfillment of navigation systems instrument accuracy requirements as stated by the navigation manufacturer, CAD Model Evaluation, ● Simulated Use Evaluation."

However, it does not provide any specific acceptance criteria (e.g., numerical thresholds for accuracy), nor does it present any results from these evaluations. Therefore, I cannot complete the requested tables and information.

To provide the requested details, I would need a more comprehensive performance study report that includes:

1. Specific numerical acceptance criteria for metrics like accuracy.
2. Reported device performance values from the engineering analysis, simulated use, etc.
3. Details of the study methodology, including sample sizes, data provenance, expert qualifications (if applicable), and ground truth establishment.
4. Information on any multi-reader multi-case (MRMC) or standalone studies.

Without this information, I can only state that the document mentions the types of evaluations performed but does not provide the results or the specifics of the acceptance criteria.

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Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

• the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated,

• · the use of stereotactic surgery may be appropriate, and
  · reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.

The provided text describes a 510(k) premarket notification for the "CROSSNAV Navigation Enabled Instruments," which are reusable instruments used in spinal surgery. The documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices. While it lists various performance data evaluations, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy thresholds with reported device performance metrics.

The document primarily states that the device's technological characteristics, design, materials, performance, and intended use are consistent with those of the predicate devices, and that testing was conducted to confirm this consistency. It mentions "Accuracy Verification through engineering analysis" and "Fulfillment of navigation systems instrument accuracy requirements," but it does not provide the specific acceptance criteria for these, nor the actual measured performance data.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size, expert qualifications, etc.) because that information is not present in the provided document.

However, I can extract the information that is present and indicate what is missing based on your request.

Acceptance Criteria and Device Performance (Information Available in Document)

The document implies that the acceptance criteria revolved around demonstrating substantial equivalence to predicate devices in terms of design, materials, performance characteristics, and intended use. The performance data listed are categories of evaluation rather than specific numerical acceptance criteria.

Missing Information (Based on your Request and Not Present in the Document)

1. Specific numerical acceptance criteria: The document does not provide a table with quantitative acceptance thresholds (e.g., accuracy within X mm, a certain pass/fail rate for a simulated use).
2. Reported device performance (quantified): While it states tests were performed (e.g., "Accuracy Verification"), it does not report the actual measured performance data against specific criteria.
3. Sample size used for the test set: Not mentioned.
4. Data provenance (country of origin, retrospective/prospective): Not mentioned.
5. Number of experts used to establish ground truth: Not applicable for the type of engineering/design validation described.
6. Qualifications of experts: Not applicable.
7. Adjudication method for the test set: Not applicable.
8. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and typically not relevant for surgical instruments unless they involve AI for image interpretation or diagnosis. The device is a "Navigation Enabled Instrument," suggesting it assists human surgeons, but the document doesn't detail a study comparing human performance with and without the device.
9. Standalone (algorithm only) performance: Not applicable as this is a physical instrument, not a standalone algorithm.
10. Type of ground truth used: For the engineering evaluations mentioned (accuracy, simulated use), the ground truth would likely be based on engineering specifications, physical measurements, and perhaps surgical standards, but is not detailed.
11. Sample size for the training set: Not applicable and not mentioned, as this is a physical instrument, not an AI model that requires a training set in the typical sense.
12. How ground truth for the training set was established: Not applicable.

Summary of what the document provides regarding validation:

The validation approach for the CROSSNAV Navigation Enabled Instruments, as presented in the 510(k) summary, primarily relies on:

• Engineering Analysis: To verify accuracy and adherence to design specifications.
• Fulfillment of Navigation System Accuracy Requirements: Ensuring compatibility and performance within existing navigation systems (VELYS Spine System and Medtronic StealthStation® System).
• CAD Model Evaluation: likely for design integrity and fit.
• Simulated Use Evaluation: To assess performance in a representative environment.

The absence of detailed quantitative performance results and specific acceptance criteria in this public 510(k) summary is common, as these details are typically found in the full submission, which is proprietary. The FDA's clearance implies that the submitted data (which includes the detailed study reports) was sufficient to demonstrate substantial equivalence to the predicate devices.

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TELIGEN Navigation Ready Instruments:

The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion.

TELIGEN Clear and TELIGEN Access Probe, when used with UNAS Navigation Rings, can be precalibrated with:

• · the VELYS Spine System using the VELYS Spine Instrument Arrays,
• · the Brainlab Navigation System using the UNAS Arrays.

TELIGEN Access Probe in conjunction with UNAS can also be manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

Discectomy Navigation Ready Instruments:

The Discectorny Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which:

• · the use of stereotactic surgery may be appropriate, and
  · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy using a navigation system and associated navigation arrays.

These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready Instruments can be pre-calibrated with the VELYS Spine System (only for TELIGEN Graft Delivery Cannula and the curettes) as well as the Brainlab Navigation System.Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:

· pre-calibrated with the VELYS Spine System using VELYS Spine System Instrument Arrays,

• · pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
  where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

TELIGEN Navigation Ready Instruments

TELIGEN Navigation Ready Instruments are part of TELIGEN Kits.

The TELIGEN Kits are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.

The TELIGEN Kits include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe.

TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Discectomy Navigation Ready Instruments

The Discectomy Navigation Ready Instruments are reusable instruments used for disc space preparation, including discectomy or bony resection. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS) and associated navigation arrays. For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set

The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays,
• . VELYS Spine/Brainlab compatible Navigation Rings and
• Medtronic compatible Navigation Ring ST. ●

The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments.

When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument:

• . VELYS Spine System Instrument Array can be attached and the instrument can be used with the VELYS Spine System as pre-calibrated instrument, or
• . UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument.

When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.

This submission pertains to the TELIGEN System Navigation Ready Instruments, which include the TELIGEN Access Probe, TELIGEN Clear, TELIGEN Graft Delivery Cannula, and associated curettes, along with the Universal Navigation Adaptor Set (UNAS). The primary purpose of this 510(k) submission is to expand the compatibility of these instruments with the VELYS Spine System.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a tabular format. However, it states the following performance aspects were evaluated:

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

The document does not specify the exact sample size or number of "test cases" for the evaluations (Accuracy Verification, CAD Model Evaluation, Simulated Use Evaluation). It refers to "engineering analysis" and "simulated use evaluation" which typically involve a set of defined tests rather than a statistical sample size of patient data.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given the nature of the device (surgical instruments with navigation capabilities), the evaluations would likely be laboratory-based and simulated environments.

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

The document does not mention the use of experts to establish ground truth for the test set. The evaluations described (engineering analysis, meeting manufacturer's requirements, CAD model, simulated use) suggest a focus on design validation and performance specifications rather than clinical evaluation with expert-defined ground truth on patient data.

4. Adjudication method for the test set:

The document does not describe any adjudication method. This type of evaluation, for surgical instruments, typically relies on direct measurement and adherence to specifications rather than subjective expert assessment requiring adjudication.

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

No mention of an MRMC comparative effectiveness study, or any studies involving human readers, is found in the provided text. The device is a set of surgical instruments, not an AI diagnostic tool that would typically involve human reader studies.

6. Standalone (algorithm only without human-in-the-loop performance) Study:

Not applicable. The device is a set of physical surgical instruments with navigation capabilities, not a standalone algorithm. Its performance is intrinsically tied to its use by a surgeon within a navigation system.

7. Type of Ground Truth Used:

Based on the evaluation types:

• For Accuracy Verification and Navigation Systems Instrument Accuracy Requirements, the ground truth would be the established engineering specifications, dimensional tolerances, and the accuracy claims/requirements published by the navigation system manufacturers (e.g., VELYS Spine System, Brainlab, Medtronic StealthStation®).
• For CAD Model Evaluation, the ground truth would be the design specifications and theoretical performance derived from the CAD models.
• For Simulated Use Evaluation, the ground truth would be the defined objective criteria for successful surgical simulation (e.g., precise instrument placement, proper interaction with simulated anatomy).

8. Sample Size for the Training Set:

Not applicable. The device is a set of physical surgical instruments, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality.

MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy.

MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.

The DePuy Synthes MatrixSTERNUM Fixation System consists of two families of plates, namely the MatrixSTERNUM Sternal Body Plates and MatrixSTERNUM Thoracotomy Plates, and two families of screws, namely the MatrixSTERNUM Self-Drilling Locking and Non-Locking Screws.

The DePuy Synthes MatrixSTERNUM Fixation System is intended for the stabilization and fixation of bones in the anterior chest wall. The subject plates are available in different shapes and sizes and are made from Titanium Alloy or commercially pure Titanium. The system also consists of non-implantable dedicated use screw guides, a screw guide handle, trays and modules, as well as general use instruments to be used as accessories with the subject implants.

The provided text describes a 510(k) premarket notification for the DePuy Synthes MatrixSTERNUM Fixation System, which is a metallic bone fixation appliance.

It is crucial to understand that this document describes a submission for a medical device (hardware), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information regarding acceptance criteria and studies that prove the device meets acceptance criteria are focused on the mechanical, material, and biological performance of physical implants, not on the performance of an AI algorithm in tasks like image interpretation or diagnosis.

Because the request is specifically about AI/SaMD performance criteria (e.g., sample size for test set, expert ground truth establishment, MRMC studies, standalone performance, training set data), the provided text does not contain the information needed to answer these questions for an AI/SaMD product.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This directly indicates that no clinical performance study, multi-reader multi-case (MRMC) study, or standalone algorithm performance study (as would be typical for AI/SaMD) was conducted.
• The performance data provided is under "Non-clinical Performance Data" and includes:
  • Mechanical performance evaluation and testing: Comparing the subject plates to predicate devices.
  • Magnetic resonance compatibility assessment.
  • Endotoxin testing.
  • Biocompatibility evaluation and testing (in accordance with ISO 10993-1).

These are standard non-clinical tests for orthopedic implants to demonstrate safety and effectiveness and substantial equivalence to existing devices. They are not metrics or study designs relevant to AI/SaMD performance.

Therefore, I cannot populate the requested table and answer the subsequent questions in the context of an AI/SaMD product, as the provided text pertains to a physical medical device.

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DePuy Synthes VOLT™ Mini Fragment Plating System:

The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Small Fragment Plating System:

The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Mini Fragment Plating System

The DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screw holes, and two screw types (cortex and locking screws). The system is available in three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in 2.4mm and 2.7mm sizes only.

The plates of this system are available in Stainless Steel and Commercially Pure Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV) respectively. Plates and screws within the VOLT™ Mini Fragment Plating System are available either sterile or non-sterile and are single-use only.

DePuy Synthes VOLT™ Small Fragment Plating System

The DePuy Synthes VOLT™ Small Fragment Plating System is a family of implantable devices consisting of 3.5mm non-contoured, non-anatomic plates with variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws.

The plates of this system are available in Stainless Steel and Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV). Plates and screws within the VOLT™ Small Fragment Plating System are available either sterile or non-sterile and are single-use only

The provided text is a 510(k) summary for the DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on non-clinical performance testing (mechanical and engineering analyses) to demonstrate substantial equivalence.

Crucially, this document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically found in clinical performance studies validating AI/ML-based medical devices, is not applicable to this submission.

This 510(k) clearance is based on the devices being "substantially equivalent" to existing predicate devices, primarily demonstrated through non-clinical performance testing (mechanical simulations and analyses), rather than clinical trials or studies involving human data and AI algorithm performance.

Therefore, I cannot provide the requested information as it is not present in the provided text. The device in question is a physical orthopedic implant, not an AI/ML software device that would require such performance evaluations.

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The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware:

• · fracture fixation (open and closed)
• · pseudoarthrosis of long bones
• · limb lengthening (epiphyseal or metaphyseal distraction)
• · joint arthrodesis
• · infected fractures or nonunions
• correction of bony or soft tissue deformities
• · correction of segmental defects.

The MAXFRAME AUTOSTRUT System is comprised of a control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT Hexapod Struts.
This submission is solely for the clearance of a sterile version of the MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME AUTOSTRUT Hexapod Struts are provided sterile and are comprised of telescopic rods made of stainless steel and aluminum and a motor adapter made from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are available in three lengths - short, medium, and long.
The MAXFRAME AUTOSTRUT Control System and Software have been cleared under K202810.

The provided text describes the 510(k) clearance for the DEPUY SYNTHES MAXFRAME AUTOSTRUT System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness for a diagnostic or therapeutic purpose.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (AutoStrut G2 K202810), primarily based on changes to the sterilization method of the Hexapod Struts (from non-sterile to sterile).

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states: "Clinical Performance Data was not necessary for the determination of substantial equivalence."

Here's a breakdown of what is mentioned, which largely pertains to non-clinical performance and a comparison to the predicate device:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics an AI or device output would be measured against. The "acceptance" here relates to demonstrating comparable safety and effectiveness to a predicate device.
• Reported Device Performance: The primary "performance" discussed is that "Bench testing demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is as safe and effective as its predicate device." This implies the new sterile version performs mechanically equivalent to the predicate, as validated by non-clinical tests.

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

• Not applicable as no clinical or diagnostic efficacy study is mentioned for this 510(k) submission. The testing performed was "Non-Clinical Performance Testing," including Mechanical Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation, and Biocompatibility Evaluation. No specific sample sizes for these tests are provided in the summary, nor is data provenance in terms of origin or retrospective/prospective nature.

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

• Not applicable as no diagnostic or clinical performance study with "ground truth" established by experts is described.

4. Adjudication method for the test set:

• Not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states, "Clinical Performance Data was not necessary for the determination of substantial equivalence."

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

• Not applicable. This device is an external fixation system (hardware), not a diagnostic algorithm. While it has a control system and software (cleared under K202810), this specific submission is only for sterile struts and does not detail a standalone algorithm performance study.

7. The type of ground truth used:

• Not applicable as no clinical or diagnostic performance study requiring ground truth (e.g., pathology, outcomes data) is mentioned. "Ground truth" for the non-clinical tests would be defined by engineering standards and test protocols.

8. The sample size for the training set:

• Not applicable as this is not a machine learning or AI algorithm development study.

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

• Not applicable for the same reasons as point 8.

In summary, the provided document focuses on regulatory clearance based on substantial equivalence for a medical device (external fixation system) where the primary change is the sterilization method of a component. It does not contain information about clinical performance trials, diagnostic accuracy studies, or AI algorithm validation against performance acceptance criteria.

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