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The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.

The Exsomed Wrist Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of straight tubular plates of varying lengths as well as a 4-hole carpal fusion plate. Screws are provided for plate fixation in locking and non-locking versions and in Ø2.5 and Ø3.2mm diameters. All of the Implants are made from Titanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-sterile.

This looks like a 510(k) premarket notification for a medical device, which typically does not involve the kind of AI/machine learning performance study you're asking about. The document describes a biocompatibility and mechanical performance assessment for a traditional medical device (metallic bone fixation plates and screws), not an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because it pertains to a different type of device and regulatory submission.

However, I can extract the relevant "performance analysis" information related to the device's mechanical properties, which is the "acceptance criteria" and "study" described in this context.

Here's a breakdown of what can be extracted based on the provided text, and what is not applicable in this context:

Acceptance Criteria and Study for Exsomed Wrist Plating System (Mechanical Performance)

This document describes the premarket notification (510(k)) for the Exsomed Wrist Plating System, a traditional medical device consisting of metallic bone plates and screws for hand and wrist fracture repair and fusion. The "acceptance criteria" and "study" described herein relate to the mechanical and material performance of these physical implants, not to the performance of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable/Available for an AI/ML Device (Based on this document):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "tests" were mechanical assays on physical samples of the device and predicate devices, not data analysis for an AI/ML algorithm.
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. Ground truth for mechanical testing is based on industry standards (ASTM) and physical measurements, not expert consensus on medical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No expert adjudication is involved in mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic or assistive tool for human readers.
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): The "ground truth" for this device's performance is derived from standardized mechanical testing methods (e.g., ASTM F382-17) and material specifications, which provide objective, measurable results.
8. The sample size for the training set: Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable. There is no training set for a mechanical device.

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The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The ExsoMed INnate Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The INnate system screws are cannulated and feature a headless design that allows for the screw to be countersunk below the surface of the bone. The system is provided sterile. The subject of this submission is the addition of a Ø3.6mm version of the INnate screw to the system to be offered in lengths of 25 to 55mm.

This document is a 510(k) summary for the ExsoMed INnate Cannulated Screw System, which is a line expansion to a previously cleared device. Therefore, it is exempt from needing to provide comprehensive study information typically found in submissions for novel devices or software. The information provided focuses on demonstrating substantial equivalence to a predicate device through performance testing.

Here's the breakdown of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test (e.g., number of screws tested for driving torque, torque to failure). It broadly states that "functionality testing" and "simulated use testing" were performed.

Data Provenance: The tests were conducted by ExsoMed Corporation, the device manufacturer. No information on country of origin of data is provided beyond the manufacturer's location in Phoenix, Arizona, USA. The testing would be considered prospective, as it was performed specifically for this submission to demonstrate equivalence.

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

This section is not applicable as the submission is for a medical device (screws for bone fixation), not an AI/Software as a Medical Device (SaMD) that relies on expert interpretation for ground truth. The "ground truth" for these tests comes from objective mechanical measurements and engineering calculations.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons outlined in point 3. Mechanical tests and engineering calculations do not involve expert adjudication in the same way clinical or image-based studies do.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic devices where human readers interpret results, and the study aims to assess the impact of AI assistance on their performance. The INnate Cannulated Screw System is a physical implant, not a diagnostic tool requiring human interpretation.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

This section is not applicable as the device is a physical implant and does not involve an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for performance testing was based on objective mechanical measurements (e.g., force, torque values) and engineering principles/calculations (e.g., for torsional strength, bending strength, pullout resistance). The criteria for each test would have been established based on industry standards, predicate device performance, and biomechanical requirements for bone fixation.

8. Sample Size for the Training Set

This section is not applicable as there is no "training set" in the context of a physical medical device like cannulated screws. Training sets are relevant for machine learning algorithms.

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

This section is not applicable for the same reasons as point 8.

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