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Reprocessed Stryker External Fixation Devices are indicated for use in patients requiring external fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

External fixation devices are specially designed frames, clamps, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

The provided text describes a 510(k) premarket notification for a medical device, specifically Reprocessed Stryker External Fixation Devices. It does not describe an AI/ML powered device, but rather a reprocessed conventional medical device. Therefore, many of the requested categories related to AI/ML device studies will not be applicable.

Here's an analysis of the provided text based on the request:

Device Name: Reprocessed Stryker External Fixation Devices

Device Description: External fixation devices are specially designed frames, clamps, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

Acceptance Criteria and Study to Prove Device Meets Criteria:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not specified. The document states "Verification analyses consisting of device functionality testing and post-reprocessing inspection of components were performed to evaluate the effects of the reprocessing procedures on the subject device." It does not detail the number of devices tested.
• Data Provenance: Not specified, but implied to be from testing conducted by Stryker Sustainability Solutions. The study is a prospective verification and validation study of the reprocessed devices.

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

• Not applicable. This device is a reprocessed physical medical device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" here is the original performance specifications of the predicate devices and the physical integrity of the reprocessed components.

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

• Not applicable. This is not a study requiring human adjudication for diagnostic or classification tasks. The acceptance criteria were based on functionality and inspection.

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-powered device.

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

• The performance testing described ("device functionality testing and post-reprocessing inspection of components") is inherently "standalone" in the sense that it evaluates the device itself against its specifications, without human intervention in its function. However, this is not an algorithm's standalone performance.

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

• The "ground truth" implicitly used for the Reprocessed Stryker External Fixation Devices is the original performance specifications and safety profiles of the new, predicate versions of the external fixation devices. The goal of the reprocessing verification was to demonstrate that the reprocessed devices perform as originally intended and meet the same standards as the new devices.

8. The sample size for the training set:

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

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

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

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