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The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

This Special 510(k) submission is intended to address modifications to the Stryker Locked Plating System. This line extension is to add additional styles of Cable Plugs. The AxSOS® Cable Plug is being modified as part of a line extension of the Stryker Locked Plating System. The AxSOS® Locked Plating System currently contains 4mm and 5mm Cable Plugs.

Here's an analysis of the provided text regarding the AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (bone plating system), not an AI/software device. Therefore, many of the requested categories (e.g., ground truth for test set, MRMC study, training set size) are not applicable to this type of submission. This document describes a "line extension" for existing hardware, focusing on demonstrating equivalence to predicate devices through mechanical and functional testing, not clinical performance metrics related to diagnostic accuracy typically seen with AI systems.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Applicable to this Device Type)

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

• Sample Size: Not explicitly stated as "test set" in the context of clinical data. For mechanical testing, samples of the cable plugs and the plating system would be used, but the exact number isn't quantified in this summary.
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data would originate from laboratory testing of the manufactured devices, most likely conducted by the manufacturer (Howmedica Osteonics Corp.). The nature of the submission (510(k) for a hardware line extension) indicates a focus on engineering and material equivalence rather than clinical efficacy studies with patient data. This would be considered prospective manufacturing and mechanical test data from the manufacturer’s facilities.

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

• Not Applicable. This is a hardware device focused on mechanical and material equivalence, not diagnostic or clinical interpretation where "experts" would establish "ground truth" on a test set (e.g., radiologists interpreting images). The "ground truth" for this device is its physical properties and performance as measured through engineering tests, compared to predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human-interpreted "cases" or "ground truth" in the clinical sense, no adjudication method would be required. The "results" are objective measurements from 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 is a hardware medical device, not an AI or software device. Therefore, no MRMC study on human readers and AI assistance was conducted or would be relevant.

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

• Not Applicable. This is a hardware medical device; there is no algorithm to assess.

7. The Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: For this device, the "ground truth" is established by the specified mechanical properties required for bone fixation devices and the demonstrated performance of the legally marketed predicate devices. The new cable plugs must perform equivalently to or better than the predicate devices under relevant mechanical stress tests.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not an AI or software model that requires a "training set."

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

• Not Applicable. As there is no training set, this question is irrelevant.

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The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long long fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

This Special 510(k) submission is intended to address modifications to the predicate Stryker Plating System. The subject and predicate devices are internal fixation plates, screws and accessories of the r no basyon attryker Locked Plating System is intended for use in long bone fracture fixation. The byeten. The Bujates are indicated for fixation of long bone fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

The provided text describes a Special 510(k) submission for the Stryker Locked Plating System, which is a medical device. This submission focuses on modifications to an existing predicate device and demonstrates substantial equivalence rather than presenting a study to prove acceptance criteria for a novel device or an AI/software component.

Therefore, the information requested in your prompt (e.g., acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth, MRMC study, standalone performance) is not applicable to this document as it pertains to a mechanical medical device seeking clearance based on substantial equivalence to a predicate device, not on clinical performance or AI/software validation.

The "study that proves the device meets the acceptance criteria" in this context is a mechanical testing comparison to the predicate device to demonstrate comparable mechanical properties.

Here's what can be extracted:

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: Not specified (refers to mechanical components, not human data).
• Data Provenance: Not applicable for mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this involves mechanical testing, not a clinical study requiring expert ground truth for interpretation.

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

• No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI/software device.

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

• Not applicable. This is a mechanical device.

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

• Not applicable. The "ground truth" for mechanical testing would be established engineering standards or the performance of the predicate device.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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