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The SkyOPSTM Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).

Device Description

The subject SkyOPS™ Orthopedic Plate System consists of various plates and screws that are used to stabilize and aid in the fusion or repair of fractures or osteotomies of small bones. The plates are offered in different lengths and sizes. The screws are offered in one diameter with different lengths. All implantable metal components are made from Ti-6Al-4V ELI per ASTM F136 or ASTM F3001. The devices are provided non-sterile to be cleaned and steam sterilized by the end user.

AI/ML Overview

The provided text is a 510(k) summary for the SkyOPS™ Orthopedic Plate System, which is a metallic bone fixation appliance. This type of device does not typically involve AI or software for diagnosis or image analysis, but rather is a physical implant. Therefore, questions related to AI performance, such as acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance, are not applicable in this context.

Instead, the performance evaluation for this device focuses on mechanical and biocompatibility testing to demonstrate substantial equivalence to predicate devices.

Here's the relevant information about the performance and acceptance criteria for the SkyOPS™ Orthopedic Plate System based on the provided document:

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

Acceptance Criteria Category	Standard/Test Method	Reported Device Performance
Biocompatibility	ISO 10993-1	Testing conducted, and results demonstrated substantial equivalence. (Implies meeting biocompatibility requirements outlined in ISO 10993-1)
Mechanical Performance	ASTM F534-17 (Annexes 1-3)	Testing conducted, and results demonstrated substantial equivalence to predicate devices. (Implies meeting or exceeding the mechanical performance of the predicates as defined by these ASTM standards)
Mechanical Performance	ASTM F384-17 (Annexes 1-2)	Testing conducted, and results demonstrated substantial equivalence to predicate devices. (Implies meeting or exceeding the mechanical performance of the predicates as defined by these ASTM standards)

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

The document does not specify the sample size for the mechanical or biocompatibility testing. These tests typically involve a defined number of samples for each specific test (e.g., a certain number of plates for fatigue testing).
The data provenance (country of origin, retrospective/prospective) is not applicable or specified for this type of in-vitro and material testing.

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 physical implant, and its performance is evaluated through standardized mechanical and biological tests, not by human expert assessment of clinical data.

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

Not applicable. Performance is based on objective measurements from standardized tests, not expert adjudication.

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 device.

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.):

For biocompatibility: Ground truth is implicitly defined by the pass/fail criteria of the ISO 10993-1 standard, often through laboratory assays and biological response evaluations.
For mechanical performance: Ground truth is implicitly defined by the specified load, displacement, or fatigue life criteria within ASTM F534-17 and ASTM F384-17, aiming to demonstrate performance comparable to, or better than, predicate devices. The "ground truth" here is objective physical properties.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

In summary, the SkyOPS™ Orthopedic Plate System is an orthopedic implant, and its performance is demonstrated through well-established biocompatibility and mechanical testing standards. The acceptance criteria are meeting the requirements of these standards and demonstrating substantial equivalence to the predicate devices in terms of performance. The study proving this involves laboratory testing in accordance with ISO 10993-1, ASTM F534-17, and ASTM F384-17.

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