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Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

The ALPS Small Bone Locked Plating System Line Extension consists of three Titanium alloy plates offered to be used with non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, fusions, revisions and reconstructive surgeries.

The provided text is related to a 510(k) submission for a medical device called the "ALPS Small Bone Locked Plating System Line Extension." This submission focuses on establishing substantial equivalence to existing predicate devices, primarily through pre-clinical data. There is no information in the provided text about acceptance criteria or a study that proves the device meets specific performance criteria in terms of a clinically relevant outcome (e.g., diagnostic accuracy, patient outcomes).

The document is a 510(k) summary, which is a regulatory submission to the FDA for medical devices that are substantially equivalent to already legally marketed devices. The "study" mentioned for demonstrating substantial equivalence is pre-clinical and focuses on mechanical properties, not an evaluation of how humans or algorithms perform with the device.

Therefore, for the information requested, I can only provide what is explicitly stated or can be inferred, and will indicate where information is not present in the provided text.

Here's a breakdown based on your request:

Acceptance Criteria and Study for ALPS Small Bone Locked Plating System Line Extension

The provided 510(k) summary primarily demonstrates substantial equivalence through pre-clinical testing, rather than studies involving human or AI performance. The "acceptance criteria" and "reported device performance" are framed in terms of mechanical and material properties, aligning with the regulatory pathway of demonstrating equivalence to existing devices.

1. Table of Acceptance Criteria and 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)

• Not Applicable / Not Provided. This device is a bone fixation system, not a diagnostic or AI-driven device that would typically involve a "test set" of patient data or data provenance in the context of diagnostic accuracy. The "test set" in this context refers to components or constructs used in pre-clinical mechanical testing. The sample sizes for these pre-clinical tests are not specified in the provided text.

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 / Not Provided. As this is a pre-clinical evaluation of a bone implant, there is no "ground truth" established by clinical experts (like radiologists for image interpretation) for a "test set" of clinical data. The "ground truth" for mechanical testing is based on engineering principles and established standards.

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

• Not Applicable / Not Provided. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This concept does not apply to the pre-clinical mechanical testing performed for this device.

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 an implantable bone fixation system, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

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

• Mechanical and Material Standards: The "ground truth" for the substantial equivalence claim is based on engineering principles, material science standards, and the performance characteristics of the predicate devices. This includes demonstrating equivalent axial load construct strength and galvanic corrosion potential.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" in the context of this device. A training set is typically used for machine learning algorithms, which are not part of this device submission.

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

• Not Applicable / Not Provided. As there is no training set, there is no ground truth established for one.

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