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The indications for use of the Osteo BOS" System bone plates and Kirschner wire, in keeping with those of other legally marketed bone plates and Kirschner wires, are as follows.

The indications for each of the Osteo BOS" System product line extension bone plates are:

• . Internal fracture fixation of long and small bones.
  The indications for the Kirschner wires with a trocar point are:

• For use as guide wires in hip pinning procedures.

• . For use in aligning and reducing long bone fractures.

• For use in securing non-long bone fractures such as olecranon fractures, patella fractures, . tibial plateau fractures, small hand and foot bone fractures, humeral, and humeral, radial and ulnar fractures, etc.

• . For use with cerclage wire/cable in treating greater trochanter fractures.

The Osteo BOS" System product line extension components are used for fracture fixation on various small and long bones. All Osteo BOS" System product line extension components are manufactured from Titanium alloy and include the following:

• Oblique T-Plate, ø4.0/03.5
• One-Third Tubular Plate, 04.0/03.5
• Kirschner wire with trocar point

This document is a 510(k) Premarket Notification for the "Osteo BOS" System Product Line Extension," a set of bone plates and Kirschner wires used for fracture fixation. The submission aims to demonstrate substantial equivalence to predicate devices, primarily those offered by Synthes.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

The document does not outline specific, quantifiable acceptance criteria or report device performance in terms of metrics like accuracy, sensitivity, specificity, or precision. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" being assessed is primarily technological and intended use equivalence, rather than a clinical outcome or diagnostic accuracy.

Acceptance Criteria (Implied by Substantial Equivalence):

• Plates: Both subject and predicate plates are for internal fracture fixation.
• Kirschner wires: Both subject and predicate are for skeletal traction, guide wires, and fracture fixation. |
  | Intended Use Equivalence: The device's intended use should be the same as legally marketed predicate devices. | The Osteo BOS™ System product line extension bone plates are intended for internal fracture fixation of various long and small bones. The Kirschner wires are intended for use in skeletal traction, as guide wires, and for fracture fixation. These indications are in keeping with those of other legally marketed bone plates and Kirschner wires (including the Synthes predicate). |
  | Technological Characteristics Equivalence: The materials and fundamental technological principles should be similar to legally marketed predicate devices. | Plates: Subject plates are manufactured from Titanium alloy. Predicate plates are manufactured from CP Titanium. The document implies this is equivalent for the intended use.
  Kirschner wires: Both subject and predicate Kirschner wires are manufactured from Titanium alloy. |

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

There is no mention of a "test set" or any experimental data being collected from patients or subjects. This is a premarket notification for a medical device that relies on demonstrating substantial equivalence to existing devices, not on proving clinical efficacy via a clinical trial with a test set. Therefore, there's no information on sample size or data provenance.

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 no "test set" or clinical study was conducted, there were no experts establishing ground truth in that context. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices.

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

Not applicable. No "test set" or clinical study was conducted, so no adjudication method was used.

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 submission for bone plates and Kirschner wires, which are mechanical fixation devices, not an AI or diagnostic imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate devices (Synthes bone plates and Kirschner wires) that are already legally marketed. The submission's goal is to show the new device is "substantially equivalent" to these known safe and effective products. There is no mention of pathology, outcomes data, or expert consensus relating to a new clinical study.

8. The sample size for the training set

Not applicable. This type of submission does not involve a "training set" in the context of an algorithm or machine learning.

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

Not applicable. No training set was used.

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