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The Osteo BOS" System in Stainless Steel components are intended for fracture fixation of long and small bones.

The Osteo BOS" System in Stainless Steel components are used for fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from ASTM F-138-92 Stainless Steel and include the following:

• Plate Wide (06.5mm/04.5mm)
• Plate - Narrow (06.5mm/04.5mm)
• Plate Wide (04.0mm/03.5mm)
• One-Third Tubular Plate (e4.0mm/03.5mm)
• Plate (@2.7mm)

This document describes a 510(k) Premarket Notification for the Osteo BOS™ System in Stainless Steel, a bone plating system. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically seen for performance evaluation studies of medical devices generating quantitative performance metrics (e.g., diagnostic devices).

Instead, this submission is focused on demonstrating substantial equivalence to a predicate device, which is a different type of regulatory pathway. Substantial equivalence is established by comparing the subject device's technological characteristics and intended use to a legally marketed predicate device. The "proof" is the argument and documentation that the new device is as safe and effective as the predicate.

Here's a breakdown of why many of your requested points cannot be directly answered from the provided text, and what information is available:

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

• Not applicable in the provided context for performance metrics. This document is a 510(k) summary, which for this type of device (bone plate), focuses on showing it's "substantially equivalent" to an existing device rather than presenting acceptance criteria for a performance study (like sensitivity/specificity for a diagnostic tool). The "performance" in this context refers to its ability to perform the intended function as a bone fixation device, which is inferred by its similarity to the predicate device and manufacturing materials.

  Instead, the "acceptance criteria" here is the FDA's determination of substantial equivalence. The "reported device performance" is implicitly understood to be equivalent to the predicate device.

  Acceptance Criteria (for 510(k) pathway)	Reported Device Performance (as demonstrated for 510(k))
  Substantial Equivalence to Predicate Device (Synthes bone plates) in terms of:
  - Intended Use	- Intended Use: Fracture fixation of long and small bones. (Matches predicate)
  - Technological Characteristics	- Material: ASTM F-138-92 Stainless Steel. (Matches predicate type)
  	- Design: Various plate sizes/types (Wide, Narrow, One-Third Tubular, etc.). (Comparable to predicate)
  - Performance (Safety and Effectiveness)	- Implied safety and effectiveness are equivalent due to similar materials, design, and intended use as the predicate device. No new safety/effectiveness concerns raised.

2. Sample size used for the test set and the data provenance

• Not applicable. This submission does not describe a clinical performance study with a "test set" of patients or data samples. The "testing" discussed is primarily related to material composition and design comparison against a predicate, not clinical outcomes in a sample population.

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

• Not applicable. There is no "ground truth" derived from expert review for a test set in this 510(k) submission. The "ground truth" for regulatory assessment is the established performance and safety of the predicate device.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is described.

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 device is a passive, implantable bone plate, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the legally marketed predicate device (Synthes bone plates). The Osteo BOS™ System in Stainless Steel demonstrates substantial equivalence to this predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

• Not applicable. As above, no training set or its associated ground truth establishment method is relevant here.

Summary of the Study/Evidence Provided in the Document:

The "study" in this context is a comparison to a predicate device to demonstrate substantial equivalence, required for a 510(k) premarket notification.

• Device Name: Osteo BOS™ System in Stainless Steel
• Predicate Device: Similar bone plates offered by Synthes.
• Basis for Equivalence:
  • Intended Use: Both the subject device and the predicate are intended for "fracture fixation of long and small bones."
  • Technological Characteristics: Both are manufactured from stainless steel (Osteo BOS™ uses ASTM F-138-92 Stainless Steel). They both comprise various plate designs (wide, narrow, one-third tubular, etc.).
• Conclusion: The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to devices marketed prior to May 28, 1976, and therefore may be marketed. This decision essentially "proves" that the device meets the regulatory acceptance criteria for substantial equivalence.

This type of regulatory submission relies on comparison to existing, proven technologies rather than generating new clinical performance data for every single new iteration of a well-understood device type.

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