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The Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus.

The Synthes Proximal Humeral Nail is an intramedullary rod that features a distal taper design. It is 150 mm in length and has holes in both the proximal and distal sections that accept locking screws.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Synthes Proximal Humeral Nail. This kind of document typically grants market clearance based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials with acceptance criteria and statistical analysis as would be found for a novel, high-risk device.

Therefore, the information required to populate the requested table and answer the study-related questions is not explicitly present within the provided text.

Here's a breakdown of what can be inferred or stated based on the document's nature:

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

• Not explicitly stated in the provided text. For a 510(k) clearance, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device, usually through mechanical testing, material characterization, and often a review of the predicate's clinical history. Detailed performance metrics with acceptance thresholds (e.g., specific fracture healing rates, complication rates, or functional outcomes) are generally not required to be submitted in the summary for a Class II device like this.

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

• Not explicitly stated. Clinical test sets with human subjects are not typically required for 510(k) submissions for devices like intramedullary nails, especially if they are substantially equivalent to existing devices. If testing were conducted, it would likely be mechanical bench 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 based on the provided text. The document does not describe a study involving expert-established ground truth for a test set.

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

• Not applicable based on the provided text. No adjudication method for a clinical test set is mentioned.

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 such study was mentioned or implied. This device is a physical medical implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable in the context of clinical "ground truth." For substantial equivalence, the "ground truth" would relate to demonstrating the device's material properties, mechanical strength, and design characteristics are comparable to the predicate device, often through engineering analysis and bench testing.

8. The sample size for the training set

• Not applicable. No machine learning or AI training set is relevant for this device clearance.

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

• Not applicable. No machine learning or AI training set is relevant for this device clearance.

Summary based on the document:

The provided text is a 510(k) clearance letter for the Synthes Proximal Humeral Nail. This clearance is based on the device demonstrating substantial equivalence to existing predicate devices (Synthes (USA) Unreamed Humeral Nail; Acumed Polarus Proximal Humeral Fixation Rod).

The core "study" for a 510(k) typically involves:

• Comparison of technological characteristics: Showing that the new device has "the same technological characteristics as the predicate device" or "different technological characteristics from the predicate device and the information submitted demonstrates that the device is substantially equivalent to the predicate device" (often through bench testing and engineering analysis).
• Material composition: Reporting the material (Ti-6Al-7Nb) and demonstrating its biocompatibility and mechanical properties.
• Indications for Use: Demonstrating the new device has the same or similar indications for use as the predicate (fractures of the proximal humerus).

The document does not contain details about specific clinical studies with acceptance criteria or performance data in the way you would expect for a novel device requiring pre-market approval (PMA) or a device leveraging AI/imaging.

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