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Synthes Dynamic Compression Locking Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.

Device Description

Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the Small Fragment DCL System. The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and, as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data. Therefore, many of the requested elements for an AI/device performance study are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable for this Submission Type)

This document does not describe specific quantitative acceptance criteria or a study with reported device performance in the way one would expect for an AI or diagnostic device approval. Instead, it demonstrates "substantial equivalence" to a previously approved predicate device.

The "performance" is implicitly deemed acceptable if the device is substantially equivalent to a device already deemed safe and effective. The key "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device has the same intended use, technological characteristics, and safety/efficacy profile as the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (for 510(k) Equivalence)	Reported Device Performance (as per document)
Intended Use: Same as predicate device.	"Synthes One-Third Tubular DCL Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System." This is stated to be the same intended use as other plates in the system.
Technological Characteristics: Same as predicate device, or differences do not raise new questions of safety or effectiveness.	"The Synthes One-Third Tubular Plate has the same technological characteristics as the predicate device/ system identified above. Both will be offered in the same materials and with the same sterility options. The only difference is that these new plates will have the locking threads and be offered as a part of the Synthes Small Fragment DCL System." The addition of locking threads is implicitly considered not to raise new safety/efficacy questions given the overall system context.
Safety and Efficacy: No new questions of safety or efficacy are raised by the differences.	"The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy." This statement is a direct assertion. This is typically supported by engineering testing (e.g., mechanical strength), biocompatibility data (if materials changed), and comparison to clinical performance of the predicate, though detailed results are not in this summary. The FDA's letter states: "we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." implying accepted safety and efficacy.

Non-Applicable / Not Provided Information for AI/Diagnostic Study:

Due to the nature of this submission (a 510(k) for a mechanical implant line extension), the following information typically relevant for an AI/diagnostic device performance study is not available or not applicable:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, not an AI or diagnostic device that relies on a "test set" of patient data in this context. Substantial equivalence is typically demonstrated through engineering tests (e.g., biomechanical), material testing, and comparison to the predicate's design and use.
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. "Ground truth" in the context of clinical expert consensus is not a concept for this type of mechanical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have an "algorithm-only" performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/diagnostic study. The "truth" for this device relates to its mechanical properties, biocompatibility, and intended function matching that of similar approved devices.
The sample size for the training set: Not applicable. This device does not use a "training set."
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a medical implant line extension. It is not an article describing a performance study for an AI or diagnostic device, and therefore the majority of the requested information about such a study is not present. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence as defined by the FDA's 510(k) pathway.

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