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The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The Synthes 3.5mm LCP Clavicle Plate System consists of metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.

Here's an analysis of the provided text regarding the Synthes 3.5mm LCP Clavicle Plate System, focusing on the acceptance criteria and the study that "proves" the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details and Analysis:

The provided document describes a 510(k) Premarket Notification, not a clinical study in the traditional sense involving human subjects or extensive clinical efficacy data. The "study" referenced here is focused on demonstrating substantial equivalence to already legally marketed predicate devices, a requirement for 510(k) clearance.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of the number of unique devices tested. The document mentions "testing conducted" to assess bending strength. For mechanical testing of medical devices, sample sizes are typically determined by statistical power analysis to detect differences, often involving multiple units of each design.
   • Data Provenance: The testing was conducted by Synthes (USA), the device manufacturer. The data is internal testing data. There is no mention of country of origin for clinical data because this is not a clinical trial; it's a mechanical testing report.

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

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" as it relates to expert consensus for clinical disease states is not relevant here. The "ground truth" for mechanical testing is established by engineering principles, validated testing methodologies, and comparisons to established performance benchmarks (the predicate devices). The experts involved would be qualified engineers and technicians performing the mechanical tests, but their number and specific qualifications are not detailed in this summary.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical image interpretation or diagnosis. For mechanical testing, if multiple tests are run, results are compared against a pre-defined acceptance criterion (e.g., maximum load, deflection, fracture point) of the predicate device. Discrepancies would likely be resolved through re-testing or investigation into the testing methodology, not expert adjudication in the clinical sense.

4. 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. This is a medical device (bone plate and screws), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study is completely irrelevant and was not performed.

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

   • No. This is a physical implantable medical device, not an algorithm. Therefore, "standalone algorithm" performance is not applicable.

6. The type of ground truth used:

   • The "ground truth" for this submission is the mechanical performance of the predicate devices. The subject device's mechanical properties (specifically bending strength) were compared against those of the predicate devices. This comparison, along with identical materials and other features, forms the basis for demonstrating substantial equivalence.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of a physical medical device's mechanical testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, this question is not relevant.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" described is a benchtop mechanical testing comparison between the Synthes 3.5mm LCP Clavicle Plate System (subject device) and its predicate devices (Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System, Synthes 3.5mm LCP Clavicle Plate System, and Synthes Small Fragment Dynamic Compression Locking System).

• Objective: To demonstrate substantial equivalence of the subject device to the predicate devices, primarily in terms of mechanical strength (specifically bending strength).
• Methodology: Mechanical testing was performed on the subject device and compared to the predicate devices. The document highlights that "functional and mechanical testing demonstrates the comparable mechanical & functional properties." It also states that manufacturing methods, packaging, and sterilization are identical, and materials are the same (stainless steel and titanium alloy).
• Conclusion: The results of the mechanical testing, coupled with similarities in intended use, design, materials, and manufacturing processes, led the FDA to determine that the device is "substantially equivalent" to the legally marketed predicate devices, thereby clearing it for market.

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Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.

Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft.

Here's an analysis of the provided text regarding the Synthes 3.5mm LCP Clavicle Plate System, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary (K073186), this device is a metallic bone fixation appliance and, as such, its acceptance criteria and the study proving it meets those criteria are not detailed in the context of typical AI/ML device evaluations. This document describes a medical device (a physical implant) cleared through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device rather than performance against defined acceptance criteria in a clinical study as would be detailed for a diagnostic AI/ML product.

Therefore, many of the requested points, particularly those related to AI/ML performance metrics, retrospective/prospective studies, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment (as applied to AI/ML models), are not applicable to this type of device and submission.

However, I can extract information relevant to the substantial equivalence claim:

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

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/ML models (e.g., sensitivity, specificity, AUC) does not directly apply here. For a metallic bone fixation appliance cleared via 510(k), "acceptance criteria" are implied by the demonstration of substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Acceptance Criteria (Implied by Substantial Equivalence):

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 in the context of typical clinical test sets for AI/ML. This is a physical implant. The "test set" would refer to non-clinical mechanical testing, biocompatibility studies, or potentially limited clinical data (if required for differences from the predicate, though often not for 510k). The document does not specify these details.

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. "Ground truth" in the AI/ML sense (e.g., expert-derived medical diagnoses) is not relevant for this physical implant.

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

• Not Applicable.

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 physical 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.

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

• Not Applicable in the AI/ML sense. For a physical implant, "ground truth" for demonstrating safety and effectiveness would come from:
  • Mechanical Testing: Based on engineering principles and established ASTM/ISO standards for strength, fatigue, and stiffness.
  • Biocompatibility Testing: According to ISO 10993 series for medical devices.
  • Clinical Data (if submitted): Patient outcomes (e.g., fusion rates, complication rates) from comparative studies, if such studies were deemed necessary (which is rare for a device cleared via substantial equivalence for minor modifications like this one). The summary does not indicate clinical data was specifically reviewed for equivalence assertion beyond possibly general clinical use of the predicate.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the AI/ML sense for this device. If physical testing was done, the "sample size" would refer to the number of devices tested mechanically or biologically, but this is not provided in the summary.

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

• Not Applicable. As no training set in the AI/ML context exists, this question is not relevant.

In summary, this 510(k) submission for the Synthes 3.5mm LCP Clavicle Plate System focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and performance data (not specifically detailed in the summary but typically including non-clinical mechanical and biocompatibility testing). The framework of AI/ML model evaluation (acceptance criteria, test/training sets, ground truth, expert adjudication, MRMC studies) does not apply to this type of medical device submission.

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