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510(k) Data Aggregation
(64 days)
The Biomet A.L.P.S Calcaneal Plating System is intended for fixation of fractures, fusions, and osteotomies of the calcaneus.
The new A.L.P.S calcaneal plating system is a series of bone plates and screws intended to stabilize calcaneal fractures. The plates come in a left and right specific MIS configuration with five size options and left and right MESH configuration that is offered in three sizes. The plates are manufactured from titanium (ASTM F136) and will utilize the legally marketed and predicate A.L.P.S screw system.
Here's an analysis of the provided text regarding the A.L.P.S Calcaneal Plating System.
Note: This submission pertains to a medical device (bone fixation plates) and not an AI/software device. Therefore, many of the requested elements that are typical for AI/software device studies (like expert adjudication, MRMC studies, ground truth for training sets, etc.) are not applicable or addressable from the provided text. The evaluation criteria for such a device are primarily focused on mechanical performance and material equivalence.
Acceptance Criteria and Device Performance Study for the A.L.P.S Calcaneal Plating System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for medical devices of this type) | Reported Device Performance |
|---|---|
| Mechanical Strength & Stability: Device must demonstrate adequate strength and stability for its intended use in calcaneal fracture fixation, fusion, and osteotomies. | "Preclinical performance tests/rationales were provided to address the subject construct's strength. Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") Acceptance has been met as per the FDA's substantial equivalence determination for safety and effectiveness. |
| Material Equivalence: Device materials must be safe and compatible with the human body, similar to predicate devices. | "The technological characteristics of the A.L.P.S calcaneal plating system are similar to the predicate devices including design, dimensions and material." (K132898, page 1, Section "Summary of the Technologies") |
| "The A.L.P.S Calcaneal Plating System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design..." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") | |
| The plates are manufactured from titanium (ASTM F136). (K132898, page 1, Section "Device description") Acceptance has been met as per the FDA's substantial equivalence determination. | |
| Design Equivalence (functional): The device's design must achieve a similar function to legally marketed predicate devices. | "The technological characteristics of the A.L.P.S calcaneal plating system are similar to the predicate devices including design, dimensions and material." (K132898, page 1, Section "Summary of the Technologies") |
| "The A.L.P.S Calcaneal Plating System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design..." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") Acceptance has been met as per the FDA's substantial equivalence determination. | |
| Safety and Effectiveness: Overall, the device must be demonstrated to be safe and effective for its stated indications for use. | "Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") |
| "No new issues of safety or efficacy have been raised." (K132898, page 1, Section "CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA") The FDA has determined the device is substantially equivalent, implying it meets safety and effectiveness criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The studies were "preclinical performance tests/rationales" and engineering rationales. For medical device mechanical testing, sample sizes are typically determined by statistical power analysis for a given test (e.g., fatigue, static strength), but the specific numbers are not disclosed here.
- Data Provenance: The studies are described as "preclinical performance tests" and "engineering rationales". This implies laboratory-based mechanical testing and engineering analysis. No country of origin is specified for the data itself, but the submitter is Biomet Manufacturing Corp. in Warsaw, IN, USA. The tests are retrospective in the sense that they are performed on manufactured components separate from a patient population, but the results are for substantiating a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not an image analysis or diagnostic AI device. "Ground truth" in this context refers to the physical properties and performance of the device under testing conditions, measured by instruments, not by expert human interpretation.
4. Adjudication method for the test set:
- Not Applicable. As a mechanical device, adjudication in the sense of reconciling expert opinions is not relevant. Mechanical test results are objective measurements.
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 not an AI/software device and therefore an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/software device. The device's "performance" is its mechanical integrity and function as a standalone implant. The preclinical tests evaluated the device in isolation, in a lab setting, independent of human interaction during the test itself.
7. The type of ground truth used:
- Objective Mechanical Measurements and Engineering Analysis: The "ground truth" for this device's performance is derived from standardized mechanical testing (e.g., fatigue testing, static load testing, material property verification) to ASTM or ISO standards, as well as engineering rationales and comparisons against predicate device performance under similar conditions. This would involve quantifiable measurements of force, displacement, cycles to failure, and material properties.
8. The sample size for the training set:
- Not Applicable. This is not an AI/software device and does not have a "training set" in that context. The device's design and manufacturing processes are developed through engineering principles, rather than machine learning on a dataset.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no "training set" as understood in AI/software, this question does not apply. The "ground truth" for the device's design and manufacturing is established through engineering specifications, material standards (e.g., ASTM F136 for titanium), and quality control processes.
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