(84 days)
Synthes 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone.
The Synthes 1.5mm Mini Fragment LCP System consists of low-profile plates of various shapes as well as locking and cortex screws which are intended to treat small bones and small fragments. The plates and screws of the 1.5mm Mini Fragment LCP System are available in stainless steel and titanium.
This document is a 510(k) summary for the Synthes (USA) 1.5mm Mini Fragment LCP System. It outlines the device's classification, predicate devices, description, and intended use as part of a submission to the FDA. The letter on page 1 confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices.
Based on the provided document, the device is a medical implant system and not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria, study details, ground truth, experts, and human-in-the-loop performance are not applicable.
Here's a breakdown of the requested information based on the provided document, addressing what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance reports in the context of an engineering or clinical study. The FDA's determination of "substantial equivalence" is the primary outcome, meaning the device performs as safely and effectively as a legally marketed predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics for this device type within the document. For medical devices like this, relevant "acceptance criteria" generally revolve around demonstrating equivalence in materials, design, and intended use to a predicate device, as well as meeting general safety and performance manufacturing standards. This is assessed through various engineering tests and comparisons which are summarized for the 510(k) rather than detailed as acceptance criteria tables in this summary. | Substantial Equivalence: The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets the necessary safety and effectiveness standards for its intended use. |
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 / Not provided: This is a submission for a medical implant (bone fixation system), not an AI/ML device that would typically involve a "test set" of data for performance evaluation in the way the question implies. The "testing" for such a device would involve mechanical and material characterization, biocompatibility, and potentially animal or cadaver studies, none of which are detailed in this 510(k) summary.
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 / Not provided: As above, this pertains to AI/ML device evaluation and is not relevant to this medical implant submission. The "ground truth" for a bone fixation system is typically established through engineering principles, mechanical testing, and clinical outcomes, not expert consensus on data sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided: This is relevant to expert review of data for AI/ML devices, not for a medical implant device's 510(k) submission.
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 / Not provided: This is specifically for AI/ML driven diagnostic or assistive devices, not for a bone fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided: This refers to AI/ML algorithm performance and does not apply to this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided in this summary directly: For a bone fixation system, "ground truth" related to its effectiveness and safety would involve:
- Mechanical Testing Data: Demonstrating strength, fatigue, and torsional properties meet industry standards and are comparable to predicate devices.
- Biocompatibility Testing: Ensuring materials are safe for implantation.
- Clinical Literature/Experience with Predicate: Reliance on the established safety and efficacy of the predicate devices.
- Intended Use Clinical Outcomes: While not explicitly detailed as "ground truth data" in this summary type, the intended use implies the device is expected to achieve stable fixation, facilitate healing, and accommodate osteopenic bone, which are ultimately assessed through clinical outcomes over time.
8. The sample size for the training set
- Not applicable / Not provided: This concept applies to AI/ML models, not traditional medical devices like this bone fixation system.
9. How the ground truth for the training set was established
- Not applicable / Not provided: This concept applies to AI/ML models, not traditional medical devices like this bone fixation system.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.