(116 days)
The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavice including osteopenic bone.
The purpose of this submission is to request clearance for the new A.L.P.S Clavicle Plating System. The A.L.P.S Clavicle Plating System implants are designed to address fractures of the clavicle. The system is comprised of plates and instruments to facilitate the installation of the implants. The plates are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.
This document is an FDA 510(k) summary for the A.L.P.S. Clavicle Plating System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner requested for AI/ML devices. Therefore, a direct answer to the prompt's structured questions is not possible from the provided text.
However, I can extract information related to the device's performance justification from a regulatory perspective:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device based on common characteristics and non-clinical testing.
| Acceptance Criteria (from a regulatory standpoint for substantial equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Similar to predicate device (K083843) | Met: The intended use of the A.L.P.S. Clavicle Plating System is "similar to the intended use cleared in K083843." |
| Indications for Use: Similar to predicate device (K083843) | Met: The indications for use are "similar to the indications for use cleared in K083843." Indicated for "fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone." |
| Materials: Manufactured from a commonly used implant grade titanium alloy (ASTM F136) | Met: Plates are manufactured from Titanium Alloy (per ASTM F136). |
| Design Features: Similar to currently marketed devices (K083843), with no identified issues impacting safety/effectiveness. | Met: "Design features for new A.L.P.S. Clavicle Plating System is similar to those in currently marketed devices cleared in K083843." "The design differences have not identified any issues that would impact the safety and effectiveness of the device." |
| Sterilization: Offered non-sterile, requiring steam sterilization by the user, similar to predicate device. | Met: Implants and instruments are offered in non-sterile configuration, similar to predicate devices currently marketed and cleared via K083843. |
| Non-Clinical Performance: Demonstrate safety and effectiveness through mechanical testing. | Met: "Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised." Specifically, the following tests were conducted: |
- Construct Static Testing
- Galvanic Corrosion Evaluation |
Regarding the other requested information:
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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. The document relies on engineering non-clinical tests and comparison to a predicate device, not a test set of data like an AI/ML study.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided, as this is not an AI/ML study involving expert ground truth.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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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/No MRMC study was done, as this is a physical medical device (plating system), not an AI/ML diagnostic or assistive tool.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/No algorithm is involved.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by established engineering standards and specifications, for example, the performance criteria for Construct Static Testing and Galvanic Corrosion Evaluation.
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8. The sample size for the training set
- Not applicable/No training set for an AI/ML algorithm.
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9. How the ground truth for the training set was established
- Not applicable/No training set for an AI/ML algorithm.
§ 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.