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The Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsal-cuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufactured from nickel titanium alloy (nitinol). The implants utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The system includes implants offered in various styles, sizes, and options; each designed for specific anatomy and procedures. The implants can accommodate Ø2.7mm, Ø3.5mm, and Ø4.0mm locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots. The system also includes reusable and disposable instrumentation necessary for implantation of the REFLEX® Hybrid Nitinol Implant.

This 510(k) clearance letter is for a medical implant system, not an AI/software device, so the typical AI-related acceptance criteria and study details (like sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document. The provided text describes the regulatory clearance process for a physical medical device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the Medline UNITE® REFLEX® Nitinol Staple System (K231885). This is achieved primarily through non-clinical (bench) testing and engineering analysis, not clinical trials or AI performance evaluations.

Here's a breakdown of the requested information based on the provided document, noting where specific AI-related questions are not applicable:

Acceptance Criteria and Device Performance (for a physical medical implant)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • For Corrosion Susceptibility: Mentioned "not all samples," implying multiple samples were tested, but an exact number for the "test set" is not specified for the initial pass/fail.
  • For Nickel-ion Release: "three (3) samples tested over 60-days."
  • For Galvanic Corrosion: "all three (3) test samples."
• Data Provenance: The testing was non-clinical (bench testing) and performed according to ASTM standards and FDA guidance documents. There is no mention of country of origin of data as it's not human or patient data. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.

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. This is a physical medical device. Ground truth as typically defined in AI/software evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the device's performance is established by standardized material and mechanical testing specifications (ASTM standards and FDA guidance).

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

• Not Applicable. This is a physical medical device. Adjudication methods are typically used for expert consensus on challenging cases in AI/software evaluations.

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 medical device, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this physical device is defined by established engineering and material science standards (ASTM F2129, ASTM F3306, ASTM F3044) and FDA guidance on biocompatibility and material safety (specifically for Nitinol implants and nickel release). Device performance is measured against these quantitative and qualitative benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

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

• Not Applicable. This is a physical medical device. There is no "training set" or corresponding ground truth establishment process in the context of machine learning.

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