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The REVCON™ Screw System is indicated for fixation of bone surgery involving reconstruction. Examples include:

• · Mono or Bi-Cortical osteotomies in the foot or hand
• · Distal or Proximal metatarsal or metacarpal osteotomies
• · Weil osteotomy
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint
• · Fixation of osteotomies for Hallux Valgus treatment
• · Akin type osteotomy
• Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
• Calcaneus/cuboid arthrodesis
• · Talar/navicular arthrodesis.

The REVCON™ Screw System is not intended for spinal use.

The REVCON™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device, to allow surgeons to perform a bunion osteotomy and fixation of the osteotomy with a minimally surgical technique. The REVCON™ Screw System contains fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) as per ASTM F136 and are provided non-sterile for end user sterilization.

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) submission for the REVCON™ Screw System:

1. Table of Acceptance Criteria and Reported Device Performance:

• Insertion Torque
• Removal Torque | Acceptable |
  | | Axial Pullout Strength: Evaluate resistance to pulling out from bone. | Acceptable |
  | Biocompatibility | Biological safety evaluation as per ISO 10993-1. Material recognized by FDA for implantation. | Determined to be substantially equivalent to predicate device. |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for the mechanical testing (e.g., number of screws tested for each mechanical property). It generally refers to "testing according to the applicable ASTM standards," which would implicitly define sample size requirements.

The data provenance is non-clinical bench testing. The document does not involve human subjects, so there's no country of origin or retrospective/prospective data as commonly understood in clinical trials. It's essentially laboratory-generated data to demonstrate the physical properties and safety of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study described is non-clinical mechanical and biocompatibility testing, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. No ground truth was established through expert adjudication. The "ground truth" for mechanical testing is derived from the objective measurements and comparison against established ASTM standards and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not required and therefore not conducted as part of this submission." This indicates that the device's performance was not evaluated through human readers, with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

No, a standalone performance study was not done. This type of study would be relevant for devices involving algorithms or AI, which is not the case for the REVCON™ Screw System. The performance evaluated here is directly tied to the physical properties of the screw system itself.

7. Type of Ground Truth Used:

The ground truth used for this submission is based on:

• Objective Mechanical Measurements: Performance against established engineering standards (ASTM F543) for torsional strength, driving torque, and axial pullout strength.
• Biocompatibility Standards: Compliance with ISO 10993-1 and the use of FDA-recognized implantable materials (Ti-6Al-4V-ELI titanium alloy per ASTM F136).
• Comparison to Predicate Device: Demonstrating substantial equivalence to the Wright Medical MICA™ Screw System (K162353), implying that the predicate's established safety and effectiveness serve as a benchmark for the "ground truth" of performance.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical implant (bone screw system) and does not involve AI/machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as above.

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