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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The BOLD ® SCREW is indicated for fixing the elective osteotomics of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include:

• · Mono or Bi-cortical osteotomies in the forefoot
• · Distal or proximal metatarsal osteotomics
• · Weil osteotomy
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint.
• · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, ... etc.)
• · Akin type ostcotomy
• · Arthrodesis base first metatarsal cunciform joint to reposition and stabilize metatarsus varus primus

The BOLD® SCREW is a cannulated screw made of a Titanium alloy. Its design includes a non-threaded shaft and a screw tip. Screws come in lengths of 10-34 mm.

The document provided is a 510(k) summary for a medical device (BOLD® SCREW) seeking substantial equivalence to predicate devices, not a study report detailing acceptance criteria and performance data for an AI/ML device. Therefore, it does not contain the information requested in points 1 through 9, which are typically found in studies for AI/ML device evaluations.

The document primarily focuses on:

• Sponsor and contact information
• Device identification (name, classification, codes)
• Description of device components and material
• Intended use and indications for use
• Predicate devices for comparison
• Comparison of technological characteristics to predicate devices
• A brief mention of a mechanical study (rupture torque)
• FDA's substantial equivalence determination letter

Regarding the mechanical study mentioned:

A study on the rupture torque of the BOLD® SCREW was performed.

• Acceptance Criteria: The device needed to comply with the French Standard Nº NF-F-90-414 for resistance to torsion.
• Reported Device Performance: The BOLD® SCREW was "found to have a resistance to torsion in compliance with the selected Standard."

However, this is a mechanical performance study of a bone screw, not a study of an AI/ML device, and thus doesn't include the detailed "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, AUC, etc., or details about ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies).

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