(63 days)
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).
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.