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The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.

The EXTREMITY MEDICAL Compression Screw

This 510(k) Premarket Notification for the EXTREMITY MEDICAL Compression Screw does not contain information about acceptance criteria or a study proving the device meets them.

The provided document is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against predefined acceptance criteria. This type of submission relies on the fact that similar, legally marketed devices (predicates) have already met regulatory requirements.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details based on the information given.

Here's a breakdown of why and what information is missing:

1. Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative acceptance criteria (e.g., tensile strength, fatigue life, screw pull-out force thresholds) or report specific performance metrics of the EXTREMITY MEDICAL Compression Screw against such criteria. The "Statement of Technological Comparison" only broadly states similarity in design and materials to predicate devices.

2. Sample Sized used for the test set and the data provenance: Not applicable, as no performance study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study data is presented.

4. Adjudication method for the test set: Not applicable, as no performance study data is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a medical implant, not an imaging or diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a medical implant, not an AI algorithm.

7. The type of ground truth used: Not applicable, as no performance study data is presented.

8. The sample size for the training set: Not applicable, as no AI/algorithm training set is involved.

9. How the ground truth for the training set was established: Not applicable, as no AI/algorithm training set is involved.

Conclusion from the document:

The conclusion states: "The EXTREMITY MEDICAL Compression Screw is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation."

This indicates that the regulatory pathway chosen here (510(k)) relies on demonstrating similarity to existing, legally marketed devices, rather than comprehensive de novo performance testing against specific acceptance criteria.

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The "new" I.CO.S Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• · Fixation of bone fragments, in long bones or small bones fractures.
• · Fractures management in the foot or hand
• · Arthrodesis in hand, foot or ankle surgery
• · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
• · Treatment of inferior tibio fibular diastasis
  The size of the chosen screw should be adapted to the specific indication.

The "new" I.CO.S" Screw is a cannulated compression screw with non-theaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controled by the surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. It is identical in design to the I.CO.S® Screw (K993762)

The provided document is a 510(k) summary for the I.CO.S® Screw, a bone fixation device. It describes the device, its intended use, and claims substantial equivalence to predicate devices already on the market. However, this document does not contain information about acceptance criteria, detailed study designs, sample sizes, or expert involvement as typically found in a clinical or performance study report for AI/CAD devices.

The "Summary of Studies" section (Section O) only briefly mentions that the "rupture torque of the 'new' I.CO.S® Screw is the same as for the device cleared, since the design has not changed. It was compared with requirements of the French Standard NºNF-S -90414 and found to have a resistance torsion in compliance with the selected standard." This is a purely mechanical performance test against a standard, not a study of device performance in a clinical setting or its effectiveness with human readers.

Therefore, I cannot provide the requested information from the provided text. The questions posed relate to the evaluation of AI/CAD devices, which involve performance metrics like sensitivity, specificity, reader studies, and ground truth establishment, none of which are present in this 510(k) summary for a mechanical bone screw.

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