(140 days)
Fixation and stabilization of bones of the feet; such as: Akin-Osteotomie, Scarf-Osteotomie, Chevron-Austin-Osteotomie, MPG-Arthrodesis, Closing-Wedge Osteotomie. The Scarf screw can be used for the fixation of almost all common osteotomies of the first metatarsal.
Fixation and stabilization of bones of the feet; such as Weil-Osteotomie
Not Found
The provided document is a 510(k) clearance letter from the FDA for two devices: OSS/(Scarf) Screws and OSW Screws (Twist-Off™ Screw for Weil-Osteotomie). This type of document establishes substantial equivalence to a predicate device, allowing the manufacturer to market the device.
However, a 510(k) clearance letter does not typically contain detailed information about acceptance criteria and the comprehensive study results that would be submitted to demonstrate performance against those criteria. The letter confirms that the FDA has reviewed the submission and found the devices substantially equivalent to legally marketed predicate devices, based on the information provided by the applicant.
Therefore, most of the information requested in your prompt cannot be extracted from this document. This document primarily focuses on the regulatory clearance for the devices and their intended indications for use.
Here's what can be inferred or stated based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided in this document. The 510(k) process relies on demonstrating substantial equivalence, often through a comparison of technological characteristics and performance data to a predicate device, but the specific acceptance criteria and detailed device performance are typically within the 510(k) submission itself, not the clearance letter.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in this document.
- 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 provided in this document.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in this document.
- 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. These are fixation screws, not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. These are fixation screws, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document.
- 8. The sample size for the training set: Not applicable as these are physical medical devices, not an AI/ML algorithm requiring a training set in that context.
- 9. How the ground truth for the training set was established: Not applicable for the same reason.
What the document does provide:
- Trade/Device Name: OSS/(Scarf) and OSW Screws
- Regulation Number: 21 CFR 888.3040
- Regulation Name: Smooth or threaded metallic bone fixation fastener
- Regulatory Class: II
- Product Code: HWC
- Indications for Use (OSS/(Scarf)-SCREW): Fixation and stabilization of bones of the feet; such as: Akin-Osteotomie, Scarf-Osteotomie, Chevron-Austin-Osteotomie, MPG-Arthrodesis, Closing-Wedge Osteotomie. The Scarf screw can be used for the fixation of almost all common osteotomies of the first metatarsal.
- Indications for Use (OSW-SCREW / Twist-Off™ Screw for Weil-Osteotomie): Fixation and stabilization of bones of the feet; such as Weil-Osteotomie.
- Prescription Use: Yes
- 510(k) Number: K042079
- Date of Clearance: December 20, 2004
To obtain the detailed study information, one would typically need to review the original 510(k) submission (if it were publicly available, which often it is not in full detail) or seek further information from the manufacturer.
§ 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.