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K Number
K063635
Device Name
SBI FOREFOOT SET
Manufacturer
SMALL BONE INNOVATIONS, INC.
Date Cleared
2007-08-29

(266 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.

Device Description

The SBi Forefoot Set consists of screws and washers that provide internal fixation of bones. The devices are supplied non-sterile and are available in various sizes and configurations.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device (SBi Forefoot Set), which is a regulatory document submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document does not typically contain information about specific acceptance criteria and the detailed study results you've requested regarding device performance, sample sizes, ground truth establishment, or clinical comparative effectiveness studies.

The document primarily focuses on:

  • Identifying the manufacturer and device.
  • Classifying the device and its product code.
  • Stating its intended use and materials.
  • Asserting its substantial equivalence to other legally marketed devices.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present. The document declares substantial equivalence, implying the device meets performance standards similar to predicates, but doesn't detail those standards or specific performance metrics.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
  6. If a standalone performance study was done: Not mentioned.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not applicable, as this is a physical medical device (screws and washers for bone fixation), not an AI/software device that would have a "training set."
  9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The 510(k) process for devices like the SBi Forefoot Set typically relies on mechanical testing, material specifications, and comparison to predicate devices, rather than clinical efficacy studies involving "test sets" with "ground truth" established by experts in the context of an AI/software device.

§ 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.