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K Number
K032197
Device Name
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
Manufacturer
SMITH & NEPHEW, INC.
Date Cleared
2003-08-08

(21 days)

Product Code
MAI
Regulation Number
888.3030
Type
Special
Panel
OR
Reference & Predicate Devices
K011299
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Reattachment of soft tissue to bone

Indications for Use:

Shoulder:

  1. Bankart Lesion Repair
  2. SLAP Lesion Repair
  3. Acromioclavicular separation repairs
  4. Rotator Cuff Repair
  5. Capsular shift or capsulolabral reconstruction
  6. Biceps tenodesis
  7. Deltoid Repair

Foot and Ankle:

  1. Hallux Valgus repair
  2. Medial or Lateral instability repairs/reconstruction
  3. Achilles tendon repair/reconstruction
  4. Midfoot reconstruction
  5. Metatarsal ligament/tendon repairs/reconstruction

Elbow, Wrist, and Hand:

  1. Scapholunate ligament reconstruction
  2. Ulnar or radial collateral ligament reconstruction
  3. Lateral epicondylitis repair
  4. Biceps tendon reattachment

Knee:

  1. Extra-capsular Repairs:
    1a. Medial Collateral Repair
    1b. Lateral Collateral Ligament
    1c. Posterior Oblique Ligament
  2. Iliotibial band tenodesis
  3. Patellar realignment and tendon repairs, including vastus medialis obliquos advancement
Device Description

The Twin Fix AB 6.5 mm anchor is a bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached.

AI/ML Overview

I am sorry, but the provided text describes a medical device (Twin Fix AB™ 6.5 mm suture anchor) and its intended use, along with regulatory information, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device. It lists:

  • The device's name, common name, and classification.
  • The predicate device.
  • A description of the device.
  • Its intended use and specific indications for use across different anatomical areas.
  • A statement of comparison of technological characteristics, asserting it is "identical in design, operating principle, material and intended use" to the predicate device.
  • The FDA's decision letter of substantial equivalence.

Therefore, for the information you requested, I can only state the following based on the provided text:

  1. A table of acceptance criteria and the reported device performance: Not available in the provided text.
  2. Sample size used for the test set and the data provenance: Not available in the provided text.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.
  4. Adjudication method for the test set: Not available in the provided text.
  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, as this is a physical medical device (suture anchor), not an AI/imaging diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
  7. The type of ground truth used: Not available in the provided text.
  8. The sample size for the training set: Not applicable, as this describes a physical medical device, not a machine learning model.
  9. How the ground truth for the training set was established: Not applicable, as this describes a physical medical device, not a machine learning model.

This type of 510(k) submission for a Class II device like a suture anchor typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive new clinical trial data with acceptance criteria for device performance. The "study" mentioned would likely refer to bench testing and material characterization to ensure consistency with the predicate, which is not detailed in this summary.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.