RESORBABLE LACTOSORB-L ACL CROSSPIN

• K Number: K014305
• Device Name: RESORBABLE LACTOSORB-L ACL CROSSPIN
• Manufacturer: ARTHROTEK, INC.
• Date Cleared: 2002-03-29 ( 88 days)
• Product Code: HTY , LEG
• Regulation Number: 888.3040
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K988497 , K974341 , K941941 , K991298 , K993025 , K011172
• Predicate For: N/A

Intended Use

The Resorbable LactoSorb-L® ACL Crosspin is indicated for ACL reconstruction.

Device Description

The Resorbable LactoSorb-L® ACL Crosspin is comprised of a PI LA:PGA copolymer. The threadless, push-in device is used for femoral fixation of a soft tissue graft. The Resorbable LactoSorb-L® ACL Crosspin includes a suture eyelet at the tip. This eyelet allows the device to be used with a technique similar to that utilized by cannulated devices, however, the crosspin is not cannulated.

AI/ML Overview

The provided document does not describe any clinical studies or acceptance criteria in the context of device performance in humans.

Instead, the document is a 510(k) premarket notification for the Resorbable LactoSorb-L® ACL Crosspin, where the manufacturer is seeking to establish substantial equivalence to previously marketed devices.

Here's what the document does state regarding testing:

• Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence."
• Clinical Testing: "Clinical testing was not used to establish substantial equivalence."

This means the device's safety and effectiveness were demonstrated through benchtop mechanical tests, comparing its physical properties to predicate devices. There was no human-subject study reported that would involve acceptance criteria for clinical performance or human reader analysis.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance (in human studies).
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study and effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 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.