(72 days)
The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs - Biceps tenodesis - Foot and Ankle - Lateral instability repairs/reconstructions - Elbow, Wrist and Hand - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment - Knee - Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
This document, K964324 for the Multitak Suture System™, is a 510(k) submission to the FDA. It does not include performance data from a clinical study to demonstrate the device meets acceptance criteria.
The document explicitly states: "The nature of device changes do not necessitate performance data testing." This indicates that the submission is for a modification to a previously cleared device (Multitak SS Suture System, K934183) and, based on the FDA's guidance for 510(k) submissions, the changes were deemed not significant enough to require new clinical performance data to prove substantial equivalence. Therefore, there is no acceptance criteria or study outlined in this document.
To answer your specific questions in the format requested, I must state that the information is "Not Applicable" or "Not Provided" as no performance study or acceptance criteria are detailed in this particular document.
Here's how I would structure the response given the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
| (No performance data provided in this submission) | (No performance data provided in this submission) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. No test set or performance data is presented in this submission.
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 Applicable. No test set or ground truth establishment is described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No test set or adjudication method is described in this submission.
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. No MRMC study was conducted or described in this submission. This device is a surgical suture system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This device is a surgical suture system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No ground truth is described as no performance study was conducted.
8. The sample size for the training set
Not Applicable. No training set is described as no performance study was conducted.
9. How the ground truth for the training set was established
Not Applicable. No ground truth for a training set is described as no performance study was conducted.
§ 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.