(47 days)
The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following:
- repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a SLAP lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction:
- repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation:
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis:
- repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments
The ANCHORLOK™ II Soft Tissue Anchor System is a single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve. The surgeon uses suture according to preference. The anchor is manufactured from titanium alloy.
This document is a 510(k) summary for the ANCHORLOK™ II Soft Tissue Anchor System. It describes a medical device, not a study or AI algorithm. Therefore, many of the requested elements pertaining to AI studies, like acceptance criteria for an AI model, sample sizes for training/test sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance, are not applicable here.
However, I can extract information related to the device's testing and intended performance based on the provided text.
Here's the closest interpretation of your request given the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format with corresponding "reported device performance" values for the ANCHORLOK™ II. Instead, it refers to a testing methodology and a general conclusion about performance.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance (Anchor) | Meet or exceed in vivo performance of the predicate 5.0mm anchor. | The 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor. |
| Suture Performance | Meet or exceed USP values for Nylon™ monofilament sutures. | The in vivo performance of Nylon™ monofilament sutures meets or exceeds the values established by USP for these devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for testing the anchors or sutures. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective. It only states that the devices "were tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993."
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)
This is not applicable as the document describes a physical medical device, not a digital image analysis or diagnostic AI system requiring expert ground truth or adjudication. The "testing" refers to mechanical and material performance rather than diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device's mechanical testing.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the anchor testing, the "ground truth" or benchmark was the "in vivo performance of the 5.0mm anchor" (presumably the predicate device). For the suture testing, the "ground truth" was "values established by USP for these devices." This indicates a reliance on established standards and comparative performance to an existing device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.