(81 days)
The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:
- In the 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;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- Female urinary incontinence due to urethral hypermobility;
- In the 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 illotibial band tenodesis:
- In the 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;
- Lateral canthoplasty.
The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile device, available in two configurations: the ANCHORLOK™, which is provided sterile, preloaded with suture and a disposable, single use driver, and the ANCHORLOK™ RL, which is provided sterile and is designed for use with reusable, resterilizable driver instrumentation, and suture provided by the surgeon. The anchors for both configurations are made of titanium alloy.
The acceptance criteria and study details for the ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System are provided below, based on the given text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pullout Strength (In vitro) | ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Mitek anchor. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the in vitro pullout strength testing. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it is an in vitro test, "retrospective" or "prospective" as applied to clinical data isn't directly relevant.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is an in vitro pullout strength test, which typically relies on laboratory measurements rather than expert consensus on a test set in the way a clinical study would.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the document. The study described is an in vitro mechanical test, not a study requiring adjudication of human readings or interpretations.
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
There was no MRMC comparative effectiveness study mentioned. The device is a soft tissue anchor system, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the device described. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established through in vitro pullout strength testing. This involves subjecting the device to controlled mechanical forces to measure its resistance to being pulled out of a simulated soft tissue material. The performance was then compared to a predicate device.
8. The Sample Size for the Training Set
This information is not applicable and is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable. The device is a physical implant, not a machine learning algorithm that requires ground truth for a training set.
§ 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.