(69 days)
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 illiotibial 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.
The ANCHORLOK™ RL 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 anchor is manufactured from titanium alloy.
The provided text for K964786 is a 510(k) summary for a medical device called the ANCHORLOK™ RL Soft Tissue Anchor System. It describes the device, its intended use, and a summary of testing. However, the information available is insufficient to fully answer many of the requested questions concerning acceptance criteria and detailed study information.
Here's a breakdown of what can be extracted and what is missing, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pullout strength of the predicate Statak™ anchor | The ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Statak™ anchor. |
Missing Information:
- Specific quantitative values for the pullout strength of the predicate device (Statak™ anchor).
- Specific quantitative pullout strength values obtained for the ANCHORLOK™ RL Anchor.
- The statistical method used for comparison (e.g., p-value, confidence interval).
- Any other acceptance criteria beyond pullout strength.
2. Sample sized used for the test set and the data provenance
Missing Information:
- The text states "In vitro pullout strength testing in the pubis" but does not specify the sample size (number of anchors tested, number of times tested, etc.).
- Data provenance (country of origin, retrospective/prospective) is not mentioned. As it's in-vitro testing, country of origin might be less relevant than for patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable/Missing Information:
- This question is typically relevant for studies involving human interpretation (e.g., imaging studies). For a mechanical in-vitro test of pullout strength, there wouldn't be "experts establishing ground truth" in the same way. The ground truth would be the measured physical force.
4. Adjudication method for the test set
Not Applicable/Missing Information:
- Similar to point 3, adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human assessments (e.g., image interpretation). This is an in-vitro mechanical test, so an adjudication method among experts is not applicable for the primary outcome measure.
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 device is a physical soft tissue anchor system, not an AI or imaging device. Therefore, an MRMC study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable:
- This is a physical medical device, not an algorithm. Standalone performance as applied to algorithms is irrelevant here.
7. The type of ground truth used
Ground Truth:
- Physical measurement: The ground truth for pullout strength testing is the directly measured force required to remove the anchor from the test medium (pubis tissue in this case).
8. The sample size for the training set
Not Applicable/Missing Information:
- For an in-vitro mechanical test of a physical device, there isn't a "training set" in the context of machine learning. The device design and manufacturing process would be informed by engineering principles and possibly prior testing, but not a formally defined "training set" in this manner.
9. How the ground truth for the training set was established
Not Applicable/Missing Information:
- As per point 8, there isn't a "training set" in the machine learning sense for this type of device and testing.
§ 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.