(42 days)
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The design enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.
The provided text describes a 510(k) premarket notification for a medical device called the Hitch™ LactoSorb® Suture Anchor. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and a device's performance against those criteria is measured using a test set with corresponding ground truth.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, and expert adjudication cannot be extracted from this document as it does not contain information about a clinical or standalone performance study.
Here's an attempt to address the points based on the provided text, heavily indicating when the information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use. |
Explanation: The document does not define specific, quantifiable acceptance criteria for the device's performance (e.g., a certain pull-out strength, a specific failure rate, or a particular clinical outcome threshold). Instead, the basis for approval is "substantial equivalence" to a legally marketed predicate device. The performance is reported as meeting this substantial equivalence through non-clinical testing.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not applicable. No clinical or standalone device performance test set is described.
- Data provenance: Not applicable. The "Non-Clinical Testing" mentioned likely refers to bench-top or mechanical tests, not human data. No country of origin is specified for these non-clinical tests.
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 ground truth was established for a test set as no such clinical or performance study involving human data or expert assessment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there is no human-involved test set requiring expert consensus.
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
- No. This device is a suture anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an implantable medical device, not an algorithm. The "Non-Clinical Testing" could be considered a form of standalone performance assessment in a mechanical sense, but it's not "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For the non-clinical testing, the "ground truth" would likely be engineering specifications, material properties, and mechanical test standards, rather than clinical or expert-derived ground truth.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, no ground truth for it was established.
Summary:
The provided 510(k) summary is for a traditional medical device (a suture anchor) and primarily relies on demonstrating "substantial equivalence" to a predicate device through non-clinical laboratory testing. It does not involve AI, clinical studies with human participants, expert adjudication, or the establishment of ground truth in the manner that would be relevant for a diagnostic or AI-powered medical device. The information requested regarding acceptance criteria and study methodology is largely absent because the regulatory pathway chosen (510(k) for a device like this) typically focuses on comparative technological characteristics and function rather than detailed clinical performance studies with defined acceptance criteria for novel outcomes.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.