(23 days)
The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: rotator cuff repair
The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:.
Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, , biceps tenodesis, acromio-clavicular separation .
Elbow: Biceps tendon reattachment
Ankle: Achilles tendon repair/reconstruction, lateral stabilization, medial stabilization at the medial talus site
Knee: Medial collateral ligament repair, lateral collateral ligament repair, joint capsule closure to anterior proximal tibia, posterior oblique ligament or joint capsule to tibia repair, extra capsular reconstruction / ITB tenodesis, patellar ligament and tendon avulsion repairs
Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, , capsule shift repair (glenoid rim)
Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC Anchor Plus Dual Suture (with ORTHOCORD) and Panalok are preloaded, PLA disposable suture anchor/ inserter assemblies designed to allow soft tissue repair to bone. The anchors are an identical anchors as that of the Panalok RC Anchor Plus (K041117) and Panalok Anchor (K970896) in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture, Panacryl Suture, Orthocord Suture.
This document is a 510(k) Pre-market Notification for medical devices, specifically suture anchors with an Orthocord suture. The primary claim for substantial equivalence is based on a comparison to previously cleared predicate devices, an important distinction from studies evaluating AI performance.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to consensus and voluntary standards. | Device descriptions and conformance to consensus and voluntary standards were the basis of the substantial equivalence determination. |
| ORTHOCORD suture conformed to the USP monograph for absorbable sutures. | "Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures..." |
| Suture compatibility and deployment met predetermined acceptance criteria. | "...and the suture compatibility and deployment met predetermined acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of an algorithm or AI. The testing mentioned is bench testing of mechanical properties.
- Sample size for bench testing: Not explicitly stated.
- Data provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not on patient data. Therefore, there's no country of origin or retrospective/prospective distinction for patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the bench testing was based on predefined engineering specifications and the USP monograph for sutures, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the testing involved objective physical measurements against established standards (e.g., USP monograph, predetermined acceptance criteria for suture compatibility/deployment).
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 document describes a traditional medical device (suture anchors) and its substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-assisted performance improvement are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for proving the device's performance (or substantial equivalence) was:
- USP monograph for absorbable sutures: A pharmacopeial standard for material properties.
- Predetermined acceptance criteria: Engineering specifications and performance metrics for suture compatibility and deployment.
- Predicate device characteristics: The design, configuration, and dimensions of the new anchors were identical to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and thus there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned in this document.
Summary:
The provided text is a 510(k) Pre-market Notification focusing on substantial equivalence for a physical medical device (suture anchors). The "study" mentioned is bench testing to confirm material properties (ORTHOCORD suture conformance to USP monograph) and mechanical performance (suture compatibility and deployment) against predetermined engineering acceptance criteria. It does not involve human readers, clinical data sets, AI algorithms, or the typical performance metrics associated with AI/software devices.
§ 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.