(260 days)
The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.
This document describes the BioKnotless Anchor, a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed for soft tissue repair to bone. The information provided outlines the safety and effectiveness summary as required for a 510(k) premarket notification.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a specific table detailing such criteria. However, it mentions the types of tests performed and the conclusion regarding substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Integrity: Anchor pullout strength from bone. | "Anchor pullout from bone testing... were conducted on the device." Data "supported the substantial equivalence." |
| In Vitro Performance: Other in vitro mechanical characteristics. | "...and in vitro testing were conducted on the device." Data "supported the substantial equivalence." |
| Biocompatibility: Meet established biocompatibility standards. | "Biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, 1995, Use of International Standard ISO-10933, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed..." Data "supported the substantial equivalence." |
| Substantial Equivalence: To predicate devices (Mitek - Knotless Anchor and Mitek - Panalok™ Wedge Anchor). | "Based on the Indications for Use, technological characteristics and safety and performance testing, the BioKnotless Anchor has been shown to be substantially equivalent to predicate devices..." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for the functional and integrity bench testing or the biocompatibility testing. The data provenance is not explicitly stated beyond the mention of "bench testing" and "in vitro testing," which generally implies laboratory-controlled studies. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical sense, as these were bench and in vitro tests, not human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The study involved bench testing and in vitro performance, not expert-derived ground truth as would be relevant for diagnostic AI/medical imaging devices. The "ground truth" here would be the physical properties and performance measured directly by scientific methods and instrumentation.
4. Adjudication method for the test set
This section is not applicable for the type of testing described (bench and in vitro performance). Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert interpretation, which is not the case here.
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, an MRMC comparative effectiveness study was not done. This device is a physical surgical anchor, not an AI or diagnostic imaging device that involves human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The BioKnotless Anchor is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation was based on objective, measurable physical and chemical properties and performance characteristics. This includes:
- Mechanical Strength: Measured through tests like anchor pullout from bone.
- In Vitro Performance: Other measurable mechanical properties under laboratory conditions.
- Biocompatibility: Assessment against established international standards (ISO-10933), likely involving laboratory assays and material characterization.
These are not "expert consensus," "pathology," or "outcomes data" in the traditional sense, but rather direct measurements of the device's physical and biological interactions.
8. The sample size for the training set
This section is not applicable. There is no "training set" in the context of evaluating a physical medical device like a surgical anchor. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this type of device evaluation.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.