(68 days)
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissues.
The provided text describes a 510(k) summary for the Smith & Nephew TwinFix Ti Quick T, a suture anchor device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a clinical or analytical validation study for an AI/CADe device.
Therefore, many of the requested categories are not applicable to this type of submission. This 510(k) is for a physical medical device (suture anchor), not an AI/CADe system.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A):
1. Table of Acceptance Criteria and Reported Device Performance
This information is typically found in performance testing reports for new medical devices, which are often summarized in the 510(k) submission but not explicitly detailed with acceptance criteria and results in this format. The 510(k) submission for the Smith & Nephew TwinFix Ti Quick T focuses on demonstrating substantial equivalence to predicate devices based on design, function, and intended use, rather than specific performance metrics against pre-defined acceptance criteria for a new clinical study.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Explanation: The 510(k) summary provided does not contain a table of acceptance criteria or specific performance data from a new study designed to meet those criteria. The submission aims to show that the new device is "substantially equivalent in design, function, and intended use" to existing predicate devices (Acufex T-Fix Rotator Cuff Guide System, K941364 and PEBA Anchor/Suture Combination, K972326). Such submissions typically rely on descriptive comparisons, material safety data, and potentially mechanical testing data (not included here) rather than detailed clinical performance against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a physical medical device (suture anchor) and focuses on establishing substantial equivalence via comparison to predicate devices, not on a clinical "test set" in the context of an AI/CADe study. There is no mention of a test set, data provenance, or study design.
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. This information pertains to studies establishing ground truth for diagnostic or AI/CADe performance, which is not relevant to this 510(k) submission for a physical surgical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there is no "test set" and no diagnostic performance evaluation in the context of this 510(k) submission, adjudication methods are not relevant.
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 is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This type of information is relevant for diagnostic performance studies, not for the substantial equivalence demonstration of a physical surgical device like a suture anchor.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or ground truth establishment relevant in the context of an AI/CADe system for this 510(k) submission.
§ 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.