(61 days)
The Smith & Nephew TWINFIX Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Foot/Ankle:
Hallux valgus repairs repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions
The TWINFIX Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter.
This document describes a 510(k) premarket notification for a medical device called the "Smith & Nephew TWINFIX Ultra PK Suture Anchor." It focuses on establishing substantial equivalence to a predicate device, not on demonstrating device performance against specific acceptance criteria through a clinical study in the same way an AI/ML device would. Therefore, most of the requested information for an AI/ML device study is not applicable.
Here's an analysis based on the provided text, highlighting what is and isn't available for a medical device clearance:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device 510(k), acceptance criteria are typically met through bench testing (mechanical, material, and sterilization validation) and comparison of technological characteristics to a legally marketed predicate device. The goal is to show the device is as safe and effective as the predicate, not necessarily to meet pre-defined performance thresholds against a "ground truth" as in an AI study.
| Acceptance Criteria (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Properties: | Testing demonstrated equivalent insertion and fixation properties. |
| (e.g., insertion force, fixation strength, tensile strength) | (Specific quantitative values are not provided in this summary document.) |
| Biocompatibility: | Materials (PEEK with polyethylene suture) are the same as the predicate and |
| (e.g., material safety, non-toxicity) | are well-established for medical implants. |
| Sterilization: | Same sterilization method (EO) as the predicate device. |
| Intended Use & Indications for Use: | Identical to the predicate device. |
| Device Design/Principles of Operation: | Similar (Screw-in suture anchor for proposed vs. Tap-in/Screw-in anchor |
| for predicate). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is typically not included in a 510(k) summary for a non-AI/ML device. The "test set" here refers to the samples used in bench testing. The document does not specify the number of anchors tested, nor the provenance of such test data (e.g., in-house lab, third-party lab). It's bench test data, not patient data.
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)
This is not applicable for a traditional medical device 510(k). "Ground truth" in the context of this device would relate to the physical and mechanical properties demonstrated through laboratory testing, not expert interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for mechanical bench testing of an orthopedic implant.
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/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is established through standards-based mechanical and physical testing. For example, tensile strength measured against an ASTM standard, or insertion force measured using a universal testing machine. The document mentions "performance testing conducted demonstrates that the insertion and fixation properties... is substantially equivalent." This implies laboratory measurements against accepted material and mechanical engineering principles.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no "training set" in the context of a physical medical implant's 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for this type of device.
Summary of the Study Discussed (510(k) Submission):
The "study" described in the provided text is a 510(k) premarket notification for the Smith & Nephew TWINFIX Ultra PK Suture Anchor. The primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (Smith & Nephew TWINFIX PK FT Suture Anchor, K072875).
- Type of Study: Non-clinical (bench) performance testing and comparative analysis with a predicate device. This is not an AI/ML device study.
- Objective: To show that the new device has equivalent safety and effectiveness to the predicate device, specifically regarding its "insertion and fixation properties."
- Methodology: The document states, "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent to the predicate TWINFIX FT PK suture anchor, cleared via K072875." It also notes that "differences in the new device and the predicate device do not raise any new issues of safety and efficacy."
- Key Findings: The device was deemed substantially equivalent to the predicate, and cleared by the FDA (K093228).
- Limitations (for AI/ML context): This document is a summary and does not provide detailed quantitative results, specific test protocols, or the number of samples used in the bench testing. It strictly focuses on the regulatory requirement of demonstrating substantial equivalence for a physical medical device.
§ 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.