(43 days)
The Smith & Nephew KINSA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP Lesion Repairs Capsular Shift of capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis
The KINSA Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.
The provided text describes a 510(k) submission for the Smith & Nephew KINSA Suture Anchor, demonstrating its substantial equivalence to a predicate device, the Smith & Nephew BIORAPTOR 2.9 Suture Anchor (K053344). The information provided is primarily focused on regulatory submission and comparison to a predicate device, rather than detailed performance study data against specific, quantitative acceptance criteria. Therefore, several sections of your request cannot be fully populated as the information is not present in the provided document.
Here's an attempt to extract and infer information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence in design | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in design... to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344." |
| Substantial equivalence in materials | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in... materials... to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344." The KINSA Anchor is manufactured from PEEK polymer. The BIORAPTOR is not explicitly stated to be PEEK in this document, but equivalence in materials is asserted. |
| Substantial equivalence in function | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in... function... to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344." The KINSA design allows suture knot within anchor body, suture loop with tension suture, and completion of repair without knot tying. The functional equivalence to BIORAPTOR 2.9 (K053344) is stated. |
| Substantial equivalence in intended use and indications for use | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the... BIORAPTOR Suture Anchor (K053344)." "The proposed and the predicate devices both have the same intended use, indications for use, suture material." Intended use: "reattachment of soft tissue to bone." Specific indications for use are listed for the shoulder (e.g., Capsular Stabilization, Bankhart Repair, Rotator Cuff Tear repairs, Biceps tenodesis). |
| Performance testing demonstrates substantial equivalence | "The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew BIORAPTOR 2.9 Suture Anchor, cleared in K053344." "The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy." |
| No new safety or efficacy issues | "The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy." |
Study Proving Acceptance Criteria:
The document refers to "Summary Performance Data" and "performance testing conducted" which demonstrated substantial equivalence to the predicate device, the Smith & Nephew BIORAPTOR 2.9 Suture Anchor (K053344). However, the specific details of this study, including test methodologies, quantitative results (e.g., pull-out strength, fatigue testing), and the actual acceptance criteria (e.g., "must meet or exceed X N/mm of pull-out strength") are not provided in the excerpt. The document states that the testing demonstrated that "differences in the new device and the predicate device do not raise any new issues of safety and efficacy." This implies that the performance data for KINSA was within acceptable limits when compared to the established performance of BIORAPTOR 2.9.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified, but implied to be from internal Smith & Nephew performance testing, likely conducted in a controlled lab environment given the nature of the device (suture anchor). No mention of patient data (retrospective or prospective) from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as the study described is a performance/mechanical testing study comparing a new device to a predicate, not one requiring expert consensus on clinical or image interpretation.
4. Adjudication method for the test set
Not applicable for a performance/mechanical testing study.
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 a medical device (suture anchor) for physical implantation, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a physical medical device.
7. The type of ground truth used
For a suture anchor, the "ground truth" for performance testing would typically be objective, quantitative measurements of mechanical properties (e.g., ultimate tensile strength, pull-out strength, fatigue life, suture retention strength) under controlled laboratory conditions, often established through standardized testing methods (e.g., ASTM standards). The document indicates "performance testing" was conducted to demonstrate equivalence, implying these types of objective measurements were the basis for comparison.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.