(83 days)
The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder, Foot and Ankle, Elbow, Knee, Hip.
BioRaptor: Preloaded 2.9 mm suture anchor manufactured from PLA (Poly(L-Lactide)) incorporating either ultra high molecular weight polyethelene suture or polyester suture on a stainless steel inserter.
TwinFix: 2.8 and 3.5mm titanium suture anchor incorporating either ultra high molecular weight polyethylene or polyester suture. TwinFix anchors are available preloaded on a stainless steel inserter shaft or unassembled. TwinFix anchors are available with or a stammess stool inserter shaft is available in two lengths, regular and XL.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the TwinFix Ti and BioRaptor 2.9 suture anchors:
No acceptance criteria or study details are provided in the given text.
The document is a 510(k) summary of safety and effectiveness information, specifically regarding an indication expansion for existing devices (TwinFix Ti 2.8 & 3.5 and BioRaptor 2.9) to include hip labral repair.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance (Table 1): The document states: "The performance testing conducted includes bench and cadaver testing that demonstrates substantial equivalence for the indication of hip labral to soft tissue repair in other joints." However, it does not specify any numerical acceptance criteria (e.g., minimum pull-out strength, maximum displacement) or the actual results obtained from these tests. It only makes a general statement of "substantial equivalence."
- Sample Size and Data Provenance (2): No information is provided regarding the specific sample sizes used for bench or cadaver testing. Data provenance (country, retrospective/prospective) is also not mentioned.
- Number of Experts and Qualifications (3): The document mentions "cadaver testing" but does not indicate the involvement of experts in establishing ground truth for a test set, which would typically be relevant for imaging or diagnostic devices.
- Adjudication Method (4): Not applicable, as no expert review process or test-set ground truth establishment is described.
- MRMC Comparative Effectiveness Study (5): This type of study is usually conducted for diagnostic aids or AI-assisted interpretation, where human readers' performance is evaluated with and without AI. This document is about a physical medical device (suture anchors), so an MRMC study is not relevant here.
- Standalone Performance (6): "Standalone performance" usually refers to the algorithm's performance without human intervention, again relevant for AI or diagnostic software. This is not applicable to a physical suture anchor device.
- Type of Ground Truth (7): For mechanical devices like suture anchors, "ground truth" often refers to the actual mechanical properties measured (e.g., maximum load at failure) or direct observation during cadaveric procedures. The document does not detail how "ground truth" was established for the performance testing beyond stating "bench and cadaver testing."
- Training Set Sample Size (8) and Ground Truth Establishment (9): These concepts are primarily relevant for AI/machine learning models that require training data. A physical device like a suture anchor does not have a "training set" in this context. Its development involves engineering design, material science, and mechanical testing.
Summary of what the document does state regarding performance data:
- Type of Testing: Bench testing and cadaver testing.
- Purpose: To demonstrate substantial equivalence for hip labral repair to soft tissue repair in other joints, comparing it to predicate devices (Smith & Nephew TwinFix Ti 2.8 & 3.5 (K972326) and BioRaptor 2.9 (K031683)).
- Conclusion: The testing "demonstrates substantial equivalence."
In conclusion, while the document acknowledges that performance testing was conducted, it does not provide the specific details required in your request regarding acceptance criteria, sample sizes, expert involvement, or adjudication methods for that testing. This is common in 510(k) summaries, which often provide only high-level statements about testing results rather than detailed raw data or criteria.
§ 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.