(110 days)
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair
The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocry18 Rapide " (composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable polydioxanone (PDS®) and non-absorbable polyethylene braided composite suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The device is provided as sterile; the device is for single patient use only.
The provided text describes a 510(k) summary for the GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY. This is a medical device, specifically a suture-anchor for soft tissue fixation to bone. The summary details its classification, predicate devices, and indications for use.
However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results as would be typical for a new, non-equivalent device. The information available about performance testing is limited.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient fixation force to secure soft tissue to bone | "Fixation force testing was conducted under in vitro condition throughout two times of healing period, and substantial equivalence of fixation performance to the predicate device has been confirmed." |
| Biocompatibility of materials | "Material biocompatibility has been also confirmed." |
| No new issues of safety and efficacy compared to predicate devices | "The proposed device raises no new issue of safety and efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document only mentions "fixation force testing was conducted." The number of samples tested is not quantified.
- Data Provenance: The testing was "in vitro." The country of origin for the data is not specified, but the applicant is DePuy Mitek, a Johnson & Johnson company, located in Raynham, MA, USA, suggesting the testing was likely conducted in the US or by a contracted lab. The testing is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or ground truth establishment in the context of clinical studies for this device. The documentation focuses on non-clinical performance testing and comparison to predicate devices, which does not typically involve expert review of clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was non-clinical testing, not a clinical study involving adjudication of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical implant (suture anchor), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For fixation force testing: The "ground truth" would be the measured physical properties of the device (e.g., pull-out strength, stiffness) compared against pre-defined engineering specifications or the performance of the predicate device. This is based on objective measurement rather than expert consensus or pathology in a clinical sense.
- For material biocompatibility: This typically involves established biocompatibility testing standards (e.g., ISO 10993 series) which determine if the material elicits an adverse biological response.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of physical medical device submission, as it does not involve machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.