(139 days)
The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or tissue fixation in the hand and wrist. Specific indications are listed below:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
The Arthrex Nano SwiveLock Suture Anchor is a two component suture anchor comprised of a hollow titanium anchor body and a PEEK (Polyetheretherketone) eyelet mounted on a disposable driver inserter. The anchor will be offered in a 2.5 mm diameter and 7 mm length. The anchor is sold sterile, single-use.
The document provided is a 510(k) summary for the Arthrex Nano SwiveLock Suture Anchor, a medical device. It details the device's characteristics and its substantial equivalence to a predicate device, rather than providing a study evaluating the performance of an AI-powered device. Therefore, I cannot extract information related to AI system acceptance criteria, reader studies, or ground truth establishment for AI.
However, I can provide information about the acceptance criteria and the study conducted for this specific medical device, which is a suture anchor.
Here's the information based on the provided text, adapted to the context of a medical device rather than an AI system:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Result) |
|---|---|
| Mechanical Performance: | |
| Pull-out strength | Statistically equivalent to the predicate device (K063479: Arthrex 2.5 mm PushLock). |
| Cyclic testing | Statistically equivalent to the predicate device (K063479: Arthrex 2.5 mm PushLock). |
| Biocompatibility: | |
| Bacterial Endotoxins Test (BET) | Meets pyrogen limit specifications (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14). |
| Cytotoxicity | Testing conducted in accordance with ISO 10993-1:2018. |
| Sensitization | Testing conducted in accordance with ISO 10993-1:2018. |
| Irritation | Testing conducted in accordance with ISO 10993-1:2018. |
| Genotoxicity | Testing conducted in accordance with ISO 10993-1:2018. |
| Systemic Toxicity | Testing conducted in accordance with ISO 10993-1:2018. |
| Subchronic/Subacute Toxicity | Testing conducted in accordance with ISO 10993-1:2018. |
| Implantation | Testing conducted in accordance with ISO 10993-1:2018. |
| Material Characterization | Testing conducted in accordance with ISO 10993-1:2018. |
| Other Attributes: | |
| Sterilization and Shelf-life | Assessment determined that the device does not introduce additional risks or concerns regarding sterilization and shelf-life, considering product, design, size, materials, manufacturing, and packaging. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for the mechanical (pull-out and cyclic) testing or the biocompatibility tests (BET, cytotoxicity, etc.). However, it indicates testing was conducted for these aspects.
- Data Provenance: Not specified in terms of country of origin. The mechanical testing was performed to demonstrate equivalence to a predicate device. Biocompatibility testing was done in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211, and 820, and in accordance with ISO 10993-1:2018. It is retrospective in the sense that results are being presented for a device that has already undergone testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a physical medical implant, not an AI system that requires expert ground truth for interpretation or diagnosis. The "ground truth" for this device's performance is established through objective physical and biological testing standards and comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation where adjudication methodologies (like 2+1, 3+1) would be used. Device performance is determined through laboratory testing against predefined specifications and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for AI systems or diagnostic tools where human interpretation or decision-making is involved. The Arthrex Nano SwiveLock Suture Anchor is a surgical implant.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's mechanical, physical, and biological properties were evaluated independently (e.g., pull-out strength, biocompatibility tests). These tests are inherent to the device itself. The results were then compared to those of a predicate device to establish substantial equivalence.
7. Type of Ground Truth Used
The "ground truth" or reference standard for this device's evaluation is primarily:
- Physical/Mechanical Performance Data: Measured forces (e.g., pull-out strength) and cycles under specific test conditions.
- Biological Standards: Compliance with pyrogen limits (BET) and established biocompatibility standards (e.g., ISO 10993-1:2018).
- Predicate Device Performance: The performance of the legally marketed Arthrex 2.5 mm PushLock (K063479) serves as a benchmark for demonstrating substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is not an AI system and therefore does not have a "training set" in the machine learning context.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
§ 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.