(25 days)
The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle:
· Medial or lateral instability repairs/reconstructions
· Achilles tendon repairs/reconstructions
The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.
The provided text is a 510(k) summary for the Smith & Nephew Q-FIX® ULTRA All-Suture Anchor. This document describes a medical device and its equivalence to existing legally marketed devices, primarily through bench testing. It does not describe an AI/ML powered device, nor does it involve a study with human readers, ground truth establishment, or typical AI acceptance criteria.
Therefore, many of the requested fields cannot be populated as they are not applicable to this type of device submission.
Here's the information that can be extracted, and explanations for why other fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed."
However, the specific numerical acceptance criteria and the quantitative results for each test are not provided in this summary. The summary only states that the device "met all required specifications" and that "Results for all tests passed."
| Test Type | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Insertion Testing | Not explicitly stated | Met all required specifications / Passed |
| Static Fixation Testing | Not explicitly stated | Met all required specifications / Passed |
| Cyclic Loading Testing | Not explicitly stated | Met all required specifications / Passed |
| Knot Tensile Strength Testing | Not explicitly stated | Met all required specifications / Passed |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a non-clinical bench study on a physical medical device. There is no "test set" in the context of an AI/ML algorithm. The "test set" would refer to the number of physical devices or constructs tested for each bench test. This information is not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no "ground truth" to establish for a physical medical device bench test in the context of human expert review. The evaluation criteria are based on engineering specifications and physical measurements.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" required for physical device bench testing in the context of human expert disagreement.
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 powered 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 powered device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device, the "ground truth" for performance is based on established engineering principles, material properties, and biomechanical standards against which the device's physical performance is measured.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML powered device. There is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML powered device. There is no "training set" or ground truth in the AI context.
§ 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.