(74 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Y-Knot All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a disposable inserter. The suture anchors are constructed of a flat suture that is interlaced longitudinally along its central width by double and triple suture strands. The flat suture and the double and tripled loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable inserter has a stainless steel shaft supporting the forked shaped tip, and a polycarbonate handle. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. The finished device is provided sterile, for single use.
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures features both surgical techniques for self-punching and pre-drill pilot hole insertion.
The provided text describes a 510(k) submission for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific performance acceptance criteria in the manner of an AI/ML device.
Here's an analysis based on the information provided, highlighting why it doesn't directly fit the AI/ML device study criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or reported device performance in a comparative table format as might be expected for an AI/ML device. Instead, it lists the types of testing performed to demonstrate safety and effectiveness for a surgical anchor:
| Acceptance Criteria Type | Reported Device Performance (Implicitly Met) |
|---|---|
| Fixation strength / pull-out | Tested (implied to meet requirements for substantial equivalence) |
| Cyclic loading | Tested (implied to meet requirements for substantial equivalence) |
| Insertion | Tested (implied to meet requirements for substantial equivalence) |
| Biocompatibility | Tested (implied to meet requirements for substantial equivalence) |
| Sterilization | Tested (implied to meet requirements for substantial equivalence) |
| Shelf-life | Tested (implied to meet requirements for substantial equivalence) |
| Packaging/transportation | Tested (implied to meet requirements for substantial equivalence) |
The core "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate device. This means the new device is as safe and effective as the legally marketed predicate. The tests performed are to support this claim.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the tests (e.g., number of anchors tested for pull-out strength). It also does not mention data provenance (country of origin, retrospective/prospective) because the tests described are bench and lab tests on the physical device, not clinical data involving human subjects or real-world usage data in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The "ground truth" for a physical device like a surgical anchor is based on engineering specifications, material science, and biomechanical performance standards, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a physical medical device's verification and validation testing. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation.
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
This is not applicable. This device is not an AI/ML diagnostic or assistive tool that would involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be defined by engineering specifications, biomechanical standards, and material properties that ensure its function (e.g., strength, durability, biocompatibility) is consistent with its intended use and equivalent to the predicate device. This is established through the specific tests listed (fixation strength, cyclic loading, etc.).
8. The sample size for the training set
This is not applicable. This device does not involve a "training set" as it is a physical surgical implant, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable for the reason stated above.
In Summary:
The provided document details a 510(k) submission for a non-absorbable suture anchor. The "study" referenced is the verification and validation testing of the device, which aims to demonstrate its safety and effectiveness and its substantial equivalence to a predicate device. The criteria for demonstrating this are based on established engineering and biocompatibility standards for surgical implants, not on AI/ML performance metrics, clinical reader studies, or data provenance in the way one would describe a software-based AI device.
§ 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.