(90 days)
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:
| Procedure | Joint |
|---|---|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |
| Bicep Tenodesis | Shoulder |
| Gluteus Medius Repair | Hip |
| Medial Patellofemoral Ligament (MPFL) | Knee |
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFTTM Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (8-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
This document is a 510(k) Premarket Notification for a medical device, the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver. It states that the proposed device is substantially equivalent to a previously cleared predicate device (K170501) with the same name. Therefore, the information provided focuses on demonstrating this equivalence rather than establishing novel acceptance criteria or conducting studies to prove the device meets them from scratch.
However, based on the type of information typically required for such submissions and what is presented, we can infer some aspects and highlight what is not explicitly stated in terms of acceptance criteria and a detailed study report.
Here's an analysis based on the provided text, focusing on the requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria in a table format, nor does it explicitly report numerical performance against such criteria. Instead, it states that "Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."
Inferred Performance/Criteria (based on "Verification Testing" and "Validation Testing"):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reliability | Met (implicitly, deemed substantially equivalent) |
| Ultimate Fixation Strength | Met (implicitly, deemed substantially equivalent) |
| Cyclic (Testing) | Met (implicitly, deemed substantially equivalent) |
| Sterilization | Met (implicitly, deemed substantially equivalent) |
| Pyrogenicity (Endotoxin) | Met the endotoxin limits |
| Biocompatibility | Met (implicitly, deemed substantially equivalent) |
| Shelf-life | Met (implicitly, deemed substantially equivalent) |
| User Validation | Met (implicitly, deemed substantially equivalent) |
| Packaging | Met (implicitly, deemed substantially equivalent) |
| Transportation | Met (implicitly, deemed substantially equivalent) |
| Clinical Performance (General) | "Test parameters utilized were supported by clinical data in the literature to support the specific indications and corresponding anatomic locations in this submission." |
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 the sample sizes used for any of the verification or validation tests. It also does not mention the country of origin or whether the data was retrospective or prospective. The statement about "clinical data in the literature" implies external, possibly previously published data, rather than specific new test set provenance.
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 entire section is not applicable to this type of device submission. This device is a surgical implant (suture anchor), not an AI/diagnostic software. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance. The "ground truth" for this device relates to its mechanical properties, biocompatibility, and sterilization, which are evaluated through laboratory and material testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no diagnostic test set or expert adjudication process for this device.
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 a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a surgical implant without an algorithmic component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is typically defined by:
- Engineering specifications and standards: These define acceptable ranges for mechanical strength, material composition, and dimensional accuracy.
- Biocompatibility standards: ISO 10993 series and other relevant standards define acceptable biological responses to the materials.
- Sterilization validation standards: These ensure the device is sterile according to established protocols.
- Clinical literature: As indicated, "clinical data in the literature" was used to support the indications, implying that established clinical outcomes data informed the acceptability of the device's intended use and performance profile.
8. The sample size for the training set
This is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.