(40 days)
The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Altoid repairs), Foot and Ankle (Hallux Valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions), Elbow, Wrist and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Tennis elbow repair, Biceps tendon reattachment), Knee (Extracapsular repairs and reattachments of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia, joint capsule closure to anterior proximal tibia; Extracapsular reconstruction, Iliotibial band tenodesis; Patellar realignment and tendon repairs), Bladder Neck Suspension (Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility).
The Pre-loaded Bio-Anchor is an injection molded Poly (L-lactic) acid suture anchoring device with an attached nonabsorbable braided polyester surure USP size #2. The device is circular in shape with three cylindrical ribs perpendicular to the long axis. The suture is passed through the eyelet of the anchor and attached to a wire by shrink tubing.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Pre-loaded Bio-Anchor Absorbable Suture Anchor). This type of document is a premarket notification to the FDA, demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device.
It is crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not necessarily on presenting original clinical studies with acceptance criteria, sample sizes, and ground truth establishment in the way one might find for a novel, high-risk device requiring PMA (Premarket Approval).
Therefore, the information you've requested about specific acceptance criteria, detailed study designs, and performance metrics (like effect size for MRMC studies or standalone algorithm performance) is not typically found in a 510(k) summary like this one.
Instead, 510(k) submissions typically reference:
- Performance data from the predicate device: The new device is compared to a previously cleared device.
- Bench testing: To demonstrate physical and mechanical properties.
- Biocompatibility testing: To ensure safety when in contact with the body.
- Sterilization validation: To confirm the device can be consistently sterilized.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. It states: "Testing has been done to prove safety and effectiveness of the devices." The primary "performance" discussed is the demonstration of substantial equivalence to predicate devices in design, function, and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. Since the submission focuses on substantial equivalence and refers to "testing," it's likely referring to bench-top mechanical testing, biocompatibility testing, and sterilization validation, not large-scale clinical trials that would have clearly defined test sets in terms of patient data.
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 information is not applicable/not provided. The assessment for a suture anchor is generally based on mechanical properties and biological interactions, not interpretation of images or patient data that would require "ground truth" established by human experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. As explained above, the "test set" and ground truth establishment do not align with methods requiring adjudication by experts.
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
An MRMC study is not applicable to this type of device. This device is a physical implant (suture anchor), not an AI diagnostic tool or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in AI/diagnostic studies is not directly applicable here. For a mechanical device like a suture anchor, "ground truth" would be related to material properties meeting specifications, biomechanical performance (e.g., pull-out strength), and biocompatibility, which are verified through engineering and biological testing, not clinical "outcomes data" in the same sense as a drug or complex diagnostic. The basis for safety and effectiveness is largely demonstrated through comparison to predicates and testing of physical properties.
8. The sample size for the training set
This information is not applicable/not provided. Training sets are relevant for AI algorithms, which this device is not.
9. How the ground truth for the training set was established
This information is not applicable/not provided. Training sets and ground truth establishment methods are primarily for AI/machine learning models.
§ 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.