(22 days)
The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER 1. Bankart repair - 2. SLAP lesion repair 3. Rotator cuff repair - 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site - 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus - 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW - 1. Biceps tendon reattachment - 2. Tennis elbow repair ANKLE - 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site - Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE - 1. Medial collateral ligament repair - 2. Lateral collateral ligament repair - 3. Joint capsule closure to anterior proximal tibia - 4. Posterior oblique ligament or joint capsule to tibia repair - 5. Extra capsular reconstruction / ITB tenodesis - 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER - 1. Bankart repair - 2. SLAP lesion repair - 3. Rotator cuff repair - 4. Capsule shift repair (glenoid rim)
The Lupines Plus The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER - 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW 1. Biceps tendon reattachment 2. Tennis elbow repair ANKLE 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia 4. Posterior oblique ligament or joint capsule to tibia repair 5. Extra capsular reconstruction / ITB tenodesis 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 2. SLAP lesion repair 3. Rotator cuff repair 3. Rotator cuff repair 4. Capsule shift repair (glenoid rim)
Bioknotless Plus Anchor / Lupine Plus are a preloaded, absorbable disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Bionotless Anchor / Lupine Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor systems may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
The provided text is for a 510(k) summary for the Bioknotless Plus Anchor and Lupine Plus Anchor. This document is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study describing the performance of a new AI/software-as-a-medical-device (SaMD) or a new diagnostic tool.
The information requested in the prompt (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the rigorous validation of diagnostic algorithms or imaging AI. This document describes a physical medical device (suture anchors) and its substantial equivalence to existing predicate devices, primarily based on design, indications for use, and bench testing, not on clinical performance metrics like sensitivity, specificity, or reader agreement that would be relevant to an AI/SaMD.
Therefore, I cannot extract the specific details requested in the prompt because the document does not contain them as it pertains to AI/SaMD validation.
However, I can provide what is available in the document regarding the "study" referenced, which is bench testing for a physical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states:
"Bench testing was performed demonstrating that the Bioknotless Anchor Plus / Lupine Anchor Plus met predetermined acceptance criteria."
However, the specific "predetermined acceptance criteria" (e.g., specific tensile strength values, insertion force ranges, etc.) and the exact "reported device performance" (e.g., actual measured strength values) are not detailed in this summary document. The summary only confirms that the criteria were met.
2. Sample size used for the test set and data provenance:
Not applicable/not provided. The document refers to "bench testing" which implies in-vitro mechanical tests, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/SaMD (e.g., expert consensus on clinical findings, pathology reports) is not relevant for bench testing of a physical anchor's mechanical properties.
4. Adjudication method for the test set:
Not applicable.
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:
No. This is not an AI/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/SaMD device.
7. The type of ground truth used:
For bench testing of a medical device, the "ground truth" would be established physical/mechanical property standards or engineering specifications. The document implies these were used ("predetermined acceptance criteria"), but doesn't specify them.
8. The sample size for the training set:
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided 510(k) summary is for a physical medical device (suture anchors) and describes bench testing to show substantial equivalence to predicate devices. It does not provide the details required for the evaluation of an AI/SaMD device because the product is fundamentally different.
§ 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.