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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
4. Biceps tenodesis
5. Acromio-clavicular separation
6. 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)

Lupine Loop System is a preloaded, absorbable disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok Loop Anchor in design, configuration and dimensions. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl may be sold with bor Orthocord Suture (K040004 and K043298).

This document, K050771, is a 510(k) Premarket Notification for the Lupine Loop Anchor system. It focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for the new device as a medical AI submission would. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not present in this type of submission.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document states that the Lupine Loop Anchor was evaluated for "suture compatibility and deployment met predetermined acceptance criteria." However, the specific numerical or descriptive acceptance criteria themselves are not provided.
• Reported Device Performance: The document states that the device "met predetermined acceptance criteria" for suture compatibility and deployment. However, the actual reported performance data (e.g., tensile strength, deployment force, success rate) is not provided.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a sample size used for any testing.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a physical medical device (a suture anchor), pre-clinical testing would typically be laboratory-based mechanical or biocompatibility testing rather than clinical data in the sense of a medical AI product.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable to this type of submission. "Ground truth" in the context of expert consensus is relevant for diagnostic or image-based AI devices. For a physical device like a suture anchor, ground truth would typically be established through engineering specifications, material properties, and mechanical testing standards.

4. Adjudication Method for the Test Set

• This information is not applicable to this type of submission. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, which is not the type of study described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a standalone physical device like a suture anchor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, in spirit, a "standalone" assessment of the device's physical properties was done. The document indicates "suture compatibility and deployment met predetermined acceptance criteria." This implies testing the device itself, independent of a human operator's skill, to ensure it functions as intended. However, this is not an "algorithm-only" standalone study as understood in AI.

7. The Type of Ground Truth Used

• The document states that the determination of substantial equivalence was based on "conformance to consensus and on a detailed device descriptions) ... ... ... Voluntary standards" and that the "ORTHOCORD suture compatibility and deployment met predetermined acceptance criteria."
• Therefore, the ground truth relies on engineering specifications, material science standards (e.g., USP monograph for sutures), and performance criteria established through mechanical and functional testing. It is not based on expert consensus, pathology, or outcomes data in the sense of a diagnostic or therapeutic AI.

8. The Sample Size for the Training Set

• This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no AI model or training set described.

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