(37 days)
The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- . Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
- . Foot/ankle indications:- Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
- . Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
The RoG™ 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:
- Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/hand indications: Scapholunate ligament reconstruction. .
- . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
- . Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The RoGTM 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
- . Foot/ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
- Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
Here's an analysis of the provided text regarding the RoGTM Suture Anchor, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device (suture anchor), not a scientific study report for an AI/ML medical device. Therefore, much of the requested information (like ground truth, expert adjudication, AI performance metrics, sample sizes for training/test sets) is not applicable to this type of device and submission. This document describes a physical surgical implant, not a diagnostic or prognostic algorithm.
The "performance characteristics" and "safety characteristics" sections in this 510(k) relate to the physical and material properties of the suture anchor and its components. The "study" mentioned is in the context of demonstrating that these characteristics have not changed from a previously cleared predicate device, and that sterility and material biocompatibility standards are met.
Description of Acceptance Criteria and Study Findings
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Reference / Basis |
|---|---|---|---|
| Material Safety | Biocompatibility requirements per ISO 10993 | "Master File demonstrating safety of the material has been supplied by the PEEK supplier and shows compliance to the requirements of ISO 10993." | PEEK supplier's Master File; Compliance to ISO 10993 |
| Sterilization | Compliance with ISO 11135 | "Sterilization of the device is in compliance with ISO 11135." | Compliance to ISO 11135 |
| Sterilant Residues | Within limits of ISO 10993-7 | "Sterilant residues are within the limits of ISO 10993-7." | Compliance to ISO 10993-7 |
| Suture Quality | Meets U.S. Pharmacopeia requirements for non-absorbable suture | "Sutures supplied with the device meet the requirements of the U.S. Pharmacopeia for non-absorbable suture..." | U.S. Pharmacopeia standards for non-absorbable suture |
| Suture Quality | Meets Class II Special Controls Guidance Document: Surgical Sutures requirements | "...as well as all requirements of Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003'." | FDA Guidance Document for Surgical Sutures |
| Device Stability (Extended Expiration) | Anchor, suture, and packaging stable for proposed extended expiration period | "Testing has shown the anchor, suture and packaging to be stable for the proposed period." | Unspecified "testing" to support extended expiration date (This is the primary change in this 510(k) from the predicate) |
| Design and Performance Equivalence | Same design considerations, assembly configurations, and performance characteristics as the predicate device (K111590) | "The subject device has the same design considerations, assembly configurations, performance characteristics and indications for use as the predicate device." | Comparison to predicate device K111590; No changes in core design or performance from predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/not specified. For this physical device, "test set" would typically refer to the number of units tested for mechanical properties, material integrity, and sterility. The document only states "Testing has shown the anchor, suture and packaging to be stable for the proposed period" for the extended expiration date, without providing specific numbers.
- Data Provenance: Not applicable/not specified in terms of country of origin or retrospective/prospective. The data pertains to material and product testing, likely conducted by the manufacturer or their suppliers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical medical device (suture anchor), not a diagnostic algorithm requiring expert "ground truth" for a test set. Ground truth, in this context, would involve laboratory analysis and adherence to established material and performance standards (e.g., ISO standards, USP).
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication method (like 2+1, 3+1) is relevant for a physical device like a suture anchor. Evaluation involves objective measurements and adherence to engineering and material science standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in imaging diagnostics. This is a surgical implant and does not involve human "readers" interacting with an AI system.
6. Standalone (Algorithm Only) Performance Study
- No. This is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- Expert Consensus, Pathology, Outcomes Data, etc.: Not applicable in the traditional sense for an AI/ML device. For this suture anchor, the "ground truth" consists of:
- Material specifications and biocompatibility standards (e.g., ISO 10993).
- Sterilization efficacy standards (e.g., ISO 11135).
- Suture quality standards (e.g., U.S. Pharmacopeia, FDA Guidance).
- Mechanical performance test results (implied for "performance characteristics" and stability testing, though specific data is not provided in this summary).
8. Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there are no "training sets" in the context of machine learning. The design and manufacturing processes are established using engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.