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510(k) Data Aggregation
(27 days)
The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.
The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.
The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Elbow: Ulnar/Medial Collateral Ligament Repair
• Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.
The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis.
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.
The VersaTap™ Suture Anchor is a self-tapping suture anchor. This anchor is designed to combine the advantages of both PEEK and Titanium. The titanium tip makes the product self-tapping, whilst the majority of the anchor is manufactured from PEEK to minimize post-operative imaging effects.
The VersaPEEK™ Suture Anchor is manufactured completely from PEEK. This material composition minimizes post-operative imaging effects. The suture anchor is designed for ultimate mechanical properties (pullout strength, tensile strength, etc). The VersaPEEK™ Suture Anchor also has a variety of suture/suture tape configurations.
The MicroTiTM Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.
The VersaLat™ Ti Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.
The VersaLat™ Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.
The provided document is a 510(k) Premarket Notification from the FDA for several suture anchor devices (VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. It does not involve AI/ML technology, imaging, or human reader studies.
Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of an AI/ML study, "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are not applicable to this type of submission.
The study described here is a mechanical and biocompatibility assessment of medical devices, not an AI/ML performance study.
Here's an adaptation of the requested information based on the provided document:
Acceptance Criteria and Study for Suture Anchors (Non-AI/ML Medical Device)
The provided submission, K242296, for the VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors, is a 510(k) Premarket Notification. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance of an AI/ML algorithm or derive clinical effectiveness from human reader studies.
The acceptance criteria and supporting studies are based on non-clinical testing to ensure the new devices are as safe and effective as their predicates.
1. Table of Acceptance Criteria (for Non-Clinical Testing) and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Criteria (Implicit) | Reported Device Performance and Conclusion |
|---|---|---|---|
| Mechanical Performance | Insertion Torque Testing | Performance comparable to or better than the predicate device to ensure proper implantation and stability. | Substantial equivalence supported by the results of mechanical testing, including insertion torque. The devices support safety and effectiveness. (Details not explicitly quantified in this summary, but determined to be acceptable). |
| Static Pullout Testing | Performance comparable to or better than the predicate device to ensure adequate fixation strength. | Substantial equivalence supported by the results of mechanical testing, including static pullout. The devices support safety and effectiveness. (Details not explicitly quantified in this summary, but determined to be acceptable). | |
| Dynamic Pullout (Fatigue) | Justification for not performing dynamic pullout testing explicitly, demonstrating it's unnecessary to prove equivalence or safety. | Justification for dynamic pullout (fatigue) testing provided according to FDA guidance. | |
| Component Interconnection | Assurance of proper and secure connection of device components. | Justification for component interconnection provided. | |
| Corrosion Testing | Materials and design ensure resistance to corrosion in the body environment. | Justification for corrosion testing provided. | |
| Biocompatibility | Material Composition | Materials must be biocompatible and safe for implantation, consistent with previously cleared devices. Performance must be non-pyrogenic. | Subject devices manufactured using the same approved suppliers, manufacturing facilities, processes, chemicals, materials, and cleaning processes as predicate devices. All materials and processes have been used in previously cleared devices. Tested to be non-pyrogenic. Biocompatibility is substantially equivalent. |
| Sterility | Sterility | Devices must achieve and maintain sterility for their shelf-life. | Methods, thresholds, and criteria for sterility are identical to the predicate device. |
| Shelf-Life | Shelf-Life | Devices must maintain their properties and safety over their intended shelf-life. | Methods, thresholds, and criteria for shelf-life are identical to the predicate device. |
| Packaging | Packaging Integrity | Packaging must protect the device and maintain sterility until use. | Methods, thresholds, and criteria for packaging are identical to the predicate device. |
| Quality Control | Manufacturing QA | Manufacturing processes adhere to established quality systems (ISO 13485, ISO 9001). | All manufacturing is conducted according to processes defined by ISO 13485 and ISO 9001. Methods, thresholds, and criteria for quality control measures are identical to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This is not an AI/ML study with a "test set" of data in the traditional sense. It's a medical device submission based on non-clinical bench testing and comparison to predicates.
- Sample Size:
- For mechanical testing (insertion torque, static pullout), specific sample sizes would have been used per test standards (e.g., ASTM, ISO). These exact numbers are not detailed in the summary document but are implied to be sufficient for demonstrating equivalence.
- For biocompatibility, the assessment relies on the prior clearance of the same materials and processes in predicate devices. New testing (e.g., non-pyrogenic) would involve a sample size relevant to that specific test.
- Data Provenance: The data provenance is from bench laboratory testing conducted by Ortho-Design (Pty) Ltd in South Africa. It is prospective testing of the new devices and comparison to the known performance and characteristics of the already cleared predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This is not applicable as this is not an AI/ML study involving human interpretation of data where "ground truth" is established by experts in an annotation or diagnostic capacity.
- The "ground truth" in this context is established by engineering and biocompatibility standards and the documented performance of legally marketed predicate devices, as determined by mechanical and chemical testing.
4. Adjudication Method for the Test Set
- Not applicable. There is no human interpretation or diagnostic "test set" requiring adjudication.
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 is specifically relevant to AI/ML software where the aim is to evaluate how AI assistance impacts human reader performance (e.g., in medical imaging diagnosis). This submission pertains to physical medical devices (suture anchors) and their mechanical/biocompatibility characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for these suture anchors is established through:
- Engineering Standards: Adherence to recognized national and international standards for mechanical testing of bone anchors (e.g., those referenced in the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions').
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (cleared in K212381), which serve as the benchmark for equivalence.
- Material Biocompatibility Data: Established safety profiles of the materials (PEEK, Titanium) as used in previously cleared medical devices, and specific biocompatibility testing (e.g., pyrogenicity) performed on the subject devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML study involving a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no "training set," there is no ground truth established for it.
Ask a specific question about this device
(29 days)
The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.
The proposed Arthrex Self Punching SwiveLock® Suture Anchors are fully threaded suture anchors comprised of a PEEK eyelet and a hollow anchor body preassembled on a disposable inserter. The anchor body is manufactured from either PLLA/βTCP or PEEK. The Arthrex Self Punching SwiveLock® Suture Anchor is intended to be used for suture (soft tissue) fixation to the bone in the shoulder.
The document describes the Arthrex Self Punching SwiveLock® Suture Anchors and its substantial equivalence to a predicate device. It briefly mentions performance data but lacks the detailed information requested for acceptance criteria and a comprehensive study description.
Here's a breakdown of the available information and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate." |
Missing Information: The specific quantitative acceptance criteria for "pull-out and insertion testing" and the actual numerical results of the device performance are not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not specified. The document only states "all samples."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This information is not applicable as the study described is a performance/mechanical test, not one involving expert review of data for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable for a mechanical performance test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. The study described is a mechanical performance test.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (suture anchor), not an algorithm or AI system.
7. Type of Ground Truth Used
- For the mechanical performance study, the "ground truth" would be the physical measurements obtained from pull-out and insertion testing, compared against pre-defined engineering or performance specifications. The document indicates these were met.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See point 8).
Summary of the Study:
The provided text indicates that Arthrex Inc. performed "Pull-out and insertion testing" on the proposed Arthrex Self Punching SwiveLock® Suture Anchors and a predicate device (K191226: Arthrex SwiveLock Suture Anchor). The purpose of this testing was to demonstrate substantial equivalence to the predicate device. The results reported state that "The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate." This suggests that the mechanical performance of the new device in terms of its ability to be inserted and its pull-out strength was comparable and within acceptable limits when compared to the established predicate device. However, the specific details of these acceptance criteria and the quantitative performance data are not included in this document.
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