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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.
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(189 days)
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction . - ◆ Scapholunate ligament reconstruction - . Lateral epicondylitis repair
The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- 0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
This 510(k) summary describes the Micro/Mini N-PK(H) Bone Anchor, a device intended for the reattachment of soft tissue to bone. The study focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Functional and Safety Testing | |
| Biocompatibility | Conducted in accordance with ISO 10993-1 standards. |
| Corrosion testing | Conducted in accordance with ASTM F2129. |
| Tensile testing | Performed to verify compliance with USP suture requirements. |
| Fixation/Static disassembly strength | Comparison testing performed. |
| Cyclic fatigue performance | Comparison testing performed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (biocompatibility, corrosion, tensile, fixation/static disassembly, cyclic fatigue). The data provenance is not specified either (e.g., country of origin, retrospective or prospective). These tests are typically performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involves laboratory-based functional and safety testing of a medical device, not a diagnostic or prognostic assessment requiring expert interpretation of results. Therefore, there is no "ground truth" in the clinical sense established by experts.
4. Adjudication method for the test set
Not applicable, as this is laboratory testing.
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
Not applicable. This is a 510(k) submission for a bone anchor, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the functional and safety testing, the "ground truth" is defined by the established industry standards and requirements against which the device's performance is measured:
- Biocompatibility: ISO 10993-1 standards.
- Corrosion: ASTM F2129 standards.
- Tensile testing: USP suture requirements.
- Fixation/Static disassembly strength and Cyclic fatigue performance: Comparison testing to predicate devices, implying that the performance of the predicate devices serves as the benchmark or "ground truth" for acceptable performance.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device testing. The device's design and materials are tested against established performance standards and predicate device performance.
9. How the ground truth for the training set was established
Not applicable, as there is no training set involved. The ground truth for the device's performance is established by recognized international and industry standards (ISO, ASTM, USP) and the performance characteristics of legally marketed predicate devices.
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(142 days)
The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.
The proposed OMNISPAN Meniscal Repair System consists of two sterile PEEK (polyetheretherketone) implants connected by a sliding loop and fixed leg of absorbable size #2-0 Orthocord suture, a sterile, disposable Deployment Gun with malleable Graft Retractor. The implants together with the suture provide compression across the tear in the meniscus.
This submission describes the OMNISPAN Meniscal Repair System, a medical device for arthroscopic fixation of meniscal tears. The submission asserts substantial equivalence to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K092836) is a 510(k) summary for a medical device seeking substantial equivalence, rather than a clinical study reporting specific performance metrics against pre-defined acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, as would be found in a clinical trial report, is not present in this document.
Instead, the document states: "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." This general statement indicates that internal testing was conducted to support the device's suitability, but the specific acceptance criteria and detailed performance results are not disclosed in this summary. The FDA's decision to clear the device implies that the agency found these undisclosed tests satisfactory.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, supported by internal performance and safety testing, the details of which are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no clinical test set is described in detail, there is no information provided regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no clinical test set is described, there is no information on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on device characteristics and predicate devices, not on direct comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a physical medical implant (OMNISPAN Meniscal Repair System), not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not reported.
7. Type of Ground Truth Used
The document does not describe a specific "ground truth" as would be used in an AI or diagnostic device study. The "ground truth" here pertains to the device's functionality and safety, which would have been established through internal engineering tests, biocompatibility assessments, and mechanical testing, rather than expert consensus on diagnostic images or pathology.
8. Sample Size for the Training Set
This device is a physical medical system; it does not involve an AI algorithm with a training set. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this device does not involve an AI algorithm, the concept of a "training set" and its associated ground truth is not applicable.
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