(136 days)
The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
The provided text is a 510(k) summary for the Mitek Biocryl Interference Screws, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against defined acceptance criteria in the typical sense for a new, novel device.
Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are common for algorithms or diagnostic devices, is not applicable to this specific document as it describes a modification to an existing device type and relies on demonstrating equivalence through design control and performance testing, not clinical outcome studies.
Here's why and what information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification."
- This indicates that performance was assessed against internal design control requirements and validation tests, not external, publicly defined acceptance criteria with reported metrics like sensitivity/specificity. The focus is on demonstrating that the modified device performs as intended and is equivalent to the predicate devices.
2. Sample Size for Test Set and Data Provenance:
- Not Applicable. No explicit "test set" in the context of clinical data or algorithm evaluation is mentioned. The "performance testing" referenced would likely involve bench testing (e.g., mechanical strength, degradation properties) for the device modification. The sample size for such engineering tests is not provided in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This type of information is relevant for studies involving human interpretation or subjective assessment, typically with diagnostic algorithms or imaging. This document describes an orthopedic implant, not a diagnostic device requiring expert ground truth establishment in this manner.
4. Adjudication Method:
- Not Applicable. No adjudication method is described as there's no "ground truth" to adjudicate in the context of this device type and submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not a diagnostic device or an AI-assisted interpretation tool. Therefore, an MRMC study is irrelevant.
6. Standalone Algorithm Performance:
- Not Applicable. This is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used:
- Not Applicable. For a physical implant, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical properties demonstrated through various engineering tests and material analyses, not clinical outcomes in the same way an algorithm is evaluated. The document states validation testing and compliance with design controls were performed.
8. Sample Size for Training Set:
- Not Applicable. This is a physical implant, not an algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not Applicable. As above, it's not an algorithm requiring a training set and associated ground truth.
Summary of what is provided:
- Device Name: Mitek Biocryl Interference Screws
- Indication for Use: Fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
- Study/Basis for Equivalence: Special 510(k) submission based on device modification. Demonstrated substantial equivalence through:
- Certification of compliance to 21 CFR 820.30 Design Control requirements.
- Descriptions of Mitek's Design Control and Risk Analysis procedures.
- Results of validation testing (performance testing) for the device modification.
- Conclusion: Based on indications for use, technological characteristics, and comparison to predicate devices, substantial equivalence was shown.
§ 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.