(196 days)
Innovasive Devices, Inc., ACL Clip-In Plate is indicated for use in the fixation of bonetendon-bone anterior cruciate ligament reconstruction surgeries.
The ACL Clip-In Plate device is a two component implant used in the fixation of bonetendon-bone grafts in anterior cruciate ligament reconstruction surgeries. The two device components are the Base and the Plate which are assembled together in the bone during the surgical procedure. The ACL Clip-In Plate device consists of an outer threaded Base which is designed to be endoscopically delivered through a prepared tibio-femoral tunnel and manually inserted into the antero-lateral femur using a hex driver. The proximal end of the Base has a flexible wire assembled to it. The Plate has two (proximal and distal) transverse spikes that are used to attach the bone end of the ligament graft on to it. The proximal end of the Plate has a circular groove equal to the diameter of the flexible wire in the Base. The flexible wire provides for a spring like property as the Plate passes through the Base. When the proximal end of the Plate engages with the flexible wire, it locks the Plate in place. With regard to implant size, the Base comes in a 10mm diameter. The Plate is size specific and can be used only with the specified Base.
The provided text describes a 510(k) submission for the "ACL Clip-In Plate" device and does not include details of a clinical study with acceptance criteria, human reader performance, or training data. Instead, it focuses on comparative performance testing of the device against a predicate device.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a table format. Instead, it describes comparative performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent or better strength of implant-graft-host bone construct (Static) | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Equivalent or better strength of implant-graft-host bone construct (Dynamic) | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Equivalent or better post-test evaluation of Host Bone-Implant Interface (after dynamic test) | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Equivalent or better post-test evaluation of Graft-Implant Interface (after dynamic test) | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Provisions for graft incorporation (e.g., equivalent or better bone-to-bone healing) | Essentially identical or better due to faster bone-to-bone healing compared to soft tissue-to-bone. Provides almost the same amount of graft-host bone surface area contact. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not specified in the provided text. The text only mentions "comparative testing with a selected predicate device" and "in each of the three tests outlined above," implying a series of mechanical tests rather than a clinical trial with human subjects.
- Data Provenance: Not explicitly stated, however, the context of mechanical testing suggests laboratory data, not patient data from a specific country or retrospective/prospective collection related to human studies.
3. Number of Experts and Qualifications for Ground Truth
This question is not applicable to the provided context. The testing described is mechanical/bench testing, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are typically used in clinical studies involving multiple readers or complex image interpretations. The described testing is mechanical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes mechanical performance testing of a device, not a comparative effectiveness study involving human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No. This document concerns a physical medical device (ACL Clip-In Plate) and its mechanical performance, not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" in this context would be the objective measurements obtained from the mechanical tests (e.g., load at failure, displacement, interface integrity). This is based on objective physical measurements rather than expert consensus, pathology, or outcomes data, which are typically found in clinical studies. The comparison is against the performance of a predicate device.
8. Sample Size for the Training Set
Not applicable. The document describes performance testing of a physical device, not an AI algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or AI algorithm.
§ 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.