(88 days)
Innovasive Devices, Inc., ACL Clip-In is indicated for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
The ACL Clip-In device is a two component implant used in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries. The two device components are the Base and the Eyelet which are assembled together in the bone during the surgical procedure. The ACL Clip-In 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 Eyelet has a smooth transverse opening to accept the soft tissue without damaging it. The proximal end of the Eyelet has a circular groove which is of a larger diameter of the flexible wire in the Base. The flexible wire provides for a spring like property as the Eyelet passes through the Base. When the proximal end of the Eyelet engages with the flexible wire, it locks the Eyelet in place. With regard to implant size, the Base comes in 8mm, 10mm and 12mm diameters. The Eyelets are size specific and can be used only with the specified base component. The components will be labeled to indicate the same.
This 510(k) summary (K973323) describes the ACL Clip-In device, its indications for use, technological characteristics, and a comparison to a predicate device to demonstrate substantial equivalence. The summary focuses on performance testing to support this claim, rather than a study with acceptance criteria in the typical sense of a diagnostic or screening device.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states that the subject device demonstrated "at a minimum equivalent or better performance compared to the selected predicate device" in various comparative tests.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Strength of implant-implant interface | Equivalent or better than predicate device | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Strength of implant-graft-host bone construct (Static) | Equivalent or better than predicate device | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Strength of implant-graft-host bone construct (Dynamic) | Equivalent or better than predicate device | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Host Bone-Implant Interface (Post-test evaluation) | Equivalent or better than predicate device | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Graft-Implant Interface (Post-test evaluation) | Equivalent or better than predicate device | Demonstrated equivalent or better performance compared to the selected predicate device. |
| Graft Incorporation (Post-test evaluation) | Essentially identical to predicate device | Provisions for graft incorporation are essentially identical between subject and predicate devices. |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample size used for the comparative testing. It only mentions "comparative testing with a selected predicate device."
The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device of this type, the testing would typically be prospective pre-clinical (bench or cadaveric) and conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this submission. The device is a direct-fixation implant, and the assessment is based on physical and mechanical properties, not interpretation by experts. Ground truth, in this context, refers to objective measurements of strength, interface integrity, and other mechanical parameters.
4. Adjudication method for the test set
This section is not applicable. As there is no human interpretation involved in establishing "ground truth," no adjudication method is required. The assessment is based on mechanical test results.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic or screening devices involving human interpretation, often assisted by AI. The ACL Clip-In is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance testing was derived from objective mechanical and physical measurements of the implant's properties and its interaction with graft and bone surrogates. This includes:
- Strength measurements (static and dynamic loads)
- Evaluation of interface integrity (implant-implant, implant-graft, host bone-implant)
- Assessment of features related to graft incorporation.
8. The sample size for the training set
This section is not applicable. The ACL Clip-In is a medical device, not an AI/ML algorithm that requires a "training set." Performance is evaluated through direct mechanical testing.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.