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510(k) Data Aggregation
(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.
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(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.
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