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The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.

The Innovasive 10mm LinX HT utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm LinX HT will be offered in two sizes, 10mm outside diameter x 40mm length, and 10mm outside diameter x 55mm length.

The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component.

The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.

The provided text describes a 510(k) premarket notification for the Innovasive 10mm LinX HT Ligament Fastener. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to establish novel performance through extensive clinical trials. Therefore, much of the requested information regarding acceptance criteria and study details for AI/software devices is not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Innovasive 10mm LinX HT device, as implied by the 510(k) submission, were based on demonstrating equivalence in mechanical performance to its predicate device.

Study Details

The study described is a mechanical testing comparison between the new device and a predicate device. This is typical for demonstrating substantial equivalence for medical devices like ligament fasteners.

1. Sample size used for the test set and data provenance:

   • Test set sample size: Not explicitly stated. The document mentions "mechanical testing," which typically involves multiple samples, but the specific number is not provided.
   • Data provenance: The testing was likely conducted in a laboratory setting by the manufacturer (Innovasive Devices, Inc.). The document doesn't specify a country of origin for the data beyond that. The study is prospective in the sense that the new device was tested against the predicate, but it is not a clinical study on human subjects.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic or AI-driven devices. For a mechanical device, the "ground truth" is established by the physical properties and performance metrics determined through testing.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) in image interpretation or clinical outcomes, which is not relevant to mechanical testing.

4. 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 mechanical device, not an AI software or diagnostic tool that involves human readers interpreting cases.

5. 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.

6. The type of ground truth used:

   • Mechanical performance data: The "ground truth" was the direct measurement of the ultimate holding strength of the devices in a bone model. The predicate's performance served as the benchmark for equivalence.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical device testing. This concept applies to machine learning algorithms.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device submission.

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The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.

The Innovasive 10mm Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm Ligament Fastener will be offered in a single size, 10mm outside diameter and 20mm long. The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component. The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. In addition, the central pin incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue graft. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.

The provided text describes a medical device, the Innovasive 10mm Ligament Fastener, and its 510(k) submission for market clearance. It includes information about the device's comparison to predicate devices and performance data. However, the document is a 510(k) summary and not a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study design specifics, expert involvement, and training set details are not present.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Note: The specific quantitative acceptance criteria for "equivalent" are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified. This sounds like bench testing ("in a bone model"), so a country of origin for clinical data or a retrospective/prospective designation isn't applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts/Qualifications: Not applicable. This was mechanical testing in a bone model, not an expert-driven assessment of clinical outcomes or images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This was mechanical 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

• MRMC Study: No. This device is a ligament fastener, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" for the mechanical testing was the ultimate holding strength of the predicate device in a bone model. This is a comparative mechanical performance rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that would require a training set. The device's "design" is based on the predicate device and engineering principles.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable for the reasons stated above.

In summary, the provided document is a regulatory submission for a physical medical device. The "study" referenced is a single mechanical test comparing the ultimate holding strength of the new device to a predicate device in a bone model. It is not a clinical study or an AI-related performance evaluation, which explains why much of the requested information is not present or applicable.

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