(89 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ultimate holding strength in a bone model | Equivalent to the strength of the predicate device (8mm LinX HT) |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
§ 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.