Search Results

The Innovasive Devices 1.9mm ROC Suture Bone Fastener is intended for the reattachment of the ulnar collateral and lateral ligaments in the thumb and the scapholunate ligament in the wrist.

The Innovasive ROC Suture Bone Fastener is an implantable soft tissue fixation comin The instrumentation needed to offer to offer to for device of the instrumentation needed to effect soft tissue fixat repaire complete with the instrumentation needed to effect soft tissue to bone repair instruments of a high density polyethyther soft tissue to bone in and tixation drive pin which is deployed into a pre-drivene softridge with an acetal drive a mornees consist of a high density polyethylene cartise with onle dever which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of mol and acent The Fastener also has a stainless steel drive tool incided polysulfone. The Fastener also has a stainles The implantable Fastener when stainless steel drive tool of the Pasceller is the implantable Fastener when deployed by the handle polysufohe the implantable Fastener when deployed by the handle the cartridge which the implantable. the implantable Fastener when deployed by the handle. The Fastener comes with various non-absorbable suture material.

In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole for in the bone for the Features of establish the proper hole for in the bone for the Fastener. A stailable to establish the proper hole for in the Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the direct and r will as onlinetor is meluded which can be used to remove the deployed be offered as reusable devices and can be autoclayor except the Fastener will be offered as reusable devices and can be autoclaved in the steples to be be offered as reusable devices and can be autoclaved in the sterifization tray provided for this pur provided for this purpose.

The Fastener will be available as a sterile. single use device in both an open and the and the with be wanable as a sterile. single use device in both an open a rthroscopic version. Both sutured and sutureless versions will be marketed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Innovasive 1.9mm ROC Suture Bone Fastener:

Summary of Acceptance Criteria and Device Performance (Based on Available Information)

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria with specific numerical targets. However, the performance data section indicates a key metric tested and the outcome related to the predicate.

Detailed Study Information (Based on Available Information)

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

   • Test Set Sample Size: Not explicitly stated. The document mentions a "Cadaver study," implying multiple cadaveric samples or tests were performed, but the exact number is not provided.
   • Data Provenance: The study was a "Cadaver study," which typically involves human cadaveric tissue. The country of origin is not specified, nor is whether the data was retrospective or prospective (though cadaver studies are inherently a type of prospective experiment).

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

   • Not applicable. This device is a mechanical fastener, and the "ground truth" for its performance (holding strength) would be measured objectively using mechanical testing equipment, not established by expert consensus.

3. Adjudication method for the test set:

   • Not applicable. As noted above, the "ground truth" for holding strength is an objective mechanical measurement, not a subjective assessment requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used for diagnostic or imaging devices where human interpretation plays a role. This is a mechanical implantable device.

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

   • Not applicable. This is not an AI/algorithm-based device. The study evaluated the mechanical performance of the implantable fastener itself.

6. The type of ground truth used:

   • Mechanical measurement of "ultimate holding strength in the bone." This is an objective, quantitative measurement of the device's physical performance.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no "training set."

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

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

Additional Considerations from the 510(k) Summary:

• Predicate Device: The study's primary goal was to demonstrate equivalence to the Ethicon USP #2/0 braided Polyester suture with suture button, specifically regarding ultimate holding strength.
• Intended Use: The device is intended for the reattachment of ulnar collateral and lateral ligaments in the thumb and the scapholunate ligament in the wrist. This context informs the choice of a cadaver study, as these anatomical structures can be replicated in cadaveric models.
• Focus on Substantial Equivalence: The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented directly supports this by showing "equivalence" in a critical performance metric.

Ask a specific question about this device