Search Results

The 2.3mm ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

ANKLE

1. Lateral instability
2. Medial instability
3. Achilles tendon reconstruction and repair
4. Mid-foot reconstructions

HAND

1. Ulnar or lateral collateral ligament reconstruction

WRIST

1. Scapholunate ligament reconstruction

FOOT

1. Hallux valgus reconstruction

ELBOW

1. Tennis elbow repair
2. Biceps tendon reattachment
3. Medial and lateral repairs

The ROC XS suture bone fastener implant tip portion consists of a shear pin, crown and anvil. The crown and anvil are fitted onto the shear pin component such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during the device deployment, the anvil forces it open. The anvil is tapered such that it will fit into the crown component as the deployment action progresses. As the crown is forced open by the anvil, the crown expands to make contact with the surrounding bone. This expanding crown results in the final fixation properties of the device. Once the anvil is completely seated inside the crown, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.

In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with a deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.

The provided text describes a 510(k) summary for the Innovasive 2.3mm ROC XS Suture Bone Fastener. It details the device, its intended use, and a comparison to predicate devices, along with performance data. However, the information provided does not contain acceptance criteria or detailed study methodologies that would allow for a comprehensive description as requested in your prompt.

Specifically, the document states:

• "Bone model testing: Comparison of the ultimate holding strength in a bone model compared to the predicate devices. The Innovasive 2.3mm ROC XS Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices."
• "Cadaver testing: Comparison of the ultimate holding strength in cadaver compared to the predicate device. Again, the Innovasive 2.3mm ROC XS Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices."

This broadly indicates that the acceptance criteria for these tests were likely based on equivalency to the predicate devices in terms of "ultimate holding strength." However, it does not specify:

• Specific numerical acceptance values or ranges.
• The exact methodology for determining "ultimate holding strength."
• The statistical methods used for "equivalency."

Given the limitations of the provided text, I cannot create the detailed table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I will outline what is available and explicitly state what information is missing based on your request.

Acceptance Criteria and Study for the Innovasive 2.3mm ROC XS Suture Bone Fastener

The provided 510(k) summary (K972436) for the Innovasive 2.3mm ROC XS Suture Bone Fastener focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of physical performance characteristics. The core acceptance criterion appears to be equivalency in ultimate holding strength compared to the predicate devices in both bone model and cadaveric testing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for this Section:

• Specific numerical thresholds or ranges for "ultimate holding strength."
• The definition of "equivalent" (e.g., within a certain percentage, statistical non-inferiority margin).
• Detailed experimental protocols.

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for either the bone model testing or the cadaver testing.
The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These studies would generally be considered prospective laboratory or preclinical studies conducted as part of the device development and regulatory submission process.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable or not provided as the studies described are biomechanical performance tests comparing holding strength, rather than diagnostic studies requiring expert human readers to establish ground truth for image interpretation or clinical diagnosis. The "ground truth" here is the measured ultimate holding strength of the devices.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the type of performance testing described. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in diagnostic studies, not for biomechanical strength measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned and is not applicable to this type of device (suture bone fastener) or the described performance tests. MRMC studies are typically used for evaluating diagnostic imaging devices or AI algorithms that assist human readers.

6. Standalone (Algorithm Only) Performance

Standalone performance, typically referring to an algorithm without human involvement, is not applicable as the device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the described studies was biomechanical measurement of ultimate holding strength. This would involve standardized testing equipment to apply forces and record the point of failure for the device in the bone model or cadaveric bone.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to the type of device and performance testing described. This device is a physical implant, not an AI/ML algorithm that requires a training dataset.

9. How Ground Truth for the Training Set was Established

As there is no "training set" for this physical device, this question is not applicable.

Ask a specific question about this device