(67 days)
The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
The Innovasive ROC Suture Bone Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a high density polyethylene cartridge with an acetyl drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener also has a stainless steel drive tool inside the cartridge which shears 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 Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener should it be necessary. 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.
This document describes a medical device called the "Innovasive ROC Suture Bone Fastener" and provides performance data for its 510(k) submission. However, it does not include information about AI/ML device performance, acceptance criteria, or studies for such devices.
The provided text describes a physical medical device used for soft tissue to bone repair, specifically for bladder neck suspension. The performance study mentioned is a cadaver study comparing the ultimate holding strength of the device to a predicate device.
Therefore, I cannot answer your request regarding:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size for the test set and data provenance (for an AI/ML device)
- Number of experts for ground truth and their qualifications (for an AI/ML device)
- Adjudication method (for an AI/ML device)
- MRMC comparative effectiveness study or effect size (for an AI/ML device)
- Standalone performance (for an AI/ML device)
- Type of ground truth used (for an AI/ML device)
- Sample size for the training set (for an AI/ML device)
- How ground truth for the training set was established (for an AI/ML device)
The document focuses on mechanical performance of a physical implant, not the performance of an AI/ML algorithm.
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NOV 1 1996
510(k) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Eric Bannon. Vice President of Quality Assurance and Regulatory Affairs Date Prepared: August 25, 1996
2. DEVICE:
Innovasive 2.8mm and 3.5mm ROC Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC Suture Bone Fastener
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive Devices 2.8mm and 3.5mm Roc Suture Bone Fastener was the Mitek GII Anchor, marketed by Mitek Surgical, Norwood, MA.
4. DEVICE DESCRIPTIONS:
The Innovasive ROC Suture Bone Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a high density polyethylene cartridge with an acetyl drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener also has a stainless steel drive tool inside the cartridge which shears 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 Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener should it be necessary. 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.
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The Fastener will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.
5. INTENDED USE:
The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Devices ROC Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.
The Mitek Mini Anchor is comprised of titanium with nitinol arcs. The arcs are imbedded in bone when placed in the predrilled hole. The intended use of the Mitek GII Anchor and the Innovasive ROC Fasteners are identical.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- l . Cadaver study: Comparison of the ultimate holding strength in the bone indicated compared to the predicate device. The Innovasive Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.
§ 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.