(85 days)
The intended use of the ROClet is to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.
The ROClet product consists of the implantable ROClet, an insertion instrument and an awl. The ROClet will be offered as a sterile single use device. The insertion instrument and awl will be offered as a non-sterile reusable instrument. The ROClet consists of a molded component 2.8mm in diameter and 6.4mm long with a flange at one end and barbs along its length. The flange is intended to rest of the humeral head bone surface. The barbs are used to keep the device in place only until the suture is tied during the repair procedure. The ROClet is fitted with a nylon suture threader assembly placed in the ID of the device and is used to pass the sutures used during the tunnel procedure down the center of the ROClet until it is eventually tied during the repair. The ROClet and suture threader assembly will be in a holding cartridge when received by the surgeon. The device is loaded onto the insertion instrument and removed from the cartridge. The sutures exiting the bone tunnel already established to repair the rotator cuff is passed through the suture threader assembly. The suture threader assembly with the suture is then withdrawn from the back of the ROClet and discarded. This results in the suture exiting the bone tunnel now passing through the center of the ROClet device and exiting the back of the device at its flanged end. If needed, the awl can be used to size the bone tunnel. This ensures the device works with all methods used to create a bone tunnel. The ROClet, still on the insertion tool is then manually pressed into the bone tunnel. The ribbed end of the ROClet, now in the tunnel, aids in keeping the device in place while the end of the suture exiting the device is tied off and the repair completed. The tied suture ensures the device remains in place in the bone tunnel hole until the bone to tissue interface heals. One ROClet is used for each bone tunnel.
This document is a 510(k) summary for a medical device called the Innovasive Devices ROClet. It describes the device, its intended use, and a comparison to a predicate device. It also briefly mentions performance data included in the submission.
However, the provided text does not contain acceptance criteria or detailed study results that prove the device meets specific criteria. The "PERFORMANCE DATA" section only lists the types of tests performed (bone model testing, ultimate strength comparison, cyclic loading characterization) but does not provide any numerical results, acceptance criteria, or a description of a study design that would include information on sample sizes, ground truth, experts, or comparative effectiveness.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies' methodologies (sample sizes, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone performance).
The provided text only states WHAT tests were done, not the RESULTS of those tests or the CRITERIA for success.
To provide the information you requested, I would need a section of the document that details:
- Specific performance metrics: e.g., "The ultimate tensile strength of sutures with ROClet must be X MPa."
- Numerical results of those metrics: e.g., "The ultimate tensile strength was Y MPa."
- Study design details: e.g., how many samples were used, how ground truth was established, who participated, etc.
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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: February 4, 1997
2. DEVICE:
Innovasive 2.8mm x 6.4mm ROClet Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROClet
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive Devices ROClet was the 2mm GORE-TEX soft tissue patch, produced by W.L. Gore, Flagstaff, AZ.
4. DEVICE DESCRIPTIONS:
The ROClet product consists of the implantable ROClet, an insertion instrument and an awl. The ROClet will be offered as a sterile single use device. The insertion instrument and awl will be offered as a non-sterile reusable instrument.
The ROClet consists of a molded component 2.8mm in diameter and 6.4mm long with a flange at one end and barbs along its length. The flange is intended to rest of the humeral head bone surface. The barbs are used to keep the device in place only until the suture is tied during the repair procedure. The ROClet is fitted with a nylon suture threader assembly placed in the ID of the device and is used to pass the sutures used during the tunnel procedure down the center of the ROClet until it is eventually tied during the repair.
The ROClet and suture threader assembly will be in a holding cartridge when received by the surgeon. The device is loaded onto the insertion instrument and removed from the cartridge. The sutures exiting the bone tunnel already established to repair the rotator cuff is passed through the suture threader assembly. The suture threader assembly with the suture is then withdrawn from the back of the ROClet and discarded. This results in the suture exiting the bone tunnel now passing through the center of the ROClet device and exiting the back
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of the device at its flanged end. If needed, the awl can be used to size the bone tunnel. This ensures the device works with all methods used to create a bone tunnel.
The ROClet, still on the insertion tool is then manually pressed into the bone tunnel. The ribbed end of the ROClet, now in the tunnel, aids in keeping the device in place while the end of the suture exiting the device is tied off and the repair completed. The tied suture ensures the device remains in place in the bone tunnel hole until the bone to tissue interface heals. One ROClet is used for each bone tunnel.
5. INTENDED USE:
The intended use of the ROClet is to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Devices ROClet is comprised of acetal plastic. This device is used to protect suture when used to complete a repair of the rotator cuff through the use of transosseous bone tunnels. The ROClet is placed into the bone tunnel and the suture passed through its center. This protects the suture from damage from the surrounding hole and prevents migration of the suture through the bone. An inserter is used to place the device and an awl is used to ensure each bone tunnel is appropriately sized to receive the device.
The 2mm GORE-TEX soft tissue patch is a square of material constructed of Goretex which is used as a pladget. The material is used to augment the strength of the bone and surrounding tissue by more evenly distributing the load from the sutures over a wider area.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Bone model testing: Comparison of the ultimate strength of suture with and without the ROClet placed in the bone tunnel. In addition, the cyclic loading with the device was characterized.
§ 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.