(75 days)
The 3.5mm Metal ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair KNEE Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repair Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs BLADDER NECK SUSPENSION Bladder neck suspension for female urinary incontinence due to urethral hypermobility
The 3.5mm Metal 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 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 3.5mm Metal ROC XS will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.
The provided text is a 510(k) summary for a medical device called the "Innovasive 3.5mm Metal ROC XS Suture Bone Fastener". This document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for software or AI-based devices.
The 510(k) notification process is about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with statistical power.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert evaluation is not available in the provided document, as it pertains to a different type of regulatory submission and device.
However, I can extract the following relevant information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided document. The 510(k) process for this device focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria regarding performance like sensitivity or specificity.
2. Sample size used for the test set and the data provenance:
This information is not available as there is no described performance study in the provided text. The submission is for a physical medical device (bone fastener), not an AI or software product that would typically have a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available as there is no described study involving ground truth experts in the provided text.
4. Adjudication method for the test set:
This information is not available as there is no described performance study or adjudication process in the provided text.
5. 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:
This information is not available. The device is a physical bone fastener, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not available. The device is a physical bone fastener, not an algorithm.
7. The type of ground truth used:
This information is not available. There is no ground truth concept applied in this 510(k) submission for a physical medical device.
8. The sample size for the training set:
This information is not available as there is no training set mentioned or applicable for this type of device submission.
9. How the ground truth for the training set was established:
This information is not available as there is no training set or ground truth concept mentioned or applicable for this type of device submission.
Summary of Available Information from the Provided Text:
The provided text focuses on the following aspects for the Innovasive 3.5mm Metal ROC XS Suture Bone Fastener:
- Device Description: A 3.5mm metal suture bone fastener with a shear pin, crown, and anvil, designed to expand and fixate into bone upon deployment. It's made of stainless steel.
- Intended Use: Reattachment of soft tissue to bone for various indications in the shoulder, knee, ankle, foot, elbow, and bladder neck suspension.
- Predicate Devices: Innovasive Devices 3.5mm ROC XS Suture Bone Fastener (plastic) and Innovasive Devices 3.5mm ROC EZ Suture Bone Fastener (plastic). All devices are marketed by Innovasive Devices.
- Comparison to Predicate Devices: The key difference is the material (stainless steel for the proposed device vs. plastic for predicates). The Indications for Use are identical to the predicate 3.5mm ROC EZ.
- Regulatory Outcome: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.
§ 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.