(74 days)
The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
SHOULDER
- 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, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.
- Patellar ligament and tendon avulsion repairs.
- Extra-capsular reconstruction, ITB tenodesis
ANKLE
- Lateral instability
- Medial instability
- Achilles tendon reconstruction and repair
- Mid-foot reconstructions
FOOT
- Hallux valgus reconstruction
BLADDER NECK SUSPENSION
- Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
The ROC LF suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, 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 an obturator, 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 in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, AUC).
Instead, the document is a 510(k) Summary for a medical device, specifically the Innovasive 2.8mm and 3.5mm ROC LF Suture Bone Fastener. The "performance data" section describes mechanical performance tests for this bone fastener, not diagnostic performance.
Therefore, I cannot provide the requested information for acceptance criteria and device performance as if it were a diagnostic AI device.
However, I can extract the information provided about the mechanical performance data which is presented to demonstrate substantial equivalence to a predicate device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria for ultimate holding strength. Instead, the performance reports "equivalence" to a predicate device.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Cadaver study | Ultimate holding strength equivalent to predicate device | Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device. |
| Bone model testing | Ultimate holding strength equivalent to predicate device | Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device. |
2. Sample size used for the test set and the data provenance:
- Cadaver study: The sample size is not specified.
- Bone model testing: The sample size is not specified.
- Data provenance: Not specified, but generally, cadaver studies are "prospective" in the sense that the test is applied to the cadaver specimen. Bone model testing is a controlled laboratory experiment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This question is not applicable. The studies described are mechanical tests of a bone fastener's holding strength, not diagnostic evaluations requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable as the studies involve mechanical measurements, not expert review or adjudication.
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 question is not applicable. This document describes a medical device (bone fastener), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This document describes a medical device (bone fastener), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in these studies is the measured ultimate holding strength of the devices. For the cadaver study, this would be the actual physical holding strength in human bone. For the bone model, it would be the physical holding strength in a synthetic bone model.
8. The sample size for the training set:
This question is not applicable. These are mechanical performance tests for a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This question is not applicable as there is no training set mentioned or implied for a physical device's mechanical performance testing.
§ 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.