(76 days)
The 2.8mm and 3.5mm ROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER - 1. Repair of rotator cuff tears 2. capsular instability 3. slap lesion repair 4. acromio-clavicular separation 5. capsule shift/capsulolabral reconstruction 6. biceps tenodesis 7. deltoid repair KNEE 1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure. 2. Patellar ligament and tendon avulsion repairs. 3. Extra-capsular reconstruction, ITB tenodesis ANKLE - 1. Lateral instability 2. Medial instability 3. Achilles tendon reconstruction and repair 4. Mid-foot reconstructions FOOT - 1. Hallux valgus reconstruction ELBOW 、 バ - Tennis elbow repair 1. - Biceps tendon reattachment 2. - Medial and lateral repairs 3. BLADDER NECK SUSPENSION 1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
The ROC EZ 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 and 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.
Here's an analysis of the provided text regarding the Innovasive ROC EZ Suture Bone Fastener, focusing on acceptance criteria and supporting studies.
Based on the provided 510(k) summary, the device is a medical implant and not an AI/software device, therefore, many of the requested fields are not applicable. I will provide information relevant to a medical device where possible.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ultimate Holding Strength in Bone Model | Equivalent to the predicate device |
| Material Composition | High-density polyethylene and polysulfone |
| Mechanism of Fixation | Expander draws into sleeve, expanding it against bone, then shear pin shears. |
| Sterilization Status (Fastener) | Sterile, single-use |
| Sterilization Status (Instrumentation) | Reusable, autoclavable |
| Intended Use | Reattachment of soft tissue to bone (specific indications listed for shoulder, knee, ankle, foot, elbow, and bladder neck suspension) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only refers to "Bone model testing" without specifying the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable for this type of device. The ground truth for device performance, in this case, is based on physical testing against defined material and mechanical properties, not expert interpretation of data.
4. Adjudication Method
Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or assessment, not physical device performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a physical implant, not an AI or software-assisted diagnostic tool that would involve human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the "Bone model testing" would be the physical measurement of ultimate holding strength in a standardized bone model, as well as the material specifications of the device components.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied for this type of physical device performance testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this context.
Study Description (Based on Provided Information)
The study was a bone model testing study comparing the modified Innovasive ROC EZ Suture Bone Fastener to its predicate device. The primary objective was to demonstrate equivalent ultimate holding strength between the two devices in a bone model.
Limitations of Information:
The provided 510(k) summary is very brief regarding the performance data. It states: "Bone model testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device."
This statement confirms that a study was conducted and met its (implied) acceptance criterion of equivalence, but it lacks critical details for a comprehensive report, such as:
- Specifics of the bone model used (e.g., synthetic bone, cadaveric bone).
- Number of samples tested for both the modified and predicate device.
- Statistical methodology used to determine "equivalence."
- Definition of "ultimate holding strength" and how it was measured.
- Any predefined acceptance limits for equivalence.
- Any other performance aspects tested (e.g., torque, deployment force, fatigue).
§ 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.