(309 days)
The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.
The provided 510(k) summary for the NCS Fish-Fit MD System is for a medical device (an implantable suture anchor) and not for a software or AI/ML-based device. Therefore, the questions related to clinical studies, ground truth, expert adjudication, MRMC studies, and training sets are not applicable to this submission.
The acceptance criteria and supporting study described are for the mechanical performance of the device, comparing it to predicate devices.
Here's the information that can be extracted from the provided text, adapted for the nature of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adequate fixation strength (comparable to predicate devices) | Non-clinical testing performed to verify adequate fixation strength. Data provided to show that NCS Fish-Fit MD System and Bone Anchor perform as well as the predicate device with respect to fixation strength. |
| Adequate pull-out strength (comparable to predicate devices) | Non-clinical testing performed to verify adequate pull-out performances. Data provided to show that NCS Fish-Fit MD System and Bone Anchor perform as well as the predicate device with respect to pull-out strength. |
2. Sample size used for the test set and the data provenance
- Test Set: The document refers to "non-clinical testing" and "data have been provided," but does not explicitly state the sample size (e.g., number of anchors tested) or the provenance (e.g., in vitro, ex vivo). It implies laboratory-based mechanical testing.
- Data Provenance: Non-clinical (likely in-vitro mechanical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a mechanical device, and the "ground truth" is measured physical properties like strength, not a diagnostic interpretation. The testing likely conformed to engineering standards.
4. Adjudication method for the test set
- Not applicable. This is a non-clinical, mechanical testing study, not a study involving human interpretation 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
- Not applicable. This is not an AI/ML device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device.
7. The type of ground truth used
- The "ground truth" for this device's performance measurement would be quantitative mechanical measurements (e.g., force in Newtons, displacement in millimeters) obtained from standardized engineering tests (e.g., universal testing machine results).
8. The sample size for the training set
- Not applicable. This is a hardware medical device; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
Summary of the Study Proving Acceptance Criteria:
The study was a non-clinical testing program conducted to assess the mechanical properties of the NCS Fish-Fit MD System, specifically its fixation strength and pull-out strength. The testing was performed in accordance with the FDA guidance document "Guidance Document for Testing Bone Anchor Devices" dated April 20, 1996. The purpose was to demonstrate that the device performs as well as (i.e., is substantially equivalent to) the identified predicate devices in these critical mechanical parameters. While specific numerical results or sample sizes are not provided in this summary, the conclusion states that the testing verified adequate performance, demonstrating substantial equivalence.
§ 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.