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Intended Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

Indications for Use
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CONMED TruShot™ with Y-Knot® Shallow All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one #0 (3.5 metric) or one #2-0 (3 metric) Hi-Fi® suture strand with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.

The provided document is a 510(k) Summary for a medical device (TruShot™ with Y-Knot® Shallow All-Suture Anchor) and describes performance data to demonstrate substantial equivalence to a predicate device, rather than defining acceptance criteria and a study to prove a device meets those acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design for proving it, and specifics related to AI/algorithm performance (like effect size with AI assistance, standalone performance, training set details) are not applicable or extractable from this type of regulatory submission.

However, I can extract information about the types of performance testing conducted to support the device's clearance.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed reported device performance values. It states that "Testing has been completed to demonstrate that the TruShot™ with Y-Knot® Shallow All-Suture Anchor performs as intended and is substantially equivalent to the predicate device." It also mentions "met the endotoxin limits" without specifying the limit itself.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for any of the tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective nature, as these tests are typically bench or lab-based for medical devices like suture anchors.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a physical medical implant, not an AI or diagnostic tool requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable for this type of device testing.

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

No such study was done or is relevant to this physical medical device. This is typically applicable to diagnostic AI devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance was done. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical and material properties (e.g., Ultimate Fixation Strength, Cyclic testing), the "ground truth" would be established by validated test methods and physical measurements, compared against established standards or performance of the predicate device. For biological tests (e.g., pyrogen, biocompatibility, sterilization), it would be against regulatory limits and specified testing standards.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/machine learning device.

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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

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.

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