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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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The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder
Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs

Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Elbow
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs: Vastus medialis obliquous advancement

Hip Abductor tendon repair

The TWINFIX Ultra Ti suture anchor is manufactured from titanium, the TWINFIX Ultra PK suture anchor manufactured from polyetheretherketone grade LT3 and the TWINFIX Ultra HA suture anchor is manufactured from poly 1lactide/hydroxylapatite. All anchors are offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with suture, preassembled onto a stainless steel inserter and offered with and without needles.

The provided text describes an Indication Expansion for a medical device (TWINFIX Ultra Ti, PK, and HA suture anchors), seeking to add "Abductor tendon repair" to its intended uses. The submission focuses on demonstrating substantial equivalence to predicate devices and does not describe a study to establish new acceptance criteria or device performance for the new indication alone.

Instead, the submission states that:

• "The performance testing conducted includes static loading, dynamic loading and in vitro degradation properties that are substantially equivalent to the indicated predicates." (Section H)
• "Testing also demonstrates that the differences in the TWINFIX Ultra Ti, PK and HA families and the predicate devices do not raise any new issues of safety and efficacy." (Section H)
• "Since there are no changes to the design the technological characteristics remain the same." (Section G)

Therefore, the acceptance criteria are implicitly those established for the predicate devices and for general suture anchors, with the new indication being supported by demonstrating that the device's performance characteristics (static loading, dynamic loading, degradation properties) are equivalent to those already accepted for similar devices with similar indications. No new, specific acceptance criteria for "Abductor tendon repair" or a dedicated study for it are detailed.

Given this, I cannot fill the requested table or answer most of the questions about a new study proving devices meet acceptance criteria as such a study is not described in the provided text. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than presenting new performance study data for novel acceptance criteria.

However, I can extract the following relevant information based on the premise of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The rest of the questions relate to a specific study demonstrating device performance against new acceptance criteria. Since this document focuses on substantial equivalence to existing devices and does not describe such a study for the indication expansion, I cannot answer them from the given text.

To reiterate, the provided text is a 510(k) summary for an indication expansion, which relies on demonstrating that the performance of the device (TWINFIX Ultra Ti, PK, and HA suture anchors) for the new indication (Abductor tendon repair) is substantially equivalent to that of already legally marketed predicate devices. It does not describe a de novo study to establish new performance criteria or a new study with the details requested in points 2-9 for the expanded indication.

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