Search Results

The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures.

The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.

The SuperBall-RC™ System is an all-inside, all-suture repair device. Each device includes two non-absorbable, soft suture bundles that are attached to each other (USP 1 UHMWPE) and preloaded within a needle delivery system along with the SuperBall securing element made of a braided, coreless sack. The adjustable depth delivery system insertion needle angles), enables the positioning and subsequent deployment of the two bundles under/within the soft tissue. Once placed, manipulation of the delivery system's the pulling suture (USP 3-0 Polyester Cottony II Green), thereby approximating the positioned bundles. The tightened implant is secured by the SuperBall is passed to nestle beside the deployed bundles. By pulling the SuperBall Actuating suture (USP 2-0 Polyester Tevdek II Green), a ball is formed, securing the implant in position.

This document is an FDA 510(k) clearance letter and 510(k) summary for the SuperBall-RC™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way that an AI/ML medical device would.

The document discusses the mechanical strength (shear pullout testing) and usability of the device, but these are general engineering and user experience validations, not a study against specific, quantified acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) typically seen for AI/ML devices.

Therefore, it's not possible to extract the requested information (like a table of acceptance criteria, sample size for test/training sets, number of experts for ground truth, MRMC study results, etc.) from this document. This device is a physical surgical implant, not an AI/ML diagnostic or therapeutic software.

Ask a specific question about this device

The Fiber System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Fiber Locker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue.

The provided FDA 510(k) summary (K241219) for the FiberLocker System does not contain any information about acceptance criteria or a study design for evaluating software or AI performance.

This document describes a medical device called the "FiberLocker System," which is a surgical mesh primarily intended for rotator cuff reinforcement. The performance data presented focuses on the physical and biological characteristics of the implant and its fixation instrument, primarily through bench testing and animal studies.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/software performance. The provided text does not describe an AI or software component for which such criteria and studies would be relevant.

Here's a breakdown of why this information is not present in the document:

1. Nature of the Device: The FiberLocker System is a physical medical device (surgical mesh and instrument), not a software or AI-driven diagnostic or treatment tool.
2. Type of Performance Data: The "Performance Data" section details mechanical properties (tensile strength, suture pull-out, tear testing, corrosion), biocompatibility, and fixation performance in an ex-vivo animal model. These are standard tests for physical implants and surgical instruments.
3. Animal Studies: The animal study described assesses the biological response and biomechanical equivalence of the FiberLocker Implant compared to a predicate device, which is typical for implantable materials.
4. No Mention of Software/AI: The entire document focuses on the hardware aspects of the device. There is no mention of an algorithm, image analysis, diagnostic capabilities, or any form of artificial intelligence.

If this document were for an AI/software device, I would look for keywords like:

• Accuracy, sensitivity, specificity, AUC
• Ground truth, expert consensus, pathology
• Training set, test set, validation set
• Reader study, MRMC study
• FROC, ROC curves
• Algorithm performance, decision support

Since these terms and concepts are entirely absent, it confirms that the provided text does not relate to an AI-enabled medical device performance study.

Ask a specific question about this device

The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.

The TissueTak device is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia or rotator cuff repairs. The Via Surgical TissueTak device, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the TissueTak firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh/patch to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.

The provided text describes a 510(k) premarket notification for the TissueTak device, which is an implantable staple used for fixation of prosthetic or biologic material to soft tissues. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (FasTouch Absorbable Fixation System), rather than establishing de novo clinical efficacy through a comprehensive clinical trial with pre-defined acceptance criteria for diagnostic performance (such as those typically seen for AI/ML devices). This is because the core technology (an implantable staple) is well-established, and the modification is minor (clarification of intended use wording).

Therefore, the information you've requested about acceptance criteria, clinical study design, expert involvement, and statistical analyses (like MRMC studies or standalone algorithm performance) for a diagnostic AI/ML enabled device is not applicable to this 510(k) submission.

The "study" here is a performance test to ensure the modified device functions equivalently to the predicate, focusing on mechanical properties rather than diagnostic accuracy.

Here's a breakdown of why this information isn't present in the provided document, and what is presented instead:

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

• Not applicable in the context of diagnostic AI/ML thresholds.
• Instead, the document focuses on "Substantial Equivalence" criteria, which are:
  • Same Intended Use & Indications for Use (with a minor clarification for rotator cuff repair)
  • Same Environments of Use
  • Same Patient Population
  • Same Delivery Device Design
  • Same Loading Mechanism
  • Same Shaft Length
  • Same Firing Mechanism
  • Same Penetration Depth
  • Same Number of Fasteners
  • Same Fastener Material
  • Same Fastener Design
  • Same Single Patient Use, Disposable
  • Same Sterilization Method
  • Same Prescription Use requirement
• Reported Device Performance (for this type of device): "Performance test was conducted in order to demonstrate that the fixation strength of the modified TissueTak device have equivalent performance to the FasTouch Absorbable Fixation System predicate and its refence device. In all instances, the modified TissueTak device functioned as intended and demonstrated equivalent performance to its predicate."
  • Note: The specific quantitative results of this fixation strength test (e.g., in Newtons or PSI, with a defined acceptance range) are not provided in this summary document, but would have been part of the full submission to the FDA. The summary simply states that equivalence was demonstrated.

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

• Not applicable for a "test set" in the diagnostic AI/ML sense.
• The "test set" here refers to the samples of devices used in the mechanical performance tests. The specific number of devices tested for fixation strength is not mentioned in this summary but would have been defined by engineering test protocols.
• Data Provenance: Not relevant for a mechanical device test; it's performed in a lab setting, likely by the manufacturer.

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

• Not applicable. Ground truth for an AI/ML diagnostic algorithm (e.g., image annotation by radiologists) is not relevant here. The ground truth for a mechanical fixation device is its physical properties (e.g., force required to detach the staple).

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

• Not applicable. This refers to expert consensus in AI/ML model validation. Mechanical tests have predefined pass/fail criteria based on engineering specifications.

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 pertains to diagnostic AI/ML where human interpretation is involved. This device is a surgical staple, not a diagnostic tool.

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

• Not applicable. This also pertains to diagnostic AI/ML.

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

• Not applicable in the diagnostic sense. For this device, the "ground truth" for its performance would be the results of mechanical and functional tests (e.g., tensile strength, securement force, deployment reliability), compared against pre-defined engineering specifications and bench-top performance of the predicate device.

8. The sample size for the training set:

• Not applicable. This relates to AI/ML model training, which is not relevant for a mechanical surgical device.

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

• Not applicable. See point 8.

In summary: The provided FDA 510(k) summary for the TissueTak device is for a mechanical surgical implantable staple, not a diagnostic AI/ML device. Consequently, the performance criteria and study details are focused on demonstrating substantial equivalence to a predicate device through mechanical performance testing and comparison of device characteristics, rather than clinical efficacy or diagnostic accuracy studies typically associated with AI/ML systems.

Ask a specific question about this device