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The TAS400 NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

The TAS400 NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.

Here's an analysis of the provided text regarding the NeoTract Anchor System's acceptance criteria and study information:

Based on the provided 510(k) summary, the device is a surgical suture system, and the focus of its submission is on substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria related to diagnostic performance. Therefore, the information you're looking for, especially concerning diagnostic performance metrics, reader studies, and ground truth establishment, is largely not applicable in this context.

The "acceptance criteria" for this type of submission are primarily about demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through in-vitro testing and material comparisons.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a surgical suture system seeking substantial equivalence to existing devices, specific "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, AUC) are not defined or reported. Instead, the acceptance criteria relate to the physical and functional properties of the device, which are evaluated through in-vitro testing.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. The document only mentions "In-vitro testing" without detailing the number of units tested.
• Data Provenance: Not specified, but generally, in-vitro testing is performed by the manufacturer (NeoTract, Inc.) in a controlled laboratory setting. It is not patient or human data, so concepts like country of origin or retrospective/prospective do not apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable. For a surgical suture system's in-vitro testing, the "ground truth" isn't established by medical experts in the diagnostic sense. It's established by engineering specifications and standards for material properties, tensile strength, securement, etc. The "experts" involved would be engineers and quality control personnel assessing compliance with these specifications.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or challenging diagnoses. In-vitro testing relies on objective measurements against predefined engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is relevant for diagnostic imaging devices or algorithms that impact human reader performance. This device is a physical surgical implant, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards. The "ground truth" for the in-vitro testing would be objective, measurable specifications for mechanical properties (e.g., strength, durability, securement), biocompatibility, and material integrity, defined by industry standards and the manufacturer's own design requirements.

8. The Sample Size for the Training Set

• Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical product, not an AI system.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable.

In Summary:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of the NeoTract Anchor System to predicate devices for its intended use (approximation of tissue in open surgical procedures). The evaluation relies on in-vitro testing to confirm material suitability and performance against established specifications. The typical metrics and study designs associated with diagnostic AI or imaging devices (like acceptance criteria for sensitivity/specificity, reader studies, ground truth establishment by experts) are not relevant or present in this submission.

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The Modified NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

The Modified NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.

The provided text describes a 510(k) summary for the "Modified NeoTract Anchor System." However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document is a premarket notification to the FDA, focusing on substantial equivalence to predicate devices, and mentions in-vitro testing only in a very general sense. It states:

"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."

This statement confirms that some testing was done and met specifications, but it does not provide any details about:

1. Specific Acceptance Criteria: What "required specifications" were, e.g., tensile strength, knot security, degradation rate.
2. Reported Device Performance: The actual numerical results of the tests.
3. Study Design: What kind of study was conducted (sample size, data provenance, etc.).
4. Clinical Performance: There is no mention of studies involving human or animal subjects to assess clinical performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them because that information is not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

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The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.

The NeoTract Anchor System consists of a single use delivery device that delivers up to two permanently implantable NeoTract Anchors. A NeoTract Anchor consists of one nitinol tube connected by nonabsorbable monofilament suture to a stainless steel pin with locking ring.

This document describes a 510(k) summary for the NeoTract Anchor System, a surgical suture device. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, the NeoTract Anchor (K061700).

Therefore, the provided text does not include information about AI/ML device performance or studies with acceptance criteria in the context of AI/ML. The device described, the NeoTract Anchor System, is a traditional medical device (surgical suture) and the supporting data pertains to biocompatibility, bench testing, and animal testing to demonstrate substantial equivalence, not AI algorithm performance.

Therefore, I cannot fulfill your request for the following reasons:

• No AI/ML Component: The provided submission is for a physical medical device (surgical suture) and does not involve an AI/ML algorithm.
• No Acceptance Criteria for AI/ML: Consequently, there are no acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies related to AI/ML to report.
• Study Type: The studies mentioned (biocompatibility, bench testing, animal testing) are standard for mechanical medical devices, not for evaluating AI performance.

If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the requested information.

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The NeoTract Anchor is intended for the approximation of tissue in open surgical procedures.
The NeoTract Anchor is intended for the approximation of soft tissue in open surgical procedures.

The NeoTract Anchor is designed to approximate tissue following open surgical procedures.

This submission (K061700) refers to a 510(k) Premarket Notification for the NeoTract Anchor, a surgical device intended for tissue approximation. The provided text, however, does not contain a study that presents acceptance criteria and reported device performance in the way typically expected for an AI/ML device.

This document describes a medical device called the "NeoTract Anchor" which is a physical surgical device (a staple/anchor for tissue approximation), not an AI/ML software device. The "Testing Summary" section notes that "Simulated use and performance testing was conducted on the NeoTract Anchor and compared to the predicate device, Onux Salute," and that "All components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide the quantitative or qualitative details of these tests, or the specific acceptance criteria.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and studies, as this document is not about such a device. The information requested (sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML algorithms and is not addressed in this 510(k) submission for a physical surgical anchor.

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