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The Ultraflex™ Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch.

This document describes a 510(k) submission for the Ultraflex™ Precision™ Colonic Stent System. It is an application for an expanded indication for a device that is already on the market. Therefore, the information provided focuses on the substantial equivalence to predicate devices and clinical data for the new indication, rather than detailed performance studies for the device itself.

Here's an analysis based on the provided text, addressing the requested information points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a tabular format. The submission relies on demonstrating substantial equivalence to existing predicate devices for its technological characteristics and presenting clinical data to support the new indication.

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

• Test Set Sample Size: Not specified in the provided text. The document mentions "Clinical data in support of the proposed indication has been collected and is presented within this submission." However, the exact number of patients or cases is not detailed here.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• This information is not provided in the given text.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

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

• No, an MRMC comparative effectiveness study is not mentioned or implied. The submission focuses on device performance and clinical effectiveness for a palliative indication, not on the improvement of human reader performance with AI assistance.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (stent system), not an AI algorithm. The performance data refers to the device's functional characteristics and clinical outcomes.

7. Type of Ground Truth Used

• Given the context of a colonic stent for malignant strictures, the "ground truth" for the clinical data would likely be based on clinical observation, patient outcomes, medical diagnoses (e.g., confirmed malignant neoplasms), and potentially imaging or endoscopic confirmation of stricture palliation. The text itself does not explicitly define the "type of ground truth," but these are standard for such medical devices.

8. Sample Size for the Training Set

• This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

• This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

Summary based on the document:

The submission for the Ultraflex™ Precision™ Colonic Stent System asserts substantial equivalence based on:

• Technological Characteristics: The proposed device has identical materials, construction, and manufacturing processes as the currently marketed Ultraflex Precision Colonic Stent (K030769).
• Performance Data: For the new indication, "Clinical data in support of the proposed indication has been collected and is presented within this submission." The document explicitly states that performance testing from the prior K030769 submission was not repeated because there are no new materials or design changes.

The focus is on demonstrating that the new indication is safe and effective and that the device is substantially equivalent to legally marketed predicate devices (K030769 and K000281). Detailed breakdowns of clinical study methodology (sample sizes, expert qualifications, adjudication, specific metrics) are not provided in this summary document.

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The Ultraflex ™Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms.

The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch. The proposed stent diameter is 25mm along the body and 30mm at the flared distal section; the lengths are 6cm, 9cm, and 12cm.

This document describes the Ultraflex™ Precision™ Colonic Stent System, a self-expanding metal stent indicated for the palliative treatment of malignant colonic strictures. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for any test sets related to human data or clinical studies. The performance data section vaguely mentions "in vivo testing" but provides no details on the number of subjects, the type of study (e.g., human clinical trial, animal study), or the data provenance (e.g., country of origin, retrospective/prospective). Given this is a 510(k) submission, the primary focus is on bench testing and comparison to predicates, with human clinical trial data often not required unless significant differences from the predicate exist.

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

The document does not mention the use of experts or ground truth establishment for any clinical test set. The evaluation is based on substantial equivalence to a predicate device, which relies heavily on engineering and material performance comparisons, not human expert interpretation of clinical data in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

As there's no mention of a clinical test set with specific ground truth established by experts, there is no adjudication method described in the document.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is typically associated with diagnostic devices where human readers interpret medical images or data, often with and without AI assistance, to measure the AI's impact on human performance. This submission is for a medical device (stent) and does not involve AI for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone performance study of an algorithm was done. This device is a physical stent with a delivery system, not an AI algorithm.

7. The Type of Ground Truth Used

For the bench and in vivo (likely animal) testing, the "ground truth" would be the engineering specifications and measurements for tensile strength, fatigue, corrosion resistance, and successful deployment/functionality of the stent within a physiological environment. For the "in vivo testing," the ground truth would be the observation of safety and effectiveness (e.g., stent patency, lack of severe adverse events) in a living organism. These are not explicitly defined as "ground truth" in the AI sense, but rather as successful outcomes meeting design requirements.

8. The Sample Size for the Training Set

Not applicable. This device is hardware; there is no "training set" in the context of machine learning or AI.

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

Not applicable. As there is no AI component, there is no training set and therefore no ground truth established for it.

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