(87 days)
The Boston Scientific Corporation Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.
The Maxforce TTS Single-Use Balloon Dilator consists of a distal tip, balloon, catheter shaft, and proximal hub.
This document is a 510(k) premarket notification for a medical device called the Maxforce TTS Single-Use Balloon Dilator. It is not a study report or a publication detailing a clinical trial with acceptance criteria and performance metrics in the way a diagnostic AI device might.
Instead, this submission is to add new contraindications to the existing device's Directions for Use, asserting that the device is substantially equivalent to a previously cleared predicate device (K934697) for its intended use. Since there are no new claims for improved performance or a new intended use, a performance study to prove the device meets acceptance criteria in the typical sense for a new diagnostic or AI-driven device is not applicable here.
The "Performance Data" section explicitly states: "FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison support a determination of substantial equivalence for the proposed device when compared to the predicate device." This indicates that the primary "proof" for this submission is based on the device's fundamental design, operating principle, materials, and intended use being the same as the predicate, rather than a clinical performance study with specific metrics.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/diagnostic device cannot be extracted from this document.
Here's an attempt to answer the questions based on the provided text, primarily noting what is not applicable or not specified given the nature of this 510(k) submission:
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A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for an existing device with new contraindications and relies on substantial equivalence to a predicate, not performance against new acceptance criteria. No new performance data or acceptance criteria are presented as a direct numerical or statistical outcome in this document.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or clinical data is mentioned for this 510(k) submission. The basis for clearance is "physical comparison" to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment by experts is described in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is described in this submission.
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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 device is a physical medical device (balloon dilator), not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is established or discussed for this 510(k) submission. The claim is based on substantial equivalence to a predicate device's design and intended use.
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The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/algorithmic device.
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How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment is mentioned.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.