(76 days)
The intended use of the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter is for the dilatation of strictures of the esophagus.
The device is an over the wire balloon catheter, with a distal balloon and a proximal hub. The balloon features two radiopaque marker bands.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way modern AI/software device submissions would.
This document is a 510(k) premarket notification for a medical device (Cordis Maxi LD Large Diameter Balloon Dilatation Catheter) from the year 2000. For devices of this type and era, the FDA approval process primarily focused on demonstrating substantial equivalence to a predicate device already on the market, rather than a detailed performance study with quantifiable acceptance criteria for a novel algorithm.
Therefore, many of the requested details related to AI/software device studies (like performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable and not present in this document.
Here's a breakdown of what information can be extracted and what is explicitly not available from the provided text, in the context of the questions asked:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for this 510(k) submission was demonstrating substantial equivalence to predicate devices through pre-clinical testing.
- Reported Device Performance: The document states "The equivalence was confirmed through pre-clinical testing." No specific performance metrics (e.g., dilatation force, burst pressure, etc.) or their results are provided in this summary.
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Available. The document refers to "pre-clinical testing" but does not provide details on the sample size of subjects, cases, or the nature of this testing (e.g., in-vitro, animal, human). No information on data provenance (country of origin, retrospective/prospective) is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Available. This concept is relevant for AI/software devices where expert consensus often establishes truth. For this mechanical device, "ground truth" would be related to physical properties measured in a lab, not expert interpretations of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. This is a method for resolving discrepancies in expert labeling for AI/software device ground truth. It's not relevant to the submission for a balloon catheter.
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
- No. This is a mechanical device, not an AI/software device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Available. For this type of device, "ground truth" would relate to objectively measured physical and mechanical properties from pre-clinical testing (e.g., burst pressure measured by instrumentation, dimensions measured by calipers). The document does not specify these.
8. The sample size for the training set
- Not Applicable. This is a mechanical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As no training set exists, this question is not relevant.
In summary, the provided document is a 510(k) clearance letter for a conventional medical device (esophageal dilator balloon catheter) based on substantial equivalence as of January 2000. It does not contain the detailed performance study information, acceptance criteria, or AI/software-specific elements requested in the prompt.
§ 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.