(216 days)
The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.
Pilling® Esophageal Bougies are weighted, cylindrical instruments used for the dilation of the larynx and esophagus. They are designed to be reusable and resterilized by the user. Made from silicone elastomer and filled with tungsten, the bougies are marketed in French sizes 20 to 60. Pilling® Bougies have two tip styles; the Maloney bougie has a long tapered tip and the Hurst has a rounded tip. Both tips are impregnated with radio-opaque material (barium sulfate) and contain calibration marks along the tubing. By inserting the bougie through the patient's mouth and down the patient's esophagus, a clinician can mechanically push a blockage out of the esophagus or can mechanically dilate a stricture in the esophagus.
This document describes the performance testing for the Pilling® Esophageal Bougies, focusing on demonstrating substantial equivalence to a predicate device rather than a standalone AI device study.
Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not directly applicable to an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile strength between bougie plug and casing shall be at least 10 lbs. | Pilling® Esophageal Bougies: Avg 20.49 lbs, Min 14.24 lbs, Max 22.76 lbs. |
| Medovations® M-Flex™ Esophageal Bougies (Predicate): Avg 14.92 lbs, Min 10.83 lbs, Max 26.83 lbs. | |
| All samples of both products met the pre-defined acceptance criteria. | All 30 samples of Pilling® Hurst Tungsten-filled Bougie (20Fr) passed. |
| All 30 samples of Medovations® M-Flex™ Hurst Tungsten-filled Bougie (20Fr) passed. |
2. Sample size used for the test set and the data provenance
- Sample size: 30 samples of the Pilling® Esophageal Bougies and 30 samples of the predicate Medovations® M-Flex™ Esophageal Bougies were tested.
- Data provenance: Not explicitly stated, but based on the context of 'bench testing' and 'Teleflex has performed', it is implied to be prospective data generated by the manufacturer for the purpose of this submission. The "country of origin of the data" is not specified but would typically be the location of the manufacturing and testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study described is a bench test evaluating the physical properties (tensile strength) of mechanical devices, not a study involving medical images or clinical data requiring expert human interpretation for ground truth. The "ground truth" here is a predefined engineering specification (10 lbs tensile strength).
4. Adjudication method for the test set
This information is not applicable. As a bench test with objective physical measurements, there is no need for expert adjudication. The results are quantitative and directly measured against the acceptance criteria.
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
This information is not applicable. This submission concerns a physical medical device (esophageal bougies) and is not an AI-powered diagnostic or therapeutic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical tool, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is a predefined engineering specification/acceptance criterion: a minimum tensile strength of 10 lbs. This is a technical standard rather than a medical ground truth like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI device or a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable. As there is no AI or machine learning involved, there is no training set or ground truth establishment method for it.
§ 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.