(88 days)
The Diamond™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of naive or synthetic arteriovenous dialysis fistulae. In addition, certain sizes of the Diamond balloon catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.
The proposed Diamond™ Balloon Dilatation catheter is an over-the-wire catheter designed to be placed over guidewires which have outer diameters of .035" or smaller.
This is a tough one, as the provided text describes a medical device from 1996, a balloon dilatation catheter, not an AI/ML powered device. The questions in your prompt are specifically tailored for AI/ML device performance studies. Therefore, many of the requested fields are not applicable to the provided document.
However, I will extract what I can and mark the non-applicable sections.
Here's an analysis of the provided text in the context of your questions:
Device Name: Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a non-AI/ML device from 1996, the "acceptance criteria" and "reported device performance" are based on functional and integrity bench testing, and biocompatibility testing, not on metrics like accuracy, sensitivity, or specificity commonly used for AI/ML devices.
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Functional and Integrity Bench Testing | Performed and data "supported the substantial equivalence" to the PEMT-5 Balloon Dilatation Catheter. |
| Biocompatibility Testing | Performed "according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993." Data "supported the substantial equivalence" to the PEMT-5 Balloon Dilatation Catheter. |
| Substantial Equivalence | Demonstrated for the Ultra-thin™ Diamond™ Balloon Dilatation Catheter to the PEMT-5 Balloon Dilatation Catheter based on functional, integrity, and biocompatibility testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For a physical medical device, "test set" would refer to the number of catheters or components used in the bench tests.
- Data Provenance (country of origin, retrospective/prospective): Not applicable in the context of an AI/ML device. The testing was done on the physical device itself, likely at the manufacturer's facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) does not apply to the safety and performance testing of a physical medical device like a catheter. The "ground truth" for a catheter would be its physical properties, material composition, and functional output measured by engineering and biomedical tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not the case here.
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
Not applicable. An MRMC study is for evaluating the impact of AI on human reader performance, which doesn't apply to a physical catheter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question is for AI/ML device performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/ML sense. The "ground truth" for a catheter's safety and performance testing would be established by:
- Engineering specifications and standards for functional and integrity measurements.
- Biocompatibility standards (e.g., ISO-10993) for biological response.
- Comparison to an already approved predicate device (PEMT-5 Balloon Dilatation Catheter) which serves as the benchmark for "substantial equivalence."
8. The sample size for the training set
Not applicable. This device is not AI/ML.
9. How the ground truth for the training set was established
Not applicable. This device is not AI/ML.
Summary of Device-Specific Information:
The provided document describes the regulatory submission for a physical medical device, the Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter. The primary evidence for its safety and effectiveness relies on:
- Bench Testing: Functional and integrity tests to confirm the physical characteristics and operational capabilities of the catheter.
- Biocompatibility Testing: Conducted according to established international standards (ISO-10993) to assess the device's interaction with biological systems.
- Substantial Equivalence: The data from these tests were used to demonstrate that the new catheter is "substantially equivalent" to previously approved predicate devices (BSC -- PEMT-5 Balloon Dilatation Catheter and BSC -- Ultra-thin™ Diamond Balloon Catheter). This means it performs as safely and effectively as a device already on the market.
The "conclusion" states that based on the indications for use, technological characteristics, and safety and performance testing, the device is considered safe and effective.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.