(67 days)
The Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The proposed Diamond™ Balloon Dilatation catheter is an over-the-wire catheter indicated for percuraneous transluminal angioplasty of the iliac, femoral arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller. The device is offered with and without Glidex™ and Medi-Glide™ coatings.
The provided text describes a medical device, the Medi-tech Ultra-thin Diamond Balloon Dilatation Catheter, and its safety and performance testing for its 510(k) submission in 1996.
However, the information requested in your prompt ("acceptance criteria and the study that proves the device meets the acceptance criteria") specifically pertains to studies often associated with AI/ML devices or diagnostic tools. The provided document details in vitro functional tests and biocompatibility tests for a mechanical medical device, not a study evaluating performance against predefined acceptance criteria in the context of diagnostic accuracy, which is what your questions imply.
Therefore, many of the specific questions (like sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to the type of device and testing described in this document.
Here's how I can address the parts that are relevant and indicate where information is missing or not applicable based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for each test, nor does it typically provide detailed quantitative "reported device performance" in the way an AI/ML study would for metrics like sensitivity, specificity, or AUC. Instead, it lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Pass Balloon Burst Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Multiple Inflation Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Inflation/Deflation Time Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Balloon Compliance Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Balloon Proximal Bond Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Sheath Withdrawal Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Wingfolded Balloon Profile Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Coating Slip/Adhesion Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Coating Coefficient of Friction Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Particulate Analysis Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Solvent Residual Testing | "performed on the Diamond™ Balloon Dilatation Catheter" |
| Pass Cytotoxicity Testing | "performed" |
| Pass Hemolysis Testing | "performed" |
| Pass U.S.P. Class IV Testing | "performed" |
| Pass Mutagenicity Testing | "performed" |
| Pass Sensitization Testing | "performed" |
| Pass Thrombogenicity Testing | "performed" |
| Pass Pyrogenicity Testing | "performed" |
| Pass 90-Day Muscle Implantation | "performed" |
| Overall Conclusion: | "Based on the Indication for Use, technological characteristics and safety and performance testing, the Diamond™ Balloon Dilatation Catheter has been shown to be safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes in vitro (laboratory) and biocompatibility tests, not a clinical study involving patient data or a diagnostic test set in the way your question implies. Sample sizes for these types of engineering and biological tests would typically be small numbers of devices or material samples, not patient cohorts. Data provenance is also not relevant here as it's not patient-level data.
3. 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)
This is not applicable. Ground truth, in the context of diagnostic accuracy established by experts, is not relevant for the in vitro functional and biocompatibility tests described. These tests have objective engineering or biological endpoints.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used to resolve disagreements in expert interpretations, which is not relevant for the types of tests described 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
This is not applicable. This device is a mechanical balloon catheter, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance evaluation would have been conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI/ML algorithms, not a mechanical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for the tests mentioned are the objective results of the physical and biological tests themselves (e.g., burst pressure, inflation time, cytotoxicity results). There's no interpretive ground truth like pathology or expert consensus involved.
8. The sample size for the training set
This is not applicable. This question relates to AI/ML models, not a mechanical device undergoing functional and biocompatibility testing. There is no "training set" for this device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).