(59 days)
The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.
Here's an analysis of the provided text regarding the Metacross OTW PTA Balloon Dilatation Catheter, addressing your specific questions.
It's important to note that the provided document is a 510(k) summary, which is a regulatory submission for medical devices. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or a multi-reader, multi-case study that would be typical for AI-powered diagnostic devices. Therefore, some of your questions may not be fully answerable from this type of document, as it pertains to a physical medical device (a balloon catheter) and its performance, rather than an AI/software device.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not explicitly provide a table of acceptance criteria and quantitative reported performance against those criteria. It states that the device "met all the predetermined acceptance criteria of design verification and validation" and that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."
However, we can infer the types of performance criteria based on the tests conducted:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Met predetermined acceptance criteria. Adequately performed for intended use |
| Dimensional Verification (e.g., balloon diameter, catheter length) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Preparation, Deployment and Retraction (e.g., ease of use, smooth operation) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Rated Burst Pressure (e.g., withstand specified pressure without bursting) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Fatigue (Repeat Balloon Inflations) (e.g., durability over multiple cycles) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Compliance (e.g., inflation characteristics, expandability) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Inflation and Deflation Time (e.g., speed of inflation/deflation) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Catheter Bond Strength (e.g., integrity of assembled components) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Flexibility and Kink Test (e.g., ability to navigate tortuous anatomy without kinking) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Torque Strength (e.g., ability to transmit rotational force) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Radiopacity (e.g., visibility under fluoroscopy) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Particulate Evaluation (e.g., absence of harmful particulates) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Rated Burst Pressure (in Stent) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Balloon Fatigue (Repeat Balloon Inflations; in Stent) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Shelf Life Testing (e.g., stability over time) | Met predetermined acceptance criteria. Adequately performed for intended use |
| Biocompatibility: | Biocompatible for intended use, similar to predicate device |
| Cytotoxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Intracutaneous reactivity (irritation) | Met acceptance criteria |
| Systemic toxicity (acute) | Met acceptance criteria |
| Pyrogenicity | Met acceptance criteria |
| Hemocompatibility (thrombogenicity, hemolysis, and immunology) | Met acceptance criteria |
| Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay) | Met acceptance criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing (in vitro tests) and biocompatibility testing. These are not clinical studies with patient data. Therefore, the concepts of "test set" in the context of clinical data, "country of origin of the data," or "retrospective/prospective" do not apply here.
For the bench tests, the sample sizes for each specific test (e.g., number of balloons tested for burst pressure) are not provided in this summary. Similarly, for biocompatibility, the number of samples or animal subjects (if applicable) is not specified.
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 question is not applicable. The product is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective engineering and biological tests, not through expert interpretation of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as in question 3. No clinical adjudication method is mentioned as these are bench and biocompatibility tests.
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. The device is a balloon catheter, not an AI-powered diagnostic system or an assistive AI for human readers. No MRMC study was conducted or would be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Engineering specifications and standards: For mechanical performance tests (e.g., burst pressure is compared against a specified pressure, dimensions against design drawings).
- Established biological safety standards: For biocompatibility tests (e.g., cytotoxicity is measured against established limits for cellular response).
- Predicate device characteristics: The ultimate goal is to demonstrate equivalence to the predicate device's established performance.
8. The sample size for the training set
This is not applicable. No "training set" in the context of machine learning or AI is involved. The device's design and manufacturing processes are developed based on engineering principles and existing knowledge.
9. How the ground truth for the training set was established
This is not applicable as there is no training set in the AI/ML sense. The "ground truth" for the various performance tests (dimensional, mechanical, biocompatibility) is established through standardized methodologies, calibrated equipment, and predefined acceptance criteria based on regulatory guidance and engineering principles.
§ 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).