(56 days)
The Unstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter, having anchoring balloon and funnel at its distal tip, and Y-connector at its proximal end. The Upstream GR Catheter is intended for use with up to 0.035" guidewires. The Upstream GR Catheter is provided in 100 cm effective length and its shaft's outer diameter is 1.7mm (5F). A hub at the Y-connector center port, at the proximal end of the Upstream GR Catheter, allows guidewire access. The Y-connector side port is used for balloon inflation and deflation. The distal balloon is used for catheter anchoring and centering. The distal funnel is used as soft tip and soft stopper when an occlusion is reached.
The provided text describes the Upstream Peripheral Technologies GR Catheter and its 510(k) summary. It details the device's intended use, technological characteristics, and the safety and performance data used to demonstrate substantial equivalence to a predicate device.
However, the information provided does not pertain to an AI/ML device or a study involving human readers or ground truth established by experts. Instead, it describes a medical device (a catheter) and the engineering bench testing and biocompatibility assessments performed to support its marketing clearance.
Therefore, many of the requested elements for describing acceptance criteria and a study for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods relevant to AI/ML, are not applicable or present in this document.
Here's an attempt to answer the questions based only on the provided text, while highlighting where the requested information is not available due to the nature of the device and study described:
Acceptance Criteria and Device Performance Study (for a non-AI medical device: Upstream GR Catheter)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Biocompatible | Meets requirements |
| Sensitization | Biocompatible | Meets requirements | |
| Irritation/Intracutaneous Reactivity | Biocompatible | Meets requirements | |
| Systemic Toxicity (Acute) | Biocompatible | Meets requirements | |
| Complement Activation | Biocompatible | Meets requirements | |
| Hemocompatibility (Hemolysis and Thromboresistance) | Biocompatible | Meets requirements | |
| Pyrogenicity | Biocompatible | Meets requirements | |
| Bench Testing (ISO-10555-1 & 4, and Internal) | Tensile Force Testing | Meets specifications | Meets intended performance |
| Air Leakage Testing | Meets specifications | Meets intended performance | |
| Corrosion Resistance Testing | Meets specifications | Meets intended performance | |
| Liquid Leakage Pressure Testing | Meets specifications | Meets intended performance | |
| Catheter Torque Testing | Meets specifications | Meets intended performance | |
| Kink Testing | Meets specifications | Meets intended performance | |
| Tip Test | Meets specifications | Meets intended performance | |
| Freedom from Leakage | Meets specifications | Meets intended performance | |
| Balloon Burst Testing | Meets specifications | Meets intended performance | |
| Surface and Dimensional Analysis | Meets specifications | Meets intended performance | |
| Radiopacity Testing | Meets specifications | Meets intended performance | |
| Package Testing | Meets specifications | Meets intended performance | |
| Sterilization Validation Testing | Meets specifications | Meets intended performance |
Note: The document states "All of these tests demonstrated that the Upstream GR Catheter meets its intended performance specifications." The specific quantitative acceptance criteria or results for each test are not detailed in this summary.
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/not provided for this type of medical device clearance. The "test set" in this context refers to physical units of the device subjected to various engineering and biocompatibility tests, not a dataset for an AI/ML algorithm. The provenance of the data would be the results from these lab tests.
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 information is not applicable/not provided. The "ground truth" for this device is established by engineering specifications and recognized biocompatibility standards (e.g., ISO 10993, ISO 10555-1, ISO 10555-4), not by expert medical review of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple expert readers, which is not relevant for the type of testing described (bench testing and biocompatibility).
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, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (a catheter), not an AI algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance evaluation in the context of an "algorithm" was not done. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Compliance with international standards (e.g., ISO 10993 for biocompatibility, ISO 10555-1 and ISO 10555-4 for catheters).
- Internal engineering and design specifications for mechanical and handling characteristics.
- The performance of the predicate device (Endocross Ltd Enabler-P Support Catheter (K082339)) as a benchmark for substantial equivalence.
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, this is not an AI/ML device.
§ 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).