(45 days)
The AngioAssist is a set of manual instruments intended to facilitate alignment and introduction of interventional devices (i.e., guide wires and catheters) within the coronary and peripheral vasculature.
The AngioAssist consists of the Docking Station , Teirstein Edge and AngioAssist Combination Device. The devices are provided sterile for single use.
The provided document is a 510(k) summary for the AngioAssist device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed device performance metrics typically found in clinical trials.
Therefore, many of the requested sections below cannot be fully extracted or are not applicable based on the content of this 510(k) summary.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed performance metrics from a study in the way a clinical trial report would. The "performance" assessment relies on non-clinical testing to ensure the device functions safely and effectively and demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device functions safely | Non-clinical testing results "provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for the indications for use." |
| Device functions effectively | Non-clinical testing results "provide reasonable assurance... conformance to the requirements for the indications for use." |
| Biocompatibility | Biocompatibility testing performed to verify safe function. |
| Substantial Equivalence to Predicate Devices | "The AngioAssist instruments are substantially equivalent to the predicate devices listed above based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the AngioAssist will perform as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical testing" and "biocompatibility testing." These generally refer to bench testing, mechanical testing, and material testing, not human patient data. Therefore, there is no "sample size" in terms of patient cases, nor "country of origin" or "retrospective/prospective" data provenance in the context of a clinical study.
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)
Not applicable. "Ground truth" established by expert consensus is relevant for diagnostic devices or AI algorithms analyzing complex data (e.g., medical images). This document describes a manual instrument (catheter guide wire accessory) and its evaluation through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies with multiple readers or experts to resolve discrepancies in diagnoses or assessments. This is not mentioned in the context of the non-clinical testing described.
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. This device is a manual instrument, not an AI or imaging diagnostic device. The concept of "human readers improve with AI" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual instrument for human use, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a device like AngioAssist, "ground truth" would relate to its functional performance (e.g., does it successfully guide a wire or catheter, does it withstand certain forces, is it biocompatible). This "ground truth" is established through engineering specifications, material standards, and predefined functional tests, rather than expert consensus on patient data, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This document describes a traditional medical device (manual instrument) and its non-clinical evaluation, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.