(98 days)
The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque markerbands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a medical device (OPTIMUS 0.035" PTA Balloon Dilatation Catheter) seeking "substantial equivalence" to a predicate device.
Here's an analysis of the provided information in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not list acceptance criteria in terms of specific performance metrics like sensitivity, specificity, or any quantitative targets that a diagnostic device would typically have.
- Reported Device Performance: The document states: "Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses." It also mentions "The device has been tested according to ISO 10993 Part 1 and has been determined to be biocompatible."
- This indicates performance was evaluated against the predicate device and in terms of biocompatibility, but no specific numerical performance values are given.
- The "performance data" section refers to non-clinical design verification/validation tests, which typically involve engineering tests (e.g., burst pressure, fatigue, trackability, etc.) to ensure the device functions as intended and safely, rather than clinical efficacy/diagnostic performance.
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 does not provide details on sample size for any test set or the provenance of data. The "tests and analyses" mentioned are non-clinical, implying benchtop or in-vitro tests, not patient studies.
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 and not provided in this document. Ground truth, experts, and their qualifications are relevant for studies determining accuracy or diagnostic performance, which is not the type of evaluation described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert assessment, which is not the subject of this 510(k) summary.
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
- An MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for AI-assisted diagnostic tools, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance assessment (algorithm only) was not done and is not mentioned. This is also relevant for AI/software devices. The OPTIMUS is a physical medical catheter.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground truth as typically understood for diagnostic device evaluation (e.g., expert consensus, pathology) is not applicable and not discussed for this device. The "ground truth" for a catheter would be its physical specifications and functional performance in a simulated environment.
8. The sample size for the training set
- A "training set" is typically associated with machine learning or AI models. This document does not mention a training set as the device is a physical catheter, not an AI or software algorithm.
9. How the ground truth for the training set was established
- This question is not applicable as there is no mention of a training set or ground truth for such a set.
Summary:
The provided document describes a 510(k) Pre-market Notification for a medical device, the OPTIMUS 0.035" PTA Balloon Dilatation Catheter. The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific diagnostic performance against quantitative acceptance criteria in a clinical setting.
The "performance data" mentioned refers to non-clinical design verification/validation tests (e.g., biocompatibility testing per ISO 10993 Part 1), which verify that the device meets its design specifications and safety requirements, and that it performs comparably to the predicate device in terms of engineering and functional characteristics. It does not involve patient data, expert interpretations, or diagnostic performance metrics like sensitivity or specificity.
§ 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).