(161 days)
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only not treatment delivery, during cardiac interventional percutaneous procedures.
The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic Ultrasound Catheters 10F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.
This document is a 510(k) premarket notification for a reprocessed medical device, specifically an ultrasound catheter, not a new device involving AI or complex software. As such, the information requested in your prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria specifically for AI/Software performance is not present in this document.
The 510(k) submission for the Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F focuses on demonstrating substantial equivalence to a predicate device (the original, single-use Siemens AcuNav Diagnostic Ultrasound Catheter). This is achieved through non-clinical testing to show that the reprocessed device performs as safely and effectively as the original.
Therefore, many of the specific points you've asked for, such as sample size for a test set for AI performance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth for training data, are not applicable to this type of device and submission.
However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this reprocessed device, which serves as its "proof" of meeting performance criteria.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of quantitative acceptance criteria with numerical performance data. Instead, it lists the types of non-clinical tests performed to demonstrate that the reprocessed device's functional characteristics are substantially equivalent to the predicate device. The implied acceptance criterion for each test is that the reprocessed device performs comparably to the original to ensure safety and effectiveness.
| Test Category | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Functional Performance | Equivalent to predicate; safe and effective in intended use. | "evaluated and found to be substantially equivalent" |
| Simulated Use | Function similar to original in a simulated environment. | Performed, result is substantial equivalence. |
| Artificial Soiling | Cleaning processes effective after simulated contamination. | Performed, result is substantial equivalence. |
| Visual Inspection | No detrimental changes or defects after reprocessing. | Performed, result is substantial equivalence. |
| Mechanical Characteristics | Maintains physical integrity and functionality. | Performed, result is substantial equivalence. |
| Ultrasound Transducer Testing | Acoustic performance equivalent to original. | Performed, result is substantial equivalence. |
| Dimensional Analysis | Dimensions remain within specified tolerances. | Performed, result is substantial equivalence. |
| Device Functionality | Performs all intended functions. | Performed, result is substantial equivalence. |
| Electrical Safety | Meets dielectric and current leakage standards. | Performed; "dielectric and current leakage" |
| Cleaning Validation | Effective removal of contaminants. | Performed |
| Biocompatibility | No adverse biological reactions. | Performed |
| Sterilization Validation | Achieves required sterility assurance level (SAL). | Performed ("bioburden testing; ethylene oxide and ethylene chlorohydrin residuals testing; and bacteriostasis/fungistasis") |
| Packaging and Shelf Life Validation | Maintains integrity and sterility over shelf life. | Performed |
| Product Stability | Remains stable over time. | Performed |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact number of units/samples used for each type of non-clinical test. This level of detail is typically found in the full testing reports submitted to the FDA, not in the public 510(k) summary.
- Data Provenance: The tests were conducted by Medline ReNewal. While not explicitly stated, such tests are generally conducted at their facilities or certified labs. The country of origin of the data would be the USA (Oregon, specifically, as per the address). The data is prospective in the sense that Medline ReNewal specifically conducted these tests to support this 510(k) submission for their reprocessed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to AI/software performance evaluation where human experts establish ground truth for image interpretation or diagnosis. For a reprocessed physical device, "ground truth" is established by adherence to engineering specifications, performance standards, and established test methodologies (e.g., AAMI standards for sterilization, ISO standards for biocompatibility). The "experts" involved would be engineers, microbiologists, and other technical personnel who design and execute these tests, and interpret the results against pre-defined success criteria.
4. Adjudication method for the test set:
- Not applicable. This refers to consensus-building among medical experts for labeling data, which is not relevant for the physical performance testing of a reprocessed medical device. Test results are compared against objective criteria and engineering specifications.
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 type of study is relevant for AI-powered diagnostic devices. This submission is for a reprocessed ultrasound catheter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This refers to the performance of a software algorithm.
7. The type of ground truth used:
- For this reprocessed device, "ground truth" is based on engineering specifications, established performance standards (e.g., mechanical strength, electrical safety, acoustic performance), and validated manufacturing processes (e.g., cleaning efficacy, sterilization efficacy). The original predicate device's performance also serves as a benchmark for comparison.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set."
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).