(29 days)
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.
The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.
This 510(k) summary describes a medical device, the PreSep Oligon Oximetry Catheters, and demonstrates its substantial equivalence to a predicate device, rather than providing a study proving performance against defined acceptance criteria in the typical sense of an AI/algorithm-driven device.
Therefore, many of the requested categories regarding AI-specific studies and ground truth establishment are not applicable. I will extract the relevant information from the provided text.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly present a table of quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it describes a comparative analysis to a predicate device for safety and effectiveness.
| Performance Aspect (Implied) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance/Functionality | Substantial equivalence to the predicate device in terms of safety and effectiveness. | "The results show that the performance functionality of the pending guidewire is substantially equivalent to the predicate device, and provides a marked improvement in the ease of use of the pending device in comparison to the predicate device." |
| Functional/Safety | Successful completion of functional and performance testing. | "The PreSep Oligon Oximetry Catheters have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing." |
| Clinical Impact | Safety and effectiveness for intended use. | "The PreSep Oligon Oximetry Catheters have been shown to be safe and effective and substantially equivalent to the cited predicate device for their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "side-by-side comparative bench and pre-clinical performance testing."
- Sample Size: Not explicitly stated. The term "pre-clinical animal studies" implies a test set of animals, but the number is not provided. "Bench" studies typically involve physical device testing, not data samples in the same way an AI algorithm uses data.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies are described as "pre-clinical animal studies," indicating they were conducted in a controlled, non-human environment. The nature (retrospective/prospective) is not explicitly given, but "pre-clinical" and "bench" studies are typically prospective tests designed for device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This device is a physical catheter, not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" would be objective measurements and observations from the bench and animal studies to assess the catheter's physical performance, safety, and functionality.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in human-AI studies involving subjective interpretations. For this device, the "adjudication" would be based on direct measurement, observation, and comparison to the predicate device's measured performance in the bench and animal studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
Not Applicable. This is not an AI/software device whose performance depends on human-in-the-loop interaction. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (catheter) with associated oximetry monitors. It is not an algorithm, so a standalone algorithm performance study is not relevant. The device itself performs the function.
7. The Type of Ground Truth Used
For a physical device like this, the "ground truth" for the test (verification and validation) would be based on:
- Physical Measurements and Observations: Direct measurements of catheter dimensions, material properties, flow rates, pressure readings, oxygen saturation readings, and observations of device interaction within the test environment (bench models, animal models).
- Biocompatibility Testing: Results from standardized tests to ensure the material is safe for contact with biological tissues.
- Predicate Device Performance: The established and legally marketed performance and safety profile of the predicate device serves as the benchmark against which the new device is compared to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/machine learning device 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 an AI algorithm, no ground truth was established for a training set in this context.
§ 870.1230 Fiberoptic oximeter catheter.
(a)
Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.(b)
Classification. Class II (performance standards).