(77 days)
The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level. It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.
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The provided document is a 510(k) clearance letter from the FDA for a device called "LevelSens". This type of letter generally declares substantial equivalence to a predicate device based on performance testing but does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader studies as would be expected for AI/ML-based devices.
Therefore, the requested information cannot be fully provided from the given document as it pertains to a different type of medical device clearance.
However, based on the limited information available in the document, here's what can be inferred or stated about the device and the nature of its clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the FDA 510(k) clearance letter. Such letters confirm substantial equivalence, which implies the device meets performance standards comparable to legally marketed predicate devices, but they do not typically detail the specific acceptance criteria or the reported performance data from testing.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a non-AI/ML medical device like LevelSens, performance testing would typically involve engineering tests to verify alarm thresholds, accuracy of level detection, and durability, rather than a "test set" in the context of AI/ML validation data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided and is generally not applicable to the clearance of a device like LevelSens. Ground truth as typically understood in AI/ML (e.g., expert consensus on image interpretation) is irrelevant for a device that monitors fluid levels.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable for this type of device clearance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided and is not applicable. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a fluid level monitoring device.
6. Standalone Performance Study (Algorithm Only):
This information is not provided. While the device operates independently to monitor levels, the term "standalone performance" in the context of an "algorithm only" study typically refers to AI/ML device performance without human intervention, which is not relevant here.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI/ML (e.g., pathology, expert consensus) is not applicable to this device. The "ground truth" for LevelSens would be the actual physical fluid level in the reservoir against which the device's measurement and alarm activation are compared.
8. Sample Size for the Training Set:
This information is not provided and is not applicable as LevelSens 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 provided and is not applicable as LevelSens is not an AI/ML device that requires a training set.
In summary, the provided document is an FDA 510(k) clearance letter for a fluid level monitoring device. It confirms that the device is substantially equivalent to a predicate device for its stated indications for use but does not contain the detailed study information typically requested for AI/ML devices, such as acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, or multi-reader studies.
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
(a)
Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.