(185 days)
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette.
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette. It is sold sterile and pyrogen free in a Tyvek peel pouch. It is constructed of a single piece of injection molded polycarbonate.
This 510(k) summary describes a medical device, the IBC CMO2 Flow Through Cuvette, but it does not contain the information requested to perform the deeper analysis of acceptance criteria, study details, and ground truth establishment typically associated with AI/ML-based device submissions.
The document is a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device (Bentley OTC Flow Through Cuvette) for a physical component, not a software algorithm. Therefore, many of the requested fields are not applicable to this type of submission.
Here's a breakdown of why the requested information cannot be fully provided based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided table is a "TABLE OF COMPARISON" demonstrating similarity to a predicate device, not pre-defined acceptance criteria for a novel performance study.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (IBC CMO2 Cuvette) |
|---|---|---|
| Packaging | Single, sterile and disposable | Single, sterile and disposable |
| Construction | Substantially equivalent (single piece vs. 4 assembled pieces) | Single piece molded |
| Sizes | 1/4", 3/8", 1/2" | 1/4", 3/8", 1/2" |
| Material | Polycarbonate | Polycarbonate |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Accuracy | Identical (r=.998) to predicate | Identical (r=.998) |
| Toxicity | Tripartite Guidelines compliant | Tripartite Guidelines |
| Blood Compatibility | Non-Hemolytic | Non-Hemolytic |
Explanation: The "acceptance criteria" here are implicitly that the IBC CMO2 Cuvette performs identically or equivalently to the Bentley OTC Cuvette. The reported performance for the CMO2 Cuvette is that it meets these equivalent characteristics. The "Accuracy" value (r=.998) is stated as "Identical" to the predicate, implying it achieves this level of accuracy, but the context of this r-value and what it measures is not detailed (e.g., correlation with a gold standard, or correlation between the two devices).
The following sections are Not Applicable (N/A) to this traditional medical device submission of a physical component because the submission does not describe a study to evaluate an algorithm or AI/ML performance.
2. Sample size used for the test set and the data provenance: N/A (no test set for AI/ML performance described)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth for AI/ML performance described)
4. Adjudication method for the test set: N/A (no adjudication for AI/ML performance 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: N/A (not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (no ground truth for AI/ML performance described)
8. The sample size for the training set: N/A (no training set for AI/ML described)
9. How the ground truth for the training set was established: N/A (no ground truth for AI/ML described)
Summary of Device and Evidence Presented:
The IBC CMO2 Flow Through Cuvette is a single-piece, single-use, disposable component for use with the Bentley OxySat Monitor. Its primary claim is substantial equivalence to the Bentley OTC Flow Through Cuvette. The evidence provided is a comparison table highlighting identical functional characteristics (e.g., material, sterilization, sizes, accuracy value (r=.998), toxicity compliance, blood compatibility), with the key difference being the construction method (single-piece molded vs. four adhesively bonded pieces). The rationale for the single-piece construction is cost reduction, elimination of leak sources, and improved geometric control. Performance is stated to be identical when used according to manufacturer's instructions. This is a traditional 510(k) submission based on equivalence, not an AI/ML performance evaluation.
§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
(a)
Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.(b)
Classification. Class II (performance standards).