(255 days)
The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.
The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device contains a polyurethane defoamer sponge and outer gross filter screen.
The provided 510(k) summary for the Sorin Biomedical Inc. Venomidicard/Midicard describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they pertain to the evaluation of AI/ML software.
However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.
Acceptance Criteria and Device Performance for Sorin Biomedical Inc. Venomidicard/Midicard
The acceptance criteria for the Venomidicard and Midicard reservoirs were based on their "substantial equivalence" to a legally marketed predicate device, the Sorin Hardshell Venous Reservoir (HSVRF), for the expanded use of chest drainage autotransfusion. Substantial equivalence was demonstrated through a comparison of technological characteristics and nonclinical test results.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured against predicate device - Sorin Hardshell Venous Reservoir) | Reported Device Performance (Venomidicard and Midicard) |
|---|---|
| Technological Characteristics: | Similar to predicate device: |
| Intended Use | Similar |
| Materials | Similar |
| Design | Similar |
| Performance Characteristics | Similar |
| Number of cardiotomy inlet ports | Similar |
| Filter elements | Similar |
| Setup and use for chest drainage | Similar |
| Nonclinical Test Results: | Similar performance characteristics to predicate device: |
| Physical Tests: | |
| Vacuum Integrity | Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir. |
| Functional Tests: | |
| Hemolysis | Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir. |
| Residual Volume | Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir. |
| Filter Pressurization | Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir. |
| Biocompatibility: | Acceptable for intended use: |
| Compatibility with blood-contacting materials (short term) | All test results comparable to negative control groups, indicating materials are acceptable for their intended use. (Previously performed on a finished, sterilized device in accordance with Tripartite Guidelines). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that "All testing was conducted on nonaged, sterile devices." It does not specify the number of units tested for each physical and functional test.
- Data Provenance: The tests were "in vitro physical and functional tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are generally more applicable to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device evaluation relies on objective physical and functional measurements, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This device evaluation relies on objective physical and functional measurements, not expert consensus or adjudication.
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 is a medical device (a physical reservoir), not an AI/ML algorithm or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance was established by comparing its physical and functional test results to those of the predicate device (Sorin Hardshell Venous Reservoir). The predicate device itself was presumably cleared based on its known performance and safety. Biocompatibility was assessed against established Tripartite Guidelines using negative control groups.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.