(112 days)
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 0730 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/4" venous inlet at the bottom section of the reservoir. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 1.2 lpm. The maximum cardiotomy flow rate is 0.9 lpm.
The provided text is a 510(k) summary for the MEDOS HILITE MVC 0730 Hardshell Venous Reservoir, a medical device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this submission.
The document describes a traditional medical device and its predicate comparison, focusing on safety, performance, and validation for its intended use.
Here's the information that can be extracted relevant to the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it broadly states that "the device meets all of its functional requirements and performance specifications" and "complies with applicable industry and safety standards."
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Requirements | Device meets all functional requirements and specifications |
| Performance Specifications | Device meets all performance specifications |
| Safety Standards | Device complies with applicable industry and safety standards |
| Intended Use | Same intended use as the predicate device |
| Technological Characteristics | Similar technological characteristics as the predicate device |
| Equivalence | Equivalent in safety and effectiveness to predicate devices |
2. Sample size used for the test set and the data provenance
The document states, "The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests..."
However, specific sample sizes for testing (e.g., number of units tested, number of in-vitro or in-vivo trials) are NOT provided. The text does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, which are typical considerations for clinical trials, not necessarily for engineering performance validation of a mechanical device like this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the ground truth concept (e.g., for diagnostic accuracy) is not relevant to the performance validation of a mechanical device like a blood reservoir. The device's performance is assessed against engineering specifications, not clinical interpretations by experts.
4. Adjudication method for the test set
This is not applicable for the same reasons as #3. Adjudication is typically used to resolve discrepancies in expert interpretations or assessments, which is not relevant for the functional and safety testing of this mechanical device.
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
This is not applicable. The device is a hardshell venous reservoir, a mechanical component of a cardiopulmonary bypass circuit. It is not an AI-driven diagnostic or assistive technology, and therefore, human reader improvement or MRMC studies are entirely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical blood reservoir, not an algorithm.
7. The type of ground truth used
For a mechanical device like this, the "ground truth" is typically defined by engineering specifications, design requirements, and applicable industry or regulatory standards. Performance tests verify if the device meets these pre-defined physical and functional parameters (e.g., flow rates, filtration efficiency, defoaming capability, material compatibility, sterile barrier integrity). There is no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy for this type of device's core validation.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML algorithm.
§ 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.