(83 days)
The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The Jostra Heater-Cooler Unit HCU 30 supplies temperature-controlled water for cardioplegia heat exchangers, for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The water temperature is adjustable from 1°C to 41°C. A 26 litre tank with ice and approx. 1ºC cold water assures quick cooling of the patient. Two independent circuits with separate temperature controls can be attached (the main side has two connections). A safety system monitors the regulation in order to prevent the temperature from rising above 42°C.
Unfortunately, the provided text does not contain the specific details required to complete your request in full regarding acceptance criteria, study design, and performance metrics. The document is primarily a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results in the format you've requested for AI/ML device evaluations.
Here's a breakdown of what can be extracted and what is missing based on your criteria:
1. A table of acceptance criteria and the reported device performance
The document lists "Technical Characteristics Comparison" between the Jostra HCU 30 and the predicate device (Terumo TCM II). While it doesn't explicitly state "acceptance criteria," the comparison table implies that the performance of the Jostra device is deemed acceptable if it is comparable to or better than the predicate device's specifications for relevant parameters.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Jostra HCU 30) |
|---|---|
| Temperature control range: 0°C - 42°C (main circuit), ice water only (cardioplegia) | 1°C - 41°C (both circuits) |
| Temperature setting resolution: 1°C | 0.1°C |
| Temperature measurement accuracy: ±0.3°C | ±0.3°C |
| Continuous cooling capacity: 4320 kJ/h (1200 W) | 4270 kJ/h (1186 W) |
| Heating Capacity: 1550 W (220 V), 2000 W (115 V) | 3180 W (230 V), 1800 W (115 V) |
| Flow capacity, patient circulation: 5.5 gal/min (21 l/min) | adjustable ca. 2.6-6.1 gal/min (10-23 l/min) |
| Flow capacity, cardioplegia circulation: 2.1 gal/min (7.8 l/min) | min. 1.8 gal/min (7.0 l/min) |
| Maximum pressure, patient circulation: ca. 15.0 psi (700 mmHg) | ca. 34.8 psi (1800 mmHg) |
| Maximum pressure, cardioplegia circulation: ca. 7.5 psi (386 mmHg) | ca. 13.1 psi (675 mmHg) |
Note on Interpretation: This table presents a comparison, and the "acceptance criteria" are implied by the performance of the legally marketed predicate device. The Jostra HCU 30 is considered acceptable if its performance is comparable and safe for its intended use. In many cases, the Jostra device meets or exceeds the predicate's specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Performance testing" and "Constructional Safety testing," but does not detail the nature of these tests in terms of sample size for a test set, data provenance, or whether they involved human subjects or real-world data in the context of an AI/ML device. For a physical device like a heater-cooler unit, these tests would likely involve bench testing and simulations rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. This concept of "ground truth" established by experts is typically relevant for diagnostic AI/ML devices where human interpretation is involved. For a physical device like a heater-cooler unit, ground truth would be established by objective measurements against known standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for subjective evaluations, often in clinical trials or image interpretation, where a consensus among experts is needed. This is not applicable to the type of device 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
There is no indication of an MRMC study, nor is "AI assistance" relevant for this device. This is a physical medical device (heater-cooler unit), not a diagnostic AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Jostra HCU 30. It is a physical device that performs a function (heating/cooling water) that is directly controlled by the device itself, not an "algorithm only" or an AI system that provides an output requiring human interpretation. Its performance is inherent to its design and operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (a heater-cooler unit), the "ground truth" would be objective physical measurements and engineering standards. For example:
- Temperature accuracy: Measured against calibrated thermometers.
- Flow capacity: Measured using flow meters.
- Pressure: Measured using pressure gauges.
- Safety features: Tested to ensure they activate at specified thresholds (e.g., temperature alarms, over-pressure relief).
The document mentions "Performance testing included: Heating mode test, Cooling mode test, Cleaning cycle test, Alarm function test, Interface test with RCU30 and HL30, Reliability test, Pressure regulation test, Flow capacity test" and "Constructional Safety testing included: Electrical Safety, Electromagnetic compatibility EMC, Package and Transportation." These tests inherently involve measuring against defined physical and electrical standards, which serve as the "ground truth."
8. The sample size for the training set
This information is not provided and is not applicable. This device is not an AI/ML model that requires a "training set." Its design and performance are based on engineering principles and physical components, not machine learning.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no training set for this type of device.
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).