(274 days)
The Galmaz Biotech® SIROCCO™ Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.
The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).
Here's an analysis of the provided text regarding the acceptance criteria and study for the ""Sirocco™ Thermal Regulating System"":
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information (especially quantitative performance data, sample sizes for training/test sets, expert qualifications, and detailed ground truth methodology) is not present in this document. The document primarily relies on non-clinical testing and comparison to existing, legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards | |
| IEC 60601-1:1993 + A1:1996 + A2:1996 + A2:1999 ERRATUM + A13:1997 (Electronic Medical Equipment: General requirements for safety) | Complied with standard |
| IEC 60601-1-2:2002 +A1:2006 (Electronic Medical Equipment: Electromagnetic compatibility) | Complied with standard |
| IEC 60601-1-4:1997 +A1:2000 (Electronic Medical Equipment: Programmable Electronic Medical systems) | Complied with standard |
| UL 60601-1:2002 (Medical Electrical Equipment: General Requirements for Safety) | Complied with standard |
| IEC ISO 10993-1:2004 (Biological sterile product evaluation) | Complied with standard |
| IEC ISO 10993-7: 1996 (Biological evaluation of sterile products: Remainders in sterilization by ethylene oxide) | Complied with standard |
| Internal Tests | |
| Initial Test of operation of electronic plates according to INS-B-001 | Successful |
| Final assembly INS-B-001 | Successful |
| Final verification of assembled product INS-B-002 | Successful |
| Visual Inspection | Successful |
| Test of operation of alarms and security systems | Successful |
| Pressure Test | Successful |
| Temperature Test | Successful |
| Electrical Safety Test | Successful |
| Final Test | Successful |
| Final labeling of the equipment INS-B-003 | Successful |
| Final packaging of the equipment INS-B-004 | Successful |
| Substantial Equivalence | |
| Similar technological characteristics to predicate devices (Augustine Medical, Inc. Bair Hugger Model 750 and 505) | Achieved |
| Same intended use as predicate devices | Achieved |
Explanation of the Study and Data:
The "study" presented here is a demonstration of substantial equivalence through non-clinical testing rather than a clinical trial with specific performance endpoints for accuracy, sensitivity, or specificity against ground truth in a patient population.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "studies conducted on the sterile disposable Sirocco™ Thermal Regulating System forced-air blanket" and "internal tests" of the warming unit in general. Specific sample sizes for these tests (e.g., number of blankets tested, number of units tested) are not provided.
- Data Provenance: The tests described are primarily bench/laboratory tests conducted internally by Galmaz Biotech S.L. and against recognized international safety and performance standards. There is no mention of patient data (retrospective or prospective) being used for this submission. The country of origin for the testing would presumably be where Galmaz Biotech S.L. operates (implied to be Spain based on other documents related to this company, though not explicitly stated in this text).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable/not specified. The grounding for this device's safety and effectiveness relies on adherence to established technical standards and internal quality control tests. There is no mention of experts establishing "ground truth" in the diagnostic or clinical sense for a test set.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Since there's no "ground truth" derived from expert consensus on patient data, there's no adjudication method in the context of clinical performance evaluation described. The "adjudication" for the non-clinical tests would be the pass/fail criteria for each standard and internal test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a thermal regulating system, not an imaging or diagnostic AI device where human reader performance would typically be measured.
- Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was conducted or relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: Yes, in a sense, the non-clinical tests can be viewed as a "standalone" evaluation of the device's technical performance against established engineering and safety standards. The device's operation (e.g., temperature regulation, alarm function) is assessed directly. However, this is not a "standalone algorithm" in the context of AI-driven diagnostic tools.
7. Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" for this device's submission is primarily based on:
- Regulatory Standards: Adherence to established international and national standards for medical electrical equipment safety, electromagnetic compatibility, biological evaluation, etc. (e.g., IEC 60601 series, ISO 10993 series, UL 60601-1).
- Internal Specifications: The device's performance against its own design specifications and quality control procedures (e.g., INS-B-001, INS-B-002, INS-B-003, INS-B-004 for electronic plates, assembly, verification, labeling, packaging; and tests for alarms, pressure, temperature, electrical safety, visual inspection).
- Predicate Device Characteristics: The functional and technological characteristics of the legally marketed predicate devices are used as a benchmark for "substantial equivalence."
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable/not mentioned. This device does not appear to use machine learning or AI that would require a "training set" in the conventional sense. The "training" of the manufacturing process and design would be based on engineering principles and quality management systems.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. Given no AI/ML component relevant to "training data," this question doesn't apply. The design and manufacturing process are validated against engineering principles and regulatory requirements.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).