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The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.

The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport. The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃. The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission. The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack. The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V). The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.

Here's an analysis of the provided text regarding the Atom Transcapsule V-707, focusing on acceptance criteria and the study proving it meets these criteria:

Device: Atom Transcapsule V-707 (Neonatal Transport Incubator)

The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for a novel device. Therefore, much of the requested information (like sample sizes for test sets, expert qualifications, MRMC studies, standalone performance with specific thresholds, and ground truth for training data) is not present. The "acceptance criteria" discussed are primarily related to meeting recognized performance standards and comparing features to a predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) Summary, the "acceptance criteria" are implied by the standards the device complies with and its performance characteristics as compared to the predicate. The "reported device performance" is a statement of compliance or the specified operating range/accuracy.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not specified. The document refers to "Performance testing has been performed per the following standards" and "The proposed device met and passed all testing criteria" (Page 3). This usually implies lab-based engineering verification and validation testing, not clinical trials with patient populations or specific test sets for algorithms.
• Data Provenance: Not applicable in the context of the provided document. The testing described is non-clinical, likely conducted by the manufacturer (Atom Medical Corporation in Japan).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is an incubator, and its performance is evaluated against engineering and safety standards, not against expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The testing described is against engineering specifications and international standards, not involving human interpretation or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-analysis AI devices where human performance is part of the comparison. The Atom Transcapsule V-707 is a medical device for infant transport, and its evaluation focuses on mechanical, electrical, and thermal performance according to recognized standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its physical and electronic components.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, international medical device standards (IEC 60601 series), and physical measurements. For example, the accuracy of temperature measurement (e.g., +/-1.0°C for air temperature) is a direct performance characteristic measured against calibrated reference instruments, not an expert consensus or pathology result.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI/ML system that requires a training set or ground truth for training.

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