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The Dual Incu i is a combination of an infant incubator and an infant warmer. The device can transition from one mode to the other on user's demand.

The Dual Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry and oxygen density controlling.

Dual Incu i (Atom Infant Incubator Model 100) is a combination of an infant incubator and an infant warmer. This device consists of hood, a main body, a control panel and a warming heater (radiant warmer) and a stand with casters. A hood consists of a canopy and access doors (snapopen access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body.

This device has a function that elevates the canopy. The device operates as an incubator when the canopy is closed, and the device operates as a radiant warmer when the canopy is opened. This product has 2 types of function modes; one is "servo control mode" (called as "skin temperature control mode" also) and another is "manual control mode".

When the device is operated as an incubator, skin temperature can be set from 34° to 38° (including override) in "servo control mode", and air temperature inside the hood can be set from 23 ° to 39 ° (including override) in "manual control mode".

When the device is operated as an infant warmer, skin temperature can be set from 34° to 38° (including override) also in "servo control mode", and heater output of the warming heater can be set from 0 to 100%(in 5% increments) in "manual control mode".

In "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature.

In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature, when the device is operated as an incubator.

The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories: "Skin temperature sensor", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements.

"SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not.

If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can go up and down.

The provided document, K102226, is a 510(k) summary for the Atom Medical Corporation's Dual Incu i (Atom Infant Incubator Model 100). This document describes the device, its intended use, a comparison to predicate devices, and the testing conducted to support its substantial equivalence.

Based on the provided text, here’s a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a "test set" in the context of data for performance evaluation in the way one might for an AI algorithm. Instead, it refers to compliance testing with established medical device standards.

• Sample Size: Not applicable in the context of a dataset; the testing was performed on the Dual Incu i device itself.
• Data Provenance: Not applicable in the context of a dataset. The testing was conducted based on international standards (IEC, ISO) for medical devices. The country of origin of the device manufacturer is Japan. The studies described are prospective tests conducted on the physical device.

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

This information is not relevant or provided in the context of this 510(k) summary, as it describes a physical medical device (infant incubator/warmer) and its compliance with engineering and safety standards, not an AI algorithm requiring expert ground truth for a diagnostic task.

4. Adjudication Method for the Test Set:

Not applicable, as the evaluation is based on compliance with specific technical standards rather than expert review of a dataset.

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 device is a physical infant incubator/warmer, not an AI system designed to assist human readers in image interpretation or other diagnostic tasks.

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

Not applicable. This device is a physical medical device.

7. The Type of Ground Truth Used:

For the performance assessment of this device, the "ground truth" refers to the established requirements and standards for medical device safety, performance, and biocompatibility.

• Type of Ground Truth:
  • Engineering Standards: IEC60601-1 (Electrical Safety), IEC60601-1-2 (EMC), IEC60601-2-19 (Infant Incubators), IEC60601-2-21 (Infant Radiant Warmers).
  • Biocompatibility Standards: ISO10993-1.
  • Software Validation Principles: While not explicitly detailed, the statement "Validation has been conducted on the device software" implies adherence to established software validation guidelines for medical devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI algorithm that undergoes training on a dataset.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for this type of device.

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The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry, and oxygen density controlling.

Incu i (Atom Infant Incubator Model 101) consists of a hood, a main body, a control panel and a stand with casters. A hood consists of a canopy and access doors (Snap-open access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body. This product has 2 types of function modes; one is skin temperature control mode and another is air temperature control mode. The skin temperature control mode is called "servo control mode" also, and the air temperature control mode is called "manual control mode" also. In "servo control mode", skin temperature can be set from 34°C to 38°C (including override). In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature. The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories; "Skin temperature probe (sensor)", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements. "SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not. If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can be gone up and down.

The provided text does not describe acceptance criteria for a medical device or a study validating performance against such criteria. It is a 510(k) summary for the "Incu i (Atom Infant Incubator Model 101)".

Instead, it contains:

• A submission summary: Basic information like sponsor details, device name, classification, predicate devices, and a general description of the Incu i incubator.
• Intended Use Statement: The target population and common applications for the incubator.
• Comparison to Predicate Devices: A statement that the Incu i is substantially equivalent to predicate devices (Atom V-2200 and Caleo) in terms of intended use, features, appearance, temperature modes, and components.
• Testing and Conclusions: A very high-level overview of tests performed:
  • Compliance with electrical safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-19).
  • Biocompatibility evaluation based on ISO10993-1, stating that infant-contacting parts are identical to predicate devices.
  • Software validation.
• FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Reiterates the intended use statement.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not on specific performance metrics or detailed clinical studies as might be found for diagnostic or interventional devices.

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