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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.

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The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.

The Sunflower Warmer is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Sunflower Warmer has the capability to control the infant's skin temperature as well as the CPR timer. It is provided in eight mechanical variants, the canopy (heat source) is identical in all variants.

Acceptance Criteria and Device Performance Study for the Sunflower Radiant Warmer

The provided document describes the substantial equivalence of the Sunflower Radiant Warmer to its predicate device, the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335. The device's performance was evaluated through bench testing against established standards and internal criteria.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sunflower Radiant Warmer are primarily demonstrated through compliance with international standards and equivalent performance specifications compared to the predicate device. Specific quantitative acceptance criteria are given for skin temperature accuracy.

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

The document states that "bench tests" were performed. However, it does not specify the sample size used for these tests. The data provenance is implied to be from internal laboratory testing conducted by Atom Medical Corporation, Japan, making it retrospective in the sense that the testing was completed prior to submission. The country of origin for the testing is Japan, where Atom Medical Corporation is based.

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

This type of information is not applicable to this submission. The device is an infant radiant warmer, and its performance testing focuses on technical specifications, safety standards, and functional benchmarks rather than subjective interpretations by human experts. The "ground truth" for these tests would be defined by the technical specifications, standard requirements (e.g., IEC 60601-1), and accurate measurements from calibrated equipment.

4. Adjudication Method for the Test Set

This information is not applicable. As the testing involves objective measurements and compliance with technical standards for a medical device, an adjudication method for reconciling expert opinions is not relevant. Pass/fail criteria are determined by pre-defined technical thresholds and compliance with regulatory standards.

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 typically performed for diagnostic or AI-assisted interpretation devices where human performance (with and without aid) is a primary outcome. For an infant radiant warmer, the focus is on the device's physical performance, safety, and functional equivalence to a predicate.

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

Yes, a standalone performance evaluation was done. The entire "Performance Testing" section describes bench tests of the device itself (the "algorithm only" in a functional sense, as there's no diagnostic algorithm) without human operators as part of the primary performance metric. The tests evaluate the warner's ability to maintain temperature, manage alarms, and comply with safety standards independently.

7. The Type of Ground Truth Used

The ground truth for the performance testing was based on:

• International Standards: Primarily IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21.
• Manufacturer's Specifications: The design specifications for the device, such as set temperature range, skin temperature display accuracy, and heater capacity.
• Predicate Device Performance: The functional and performance characteristics of the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 served as a benchmark for equivalence.
• Bench Test Pass/Fail Criteria: Specific objective criteria established for each internal test (e.g., alarm activation at correct thresholds, stable temperature control).

8. The Sample Size for the Training Set

Not applicable. The Sunflower Radiant Warmer is a hardware device with embedded control systems, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Its internal control logic is designed and validated, not trained on data.

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

Not applicable. As explained above, there is no "training set" for this type of medical device. The "ground truth" for its design and performance validation relies on engineering principles, recognized safety standards, and performance specifications derived from the intended use and predicate device.

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The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.

The BILI-THERAPY Pad Type is a Bili-therapy unit available with large and small pads. The light source can be mounted to the incubator / warmer or an optional stand. The unit provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital / institutional settings. The BILI-THERAPY Pad Type emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. Light is generated in the light source and conducted to the patient via light guides to the pads are reusable and are intended to be covered with disposable pad covers. Eye masks are recommended for use with this product but are not included in this submission. Reference to commercially available eye masks is provided in the instructions for use.

The provided text describes the BILI-THERAPY Pad Type, a neonatal phototherapy unit, and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be structured (e.g., using a test set, ground truth established by experts, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance).

Instead, this document (a 510(k) summary) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Respironics Bili-Tx K070180) based on similarities in intended use, patient population, environment of use, technology, and performance specifications. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence and conforming to relevant safety and performance standards.

Here's a breakdown of the information that is available, formatted to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are primarily the performance and safety standards, and the "reported device performance" are the specifications stated for the BILI-THERAPY Pad Type and compared against the predicate.

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

This document does not describe a test set or data provenance in the context of an algorithm or clinical performance study. The "testing" mentioned refers to bench tests to verify compliance with engineering specifications and safety standards, as well as a comparison to the predicate device's specifications.

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

Not applicable. This document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a phototherapy unit, not an AI-assisted diagnostic tool.

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

Not applicable. This is hardware, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of an AI/algorithm study. For device performance validation, the "ground truth" would be the engineering specifications and the requirements of the international standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

Not applicable.

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The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.

Environment of use - Hospitals, delivery suites, NICU

There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.

• Resuscitation Unit 105PV .
• . Resuscitation Unit 105EV
  They have the same basic design. Table 1 outlines the basic features and differences of each model.

The Atom Medical Corporation Resuscitation Unit 105EV and 105PV are medical devices intended to remove secretions from neonatal/infant airways and to provide blended air and oxygen at a desired concentration (21-100%) to respiratory assist devices. The devices underwent performance testing to demonstrate substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

• Range: 21-100%
• Accuracy: ±3%O₂ | Achieved 21-100% oxygen concentration with ±3%O₂ accuracy (implied by substantial equivalence to predicates like Bio-Med Devices BMD air/oxygen blender K925982 and Precision Medical Precision Blender K053232). |
  | Airway pressure manometer:
• Range: -20 to 80cmH₂O
• Accuracy: ±1% of full scale | Achieved -20 to 80cmH₂O range with ±1% of full scale accuracy (implied by substantial equivalence to Atom V-505 Infant Warmer K060461, which features an airway pressure manometer). |
  | Relieving valve:
• Set to 5.9 kPa (60 cmH₂O) for preventing excessive airway pressure | The device has a relieving valve with a default setting of 5.9kPa (60cmH₂O), which is a feature not present in some predicates, indicating it meets or exceeds this safety aspect. |
  | Gas sources input pressure:
• Air/O₂: 206-517kPa | Achieved 300-500kPa (which falls within the predicate's range of 206-517kPa and implies compliance). |
  | Gas flow rate range (blender):
• ≥ 30 lpm (for certain predicates) |

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The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP).

The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure.

All are intended for neonates and infants (≤ 10kg or 22 lbs) in a delivery room and a NICU.

There are four (4) models of the Resusci Flow resuscitator.

• Resusci Flow ●
• Resusci Flow with blender ●
• Resusci Flow 104PV .
• Resusci Flow 104EV .

They all have the same basic design. Table 1 outlines the basic features and differences of each model.

The Atom Medical Corporation's Resusci Flow series resuscitator (models: Resusci Flow, Resusci Flow with blender, Resusci Flow 104 PV, and Resusci Flow 104 EV) underwent performance testing to demonstrate substantial equivalence to predicate devices and adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance tests conducted, referencing ISO standards and internal criteria. The reported device performance for all listed criteria was that the Resusci Flow series "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates."

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

The document states that "bench tests" were performed. However, it does not specify the sample size (number of devices, number of tests run for each criterion) used for these tests. The data provenance is internal to Atom Medical Corporation ("We have performed bench tests"), implying the tests were conducted by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location (Tokyo, Japan). The tests are described as performance testing, implying a prospective evaluation of the device's capabilities against established standards and predicates, rather than retrospective analysis of existing data.

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

The provided text details bench testing against international standards and comparison to predicate devices, rather than a clinical study requiring expert assessment of ground truth in a clinical context. Therefore, this information is not applicable. The "ground truth" for the bench tests would be the specifications and requirements outlined in the cited ISO standards.

4. Adjudication Method for the Test Set:

Not applicable, as this describes bench testing against established standards and specifications, not a clinical study requiring expert adjudication of clinical outcomes or images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence through bench testing and comparison to predicate device specifications. There is no mention of human readers or AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study in the form of "bench tests" was done. The performance of the Resusci Flow series was evaluated against a list of ISO standards and internal criteria. The conclusion was that the devices "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates." This constitutes an evaluation of the algorithm (or device in this case) alone without human-in-the-loop performance.

7. Type of Ground Truth Used:

The ground truth used for the performance testing was based on:

• International Standards: Specifically, ISO 10651-5 for powered resuscitators, ISO 10079-3 for suction equipment, and ISO 11195 for gas mixers. These standards define the acceptable performance parameters and test methods.
• Predicate Device Specifications: The applicant claims the device has "equivalent specifications of performance as the predicate" devices (Fisher & Paykel NeoPuff and GE Giraffe/Panda T-piece resuscitator). This implies that the performance parameters of the predicate devices served as a benchmark for equivalence.
• Internal Pass/Fail Criteria: The document mentions "all pass/fail criteria," which would typically be internal, pre-defined thresholds for acceptable performance for each test.

8. Sample Size for the Training Set:

Not applicable. This is a medical device submission based on substantial equivalence through bench testing, not an artificial intelligence/machine learning algorithm requiring a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

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The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.

The BILI-THERAPY Spot Type is an overhead unit available in two versions: Arm and Stand. The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.

This document describes the regulatory submission for the BILI-THERAPY Spot Type, a neonatal phototherapy unit. The submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness through a standalone study of the device's diagnostic or therapeutic performance using statistical metrics like sensitivity and specificity. Therefore, many of the requested criteria related to such studies (e.g., sample size for test sets, expert qualifications, HRMR, standalone performance) are not applicable or derivable from this type of regulatory summary.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device (Respironics Bili-Tx K070180) across various parameters and compliance with recognized standards. The "performance" reported is primarily in relation to these equivalency criteria and bench testing.

Details of the Study Proving Acceptance Criteria

The study described is a bench testing program and an equivalency comparison to a predicate device, as typically performed for a 510(k) premarket notification. It is not a clinical study involving patients or diagnostic performance metrics.

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

• Test Set Sample Size: Not applicable. This was a physical device comparison and bench testing, not a study involving patient data.
• Data Provenance: Not applicable, as no patient data was used. The performance data comes from the specific BILI-THERAPY Spot Type device under test.

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

• Not applicable. There was no "ground truth" to establish in the context of clinical outcomes, as this was a bench test and comparison study. The "ground truth" for the technical specifications would be metrology standards and predefined engineering specifications.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical data or expert review requiring adjudication in this context. The "adjudication" was based on adherence to engineering specifications and international standards.

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

• No. An MRMC study is relevant for comparing human diagnostic performance with and without AI assistance, or comparing different diagnostic methods. This document describes a medical device's technical and safety equivalence to a predicate, not a diagnostic AI or imaging device requiring such a study.

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

• No. This device is a phototherapy unit, not an algorithm or AI system. Its performance is directly related to its physical properties and light output, not an algorithm's output.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is established through international safety and performance standards (e.g., IEC 60601 series) and the technical specifications of the predicate device. The BILI-THERAPY Spot Type demonstrates its performance by meeting or being equivalent to these established benchmarks.

8. The Sample Size for the Training Set:

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

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

Infa Warmer i (Atom Infant Warmer Model 103) consists of a canopy, a warming heater (heater), a pole, a control panel, a mattress, a mattress platform, baby guards and a stand with casters. This product has 3 types (Type Name: HE, MS, ST) according to the following specification.

HE: (1)With mattress platform, stand can go up and down

MS: (2)With mattress platform, stand cannot go up and down

ST: (3)Without mattress platform

A warming heater is installed in the canopy.

Skin temperature sensors are connected to front panel of the pole.

This product has 2 types of function modes; one is "servo control model" (called as "skin temperature control mode") and another is manual control mode.

In "servo control mode", skin temperature can be set from 34°C to 38°C

In "bel to control mode", heater output of the warming heater can be set from 0 to 100% (in 5% increments).

When the product is functioned 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.

When the product is functioned in "manual control mode", heater output of the warming heater is controlled manually according to measured baby's skin temperature. The mattress platform can be tilted.

The mattress platform can be tilted.
The skin temperature sensors and X-ray cassette tray

The skin temperature sensors and X-ray cassette tray are accessories.

The X-ray cassette tray is optional accessory, and it can be installed under the mattress platform. These accessories are available separately as replacements.

SpO2 module is component of this product, and it is optional whether they are attached initially or not. If it is not attached initially, it can be attached later, and SpO2/pulse monitoring can be available. The component can be supplied individually.

This product has a space inside the pole, and gas powered resuscitator or oxygen/air gas blender whose sizes are within the space, can be installed in the space, so that resuscitation or oxygen therapy can be done immediately for any new born baby who needs such the treatments. When the resuscitator or the blender is installed in this space, it is completely separated from this product, and it does not have any connections with this product regarding function, operation and power source. Therefore, this product operates normally without the resuscitator or the blender. Also, this product operates normally, even if the resuscitator or the blender is out of order.

The provided text is a 510(k) summary for a medical device, the Infa Warmer i (Atom Infant Warmer Model 103). It describes the device, its intended use, comparison to a predicate device, and the testing performed. However, it does not provide a detailed study that proves the device meets specific acceptance criteria in the format requested.

The document states that "tests based on IEC60601-1-2 and IEC60601-2-21 standards were carried out for Infa Warmer i, and it was verified that Infa Warmer i is met to requirements of IEC60601-1, IEC60601-1-2 and IEC60601-2-21." It also mentions "Biocompatibility was evaluated based on ISO10993-1" and "Validation has been conducted on the device software."

This indicates that the device met the requirements of these standards, which serve as the acceptance criteria for regulatory clearance. However, the document does not elaborate on:

• Specific performance metrics within those standards (e.g., what specific temperature accuracy was achieved, what EMC levels were passed, etc.).
• The detailed results of these tests.
• Sample sizes for performance testing (beyond the device itself for electrical and biocompatibility).
• Ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these are typically relevant for AI/imaging device evaluations, which this infant warmer is not.

Therefore, I can only extract a very high-level summary based on the provided text, and many of the requested fields cannot be filled.

Acceptance Criteria and Device Performance

Detailed Study Information (Based on available text)

1. Sample size used for the test set and the data provenance:

   • Test set size: Not specified in terms of patient data or clinical trials. The testing primarily involved the device itself for electrical, mechanical, and safety standards.
   • Data provenance: Not applicable in the context of clinical data. The tests were performed on the device itself.

2. 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 infant radiant warmer, and its performance testing focused on engineering standards, not interpretation of clinical data by experts.

3. Adjudication method for the test set: Not applicable.

4. 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 is not an AI/imaging diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here refers to the defined limits and requirements set by the international standards (IEC60601 series, ISO10993) for infant radiant warmers, electrical safety, and biocompatibility.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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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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The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.

The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control).

The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated b the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. It is equipped with a skim temperature control function o maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray.

There are 2 functional modes:

• Skin temperature control mode referred to as "Servo Control Mode" 1.
• Air temperature control mode referred to as "Manual Control Mode" 2.

The provided text describes the Neo-Servo i Atom Infant Incubator Model 102 and its substantial equivalence to a predicate device (Atom Model V-2200 – K061856). The information focuses on design, indications for use, and adherence to performance standards rather than a study proving the device meets specific acceptance criteria through a clinical trial or AI model evaluation.

Therefore, many of the requested categories related to AI performance, sample sizes, expert ground truth, and adjudication methods are not applicable to this document. The document primarily demonstrates substantial equivalence by comparing the device's features and compliance with recognized safety and performance standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to a predicate device, which implicitly defines "acceptance criteria" as meeting or exceeding the predicate's performance and complying with relevant standards.

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