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510(k) Data Aggregation
(111 days)
The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.
The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document describes a 510(k) summary for a medical device called "NeoPIP™ Resuscitation Circuit with PEEP," which is a physical breathing circuit for neonatal resuscitation.
The submission focuses on establishing substantial equivalence to a predicate device based on design, materials, and operational and technological characteristics, not on the performance of a software algorithm or AI model. Therefore, directly answering the questions related to AI/ML performance metrics, sample sizes for test/training sets, experts, and ground truth as outlined in the prompt is not possible from the provided text.
Here's a breakdown of why each requested point cannot be addressed:
- Table of acceptance criteria and reported device performance: Not applicable. The document discusses "performance data" in the sense of demonstrating equivalence to a predicate device, not in the context of specific quantitative performance metrics for an AI/ML system.
- Sample size for test set and data provenance: No test set is mentioned, as this is a hardware device.
- Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for AI/ML is not relevant for this device.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as it's not an AI-assisted diagnostic tool.
- Standalone (algorithm only) performance: Not applicable, as there is no algorithm described.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
Instead, the document focuses on:
- Intended Use: An accessory to add positive end expiratory pressure (PEEP) breathing capability to a T-Piece Resuscitator for neonatal patients < 10Kg.
- Substantial Equivalence: Claimed based on similarity in intended use, design, operational and technological characteristics, and principles of operation to legally marketed predicate devices (K070416 NeoPEEP Neonatal Resuscitation Circuit with PEEP and Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP).
- Performance Data (for equivalence): States that the technological characteristics (design and materials) are the same as the predicate device and that performance data demonstrate equivalence to the predicate device. This implies engineering or functional testing to ensure the device operates as expected and similarly to the predicate, not AI/ML performance evaluation.
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(114 days)
The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
The NeoPIP Infant Resuscitator with Flow Meter is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.
The provided text is a 510(k) summary for the NeoPIP Infant Resuscitator with Flow Meter. The document focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving specific acceptance criteria for device performance as would be expected for an AI/ML powered device.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not available in the provided text. The document primarily describes the device, its intended use, classification, and asserts substantial equivalence to existing devices.
Here's an analysis based on the information provided, highlighting what is implicitly or explicitly stated and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a detailed performance report in the format of a table. The "Performance Standards" section explicitly states "None applicable." The premise of the 510(k) summary is to demonstrate substantial equivalence, meaning its performance should be comparable to the predicate devices, rather than meeting specific quantifiable performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. | Not explicitly stated in the document, but implicitly expected to be comparable to predicate devices for intended use, safety, and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a test set, sample size, or data provenance as it would for an AI/ML powered device. The 510(k) is a marketing clearance application for a medical device (a resuscitator), and the "study" demonstrating its safety and effectiveness relies on comparison to predicate devices, not on a data-driven performance study.
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)
Not applicable. The document does not describe a test set or the establishment of a ground truth by experts. Substantial equivalence relies on engineering and functional comparisons, not expert-adjudicated datasets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process 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
Not applicable. The device is a "manual emergency ventilator" (resuscitator), not an AI/ML-powered diagnostic or assistive tool for human readers. There would be no MRMC study in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical, manually-operated medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as used in AI/ML performance evaluation is not relevant for this device. The safety and effectiveness are established through design, manufacturing controls, and comparison to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.
In summary: The provided 510(k) summary is for a traditional mechanical medical device, not an AI/ML-powered one. Therefore, the questions related to acceptance criteria for AI performance, test sets, experts, and ground truth are not addressed in this type of document. The entire document serves as a demonstration of "substantial equivalence" of the NeoPIP Infant Resuscitator with Flow Meter to legally marketed predicate devices in terms of intended use, safety, and effectiveness.
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(90 days)
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
This is a prescription device.
The ISPIRA Resuscitation System is intended to deliver a consistent tidal volume rescue breath of oxygen or blended gas to a pediatric or adult patient. Peak Inspiratory Pressure and flow are set by the user. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated. In addition to resuscitation the device also provides CPAP capability.
The provided text is a 510(k) summary for the ISPIRA Resuscitation System, which is a regulatory document submitted to the FDA. It does not include a description of a clinical study with acceptance criteria, sample sizes, expert involvement, or any of the detailed information requested regarding device performance.
The document focuses on the device description, intended use, and its substantial equivalence to predicate devices, which is typical for a 510(k) submission. It establishes that the device is an emergency resuscitation device with CPAP capability, manually operated, and gas-powered for pediatric and adult patients (>10kg).
Therefore, I cannot provide the requested information about acceptance criteria, study details, or performance metrics because those details are not present in the provided text. The submission itself is the "study" in a regulatory sense, proving substantial equivalence rather than a clinical performance study against specific acceptance criteria.
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(51 days)
The NeoPIP Infant Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
The NeoPIP Infant Resuscitation Unit is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.
This 510(k) submission for the NeoPIP Infant Resuscitation Unit does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and performance.
Here's why and what information is missing:
- Type of Submission: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific performance against pre-defined acceptance criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
- Focus on Substantial Equivalence: The document primarily focuses on stating the intended use, device description, and claiming substantial equivalence to the predicate device (K892885 Fisher & Paykel, Neopuff Infant Resuscitator).
- Lack of Performance Data: There is no section detailing specific performance metrics, test methods, results, or acceptance criteria within the provided text. The document states "Performance Standards: None applicable," which further indicates that the submission doesn't rely on meeting specific quantitative performance metrics defined by external standards for approval.
- No Clinical Study Description: There is no mention of any clinical study, either standalone or comparative, involving human readers, experts, or ground truth establishment. The document describes a "manually operated, gas powered device," suggesting its evaluation would revolve around engineering and functional testing rather than image-based diagnostic performance.
Therefore, I cannot provide the requested table and study description based on the input. The provided text is a regulatory clearance letter and a summary of the device, not a detailed performance study.
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(106 days)
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.
This is a prescription device.
The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
This document is a 510(k) summary for the NeoPEEP Neonatal Resuscitation Circuit with PEEP. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.
However, based on the provided text, we can infer some information relevant to the device's functional performance:
- Device Description: The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
- Intended Use: The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.
- Predicate Device: The substantial equivalence claim is based on comparison to the Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP. This suggests that the performance characteristics of the NeoPEEP would be expected to be similar to this predicate device.
Given that this is a 510(k) submission for a non-AI medical device, the typical "study" proving acceptance criteria involves demonstrating that the device meets established safety and performance standards for its class and is substantially equivalent to a legally marketed predicate device. This usually involves engineering testing, biocompatibility assessments, and performance verification to ensure it functions as intended and safely. The document does not describe a clinical trial or a study with a test set, ground truth, or expert review in the manner one would for an AI diagnostic device.
Here's an attempt to answer the questions based on the available information, noting where the information is not provided:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria and reported device performance is present in the provided text. The document's primary purpose is to establish substantial equivalence to a predicate device based on "intended use, design, operational and technological characteristics, and principles of operation." This implies that the device is expected to perform comparably to the predicate device in delivering positive end expiratory pressure during neonatal resuscitation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document pertains to a hardware medical device (resuscitation circuit) and does not describe a clinical study with a test set of data (e.g., images, patient records) or data provenance in the context of an AI algorithm.
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)
Not applicable. Ground truth and expert review in this context would typically refer to the validation of a diagnostic AI device, which is not what this submission is about.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this document.
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 is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" might refer to engineering specifications or regulatory standards for pressure delivery and safety, but it's not discussed in terms of clinical outcomes or expert review in the text.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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(50 days)
The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
This device is not intended for home use.
This device is not intended as a transport incubator.
This is a prescription device.
This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by 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. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired
The provided document does not contain the information requested for acceptance criteria and a study proving device performance.
The document is a 510(k) summary for the V-2200 Infant Incubator, focusing on its substantial equivalence to predicate devices due to a user interface display modification. It describes the device, its intended use, and the regulatory approval process.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about a study conducted to demonstrate the device meets any specific performance criteria.
- Information on sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment for any such study.
- Any mention of AI, MRMC comparative effectiveness studies, or standalone algorithm performance.
The document is a regulatory submission for a medical device (infant incubator), and while it mentions "performance standards: none applicable," it does not include performance data or studies that would fall under the categories requested. The "description of modifications" section explicitly states the difference between the V2200 and the V2100G is solely the user interface display (an independent component, multicolor LCD). This suggests the core therapeutic functions (temperature and humidity control) were likely considered equivalent to the predicate without requiring new performance studies for those aspects.
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