(49 days)
The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.
The Sechrist Millennium Infant Ventilator is an electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator. It is designed to ventilate neonatal to pediatric patients in Assist/Control, Synchronous Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP), and Standby modes. In addition, pressure triggered ventilation and spontaneous breathing is also provided.
The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control.
The electronically controlled subsystem uses the respiratory rate and inspiratory time control inputs to activate or deactivate the exhalation valve. The electronic subsystem also includes the pressure trigger sensing and manual breath functions.
Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.
This 510(k) summary does not contain the detailed information necessary to fully answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided document is a 510(k) summary for a medical device (ventilator), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown of why the information is not present and what can be inferred:
- Acceptance Criteria and Reported Device Performance: This document states, "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators." This strongly indicates that there are no specific, quantitative acceptance criteria for this device that would be reported in a table. The primary method of demonstrating safety and effectiveness for a 510(k) submission, especially when no performance standards exist, is via substantial equivalence to a legally marketed predicate device.
- Study Details: Since the submission is based on substantial equivalence, a formal performance study proving the device meets specific acceptance criteria in the manner described by your questions (e.g., sample size, ground truth, expert consensus, MRMC studies) is typically not part of the 510(k) summary. Instead, the submission would rely on internal testing to ensure the device performs as intended and similarly to its predicate.
Based on the provided text, I can respond to your questions as follows:
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A table of acceptance criteria and the reported device performance
Not applicable. The document states, "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators." Therefore, specific, quantitative acceptance criteria for device performance are not provided. The submission relies on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable to theirs. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary demonstrating substantial equivalence. It does not describe a clinical or performance study with a test set, sample size, or data provenance in the context of proving specific acceptance criteria. -
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. No clinical or performance study involving expert-established ground truth for a test set is described in this 510(k) summary. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance study involving adjudication of a test set is described in this 510(k) summary. -
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. MRMC studies, especially those involving AI assistance, are typically for diagnostic devices or those requiring human interpretation of output. This device is a ventilator, and the summary does not mention any AI components or MRMC studies. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electro-pneumatic ventilator. The summary does not provide details of any standalone algorithm performance testing. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described as having been used for a performance study in this 510(k) summary. -
The sample size for the training set
Not applicable. No training set is mentioned as part of this 510(k) submission. -
How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is mentioned in this 510(k) submission.
In summary: The provided text is a 510(k) summary for a ventilator that primarily focuses on demonstrating substantial equivalence to existing predicate devices. It explicitly states that no performance standards have been established for infant ventilators. Therefore, the document does not include information about specific acceptance criteria, detailed performance studies, sample sizes, ground truth establishment, or expert involvement as would be found for a device requiring such studies to prove performance against specified criteria.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).