Search Results
Found 1 results
510(k) Data Aggregation
(87 days)
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
The document provided outlines the A Plus Medical Babi.Plus™ Neonatal Resuscitation Bag and its substantial equivalence to a predicate device. The primary study presented relates to comparative technological characteristics rather than a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ISO 10651-4:2002 standard ("Lung ventilators - Part 4: Particular requirements for opered resuscitators") and the predicate device's performance. The "Babi.Plus™" column shows the reported device performance.
| Item | Acceptance Criteria (Implied by Predicate/ISO) | Reported Device Performance (Babi.Plus™) |
|---|---|---|
| Patient Connector: | 15 mm I.D. / 22 mm O.D. (Predicate) | 15 mm I.D. |
| Face Mask: | Option offered, 15 mm O.D. (Predicate) | Option offered, 15 mm O.D. |
| Pressure Gauge Connector: | None (Predicate) | 4.0 mm O.D. tapered |
| Supplemental oxygen delivery: | (Predicate values given) | VT-20 mls, Rate – 60 BPM:@ 2 LPM – 91%, @ 10 LPM – 99+%VT-20 mls, Rate – 120 BPM:@ 2 LPM – 91%, @ 10 LPM – 99+ %VT-50 mls, Rate – 30 BPM:@ 2 LPM – 75%, @ 10 LPM – 99+%VT-50 mls, Rate – 60 BPM:@ 2 LPM – 66%, @ 10 LPM – 99+% |
| Expiratory resistance: | < 2.8 cm H2O @ 5 LPM (Predicate) | < 1.7 cm H2O @ 5 LPM |
| Inspiratory resistance: | < 2.8 cm H2O @ 5 LPM (Predicate) | < 1.3 cm H2O @ 5 LPM |
| Patient Valve malfunction: | < 6.0 cm H2O @ 30 LPM (Predicate) | < 6.0 cm H2O @ 30 LPM |
| Dead space: | 6.8 mls (Predicate) | 6.35 mls |
| Minimum / Maximum Volume: | 20 mls / 150 mls (Predicate) | 20 mls / 50 mls |
| Body mass range: | ≤ 10.0 Kg (Predicate) | ≤3.3 Kg |
| Pressure limitation: | 40 cm H2O ± 5.0 cm H2O with over-ride, unlimited pressure (Predicate) | 25 cm H2O ± 3.0 cm H2O with 40 cmH2O ± 5.0 cm H2O over-ride |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a pre-market notification (510(k)) based on substantial equivalence, primarily through a comparison of technical characteristics to a known predicate device and conformity to an international standard (ISO 10651-4:2002).
- Test Set Sample Size: Not applicable. The "study" presented here is a summary of comparative technical specifications, not a clinical trial or performance evaluation using a "test set" in the context of AI/diagnostic device validation. The performance values listed (e.g., oxygen delivery, resistance) would have been determined through engineering tests on a sample of the device, but the sample size for these specific tests is not provided.
- Data Provenance: Not applicable in the sense of clinical data. The performance data is generated through laboratory testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study that involves expert ground truth for image interpretation or diagnosis. The "ground truth" for the technical specifications is based on established engineering principles, metrology, and compliance with the ISO standard.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described or implied for the generation of these technical performance metrics.
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-enabled diagnostic device, nor is it a multi-reader study. It is a manual resuscitation bag.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (manual resuscitation bag), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance characteristics (e.g., flow rates, volumes, resistances) is established through physical measurement and testing against the requirements of ISO 10651-4:2002 and comparison with the specifications of the predicate device. It is an engineering "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or corresponding ground truth establishment described.
Ask a specific question about this device
Page 1 of 1