(29 days)
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. ●
- Breath types including Volume, Pressure Control and Pressure Support. ●
The ventilator is suitable for use in institutional, home, or transport settings.
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
- . Assist/Control, SIMV, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control and Pressure Support. .
The modification intended to be cleared by this submission is: - The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.
The provided 510(k) summary for the Pulmonetic Systems LTV 1000 Ventilator (K051767) primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a new "Spontaneous Breathing Trial (SBT)" function. This type of submission, for a ventilator modification, does not typically include detailed performance studies with acceptance criteria in the same way an AI/ML device would.
Based on the provided document, here's an analysis concerning acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of quantitative acceptance criteria and reported 'performance' in the sense of a diagnostic or predictive device. Instead, it compares characteristics of the modified LTV 1000 Ventilator with its predicate devices to demonstrate equivalence.
| Characteristic (LTV Modification) | Acceptance Criteria (Implied) | Reported Device Performance (LTV 1000 with SBT Function) |
|---|---|---|
| Spontaneous Breathing (SBT) Function | Functionality is comparable to predicate, with beneficial enhancements and no new patient risk or technology. | Software Application: The software application to allow input presets for CPAP mode/parameters and alarm parameters is an addition to the existing LTV 1000 preset menu options. |
| SBT Time Duration | Time duration meets clinician requests (potentially longer). | Offers SBT time duration via menu selection from 15-120 minutes. (Predicate LTV 1000 required manual CPAP mode/parameter setting; Engstrom Carestation offered 5-60 minutes). This longer duration is provided at the request of clinicians. |
| Safety and Risk | No introduction of additional or new patient risk. | The software application "does not introduce any additional or new patient risk or involve the application of new technology." (Comparison to predicate LTV 1000, which required manual CPAP settings and had an alarm for trial end). The predicate Engstrom Carestation also required manual CPAP settings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This submission is for a modification to a medical device (ventilator software feature), not a diagnostic or AI/ML device that would typically involve a "test set" of patient data for performance evaluation in the way a clinical study would. Therefore, there is no specific sample size, test set, or data provenance mentioned in relation to proving the SBT function's performance. The evaluation is based on engineering design, comparison to predicate devices, and potentially internal validation/verification testing which is not detailed in this public summary.
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. As this is not a diagnostic device relying on expert interpretation for ground truth, there's no mention of experts establishing ground truth for a test set. The statement about "Longer time duration is provided at the request of clinicians" suggests input from medical professionals informed the feature design, but not for establishing ground truth in a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication method described in the context of this submission.
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 diagnostic device, and therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a ventilator with a software function. The "performance" is inherent to the function's design and operation, not an algorithm providing a diagnostic output independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the traditional sense of a diagnostic performance study. The "ground truth" for the SBT function would be its adherence to engineering specifications, correct implementation of the defined parameters (e.g., timing, mode switching), and safe operation in a simulated or actual clinical environment. This type of validation is typically conducted through internal engineering testing, which is not detailed here but implied by regulatory compliance.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that would require a 'training set'.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
Summary:
The 510(k) summary for K051767 focuses on demonstrating "substantial equivalence" of a modified ventilator with a new Spontaneous Breathing Trial (SBT) function to previously cleared predicate devices. The "acceptance criteria" here are implicitly tied to ensuring the new function is safe, effective, and performs comparably or superiorly without introducing new risks compared to existing methods or devices. The "study" proving this largely relies on design comparison, engineering assessment of the software modification, and the assertion that it does not introduce new technology or patient risk. It does not involve a clinical performance study with patient data, ground truth establishment, or human reader evaluations as would be expected for a diagnostic or AI/ML device.
§ 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).