(152 days)
PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
Federal law (USA) restricts the sale of this device except by or on the order of a physician.
The PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
The PTV platform provides for the following features:
- . High performance ventilation in a small lightweight package
- A range of maneuvers including Inspiratory and Expiratory hold . and synchronized Nebulization (touch screen models only)
- . Internal flow generator, allowing the PTV to operate without an external compressed gas source
- . Four distinct breath types offering a range of treatment options. CPAP with optional Pressure Support 1, SIMV2, Control, Assist / Control
- Configurable Apnea back-up ventilation .
- NPPV3 ventilation, providing an alarm package suitable for . mask ventilation of patients whose needs do not extend to life support
- Volume Control, Pressure Control and PRVC4 ventilation modes t
- Adjustable alarm settings including High Peak Pressure. Low . Peak Pressure, Low Minute Volume, and Apnea
- Oxygen blending from a high-pressure oxygen source (optional) . or low-pressure oxygen bleed-in
- Lockable front panel controls .
- A wide range of monitors including Breath Rate (f), I:E Ratio . (Measured), MAP, Exhaled Minute Volume (VE), PEEP, PIP and Tidal Volume (Vte)
- Dynamic waveform and loop displays .
- . Graphic trending histogram display
- Real-time patient circuit pressure display .
- . Variable termination options for Pressure Support breaths, including maximum inspiratory time and percentage of peak flow
- . Selectable Percentage of Peak Flow termination for Pressure Control breaths
- Leak Compensation to improve patient triggering when a circuit . leak is present
- . Operation from a variety of power sources including AC power. removable battery and external DC power sources
- . Optional FIO2 sensor package.
- . Optional Oximetry module
Here's an analysis of the provided text regarding the acceptance criteria and study for the PALMTop PTV Models 8/10 ventilator, formatted to answer your questions:
Acceptance Criteria and Study Analysis for PALMTop PTV Models 8/10
The provided 510(k) summary for the PALMTop PTV Models 8/10 describes the device and its intended use, and states that performance testing (Bench testing) was conducted to verify that the device meets specified performance requirements and is substantially equivalent to predicate devices.
However, the document does not explicitly provide a table of acceptance criteria with numerical thresholds, nor does it detail a specific clinical study with human subjects, ground truth establishment, or expert adjudication that would typically be associated with AI/ML-driven medical devices. The testing described appears to be traditional engineering performance verification against specifications, rather than a statistical study comparing device output to expert-established ground truth in a diagnostic or predictive context.
Based on the provided information, I can fill in what is available and clarify what is not.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific numerical acceptance criteria (e.g., accuracy > X%, sensitivity > Y%, etc.) or corresponding reported device performance metrics in a quantitative manner. Instead, it broadly states that "Performance testing (Bench testing) verified that the Palmtop Models PTV 8/10 meet specified performance requirements and that the devices are substantially equivalent to the predicate devices listed below."
Therefore, no direct table can be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Performance testing (Bench testing)", which implies laboratory or engineering testing of the device's functionality rather than a test set of patient data. As such:
- Sample Size for Test Set: Not applicable or not specified in terms of patient data. The testing involved the device in a benchtop environment.
- Data Provenance: Not applicable, as there is no patient data described as part of the performance verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. Given that the testing involved "Bench testing," it's likely that ground truth was established by engineering specifications, calibration standards, and established medical device performance parameters, rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. Since there's no mention of a test set involving human data or interpretations, an adjudication method like 2+1 or 3+1 would not be relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, there is no indication that an MRMC comparative effectiveness study was done. The device is a ventilator, a life-support system, and the "Bench testing" described focuses on its mechanical and functional performance, not on interpretation of medical images or signals by human readers assisted by AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device, a ventilator, is a therapeutic and monitoring device, not an AI algorithm. Its performance is inherent in its operation (e.g., delivering specified pressures or volumes). The "Bench testing" would assess this standalone functional performance. However, there's no "algorithm only" performance reported in the context of diagnostic AI.
7. The Type of Ground Truth Used
The ground truth for the "Bench testing" would have been based on:
- Engineering Specifications: The pre-defined parameters and operational ranges the ventilator is designed to achieve.
- Calibration Standards: Reference measurements to ensure the device's sensors and outputs (e.g., pressure, flow, volume) are accurate.
- Predicate Device Performance: Comparison to the established performance of the legally marketed predicate devices to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The PALMTop PTV Models 8/10 is a traditional medical device (a ventilator), not a machine learning or AI-driven system that would require a "training set" of data in the common sense of AI development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML device described for this product.
In summary: The provided document describes the regulatory submission for a ventilator, a traditional medical device. The "performance testing" mentioned refers to engineering validation and verification (bench testing) against predefined device specifications and predicate device performance, not a clinical study involving human data, expert adjudication, or AI algorithm training/testing. Therefore, many of the questions related to AI/ML device evaluation criteria are not applicable to this submission.
§ 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).