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The VPAP III ST-A system is intended to provide non-invasive ventilation for adult patients (>66 Ibs) and pediatric patients aged 7 years or older (>40 lbs) with respiratory insufficiency or obstructive sleep apnea (OSA). The device is intended for use in the hospital or home.

The VPAP III ST-A is a flow-cycled, pressure-limited ventilator. A blower assembly generates airway pressure. A flow sensor and a pressure sensor in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. The device constantly adjusts air flow to maintain pressure and breath synchronisation, can deliver an operating pressure up to 30cmH2O, and compensates for pressure drop in air tubing. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The VPAP III ST-A provides a mode of non-invasive positive pressure ventilation (NPPV) called Pressure Support with PEEP, which delivers two treatment pressures (bi-level ventilation). A higher pressure is applied when the patient inhales - IPAP or inspiratory positive airway pressure, and a lower pressure is applied when the patient exhales - EPAP or expiratory positive airway pressure, sometimes referred to as PEEP or positive end-expiratory pressure. The difference between the two treatment pressures represents the amount of pressure support provided to the patient. The VPAP III ST-A has a CPAP mode in which a fixed pressure is delivered, and three bi-level operating modes which determine how the changes between IPAP and EPAP pressures are made: Spontaneous, Spontaneous/Timed and Timed. Patients indicated for Obstructive Sleep Apnea (OSA) are treated through the device providing a splint to keep the airway open, whilst patients indicated for respiratory insufficiency are treating through the device providing breathing assistance through pressure support. The VPAP III ST-A is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The addition of the Mirage Micro for Kidz Mask provides an additional mask option for pediatric users. The small sized frame and cushion and the small size headgear from the previously cleared Mirage Micro (K072940) has been adopted as the standard configuration for the Mirage Micro for Kidz Mask, to meet the requirements of the pediatric population. The Mirage Micro for Kidz Mask provides therapy through the nose only. The Mirage Micro for Kidz Mask comprises a mask frame and elbow with integrated exhaust vent, mask cushion and laminated headgear. The anthopometric profile of the Mirage Micro for Kidz Mask matches that of the Kidsta Mask cleared in K060105. The patient exposure materials used in the device are predicate materials.

The provided text describes a 510(k) submission for a non-continuous ventilator, the VPAP III ST-A, with an additional pediatric mask. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with detailed acceptance criteria and performance data for a new device.

Therefore, the requested information about acceptance criteria, specific device performance metrics, sample sizes, expert involvement, and ground truth establishment from a clinical or performance study is not available in the provided text, as this type of submission relies on demonstrating equivalence to existing cleared devices.

However, I can extract what is explicitly stated regarding the compatibility assessment for the new pediatric mask and the general statement about meeting acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that a compatibility assessment of the Mirage Micro for Kidz Mask with the VPAP III ST-A was performed. This assessment included:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify sample sizes for any of the tests conducted for the compatibility assessment. It also doesn't provide data provenance in terms of country of origin or whether the data was retrospective or prospective. The testing appears to be in-house engineering and functional testing rather than clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish "ground truth" in the context of clinical interpretation or diagnosis for the reported compatibility assessment. The assessment focuses on engineering and functional performance.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the testing described is primarily focused on meeting technical specifications and demonstrating equivalence rather than interpreting clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned. The submission is for a ventilator system, and the focus is on the device's functional equivalence and safety, not on human reader performance with or without AI assistance.

6. If a Standalone Performance Study Was Done:

The document indicates that compatibility assessment was performed for the new mask, and existing device testing for the VPAP III ST-A (pressure performance, triggering & cycling, and alarm performance) was considered valid. This implies standalone testing of the mask's characteristics (pressure & flow, deadspace, CO2 flushing) was done as part of the compatibility assessment. However, "standalone" in the context of an algorithm or AI is not applicable here.

7. The Type of Ground Truth Used:

For the compatibility assessment, the "ground truth" would be the predetermined engineering specifications, safety standards, and functional requirements for respiratory devices and masks, as well as the characteristics of the predicate devices (K060105 and K072940). For anthropometric analysis, the ground truth was the "profile of the Kidsta Mask cleared in K060105."

8. The Sample Size for the Training Set:

This information is not applicable. The device is a hardware ventilator with an additional mask. There is no mention of a "training set" in the context of machine learning or AI models. The design and testing are based on engineering principles and regulatory standards.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

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The VPAP III ST-A/Kidsta Mask system is intended to provide non-invasive ventilation for pediatric patients aged 7 years or older (>40lbs) with respiratory insufficiency or obstructive sleep apnea (OSA). The device is intended for use in the hospital or home.

The VPAP III ST-A is a flow-cycled, pressure-limited ventilator. A blower assembly generates airway pressure. A flow sensor and a pressure sensor in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The VPAP III ST-A has a CPAP mode in which a fixed pressure is delivered, and three bi-level operating modes which determine how the changes between IPAP (Inspiratory Positive Airway Pressure) and EPAP (Expiratory Positive Airway Pressure) pressures are made: Spontaneous, Spontaneous/Timed and Timed.

The VPAP III ST-A is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The Mirage Kidsta cushion size and headgear has been modified from the Mirage Vista to meet the requirements of the pediatric population. The Kidsta mask provides therapy through the nose only. The Mirage Kidsta comprises the following

• Mask frame, with two ports for connection to pressure sensor tubing. A 2-. ports cap can cover one or both ports.
• Mask elbow, connected to short air tubing, with a swivel, which allows a 360° . rotation of the air tube. The elbow has an integral exhaust vent for flushing CO2 in order to prevent re-breathing.
• Mask cushion, for patient comfort and adequate sealing between mask and . face.
• Headgear, a three-layered fabric attached to the mask frame by means of . clips to enable fast release of the mask. The mask can be tilted at five different angles by pressing on the tabs and changing the slot position on the headgear clips. The headgear side straps, connected to the headgear clips, are reinforced for increased stability.

The Mirage Kidsta mask comes in one frame size and cushion.

This 510(k) summary does not contain information on specific acceptance criteria and study results in the format requested. The document describes a submission for a pediatric indication for an existing device (VPAP III ST-A) and a modified mask (Mirage Kidsta). It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics from a specific clinical study with acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred, along with what is explicitly stated as not available.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: NOT AVAILABLE. The document mentions "Additional testing" and "Human factors considerations and usability trials" but does not specify the number of subjects or cases included in these tests.
• Data Provenance: NOT AVAILABLE. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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/NOT AVAILABLE. The document highlights "risk analysis" and "human factors considerations and usability trials," which likely involved expert input. However, it does not describe a process for establishing a "ground truth" for a test set in the way one would for diagnostic imaging or a comparable classification task, nor does it specify the number or qualifications of experts involved in these assessments. The focus is on safety and efficacy in the pediatric population rather than diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• NOT APPLICABLE/NOT AVAILABLE. As no specific "test set" for diagnostic performance or ground truth establishment is described, an adjudication method is not mentioned.

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

• NO. This device is a ventilator system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The VPAP III ST-A is a medical device (ventilator), not an algorithm that performs a standalone diagnostic or predictive function. Its performance is inherent to its mechanical and software operation in delivering ventilation, which is always in conjunction with a patient and overseen by healthcare professionals or caregivers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• NOT APPLICABLE/NOT AVAILABLE in the context of diagnostic "ground truth." The "ground truth" for this device's efficacy and safety would be established through engineering validation, simulated use, and clinical observations to confirm that it effectively delivers non-invasive ventilation and manages respiratory insufficiency or OSA in the target pediatric population without adverse effects. This is assessed against established physiological parameters and safety standards, rather than a diagnostic gold standard like pathology. The document states "Testing confirms that the unmodified VPAP III ST-A when used with the Mirage Kidsta mask can be safely and effectively used to treat the pediatric patient (>7 years and >40lbs)." This implies successful performance against pre-defined safety and efficacy benchmarks, though these benchmarks are not detailed.

8. The sample size for the training set

• NOT APPLICABLE. This device is a hardware and software system for ventilation, not a machine learning algorithm that requires a "training set" in the conventional sense. Its development follows traditional engineering design and testing processes.

9. How the ground truth for the training set was established

• NOT APPLICABLE. As there is no "training set" for a machine learning algorithm, there is no ground truth established in this manner.

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The VPAP III ST-A system is Intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea (OSA), in the hospital or home.

The VPAP III ST-A provides a mode of non-invasive positive pressure ventilation (NPPV) called Pressure Support with PEEP, which delivers two treatment pressures (bi-level ventilation). A higher pressure is applied when the patient inhales - IPAP or inspiratory positive airway pressure, and a lower pressure is applied when the patient exhales - EPAP or expiratory positive airway pressure, sometimes referred to as PEEP or positive end-expiratory pressure. The difference between the two treatment pressures represents the amount of pressure support provided to the patient.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The text is a 510(k) premarket notification letter and summary for a medical device (Resmed VPAP III-STA). While it discusses the device's technical characteristics, its intended use, and states that performance data was collected, it does not provide the acceptance criteria or the specific detailed results of the study.

Here's what I can tell you based on the provided text, and what's missing:

What is present:

• Device Name: Resmed VPAP III-STA
• Predicate Device: VPAP II ST-A (K974417)
• Intended Use: "The VPAP III ST-A system is intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea (OSA), in the hospital or home."
• Performance Data Mention: "The VPAP III ST-A was tested in accordance with the recommendations of the FDA Draft Reviewer Guidance for Ventilators (July 1995)." and "The VPAP III ST-A ventilator complies with the following standards: IEC 60601-1-2; IEC 60068-2-27/ -6/ -34; IEC 10993-1; ASTM F 1100-90."
• Conclusion: The device is "substantially equivalent" to its predicate.

What is missing (and therefore I cannot provide answers to your specific questions):

1. Table of acceptance criteria and reported device performance: The text mentions testing was done and standards were complied with, but it does not specify what the acceptance criteria were (e.g., specific pressure accuracy ranges, flow rate tolerances) or what the measured performance results were.
2. Sample size used for the test set and data provenance: No information on the number of subjects, cases, or the origin (country, retrospective/prospective) of any clinical test data is provided.
3. Number of experts used to establish ground truth and qualifications: There is no mention of experts, ground truth, or adjudication methods for any clinical study because the document focuses on substantial equivalence based on technological characteristics and compliance with standards, not necessarily a clinical outcomes study with human readers.
4. Adjudication method: Not applicable as there is no mention of expert review or ground truth establishment in this context.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The filing is for a ventilator, not an AI or imaging diagnostic tool that typically uses MRMC studies.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device (ventilator), not a diagnostic algorithm.
7. Type of ground truth used: Not specified, as detailed study results are absent.
8. Sample size for the training set: Not applicable as this is a physical medical device, not an AI model that typically uses a training set for machine learning.
9. How ground truth for the training set was established: Not applicable.

To obtain the information you're asking for, you would generally need to review the full submission to the FDA, which would include detailed test reports, or clinical study reports if they were conducted. The provided text is a high-level summary and approval letter, not the detailed technical and clinical evidence itself.

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