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InSee is an accessory to the Vyaire Medical AirLife Incentive Spirometer (2500 mL and 4000 mL). InSee is indicated to flag and digitally record successful incentive spirometry attempts, use-related data and provide reminders to patients who are prescribed the Vyaire Medical AirLife Incentive Spirometer. It is intended to be used in a hospital environment by clinicians and patients.

InSee is an accessory to the Vyaire Medical AirLife incentive spirometer. InSee consists of a plastic enclosure which attaches to the base of the AirLife incentive spirometer and records the following parameters: the number of attempts above 250 ml (AT), the Target Volume (TA), the number of successful attempts (SU) and the maximum target volume (MX). The InSee device also provide patient reminders. This device is only compatible with the Vyaire AirLife Volumetric Incentive Spirometer- 2500 & 4000 mL. InSee is intended for use in the Hospital environment by clinicians and patients. The device is non-invasive, reusable, and intended for use by one patient at a time.

The InSee device, an accessory for incentive spirometers, underwent rigorous performance evaluation to demonstrate its safety and effectiveness. The following details outline the acceptance criteria and the study that validated the device's performance:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set: 30 subjects
• Data Provenance: The study was a "prospective, IRB-approved performance validation study," implying the data was collected specifically for this study. The location of the study (e.g., country of origin) is not explicitly stated, but an IRB approval suggests it was conducted in a regulated clinical setting.

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

• Number of Experts: Not explicitly stated, but the ground truth was established by "blinded physician observation." It is implied that at least one, and likely multiple, physicians were involved in the observation to ensure blinding and robust ground truth establishment.
• Qualifications of Experts: "Physician" is stated, but further specific qualifications (e.g., medical specialty, years of experience) are not provided in the document. The blinding suggests an objective assessment.

4. Adjudication Method for the Test Set

• The document states "100% agreement with blinded physician observation." This implies that the physician's observations served as the direct ground truth for comparison, and no specific multi-reader adjudication method (e.g., 2+1, 3+1) beyond this single (or implicit consensus of multiple) blinded observation is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study focused on the accuracy of the InSee device's detection capabilities against human observation, rather than comparing human reader performance with and without AI assistance. The InSee device is an accessory that records data and provides reminders, not an AI interpretation tool that assists human readers in making diagnoses.

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

• Yes, the performance validation study evaluated the InSee device's ability to "accurately detect when the IS piston crossed the target mark, activated its audiovisual alert, and logged the inspiratory volume" in an automated fashion. The "blinded physician observation" served as the independent ground truth to verify the device's standalone accuracy in these functions.

7. The Type of Ground Truth Used

• Expert Consensus/Observation: The ground truth was established by "blinded physician observation" of the incentive spirometry attempts, serving as the gold standard for verifying the InSee device's accuracy in detecting successful attempts and logging inspiratory volume.

8. The Sample Size for the Training Set

• The document does not provide information regarding a distinct training set sample size. The description of the performance evaluation focuses on the "prospective ... performance validation study" of the device, which is typically a test or validation set for a final product. Given the nature of this device (an accessory that records physical parameters rather than an AI model learning from vast datasets), a separate, explicit "training set" might not be applicable in the traditional machine learning sense, or its "training" might be based on engineering principles and calibration rather than data-driven model training.

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

• As the document does not mention a distinct training set in the context of an algorithm or AI model, there is no information provided on how ground truth for such a set would have been established. The device appears to rely on sensors and predefined logic to detect spirometer events, rather than a learned AI model requiring labeled training data.

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The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.

AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.

Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.

The provided text is a 510(k) premarket notification FDA review letter for the "AllPEP" device, classified as an Incentive Spirometer. It addresses the substantial equivalence of the AllPEP device to a predicate device, DHD Acapella K991561.

The document details the device's indications for use, patient population, environment of use, and a comparison of its features and performance to the predicate device. Crucially, it highlights non-clinical bench testing as the primary method to demonstrate substantial equivalence, rather than clinical studies involving human participants or MRMC studies.

Therefore, the following is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the information provided in the document.

Acceptance Criteria and Device Performance for AllPEP

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The Lung Trainer device is intended to be used as (1) an expiratory breathing exerciser for respiratory muscles, and (2) to be used as an expiratory resistance device, providing positive expiratory pressure (PEP) to substitute for pursed lip breathing and to assist in mucus clearance. The LungTrainer device is intended for use in patients ages 12 years and up in a clinical or home use environment.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the "LungTrainer (MD2 & MD3)" device, outlining its regulation, product code, and indications for use. It primarily addresses administrative and regulatory compliance aspects rather than technical performance studies or acceptance criteria. Therefore, I cannot extract the requested information from this document.

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The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or home care setting.

The subject device provides PEP only. The subject device is an oral device that provides positive expiratory airway pressures to enhance expiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-free.

The provided submission for the Breathe+ device, a Positive Expiratory Pressure (PEP) device, does not contain a typical study that proves the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study. Instead, it focuses on bench testing and a comparison to predicate and reference devices to demonstrate substantial equivalence for FDA clearance.

Therefore, the following information will be drawn from the provided text regarding the bench testing that was performed for the device. The document does not describe a clinical study with an AI component or expert ground truth adjudication.

Acceptance Criteria and Reported Device Performance (Bench Testing)

Note: The exact acceptance thresholds for "repeatability and accuracy" are not explicitly stated in the document, but the discussion concludes "The device performance was tested and does not raise any new concerns of safety or effectiveness."

Study Details (Bench Testing)

1. Sample size used for the test set and the data provenance: Unspecified number of "final, finished samples" of the Breathe+ device. The data provenance is internal testing performed by PEEP Medical, LLC. It is prospective testing on newly manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was bench testing of a physical device's mechanical performance, not an AI or diagnostic study requiring expert ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was mechanical bench testing.

4. 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. No MRMC study was performed as this is a mechanical medical device, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench testing was based on direct physical measurements of the device's performance, such as pressure readings (cmH2O) at various flow rates (lpm) using calibrated equipment.

7. The sample size for the training set: Not applicable. This refers to bench testing of a physical device.

8. How the ground truth for the training set was established: Not applicable.

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The Hudson RCI Triflo II Incentive Deep Breathing Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients.

Intended for single-patient, multi-use in a hospital or home care setting.

The Hudson RCI Triflo II Incentive Deep Breathing Exerciser. The device is a non-diagnostic, therapeutic spirometer (inspiratory deep-breathing exerciser) designed for a maximum flow rate of approximately 1200 cc/sec. It is supplied in clean, sanitary condition, ready for use. It is designed for single patient use and discarded when no longer needed by the patient to whom assigned. By sequentially lifting the balls that are inside every chamber it provides an exercise incentive to patients who require sustained maximal inspiration (SMI), or similar maneuvers.

The provided document is a 510(k) premarket notification for a medical device, specifically an Incentive Spirometer. It contains information about the device, its intended use, comparison with predicate devices, and performance data.

However, the document does not describe a study involving:

• An AI/algorithm-based device.
• Establishment of ground truth by experts.
• Sample sizes for test sets or training sets in the context of an AI study.
• Multi-reader multi-case (MRMC) studies.
• The effect size of human readers improving with AI assistance.
• Standalone algorithm performance.

The "Performance Data" section (Section VII) details bench testing for the physical device (biocompatibility, cleaning validation, and various physical performance tests like flow accuracy, useful life, drop testing, packaging). These are standard engineering and safety tests for a physical medical device, not a study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving an AI device meets acceptance criteria. The document describes a traditional medical device (an incentive spirometer) and its associated regulatory clearance process.

If you can provide a document that discusses the development and validation of an AI-powered medical device, I would be happy to analyze it against your specified criteria.

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Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device.

• The use of Pulsehaler™ improves clearance of secretions .
• The use of Pulsehaler™ may reduce the need for postural drainage ●
• Pulsehaler™ facilitates opening of airways in patients ●
• Pulsehaler™ may be used to prevent or reverse atelectasis ●
• Pulsehaler™ mav also be useful in the removal of mucus from the lungs ●

Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.

Pulsehaler™ is a non-invasive handheld treatment device used daily by the patient to promote airway opening and secretion clearance by vibrating the airways at a variety of different frequencies. It consists of Base Unit with an LCD touch screen that provides a pressure source, and a Hand Unit with a rotating disc that periodically interrupts the pressure source to deliver pressure pulsations to the patient. These components are connected by an air hose and an electrical power and data cable.

While sitting in a relaxed position, the patient holds the Hand Unit and breathes normally through its mouthpiece. A steady flow of pressurized air is delivered to the Hand Unit component by the Base Unit and enters the air inlet of the Hand Unit. The pressurized air passes along the internal airflow duct of the Hand Unit through an air filter until it reaches the rotating disc. When it rotates the disc interrupts the continuous flow of air from the Base Unit and then releases the flow in pulses at a rate corresponding to the rotation speed. The rotation speed of the disc is determined by the software using a pre-set protocol.

The exhalation port is restricted in size, which together with the positive pressure generated by the Base Unit, induces PEP.

The patient is treated with the device for 20 minutes at a time, up to three times a day according to the prescribing physician's instructions. During each 20-minute treatment, Pulsehaler™ delivers pulses varying from 5 to 50 pulses per second. The patient may use the User Interface to pause the treatment at any time or resume after a pause.

Pulsehaler™ is intended for single adult patient, multiple reuse, at home or in a healthcare facility and is non-sterile. The instructions for use contain cleaning and high-level disinfection instructions that involve the use of Cidex.

Expected Use Life of the device is 5 years and Shelf Life is 6 Months.

The provided document is a 510(k) premarket notification for the Pulsehaler™ device, which is a Positive Expiratory Pressure (PEP) Device. The document details the device, its indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets the Acceptance Criteria are primarily focused on non-clinical testing and comparison to predicate devices, rather than a clinical study with human subjects, especially not a multi-reader, multi-case (MRMC) comparative effectiveness study of an AI-powered device. The device is a mechanical PEP device, not an AI-powered diagnostic or therapeutic device that would typically involve AI-specific performance metrics like sensitivity, specificity, or AUC, or human reader improvement studies.

Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI models, and training/test set sizes for AI data are not applicable to this specific submission. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K140772) through technical and functional comparisons, and non-clinical testing.

Here's an attempt to answer the questions based only on the provided document, noting the limitations of the document for an AI-focused query:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for performance in the way one might see for an AI device (e.g., "Sensitivity must be >X%"). Instead, the device's "performance" is demonstrated by its functional characteristics being similar or equivalent to its predicate device. The document summarizes non-clinical testing and then provides a comparison table.

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The D R Burton® OxyPAP™ device is indicated for the treatment and prevention of atelectasis. It also has the ability to provide supplemental oxygen when used with compressed oxygen. It includes the option of a pressure manometer. The device is for patients (ages 5 years and above) who are capable of following directions for positive airway pressure (PAP) therapy.

Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.

The environment of use is for hospital and clinical setting.

The OxyPAP device is a handheld respiratory therapy device that creates a positive airway pressure. The OxyPAP device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The OxyPAP device is a single patient use device.

The provided text describes the D R Burton OxyPAP device, its indications for use, and a comparison to predicate and reference devices for a 510(k) submission. However, this document does not contain any information about acceptance criteria, a specific study proving the device meets these criteria, or details regarding AI/algorithm performance and ground truth establishment.

The document is a US FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated standalone study. The "Performance" and "Non-clinical Comparative Performance" sections primarily describe comparative testing to show similarity to existing devices.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will explain what information is present and what is missing.

Summary of what can be extracted from the document:

• Device Name: D R Burton OxyPAP
• Device Type: Incentive Spirometer, Positive Airway Pressure (PAP) Therapy Device
• Indications for Use: Treatment and prevention of atelectasis; ability to provide supplemental oxygen when used with compressed oxygen. For patients (ages 5 years and above) capable of following directions for PAP therapy. Normal use not more than 24 hours total combined time. Environment of use: hospital and clinical setting.
• Predicate Device: K991300 – DHD Healthcare Corp. – Boeing, Positive Airway Pressure (PAP) Therapy Device
• Reference Devices: K173819 – Trudell VersaPAP™ Device; K040991 – Ambu Disposable Pressure Manometer

Missing/Not Applicable Information based on the prompt's requirements:

The document focuses on substantial equivalence for a medical device that is not an AI/ML powered device. As such, information typically associated with AI/ML device validation studies (like distinct acceptance criteria for algorithm performance, expert review for ground truth, MRMC studies, training/test set details, etc.) is not present and not applicable to this type of device submission.

Specifically, the following sections of your request cannot be answered from the provided text:

• 1. A table of acceptance criteria and the reported device performance: The document presents comparative performance data (e.g., Mean PEEP, Mean Peak Expiratory Pressure), but these are comparisons to predicate/reference devices, not explicit acceptance criteria for a standalone study performance. There are no clear quantitative acceptance criteria stated for the D R Burton OxyPAP itself beyond being "substantially equivalent" to the predicate.
• 2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device, not an algorithm being tested on a data set. The "bench testing" mentioned includes performance testing and drop testing, but no "sample size" in the context of data points.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering and clinical performance testing, not expert review of AI outputs.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for an AI-assisted workflow, which is not the case here.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• 7. The type of ground truth used: For a physical device, "ground truth" would refer to measured physical properties or clinical outcomes. The document discusses "Biocompatibility" (material certification to a legally marketed device) and "Bench Testing" (comparative performance, drop testing, effects of aging). These are the "truths" for this device.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

Information that is present (though not in the requested format for AI/ML devices):

• Device Performance Reported (Comparative, not against specific acceptance criteria):
  • Proposed OxyPAP:
    • Mean PEEP (cmH2O) @800 ml TV: 2.81 @ 5 Lpm, 12 @ 10 Lpm, 12.75 @ 15 Lpm
    • Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 20 (400 TV) / 21 (800 TV)
    • Mean Inspiratory Pressure (cmH2O) @800 ml TV: -0.7 @ 5 Lpm, -4.7 @ 10 Lpm, -3.46 @ 15 Lpm
    • Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 3.1 @ 5 Lpm, 12.1 @ 10 Lpm, 13 @ 15 Lpm
  • Predicate DHD EzPAP (for comparison):
    • Mean PEEP (cmH2O) @800 ml TV: 2 @ 5 Lpm, 8 @ 10 Lpm, 16 @ 15 Lpm
    • Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 22 (400 TV) / 26 (800 TV)
    • Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 5 @ 5 Lpm, 11 @ 10 Lpm, 20 @ 15 Lpm

The core conclusion of the document is that "Based upon the comparative performance testing we have demonstrated that the proposed device compared to the predicate and reference devices can be found to be substantially equivalent." This is the primary "acceptance criterion" for a 510(k) submission of this nature.

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The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.

The subject and predicate acapella® devices are within Smiths Medical's product family for a therapeutic spirometer hand-held vibratory positive expiratory pressure (PEP) device provided to the end-user as a non-sterile, single patient use. The subject device helps aid in the mobilization and expectoration of secretions that accumulate in the lungs of adult and pediatric users who may have Cystic Fibrosis, COPD, asthma, including lung diseases with secretory problems, and patients with atelectasis.

The subject device provides PEP therapy to a patient by producing airflow vibrations that can be delivered in any position to effectively mobilize secretions, open airways and deliver medication (nebulization). These devices have been found to give independence to patients with chronic respiratory diseases, as the therapy can be done at the patient's convenience without the need for clinical assistance.

This document, a 510(k) Premarket Notification from Smiths Medical for the acapella® Choice Blue Vibratory PEP Device, focuses on demonstrating substantial equivalence to a predicate device (acapella® DH) rather than proving the device meets new acceptance criteria through a comprehensive clinical study as one might expect for a novel AI/imaging device. Therefore, much of the requested information regarding AI model performance (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone performance) is not applicable or present in this document, as the device is a mechanical medical device, not an AI or imaging system.

The "acceptance criteria" discussed here primarily revolve around demonstrating that the new device's performance is comparable to or better than the predicate device across various non-clinical engineering and functional characteristics.

Here's the information extracted and interpreted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a single, consolidated table of clearly defined "acceptance criteria" with quantitative "reported device performance" for each. Instead, it describes general non-clinical tests and states that they "passed and were verified against their requirements and acceptance criteria." The comparison is primarily against the predicate device.

Key Performance / Equivalence Assessments:

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

• Sample Size for Test Set:
  • For Nebulizer compatibility/drug delivery verification: "Three (3) device samples were tested per each drug." (Drugs mentioned: albuterol sulfate, cromolyn sodium, ipratropium bromide). This indicates a sample size of 3 devices per drug for this specific test.
  • For other non-clinical bench tests (e.g., performance, reprocessing, packaging, biocompatibility, temperature exposure/accelerated aging), specific sample sizes are not provided in this summary, but it's stated that "components comprising each configuration... were assessed and tested appropriately to design controls."
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a physical medical device, the data provenance would be from internal laboratory bench testing and verification studies conducted by the manufacturer, Smiths Medical, or their designated testing facilities. It is inherently "prospective" in the sense that the new device was built and then tested to demonstrate performance. Origin (country) is not specified but Smiths Medical is listed with a Minneapolis, MN address.

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

This information is not applicable and not provided in this document. This is a submission for a mechanical medical device, not an AI/imaging device requiring expert interpretation of diagnostic output to establish ground truth. The "ground truth" for this device's performance is based on physical measurements and adherence to engineering specifications and comparison to the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. This document describes non-clinical engineering and functional testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for AI systems or diagnostic tools where human readers are interpreting images or data, and the effect of AI assistance on human performance is being evaluated. This document is for a mechanical therapeutic device.

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

This concept is not applicable to this device. A "standalone" performance study refers to an AI algorithm's diagnostic accuracy without human involvement. This device is a physical therapeutic device, not an algorithm. Bench tests were performed on the device to assess its mechanical and physical performance.

7. The Type of Ground Truth Used

The "ground truth" for this review is primarily based on:

• Engineering Specifications and Bench Test Results: Adherence to defined physical parameters, flow rates, pressure generation, durability, and material properties.
• Comparison to Predicate Device: The performance and characteristics of the new device are directly compared to the legally marketed predicate device (acapella® DH) to demonstrate substantial equivalence.
• Established Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 18562 for gas pathway safety) and ASTM standards (e.g., ASTM D4169 for packaging).

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided, as there is no training set for a mechanical medical device.

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The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 - 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.

The Aerobika® OPEP device and VersaPAP™ device can be used independently or combined. When combined for ease of use. The combined device creates oscillations during the exhalation phase (OPEP) to aid in secretion clearance and during the inhalation phase (PAP) helps to maintain positive airway pressure for the treatment and prevention of atelectasis.

The provided text is a 510(k) summary for the "Combined VersaPAP™ device and Aerobika® OPEP" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the format requested.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the detailed format you requested (table, sample size, expert information, MRMC study, standalone performance, ground truth). The document is a regulatory submission for a medical device that performs a physical function (providing positive airway pressure and positive expiratory pressure), not an AI/software as a medical device (SaMD) that typically undergoes rigorous performance studies with the criteria you outlined.

However, I can extract the information relevant to what I can infer as "acceptance criteria" and "study" within the context of this device application:

The "acceptance criteria" for this type of device are primarily demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it is as safe and effective as the predicates. The "study" that proves this involves bench testing and comparison of features and performance characteristics to the predicates.

Here's how I can reframe the information based on the provided text:

Inferred Acceptance Criteria and Study to Prove Device Meets Them:

For this device, "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance (like sensitivity/specificity for AI), but rather as proof of substantial equivalence to legally marketed predicate devices. The "study" involves bench testing and a detailed comparison of technical and performance characteristics to demonstrate this equivalence.

1. Table of Acceptance Criteria (as inferred) and Reported Device Performance:

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

• Sample Size: Not applicable in the context of an FDA 510(k) for this type of physical device; there isn't a "test set" of patient data for diagnostic performance. The "testing" refers to bench testing of the device's physical performance. The document states, "We performed comparative testing at adult and child breathing setting to the predicates and reference." However, no specific number of test runs or 'samples' is given.
• Data Provenance: Not applicable in the way it would be for an AI model (e.g., retrospective/prospective patient data, country of origin). The data provenance is from bench testing conducted by the manufacturer, Trudell Medical International (located in London, ON, Canada).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This is not a study requiring expert consensus for ground truth as it's a physical device, not an AI diagnostic tool.

4. Adjudication Method for the Test Set:

• Not applicable. There's no "test set" that requires adjudication by human readers/experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is typically done for AI-assisted diagnostic tools to assess human reader improvement. This is a physical medical device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a physical device, not an algorithm. Its "standalone" performance would refer to its physical output which is measured via bench testing as described in bullet 1.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by engineering and physiological measurement standards (e.g., measuring pressure, flow rate, and frequency) during bench testing, and comparing these measurements to the established performance of predicate devices and expected physiological ranges.

8. Sample Size for the Training Set:

• Not applicable. This is a manufactured physical device, not a machine learning model.

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

• Not applicable. There is no concept of a "training set" or "ground truth establishment" in the AI sense for this device. Its design and manufacturing (analogous to "training") are based on engineering principles and regulatory requirements for medical devices.

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The Hudson RCI Voldyne Volumetric Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 yrs) patients. It is a single patient, multi-use device used in hospital or home care setting.

The Hudson RCI® Voldyne® Volumetric Exerciser ("Voldyne") is a volumetric incentive spirometer. It is a single patient multi-use device. The primary interface of the user with the device is through a mouthpiece. The device contains two chambers; one for the flow chip, and one for the piston. The piston chamber is marked with a graduation from 500 ml to 4,000 ml (for the Voldyne 4000) or 250 ml to 2,500 ml (for the Voldyne 2500 and Voldyne Pediatric) on the front and the back of the main housing. The flow chip chamber for the device is marked with a happy face symbol with arrows pointing to the optimum position of the Voldyne Pediatric version includes a sticker sheet with clouds and trees graphics, which can be placed onto the device. When the patient inhales the flow chip and piston rise due to the negative pressure created; this indicates breathing volume and flow, while the device provides an exercise incentive to patients who require sustained maximal inspiration (SMI).

This document describes the premarket notification (510(k)) for the Teleflex Medical, Inc. Hudson RCI® Voldyne® Volumetric Exerciser (K182847). The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the Besmed Volumetric Incentive Spirometer (K141355).

Based on the provided text, the device is an incentive spirometer, a medical device used for inspiratory deep breathing exercises. The information provided heavily focuses on justifying substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study with an "AI" component. Therefore, much of the requested information regarding AI device performance, expert review, MRMC studies, and ground truth definitions for AI models is not present in the provided 510(k) summary, as this is a traditional medical device, not an AI/ML software as a medical device (SaMD).

Here's an analysis of the available information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format typically seen for AI/ML device evaluations against specific metrics like sensitivity, specificity, or AUC. Instead, it relies on demonstrating equivalence to the predicate device and meeting applicable standards and internal performance specifications for a mechanical device.

The closest to "acceptance criteria" and "reported performance" for an incentive spirometer device, as presented in this document, are:

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

This information is not provided in the document as it pertains to a clinical study dataset for an AI/ML device. The performance data refers to device engineering tests (e.g., shelf life, cleaning validation, biocompatibility, mechanical performance tests like volume accuracy and leakage). Details on specific sample sizes for these engineering tests are not provided in this summary, nor is data provenance in the sense of patient data.

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)

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnostic accuracy.

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

This is not applicable as this is not an AI/ML device requiring expert adjudication for ground truth.

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

A MRMC study comparing human performance with and without AI assistance was not done. This is not an AI/ML device.

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

A standalone algorithm performance study was not done. This is not an AI/ML device.

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

The concept of "ground truth" as it relates to AI/ML models is not applicable here. For this physical medical device, the "ground truth" for its performance is derived from:

• Physical measurements: Accuracy of volume, leakage tests, engagement tests.
• Compliance with standards: ISO 10993 (biocompatibility), ISO 5356-1 (conical connectors).
• Bench testing: Age testing (pre and post aging).

8. The sample size for the training set

This information is not applicable as this is a traditional medical device, not an AI/ML device that requires a "training set."

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

This information is not applicable as this is a traditional medical device, not an AI/ML device that requires a "training set" with established ground truth.

In summary:

The provided document is a 510(k) summary for a traditional medical device (incentive spirometer). It focuses on demonstrating substantial equivalence to an existing predicate device through comparative feature analysis and engineering performance testing (e.g., biocompatibility, mechanical performance). It does not involve any Artificial Intelligence (AI) or Machine Learning (ML) components, and therefore, many of the questions related to AI acceptance criteria, clinical study designs for AI, expert reviews, and ground truth for AI models are not addressed in this document. The "study that proves the device meets the acceptance criteria" refers to the engineering and biocompatibility tests conducted, not a clinical trial or AI performance study.

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