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The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.

The VenAir Sequential Compression System is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism.

The product consists of the machine, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.

The system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow the user manual to check the error code and action as advised.

The provided text describes the VenAir Sequential Compression System (K213577) and its substantial equivalence determination to the predicate device, Kendall SCD 700 Sequential Compression Controller (K120944). Based on the text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing against pre-defined acceptance criteria derived from relevant standards and device performance requirements. Specific numerical acceptance criteria are not explicitly detailed in a consolidated table, but the results are stated as meeting the requirements.

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

The document does not explicitly state the sample sizes for individual non-clinical tests (e.g., how many units were tested for shelf life, how many samples for biocompatibility). The testing described is non-clinical, involving the device itself rather than human or patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective studies are not applicable.

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

Since this is a non-clinical device performance study (testing the physical device and its software), there is no mention of "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" is established by the specifications, standards, and engineering requirements for the device's functionality.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like '2+1' are typically used when comparing multiple human interpretations or human interpretations against AI outputs in clinical studies. This document describes non-clinical engineering and performance testing.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study would fall under clinical testing.

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

While software validation was performed, the device is a physical medical device (Sequential Compression System) with integrated hardware and software. The "standalone" performance described refers to the device itself operating according to its design specifications, not an algorithm's isolated performance on a dataset in a diagnostic context. The performance tests (e.g., pressure accuracy, cycle time) represent the device's standalone operation.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is based on:

• Industry Standards: ISO 10993 series, USP , OECD404, OECD406 for biocompatibility.
• Device Specifications and Requirements: Internal engineering specifications for pressure, timing, alarms, battery performance, shelf-life, electrical safety, EMC, and usability.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. The "training set" concept is relevant for AI/ML algorithms that learn from data. While the device contains software, there is no indication that it utilizes a learning algorithm that requires a "training set" in the context of AI/ML.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device.

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WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bilevel system) has been prescribed.

The WiZARD 510 Nasal Mask provides an interface to direct airflow from a positive pressure source to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face. The elbow connector is designed with a series of vent holes to exhale air from the mask. WiZARD 510 nasal mask is connected to a CPAP or bi-level system via a standard 22 mm breathing tube. A quick release mechanism allows users to quickly remove the mask from the face. WiZARD 510 Nasal Mask is safe when used under the conditions and purposes as indicated in the labeling provided with the product. WiZARD 510 Nasal Mask is a prescription device supplied in non-sterile condition.

The provided text is a 510(k) Summary for the WiZARD 510 Nasal Mask. This document largely focuses on demonstrating substantial equivalence to a predicate device through comparison of features and non-clinical testing. It does not contain information about a study involving expert readers and AI for diagnostic purposes as requested in the prompt. Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (in the context of AI/human reader performance)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for the test set
• MRMC comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The document describes non-clinical performance and a comparison to a predicate device, as seen in the "Non-clinical data" section and the "Comparison of subject device to predicate device" table.

The device in question, the WiZARD 510 Nasal Mask, is a medical device (CPAP mask), not an AI/ML-driven diagnostic tool. The acceptance criteria and study described in the document relate to the mask's physical, mechanical, and biocompatibility properties to ensure it functions safely and effectively as an interface for CPAP/bi-level therapy.

Here's an overview of the acceptance criteria and proof provided, based on the document's content:

Acceptance Criteria and Device Performance (as related to the physical mask):

The acceptance criteria are generally established by meeting the requirements of relevant ISO standards and demonstrating equivalence to a legally marketed predicate device. The document states that "Non-clinical verification and validation testing completed for the subjected device demonstrated that the WiZARD 510 Nasal Mask met all intended performance requirements."

Although not presented in a single table, the acceptance criteria are implicitly met by:

• Biocompatibility: Meeting ISO 10993 series and ISO 18562 series standards for biological evaluation of medical devices and breathing gas pathways.
• Reliability: Meeting ISO 17510:2015 for Medical devices – Sleep apnoea breathing therapy – Masks and application accessories. This includes mechanical integrity performance following various exposures (home cleaning, transportation, storage, operational temperature/humidity, drop test, sit test, shelf life).
• Risk Assessment: Adhering to ISO 14971:2007 for risk management.
• Reprocessing: Validation of cleaning and disinfection efficacy, and mechanical integrity after reprocessing.

The "Comparison of subject device to predicate device" and "Comparison of subject device to reference device" tables (found on pages 4-7) serve as the primary "proof" of meeting performance and equivalence criteria by demonstrating that key specifications and features of the WiZARD 510 Nasal Mask are "Same as predicate" or "Same as reference devices" or otherwise comparable within acceptable limits.

Example Comparison Data (from "Comparison of subject device to predicate device" table):

Data Provenance and Sample Size:

The document does not detail specific sample sizes for each non-clinical test (e.g., how many masks were tested for biocompatibility or reliability). The tests are described as "Non-clinical verification and validation testing," indicating they were conducted to a standard deemed sufficient for regulatory approval. Data provenance is implied to be from Apex Medical Corp. and certified testing laboratories. These are typically controlled, prospective tests designed to specifications.

Experts, Ground Truth, MRMC Studies, Standalone Performance:

As this is a physical medical device and not a diagnostic AI/ML tool, the concepts of "experts," "ground truth" (in the diagnostic sense of disease presence), "MRMC studies," and "standalone algorithm performance" are not applicable. The "ground truth" for this device would be its physical specifications, material properties, and functional performance under simulated conditions, all validated by engineering and biocompatibility testing against defined standards.

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WIZARD 310/320 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask provide an interface such that airflow from a positive pressure source is directed to the patient's nostril and mouth. The masks are held in place with adjustable headgear that straps the mask to the face. Series of vent are feature on the cushion that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. WiZARD 310/320 series CPAP mask are connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly.

The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are appropriate when used under the conditions and purposes intended as indicated in the labeling provided with the product. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are the prescription device supplied non-sterile.

The provided text describes a CPAP mask and its FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device's performance against specific clinical acceptance criteria.

Therefore, I cannot create a table of acceptance criteria and reported device performance because the provided document does not contain this information in the context of a new study proving performance. The document primarily highlights:

• Comparison to a predicate device: The core of the submission is to show the WiZARD 310/320 series CPAP Mask is substantially equivalent to the WiZARD 210/220 Series CPAP Mask (K103174) and reference devices AirFit F20 (K170924) and AirFit N20 (K171212).
• Safety and Performance Testing: Non-clinical testing was performed to demonstrate equivalent performance to the predicate device, focusing on biocompatibility and reliability.

Here's a breakdown of the information that can be extracted based on the provided text, and what information is not available within this document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not explicitly provided as a set of clinical performance acceptance criteria with corresponding study results. The document focuses on demonstrating substantial equivalence through comparison to a predicate device and non-clinical testing.
• Instead, the document lists "performance characteristics" that are deemed similar to the predicate device. These are not acceptance criteria in the sense of demonstrating a certain level of efficacy or diagnostic accuracy. They are design and functional specifications.

Summary of "Similar Performance Characteristics" to Predicate Device:

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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

The modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.

The provided text describes a 510(k) premarket notification for a medical device, the iCH CPAP with PVA 9S-007XXX Series. This is a modified version of a previously cleared predicate device (K141522). The document focuses on demonstrating substantial equivalence to the predicate device, rather than proving the device meets acceptance criteria in the sense of a clinical performance study with specific metrics like sensitivity or specificity.

Instead, the "acceptance criteria" here are defined by compliance with recognized standards and successful performance of a suite of engineering and functional tests designed to show that the modified device performs as safely and effectively as the predicate. The study described is a design verification and comparison study against a predicate device.

Here's a breakdown based on your request, interpreting "acceptance criteria" as the performance benchmarks and regulatory compliance targets set by the referenced standards and the comparison with the predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it establishes acceptance by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

The "acceptance criteria" implicitly include:

• Compliance with various safety, EMC, and performance standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 17510-1, ISO 8185).
• Demonstration that changes (impeller material, PCB layout) do not negatively impact the device's safety or effectiveness compared to the predicate.
• Successful completion of design verification tests, including (but not limited to):
  • Safety and EMC tests
  • Firmware Validation
  • Noise Test
  • Performance Tests (Pressure Long-term Stability, Dynamic Pressure Stability, Static Pressure Stability, Maximum Temperature, Maximum Flow, Limitation of Maximum Pressure, Overflow Test, Expected Useful Life Validation)
  • Humidification Performance
  • PVA Function Comparison Test (Endurance Operation, Dynamic Testing, APAP Auto titration & AHI Test, PVA Waveform comparison, PVA feature handling disordered breathing, PVA Waveform upper and lower pressure control, PVA Pressure Average and Tolerance Error, Performance Characteristics of PVA Comparison)
  • Biocompatibility Assessment
  • Particle Test
  • VOC Test

The reported device performance is that the "modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards" and the "above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."

No specific numerical performance metrics (e.g., accuracy percentages, error rates) are provided in this summary, as the focus is on equivalence and compliance, not novel clinical performance claims.

Study Details

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

   • Acceptance Criteria (Implicitly from Standards & Predicate Comparison):
     • Safety and EMC compliance (ANSI/AAMI ES60601-1, IEC 60601-1-2)
     • Firmware validation according to FDA guidance.
     • Noise levels within acceptable limits (ISO 11201, ISO 7779).
     • Performance (pressure stability, flow, temperature, maximum pressure limitation) meets ISO 17510-1.
     • Humidification performance meets ISO 8185.
     • PVA function comparable to predicate (Endurance, Dynamic, APAP Auto titration & AHI, Waveform, disordered breathing handling, pressure control, average/tolerance error, performance characteristics).
     • Biocompatibility (ISO 10993 series).
     • Particle and VOC emissions meet US EPA standards.
     • Overall substantial equivalence to predicate device (K141522) in terms of intended use, operating principle, technology, and manufacturing process.
   • Reported Device Performance:
     • "The modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards..."
     • "...the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."
     • Specific comparative details were provided (e.g., intended user, air outlet, user, operating environment, pressure range, increment, ramp time, pressure/altitude compensate, APAP mode, PVA, alarm system) showing equivalence.

2. Sample size used for the test set and the data provenance

   • The document does not specify sample sizes in terms of patient data or clinical cases. This is primarily an engineering and performance verification study, likely using a limited number of device units for testing against established standards and the predicate.
   • The data provenance is not explicitly mentioned as a clinical study with patients; rather, it refers to laboratory testing and design verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable in the context of this engineering and predicate comparison study. "Ground truth" here is defined by compliance with recognized standards and the performance of the predicate device. The experts involved would be engineers and technical specialists conducting the tests, not clinical adjudicators establishing a diagnostic ground truth from patient data.

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

   • Not applicable. This is not a clinical study involving human interpretation of results requiring adjudication. Performance is assessed against quantitative engineering specifications and comparative data to the predicate.

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 device is a CPAP machine, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

   • This is a standalone medical device (CPAP machine) but not an "algorithm only" device in the context of AI/ML. Its performance is measured directly through engineering tests.

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

   • The "ground truth" for this submission is implicitly established by:
     • Recognized International and National Standards: e.g., ISO 17510-1 for sleep apnea breathing therapy equipment, ISO 8185 for humidifiers, ISO 10993 series for biocompatibility, etc.
     • The Performance of the Predicate Device: The modified device's performance is compared directly to its legally marketed predecessor (K141522) to demonstrate substantial equivalence.

8. The sample size for the training set

   • Not applicable. This is not a machine learning or AI device that requires a "training set."

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

   • Not applicable, as there is no training set for this type of device submission.

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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

The iCH CPAP with PVA 9S-007XXX Series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA). It is a modification of iCH CPAP 9S-007XXX (K120035) with the same algorithm of XT Auto with PVA 9S-005720 (K112079). It shares the same construction and auto adjustment algorithm with iCH CPAP 9S-007XXX but adds the identical Pressure Variation Algorithm with the predicate device XT Auto with PVA 9S-005720 (K112079). The Pressure Variation Algorithm provides a release pressure during expiration phase which is designed for patients who have difficulty exhaling against high CPAP pressure. It works by reducing the CPAP setting pressure in the normal breath status of expiratory phase from the treatment pressure in either CPAP or APAP mode.

A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series are designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience. The modified iCH CPAP series (with PVA) are from the iCH CPAP 9S-007XXX (K120035), but the algorithm for pressure variation algorithm(PVA) of the device comes from XT Auto with PVA (K112079).

The PVA Pressure Variation Alqorithm for the subject and predicated device (K112079) is an exhalation pressure relief function which is designed for patients who have difficulty exhaling against high CPAP pressure. Pressure can be reduced to three different levels (according to patient need) during the transition from Inspiration to Expiration phase. This reduced pressure level (depending on the PVA setting) will be maintained during Expiration phase and will return to the therapeutic pressure in the end of Expiration phase. In order to ensure the effectiveness of CPAP therapy, PVA will be automatically suspended if apneas are detected. After apneas disappear, PVA will re-start.

The provided text describes a 510(k) summary for the iCH CPAP with PVA 9S-007XXX series, which is a modified version of an existing device. The summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study to prove acceptance criteria for a novel algorithm's performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory document. The focus here is on engineering verification and comparison to existing, cleared devices.

Here's an attempt to extract relevant information and note where the requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity for disease detection). Instead, it relies on design verification tests to ensure the modified device functions similarly and safely to the predicate devices. The "reported device performance" is framed as "equivalent" or "identical" to the predicate.

Design Verification Tests Performed:

• Safety and EMC: According to iCH CPAP 9S-007XXX series (K120035) verification procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1 & IEC 60601-1-2.
• FDA Draft Reviewer Guidance for Ventilators (July 1995)
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
• Side-by-side waveform testing: At various pressure and frequency levels with the predicate device(s).
• Algorithm analysis (for PVA):
  • Step function
  • PVA waveform with different breathing frequencies and flow volumes
  • PVA feature handling conditions of disordered breathing (apneas and hypopneas)
  • PVA waveform upper and lower pressure control
  • PVA pressure average and tolerance error
  • Performance characteristics of PVA

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

This information is not provided in the document. The "test set" here refers to the engineering and algorithm verification tests, not a clinical trial with human subjects. The data provenance would be from internal testing, not patient data in the context of a clinical study.

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

This information is not provided. The ground truth for engineering tests is typically established by comparing the device's output to expected behavior based on specifications and predicate device performance, often using calibrated instruments.

4. Adjudication Method for the Test Set

This information is not provided. This refers to clinical adjudication, which is not described for these engineering/algorithm verification tests.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (CPAP machine for treating OSA) or its regulatory submission, which focuses on device functionality and substantial equivalence. This device does not involve "human readers" interpreting medical images or data with AI assistance.

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

Yes, an algorithmic analysis was performed for the Pressure Variation Algorithm (PVA). The document states:

• "Algorithm analysis; by comparing the test items as below:
  • a. Step function
  • b. PVA waveform with different breathing frequencies and flow volumes
  • c. PVA feature handling conditions of disordered breathing (apneas and hypopneas)
  • d. PVA waveform upper and lower pressure control
  • e. PVA pressure average and tolerance error
  • f. Performance characteristics of PVA"

This constitutes a standalone (algorithm-only) assessment of the PVA's expected behavior. However, it's an engineering verification, not a clinical standalone performance study.

7. The Type of Ground Truth Used

For the engineering and algorithm analysis tests, the ground truth would be based on:

• Specifications and engineering requirements: For characteristics like pressure range, increment, ramp time, etc.
• Predicate device performance: The behavior of the previously cleared XT Auto with PVA (K112079) served as the reference for the PVA algorithm's expected output.
• Physiological models/simulations: To test responses to different breathing frequencies, flow volumes, and disordered breathing conditions.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a hardware device with an algorithm for pressure variation, not a machine learning model that requires a "training set" in the conventional sense of AI/ML software. The algorithm is stated to be "the same algorithm of XT Auto with PVA 9S-005720 (K112079)," implying it was previously developed and validated.

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

This information is not applicable/provided for the reasons mentioned in point 8.

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WiZARD 230 Nasal Pillow Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. This mask only can be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

The WiZARD 230 Nasal Pillow Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face.

WiZARD 230 Nasal Pillow Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

WiZARD 230 Nasal Pillow Mask is a prescription device supplied nonsterile.

The provided document describes the acceptance criteria and the study that proves the WiZARD 230 Nasal Pillow Mask meets these criteria. This is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be conducted in a laboratory or controlled environment to meet international standards (ISO 10993-1, ISO 17510-2) rather than using patient-specific data.

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 for a test set. The evaluation seems to be based on compliance with established international standards for medical devices and their materials.

4. Adjudication Method

The document does not describe an adjudication method. The "testing" referred to is compliance testing against ISO standards for performance, safety, and biocompatibility, which typically involves objective measurements and pass/fail criteria rather than expert adjudication.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. This is a device for delivering CPAP therapy, and the evaluation is primarily focused on its physical and functional compliance with safety and performance standards, not on interpretation of medical images or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable. The WiZARD 230 Nasal Pillow Mask is a physical medical device, not an algorithm or AI system. Its performance is evaluated based on its physical characteristics, material safety, and functional capabilities in delivering airflow, as per ISO standards.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria is based on international standards for medical devices:

• ISO 10993-1: For biocompatibility of materials.
• ISO 17510-2: For the performance and safety of respiratory protective devices.

8. Sample Size for the Training Set

This question is not applicable. As the device is a physical product and not an AI or machine learning model, there is no "training set."

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

This question is not applicable for the same reason as above.

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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for use in the home or hospital/institutional environment.

XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720 is intended to be used to deriving continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) in adult patients and home environment. It is a modification of XT Auto CPAP Model 9S-005200(K083656). It shares the same construction and auto adjustment algorithm with XT Auto CPAP but adds expiration pressure release with three constant levels in firmware and has the same downloading function as XT Auto CPAP. XT Auto CPAP with Pressure Variation Algorithm provides a release pressure during expiration phase; it is equivalent to Expiratory Pressure Relief (EPR) of the predicate device RESMED S8 ADVANCE (K082979).

Here's a breakdown of the acceptance criteria and study information for the Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 9S-005720, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the device's characteristics and compares them to predicate devices to establish substantial equivalence, rather than setting explicit numerical acceptance criteria for clinical performance metrics. The implicit acceptance criterion is that the new device's performance characteristics are equivalent to the predicate devices, particularly regarding the new "Expiration Pressure Release" feature.

Study Information

The provided document describes a design verification testing approach to demonstrate substantial equivalence, rather than a clinical study with human subjects.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of human subjects or a dataset. The testing was performed on the device itself and compared to predicate device specifications and waveforms.
   • Data Provenance: The study involved "Side by side waveform testing at various pressure and frequency levels with the predicate device(s)" and "Closed-loop control analysis." This suggests the data was generated in a lab setting through device testing, not from patient data or a specific country. This is a retrospective comparison of device characteristics against pre-existing predicate specifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of submission is the technical specifications and performance of the legally marketed predicate devices, as well as adherence to relevant standards like IEC 60601-1. Expert consensus was not used to establish the technical "ground truth" for the device's technical performance.

3. Adjudication method for the test set: Not applicable. The testing described focuses on direct technical comparisons and adherence to standards, not human interpretation requiring adjudication.

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. This device is a CPAP machine, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided information indicates standalone testing of the device's performance and its algorithm. The "Closed-loop control analysis" specifically refers to the algorithm's performance independent of human input during operation. The device itself operates semi-autonomously based on its pressure variation algorithm.

6. The type of ground truth used:

   • Technical Specifications and Performance of Predicate Devices: The primary "ground truth" was the established and legally marketed characteristics and performance of the RESMED S8 ADVANCE (K082979) and XT Auto CPAP (K083656).
   • Regulatory Standards: Adherence to standards like IEC 60601-1 & IEC 60601-1-2, FDA reviewer guidance 638.pdf, FDA Draft Reviewer Guidance for Ventilators (July 1995), and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) served as "ground truth" for safety and other requirements.
   • Waveform Matching: For the Expiration Pressure Release feature, the "ground truth" was the waveform of the predicate device (RESMED S8 ADVANCE) at various pressure and frequency levels.

7. The sample size for the training set: Not applicable. This device is a hardware CPAP machine with an algorithm, not a machine learning model that requires a "training set" in the traditional sense. The algorithm's design and parameters would have been developed by engineers.

8. How the ground truth for the training set was established: Not applicable. As it's not a machine learning model, there's no "training set." The device's algorithm for auto-adjustment and pressure variation would have been designed based on engineering principles and physiological understanding of OSA.

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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA) for adult patients in the home environment.

9S-007XXX series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA) in home care environment. A built-in heated humidifier of 9S-007xxx series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Medical Corp. iCH CPAP 9S-007XXX device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly detail specific quantitative acceptance criteria or corresponding reported device performance values in a table format. Instead, it relies on a comparison to a predicate device and adherence to established regulatory standards and testing procedures.

The text states: "Above tests were verified to meet the required acceptance criteria." This indicates that the device did meet criteria, but the specific numerical values of these criteria are not provided in this summary.

Here's a generalized table based on the information available:

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

The document describes design verification tests performed on the new device, comparing it to predicate devices. However, it does not provide details on:

• Sample size: No specific number of devices or test iterations is mentioned for any of the verification tests (safety, EMC, vapor/particle, firmware).
• Data Provenance: The document doesn't specify the country of origin of the data or whether the data was retrospective or prospective. Given that these are design verification tests, they would be conducted in a controlled lab or manufacturing environment.

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

The document does not describe the use of human experts to establish "ground truth" for the test set. The tests performed are engineering and regulatory compliance validations (e.g., electrical safety, electromagnetic compatibility, firmware functionality, particle emissions). These would be evaluated against pre-defined engineering specifications, regulatory standards, and established laboratory protocols, rather than expert consensus on diagnostic accuracy.

4. Adjudication Method for the Test Set

As the "test set" consists of engineering and regulatory compliance tests, there is no mention of an adjudication method (like 2+1 or 3+1). The "ground truth" here is objective compliance with specified standards or successful execution of pre-defined procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was performed or mentioned. This submission is for a CPAP device, which is a therapeutic device for sleep apnea, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable to this device or its submission.

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

This device is not an algorithm or AI system. It is a physical medical device (CPAP machine). Therefore, a standalone algorithm performance study is not applicable. The performance is assessed based on its physical and electrical characteristics as per the verification tests.

7. The Type of Ground Truth Used

For the design verification tests (safety, EMC, vapor/particle, firmware), the "ground truth" is based on:

• Regulatory Standards: IEC 60601-1, IEC 60601-1-2.
• Environmental Standards: EPA PM2.5, EPA TO-15.
• FDA Guidance Documents: FDA reviewer guidance 638.pdf, "Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Predicate Device Testing Procedures: The testing procedures established and validated for the APEX MEDICAL XT Auto CPAP MODEL 9S-005200 (K083656) and APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664).

Essentially, the ground truth is compliance with established engineering, safety, and regulatory benchmarks.

8. The Sample Size for the Training Set

This device does not use machine learning or AI algorithms that require a "training set." Therefore, this question is not applicable.

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

As there is no training set for this device, this question is not applicable.

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WiZARD 210/220 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

WiZARD series mask consists of a frame with a cushion seal on the face. Different height forehead support pad are offer to user allow fitting forehead better. Series of vents are feature on the elbow that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. There is no whistling or whooshing sound from the exhalation vent and no jet of air blowing on the bed partner. WiZARD serous mask is connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly

The provided 510(k) summary for the WiZARD 210/220 Series CPAP Mask is for a medical device that does not involve AI. Therefore, many of the requested categories related to AI models and their evaluation (such as sample sizes for test/training sets, ground truth establishment methods, number/qualifications of experts, adjudication, MRMC studies, and standalone performance) are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices through compliance with established international standards for non-continuous ventilators.

Here's a breakdown of the available information based on your request:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. The "test set" in this context refers to physical testing performed on the device to ensure compliance with specified standards, not a data-based test set for an algorithm. The 510(k) summary does not specify the number of units tested for each criterion.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device does not involve expert-labeled ground truth as it is a physical medical device, not an AI/ML system. The "ground truth" for the performance and safety criteria is defined by the requirements of the ISO standards themselves.

4. Adjudication method for the test set

Not applicable. As this is not an AI/ML system, there is no adjudication process for conflicting interpretations of data. Compliance is assessed against objective engineering and safety standards.

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 a physical medical device (CPAP mask) and does not involve AI or human "readers" interacting with an AI system.

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

Not applicable. This device does not include an algorithm.

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

The "ground truth" for the device's performance and safety is defined by compliance with international standards: ISO 10993-1 for biocompatibility and ISO 17510-2 for performance and safety. These standards specify objective measurement methods and acceptable limits.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI/ML system.

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

Not applicable. No training set is involved.

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The device is to be used to remove fluids from the treated tracheotomy patient airway.

VacPlus is the portable AC/DC powered suction unit. Each one consists of an on/off switch, a pump unit, a non detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing.

The provided text describes the VacPlus device, an aspirator (powered suction pump), and its FDA 510(k) submission. However, it does not contain any information about a study involving AI, human readers, or image analysis for establishing acceptance criteria or assessing device performance in the context of AI.

The document focuses on the mechanical and electrical performance of the VacPlus device as a medical suction pump, comparing it to a predicate device (DeVilbiss Suction Unit, Model 7305P). The "Performance Testing" section explicitly states:

"Bench testing was performed to support a determination of substantial equivalence and consisted of packaging, electrical safety testing and all testing identified in EN 60601-1, EN 60601-1-2 and EN/ISO 10079-1. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operations. Biocompatibility testing is not applicable since the proposed device has no direct patient contact."

Therefore, based on the provided text, I cannot generate the requested information regarding AI acceptance criteria and related studies. The information you're asking for (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types) is relevant for AI/ML-based medical devices, which the VacPlus aspirator is not, as described in this document.

To answer your prompt, I would need a different source document that details the development and validation of an AI-powered medical device.

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