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The eFlow® is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

The PARI eFlow® Electronic Nebulizer is a small, single-patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device, containing a capped medication cup that can be filled by the user. Power input is provided by either four AA batteries or a DC or AC adapter. Alternate power cords/plugs/adapters allow its use in any country.

Here's a breakdown of the acceptance criteria and study information for the eFlow® Electronic Nebulizer, based on the provided text:

Based on the provided text, the device in question is a modified eFlow® Electronic Nebulizer, specifically the addition of a new control unit with an LCD. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trials with specific acceptance criteria in the same way a new drug or high-risk medical device might.

The "acceptance criteria" here are implicitly tied to demonstrating that the modifications do not adversely affect safety or performance and that the modified device remains substantially equivalent to the predicate. The study described focuses on technical verification and validation, not on clinical performance metrics like sensitivity, specificity, or reader agreement.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1-2
• CAN/CSA C22.2 NO 601.1-M90
• UL 1431 |
  | Stress Testing
  (Compliance with specified standards for intended operational environment) | Testing performed to the applicable requirements of:
• IEC/EN/DIN 60068-2-3
• 60068-2-6
• 60068-2-14
• 60068-2-29
• 60068-2-64
• 60068-2-78 |
  | Overall Impact on Performance, Safety, or Effectiveness
  (No new issues or adverse effects) | "Testing demonstrated that the modifications to the new, optional control unit do not affect the performance of the eFlow Electronic Nebulizer, and raise no new issues of safety or effectiveness."
  "The addition of the modified unit does not affect the intended use, or alter the fundamental scientific technology of the legally-marketed PARI eFlow."
  "Additionally, there is no change to the legally-marketed device's: (1) materials; (2) performance specifications; (3) dimensional specifications: (4) environmental specifications: (5) energy sources; or; (6) packaging." |
  | Substantial Equivalence to Predicate Device
  (Based on 21 CFR 807.87 and New 510(k) Paradigm) | The manufacturer believes the modifications are substantially equivalent to the eFlow® Electronic Nebulizer (K033833), cleared on May 5, 2004.
  (The FDA's letter concurs with this finding of substantial equivalence). |

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

The provided text does not contain information about a "test set" in the context of patient data. The testing described is primarily engineering and software verification/validation on the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable to the reported studies.

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

This information is not applicable to the type of testing described. The studies focus on technical compliance with standards and the functionality of the device's new components, not on medical diagnoses or interpretations by experts for a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a "test set" requiring adjudication by experts in the context of medical diagnoses.

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 done or at least not described in this document. This submission focuses on the technical aspects of a device modification, not on clinical performance comparisons of human readers with or without AI assistance.

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

This is not applicable. The device is an electronic nebulizer, which is a physical medical device for drug delivery, not an AI algorithm. Its performance is inherent in its electromechanical function and software control, not in an "algorithm only" sense like a diagnostic AI.

7. The Type of Ground Truth Used

The "ground truth" for the reported studies is primarily the technical specifications and requirements defined by the referenced industry standards (e.g., IEC, CAN/CSA, UL, DIN) and the manufacturer's own SOPs. For software, it's the expected functional behavior as defined in specifications. For electrical safety and EMC, it's compliance with the limits and conditions of the standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical electronic nebulizer, and the testing described is not related to training an AI algorithm.

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

This information is not applicable for the same reason as above – no AI algorithm training is described.

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The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute institutions.

The Hvdrate V is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A breathing circuit is used to deliver the heated and humidified gas to the patient.

The provided 510(k) summary for the PARI Hydrate V describes a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than a study against explicit acceptance criteria with reported device performance in the format typically used for AI/ML-based device evaluations. The summary focuses on comparing the device's technical characteristics and performance to existing, legally marketed humidifiers.

Therefore, the following analysis is based on interpreting the provided information in the context of a 510(k) submission for a non-AI/ML medical device, where the "acceptance criteria" are implied by performance equivalence to predicate devices and adherence to relevant standards.

Acceptance Criteria and Study Details

The PARI Hydrate V is a respiratory gas humidifier. For such a device, the primary performance characteristic is its ability to warm and add moisture to breathing gases effectively and safely. The acceptance criteria are implicitly defined by the performance of the predicate devices and adherence to international standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a non-AI/ML device, the "acceptance criteria" are based on equivalence to predicate devices and relevant industry standards (ISO 8185). The reported device performance is stated as being "comparable to the predicates."

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

The summary describes "non-clinical testing" which typically involves bench testing rather than patient data.

• Sample Size: Not explicitly stated but refers to "a gravimetric test standard for humidifier output across the range of flows." This implies multiple measurements were taken at different flow rates to demonstrate consistent performance. The "sample" in this context would likely be the device itself and a series of test conditions.
• Data Provenance: Bench test data. Not applicable in terms of country of origin or retrospective/prospective as it doesn't involve patient data.

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

Not applicable. For a non-clinical bench test of a humidifier, the "ground truth" is typically established by objective physical measurements (e.g., gravimetric analysis for humidity output) using calibrated laboratory equipment, not by human expert assessment. The testing would have been conducted by engineers or technicians in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is determined by objective measurements against a standard.

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

Not applicable. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often in conjunction with AI assistance. The PARI Hydrate V is a therapeutic device, and its performance is assessed via engineering and physical tests.

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

Not applicable. This device does not incorporate an AI algorithm. Its performance is inherent to its physical design and operation.

7. Type of Ground Truth Used

• Objective Measurements: The ground truth for the device's performance (humidification output) was established through objective gravimetric measurements according to a "test standard for humidifier output," likely following the procedures outlined in ISO 8185. This involves precisely measuring the mass of water added to a gas stream over time.
• Predicate Device Performance: The ground truth for comparative purposes was the established performance of the legally marketed predicate devices (PARI Hydrate G and Fisher & Paykel MR 850), as well as the requirements of ISO 8185.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML device and therefore does not have a "training set" in the computational sense. Its design and development would have involved engineering principles and prototype testing, but not machine learning training.

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

Not applicable for the same reasons as above.

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Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.

The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document does not contain the level of detail typically found in a clinical study report regarding device performance beyond a basic declaration of substantial equivalence.

The provided text is a 510(k) Premarket Notification for a saline solution, not a complex AI/ML-driven medical device. Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable or not present in this type of submission.

Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text)

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

   • Sample Size: Not applicable/Not provided. This is a 510(k) submission for a saline solution, which typically relies on chemical and manufacturing standards, and substantial equivalence to a predicate, rather than large-scale clinical trials with test sets in the context of an AI/ML device.
   • Data Provenance: Not applicable in the context of clinical trial data. The data provenance primarily relates to the formulation and manufacturing process ensuring compliance with USP standards, and the comparison to an existing legally marketed device.

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

   • Not applicable. Ground truth in the context of clinical outcomes or expert consensus for interpretation tasks is not relevant for this type of device. The "ground truth" here is adherence to chemical specifications and the established safety and effectiveness of the predicate device.

3. Adjudication method for the test set:

   • Not applicable. No clinical test set requiring adjudication in the context of diagnostic or interpretive accuracy is mentioned.

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 not an AI/ML-driven diagnostic or assistive tool for human readers.

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

   • Not applicable. This device is a saline solution, not an algorithm.

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

   • The "ground truth" for this submission is based on established chemical standards (USP monograph) for sodium chloride solutions and the demonstrated safety and effectiveness of a legally marketed predicate device (DEY K972778) as determined by the FDA's substantial equivalence review process. Real-world clinical outcomes or pathology data were not used to establish a performance "ground truth" in the way they would be for a diagnostic tool.

7. The sample size for the training set:

   • Not applicable. There is no concept of a "training set" for a saline solution in the context of AI/ML.

8. How the ground truth for the training set was established:

   • Not applicable.

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The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to infant, pediatric, and adult patients. The Hydrate G is intended for use in homes, hospitals, and sub-acute institutions.

The Hydrate G is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A nasal cannula is used to deliver the heated and humidified gas to the patient.

Here's an analysis of the provided text regarding the PARI Hydrate G and its acceptance criteria, structured as requested:

Acceptance Criteria and Device Performance for PARI Hydrate G

Study Details:

The provided submission, K070107 for the PARI Hydrate G, describes a non-clinical test summary rather than clinical studies.

1. 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 specified. The submission mentions a "gravimetric test standard for humidifier output across the range of flows" but does not give specific numbers of test samples (e.g., number of devices tested, number of readings taken).
   • Data Provenance: Not specified. The testing was reported by PARI Innovative Manufacturers, Inc., based in Midlothian, VA, suggesting it was likely conducted in the US, but this is not explicitly stated. It was a non-clinical, in-vitro comparison rather than data from patients. The nature of the testing (comparing output) implies it was prospective for the specific purpose of the 510(k) submission.

2. 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. This was an engineering/performance comparison against existing devices and an international standard (ISO 8185), not a clinical assessment requiring expert-established ground truth. The "ground truth" here would be the measured physical properties (humidification output) of the device and predicate devices, as well as the ISO standard specifications.

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

   • Not applicable. Adjudication methods are typically used in clinical studies for human interpretation or assessment, which was not performed here. The performance was measured directly.

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:

   • No MRMC study was done. This device is a medical device (humidifier) and not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • This is not an algorithm-only device. Performance testing was done on the physical device itself in a standalone manner (without patient interaction for this specific regulatory requirement). The "standalone" performance here refers to the device's ability to produce comparable humidification output in laboratory conditions.

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

   • The "ground truth" for the non-clinical testing was based on:
     • Measured humidification output of the predicate devices.
     • Specifications/requirements of ISO 8185 for humidifier output.
     • The principle that "Active High Flow Gas Humidification systems" should produce comparable humidification output, regardless of the specific technology.

7. The sample size for the training set:

   • Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."

8. How the ground truth for the training set was established:

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

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The LC Sprint Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint Star is intended for pediatric and adult patients consistent with the indications for the aerosol medication.

The LC Sprint Star is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescriptionuse only, intended for use in hospital, clinic, or home environments.

LC Sprint Star is a cosmetically and geometrically modified version of the LC Sprint nebulizer currently marketed by PARI. The LC Sprint Star has an inspiratory balve on the top component and an expiratory valve on the mouthpiece, allowing for breathcontrolled aerosol output.

The LC Sprint Star will be available as a stand-alone item or a configuration component containing:

• LC Sprint Star nebulizer (consisting of nebulizer cup, top, and baffle insert) I
• L Mouthpiece
• Oxygen tubing (optional) 트
• 트 Mask (optional)

The provided text describes a 510(k) submission for a nebulizer, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device cannot be extracted from this document, as it does not pertain to such a device.

The document discusses the LC Sprint Star Reusable Nebulizer, comparing it to predicate devices and detailing its indications for use. It's a medical device clearance, not an AI/ML product.

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The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.

The LC Star reusable nebulizer with nasal adapter is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The provided text is a 510(k) summary for the LC Star Reusable Nebulizer with Nasal Adapter. It details the device, its intended use, and a non-clinical test summary. However, it explicitly states that clinical testing was not completed/is not required to show substantial equivalence. Therefore, it does not contain information about acceptance criteria for device performance based on a study, nor does it provide details about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, or training set information.

Based on the provided information, here's what can be extracted:

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

The document does not explicitly state numerical acceptance criteria. Instead, it uses comparative language.

2. Sample sized used for the test set and the data provenance:

Not applicable. The document states "Clinical testing was not completed/is not required." Non-clinical tests typically involve device measurements and performance characteristics rather than patient data.

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

Not applicable. No clinical study for substantial equivalence was conducted, therefore no expert ground truth was established from patient data.

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

Not applicable. No clinical study for substantial equivalence was conducted.

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 medical device (nebulizer) and not an AI-powered diagnostic tool. No MRMC study was mentioned or would be relevant.

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

Not applicable. This device is a medical device and not an algorithm. Performance was assessed based on non-clinical measurements described in the summary.

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

Not applicable. For the non-clinical tests (MMAD, RM, Total Mass), the "ground truth" would be the measured values from the predicate devices, against which the new device's measurements were compared.

8. The sample size for the training set:

Not applicable. No clinical study with a training set was conducted.

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

Not applicable. No clinical study with a training set was conducted.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was non-clinical testing. The 510(k) summary explicitly states: "The LC Star with nasal adapter was tested to compare performance to the predicate devices, including: MMAD: LC Star with nasal adapter MMAD is comparable to the predicate devices, RM: LC Star with nasal adapter RM is comparable to the predicate devices, Total Mass: LC Star with nasal adapter Total Mass is comparable to the predicate devices."

The conclusion from this non-clinical testing was that "LC Star with nasal adapter meets performance requirements and raises no new issues of safety or effectiveness." This comparison to legally marketed predicate devices (MABIS NB-02 Ultrasonic Nebulizer and PARI LC® Star Nebulizer) forms the basis for the substantial equivalence determination and indicates that the device's technical specifications are within an acceptable range relative to established devices. No clinical data or human subject studies were required or performed to demonstrate equivalence.

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The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.

The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The provided document, K060357, describes a 510(k) submission for the PARI Trek™ S nebulizer compressor. This device is a nebulizer compressor, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as ground truth, expert adjudication, MRMC studies, training set, etc.) are not applicable in this context.

The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance summaries.

1. Table of Acceptance Criteria and Reported Device Performance

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The LC Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.

The LC Sprint is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The provided text describes the LC Sprint Reusable Nebulizer, its indications for use, and a comparison to predicate devices, but it contains limited information regarding specific acceptance criteria and the detailed study proving the device meets accepted criteria.

Based on the available information:

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 performance tests (MMAD, RM, Total Mass). It is only stated that the LC Sprint was "tested to compare performance to the predicate devices." The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

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

This information is not applicable and not provided. The study focuses on objective performance metrics of the device compared to predicate devices, not on expert interpretations or diagnoses that would require ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study involves measuring physical device performance metrics, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a nebulizer for medication delivery, and its performance is assessed through physical characteristics (MMAD, RM, Total Mass) rather than through diagnostic interpretation by human readers.

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

This information is not applicable. The device is a physical medical device, not an AI algorithm. Its performance is inherent in its design and operation.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the independent measurement of the physical properties related to aerosolized medication delivery, specifically:

• MMAD (Mass Median Aerodynamic Diameter): A measure of the particle size of the aerosol.
• RM (Residual Medication): The amount of medication remaining in the nebulizer after use.
• Total Mass: The total quantity of medication delivered.

These metrics are considered objective and measurable, and their values are compared directly to those of legally marketed predicate devices to establish substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The LC Sprint is a physical medical device, not a machine learning algorithm, and therefore does not have a "training set" in the computational sense.

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

This information is not applicable, as there is no "training set" for this type of device.

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The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.

This 510(k) submission for the eFlow™ Electronic Nebulizer does not contain a study proving the device meets specific acceptance criteria in the way described in your request.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing. It explicitly states that clinical testing was not completed/is not required to show substantial equivalence.

Therefore, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies are not part of this 510(k) submission for this particular device.

Here's a breakdown of what is provided, addressing your points where possible, and clearly indicating when information is absent based on the provided text:

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

• Not applicable. The submission does not define specific acceptance criteria (e.g., a "target accuracy of 90%") or report performance against such criteria. It makes comparative statements against predicate devices.

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

• Not applicable. No clinical test set details are provided as no clinical testing was performed for substantial equivalence demonstration. The "test set" described relates to non-clinical engineering performance.

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. No expert ground truth establishment method is described for this submission's non-clinical testing.

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

• Not applicable. No adjudication method is described for this submission's non-clinical testing.

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 medical device (nebulizer), not an AI-powered diagnostic or decision support system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not mentioned.

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

• Not applicable. This is a medical device, not an algorithm.

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

• Not applicable. For the non-clinical tests (MMAD, RF, TOR), the "ground truth" would be the measured physical properties of the aerosol generated by the device, as determined by standard laboratory methods. There is no mention of expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is relevant or provided.

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

• Not applicable. No training set for an algorithm is relevant or provided.

Summary of Non-Clinical Test Findings (as provided):

The submission states: "EFlow was tested to compare performance to the predicate devices, including:"

• MMAD (Mass Median Aerodynamic Diameter): "eFlow MMAD is comparable to or lower than prodicate devices."
• RF (Respirable Fraction): "eFlow RF is comparable to or greater than predicate devices."
• TOR (Total Output Rate): "eFlow TOR is comparable to or greater than predicate devices."
• Safety/EMC (Electromagnetic Compatibility): "eFlow meets the requirements of EN/IEC 60601-1, DIN EN 60601-2 and UL 1431."

The conclusion from these tests is: "eFlow meets performance requirements and raises no new issues of safety or effectiveness." This demonstrates "substantial equivalence" as required for a 510(k) submission, rather than meeting acceptance criteria for a specific clinical performance claim.

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Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.

Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.

Vortex will be available as a stand-alone item and will also be available packaged with a mask.

Here's a breakdown of the acceptance criteria and study 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 specify the exact sample sizes for the "test set" (i.e., the number of devices or experimental replicates used in the non-clinical testing). It only states that "Testing to compare Vortex to Aerochamber was conducted."

The data provenance is retrospective, as the testing was conducted for the purpose of a 510(k) submission to demonstrate substantial equivalence to an already legally marketed device. The country of origin of the data is not explicitly stated.

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

This information is not applicable as the provided document describes non-clinical performance testing of a medical device (a valved holding chamber/spacer), not a diagnostic or AI-driven system that requires expert-established ground truth. The "ground truth" here is objective physical measurements (e.g., drug delivery, resistance).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods are typically relevant for subjective assessments or when multiple experts review the same data, which is not the case for this non-clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence." MRMC studies typically involve human readers and clinical outcomes.

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

This question is not applicable as the device (Vortex valved holding chamber) is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance assessment was based on objective physical measurements and established testing methodologies. For example:

• Drug delivery: Measured quantitatively according to FDA guidance.
• Fit with MDI elbows: An objective assessment of physical compatibility.
• Inhalation and exhalation resistance: Measured quantitatively using instruments (e.g., in pascal at a specific flow rate).

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The performance testing was conducted on the physical device itself.

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

This information is not applicable for the same reason as point 8.

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