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510(k) Data Aggregation
(132 days)
NVP
This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.
The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.
The provided text is a 510(k) summary for a medical device (AeroChamber2go Anti-Static Valved Holding Chamber). It describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
It does NOT describe a study that proves the device meets the acceptance criteria of an AI/ML model for an image analysis task.
Therefore, I cannot fulfill your request for information related to AI/ML model performance, ground truth, expert adjudication, or MRMC studies based on this document. The document pertains to the physical and chemical properties of a medical device, not a software-driven diagnostic or image analysis tool.
The "acceptance criteria" discussed in this document refer to the device's mechanical, material, and aerosol delivery performance characteristics, not the performance of an AI system.
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(400 days)
NVP
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healtheare professional.
The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire® BASIC) and the modified LiteAire® Dual Valved, Collapsible MDI Holding Chamber (also referred to as the modified LiteAire®), are intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The subject devices feature a universal port designed for compatibility with most MDI medications. The subject devices are intended for use by a single patient and, when properly cared for, are reusable for up to one week. The devices consist of a collapsible paperboard housing and two one-way valves to control the direction of air flow when the patient inhales and exhales through the devices are popped-up by the user prior to use by pressing against the sides of the devices, can be collapsed flat between uses, and are anti-static. The intended environments of use include the home, hospitals and clinics. Note that the only differences between the modified LiteAire® and LiteAire® BASIC configurations is the removal of the window.
The provided text describes modifications to an existing medical device, the LiteAire Dual-Valved, Collapsible MDI Holding Chamber, and presents testing to demonstrate its substantial equivalence to the predicate device. It does not describe an AI/ML powered device, therefore the response below is based on the available information and identifies when specific AI/ML related questions are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the modified devices (LiteAire BASIC and Modified LiteAire) is to demonstrate substantial equivalence to the predicate device (LiteAire K160109) in terms of aerosol characterization (particle size distributions) and other performance aspects. The tables below summarize the key aerosol characterization data.
Table 1: Acceptance Criteria and Reported Device Performance (Aerosol Characterization at Adult Flow Rates - 28.3 L/min)
| Parameter (MDI Medication) | Acceptance Criteria (Implicit: No statistically significant difference from Predicate) | Predicate LiteAire (N=9) Mean ± SD, 95% CI | LiteAire BASIC (N=9) Mean ± SD, 95% CI | Modified LiteAire (N=9) Mean ± SD, 95% CI | Test Result/Conclusion |
|---|---|---|---|---|---|
| Albuterol Sulfate | |||||
| Total Emitted Dose (µg) | Statistically similar to predicate | 56.06 ± 6.94, 50.73–61.40 | 54.75 ± 4.96, 50.94–58.45 | 53.85 ± 2.66, 51.81–55.90 | Deemed substantially equivalent |
| Fine Particle Dose (µg) | Statistically similar to predicate | 56.06 ± 6.94, 50.73–61.40 | 54.66 ± 4.99, 50.83–58.50 | 53.85 ± 2.57, 51.72–55.67 | Deemed substantially equivalent |
| MMAD (µm) | Statistically similar to predicate | 2.15 ± 0.05, 2.12–2.19 | 2.17 ± 0.05, 2.14–2.21 | 2.24 ± 0.06, 2.19–2.28 | Deemed substantially equivalent |
| GSD (µm) | Statistically similar to predicate | 1.44 ± 0.07, 1.39–1.49 | 1.43 ± 0.08, 1.37–1.49 | 1.41 ± 0.02, 1.39–1.43 | Deemed substantially equivalent |
| Ipratropium Bromide | |||||
| Total Emitted Dose (µg) | Statistically similar to predicate | 7.39 ± 0.55, 6.96–7.81 | 7.46 ± 0.61, 6.99–7.92 | 7.71 ± 0.62, 7.10–8.25 | Deemed substantially equivalent |
| Fine Particle Dose (µg) | Statistically similar to predicate | 7.39 ± 0.55, 6.96–7.81 | 7.46 ± 0.61, 6.99–7.92 | 7.71 ± 0.62, 7.10–8.25 | Deemed substantially equivalent |
| MMAD (µm) | Statistically similar to predicate | 0.51 ± 0.06, 0.46–0.55 | 0.57 ± 0.14, 0.46–0.67 | 0.60 ± 0.09, 0.53–0.66 | Deemed substantially equivalent |
| GSD (µm) | Statistically similar to predicate | 4.79 ± 0.70, 4.26–5.33 | 3.90 ± 1.81, 2.51–5.29 | 3.44 ± 0.95, 2.71–4.17 | Deemed substantially equivalent |
| Fluticasone Propionate | |||||
| Total Emitted Dose (µg) | Statistically similar to predicate | 40.96 ± 5.23, 36.94–44.98 | 41.27 ± 6.33, 36.41–46.14 | 38.43 ± 11.26, 28.72–44.55 | Deemed substantially equivalent |
| Fine Particle Dose (µg) | Statistically similar to predicate | 40.96 ± 5.23, 36.94–44.98 | 41.27 ± 6.33, 36.41–46.14 | 38.43 ± 11.26, 29.78–47.09 | Deemed substantially equivalent |
| MMAD (µm) | Statistically similar to predicate | 2.49 ± 0.17, 2.358–2.619 | 2.52 ± 0.03, 2.50–2.54 | 2.54 ± 0.06, 2.50–2.59 | Deemed substantially equivalent |
| GSD (µm) | Statistically similar to predicate | 1.39 ± 0.02, 1.38–1.41 | 1.41 ± 0.03, 1.39–1.43 | 1.46 ± 0.05, 1.426–1.499 | Deemed substantially equivalent |
(Note: "Deemed substantially equivalent" is concluded from the 510(k) summary statement that "the modification in design of the subject devices does not negatively impact the device performance and the modified (subject) devices continues to perform with substantial equivalence to the cleared (predicate) device." Statistical methods for "statistically similar" are not explicitly detailed but are implied by the comparison of means and confidence intervals.)
Table 2: Other Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Test Result/Conclusion |
|---|---|---|
| Biocompatibility (per ISO 10993-1) | Confirmed using FDA guidance document, no new risks identified due to material or process changes. Materials, manufacturing processes, finished device geometry, and body/fluid contact characterization are the same as the predicate (K160109). | Met |
| Visual Inspection | All tests passed | Passed |
| First Article Inspection | All tests passed | Passed |
| Accelerated Aging | All tests passed | Passed |
| Pop/Collapse functionality | All tests passed | Passed |
| Functional Equivalence (purpose, function, scientific technology, method of operation) | "The subject devices are substantially equivalent to the predicate device (K160109) in purpose, function, scientific technology and method of operation." | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Aerosol Characterization: N=9 for each device (Predicate LiteAire, LiteAire BASIC, Modified LiteAire) for each MDI medication and flow rate tested (adult and pediatric). This means 9 units of each device type were tested for each specific drug and inhalation profile combination.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given that it's a bench performance test for a medical device's physical properties, the concept of "retrospective or prospective" as applied to clinical studies is not directly applicable. These are laboratory-based, controlled experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is Not Applicable as the device is a medical device (MDI Holding Chamber), not an Artificial Intelligence/Machine Learning (AI/ML) powered device that relies on expert interpretation for ground truth establishment. The performance is measured through objective physical and chemical tests (e.g., aerosol particle size, emitted dose).
4. Adjudication Method for the Test Set
This section is Not Applicable as adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers. The tests performed here are objective bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This section is Not Applicable as the device is a medical device (MDI Holding Chamber), not an AI/ML powered device, and no human-in-the-loop performance or reader studies were conducted or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable as the device is a physical medical device, not an algorithm or AI/ML product.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through objective physical and chemical measurements obtained from standardized laboratory tests, specifically:
- Aerosol Characterization: Particle size distributions (MMAD, GSD), Total Emitted Dose, and Fine Particle Dose measured using an Andersen Cascade Impactor (ACI) as per FDA guidance.
- Biocompatibility: Conformance to ISO 10993-1, confirmed by material composition and manufacturing process identical to a previously cleared device.
- Bench Performance: Visual inspection, first article inspection, accelerated aging, and pop/collapse functionality.
The performance values obtained from the predicate device served as the reference for establishing substantial equivalence.
8. The Sample Size for the Training Set
This section is Not Applicable as the device is a traditional medical device, not an AI/ML powered device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable for the reasons stated above.
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(203 days)
NVP
The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home. It is a single patient, multiple use device.
The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a holding chamber used for the administration of aerosolized medications. The AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products is designed to be used with a broad range of FDA approved pressurized metered dose inhaler (pMDI) or soft mist inhaler (SMI) pharmaceutical formulations prescribed by a healthcare provider. It is a single patient, multi-use device intended to be used by patients who are under the care or treatment of a licensed health care professional. This device is not used with a specific drug nor is it distributed with such drugs.
The provided text describes two main evaluations for the AeroChamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC):
- Change in Intended Use: Evaluating the device's performance with "Soft Mist Inhaler" (SMI) formulations, in addition to its existing use with Metered Dose Inhalers (MDIs).
- Addition of a New Configuration: Evaluating the "Adult Small Mask" configuration.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to existing methods (SMI alone for the new intended use) or predicate devices (Adult Large Mask for the new VHC configuration). The goal is to demonstrate comparable performance and no new safety/effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Aerosol Characteristics (SMI Use - Adult Flow) | Maintain or improve aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD, GSD) when using SMI with VHC compared to SMI alone. | SMI Formulation 1 (2 APIs): Fine Particle Fraction (FPF) generally increased with VHC (e.g., Ipratropium bromide increased from 66.6% to 70.3-76.0%; Salbutamol increased from 65.5% to 68.5-77.0%). MMAD generally decreased, indicating smaller particles (e.g., Ipratropium bromide from 2.8 µm to 2.1-2.5 µm). |
| SMI Formulation 2 (2 APIs): FPF generally increased with VHC (e.g., Tiotropium bromide from 60.5% to 67.7-79.0%). MMAD generally decreased (e.g., Tiotropium bromide from 3.2 µm to 2.1-2.8 µm). | ||
| SMI Formulation 3 (1 API): FPF generally increased with VHC (e.g., Tiotropium bromide from 62.4% to 64.5-71.7%). MMAD generally decreased (from 3.1 µm to 2.4-2.7 µm). | ||
| Aerosol Characteristics (SMI Use - Pediatric Flow) | Maintain or improve aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD) when using SMI with VHC compared to SMI alone at pediatric flow rates. | SMI Formulation 1: FPF generally increased with VHC (e.g., Ipratropium bromide from 53.0% to 70.6-78.4%; Salbutamol from 51.9% to 72.8-77.9%). MMAD significantly decreased (e.g., Ipratropium bromide from 4.9 µm to 1.5-1.8 µm). |
| Aerosol Characteristics (New Adult Small Mask Configuration) | Comparable aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD, GSD) to the predicate "Adult Large Mask" configuration when used with pMDIs. | pMDI Formulations: Performance metrics (Total Mass Recovered, Fine Particle Dose, Fine Particle Fraction, MMAD) are generally similar between the Adult Small Mask (Subject Device) and Adult Large Mask (Predicate Device). For example, Ipratropium bromide FPF was 93.0% (Subject) vs 90.5% (Predicate). |
| Biocompatibility | Meet ISO 10993 standards for biological endpoints relevant to an externally communicating device with prolonged contact (e.g., cytotoxicity, sensitization, systemic toxicity, genotoxicity, extractables/leachables). | All listed ISO 10993 tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables/Leachables with Biological Risk Assessment) were performed by an independent source. (The text states they were performed, implying successful completion, not explicit results). |
| Mechanical Testing | Demonstrate mechanical integrity and performance as expected for the device (e.g., environmental, flow performance, life cycle, drop, resistivity). | Environmental Testing, Flow Performance, Life Cycle Testing, Drop Testing, and Resistivity Verification were performed on the subject device. (The text states they were performed, implying successful completion). |
| Safety and Effectiveness | No new questions of safety and/or effectiveness are raised by the changes. | "The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC (facemask and mouthpiece configurations) used in combination with Soft Mist Inhaler formulations is comparable to use of a SMI formulation alone. Use of the VHC device with an SMI does not raise any new questions of safety and/or effectiveness." |
| "The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask is substantially equivalent to the predicate (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Large Mask). Use of the subject device does not raise any new questions of safety and/or effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size (number of devices or measurements per condition) for the aerosol characterization tests. It provides mean and standard deviation values for the aerosol characteristics, which suggests multiple measurements were taken for each condition.
- Data Provenance: The studies are non-clinical, involving in vitro aerosol characterization testing and biocompatibility/mechanical testing. The data provenance is internal to the manufacturer (or contracted labs) conducting the tests in a controlled laboratory environment. There is no mention of country of origin for the data or whether it's retrospective or prospective, as it pertains to controlled lab testing, not clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the studies are non-clinical. The "ground truth" for aerosol characteristics is established by direct physical measurement using standardized laboratory techniques (e.g., cascade impaction, chemical analysis) based on recognized guidance documents ("Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" FDA/CDRH - 1993). Similarly, biocompatibility and mechanical testing follow ISO standards and engineering principles. There are no human "experts" establishing ground truth in the sense of clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable as the studies are non-clinical. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For laboratory-based performance testing, the "ground truth" is determined by reference methods or validated instrumentation.
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. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The submitted information focuses on the physical and performance characteristics of a valved holding chamber, not a diagnostic imaging AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a physical medical device (a valved holding chamber), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance data presented (aerosol characteristics) is "standalone" in the sense that it measures the device's physical output without human intervention during the measurement process, but not in the context of an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical studies is based on:
- Physical Measurement: For aerosol characteristics, the ground truth is the direct measurement of particle size distribution, mass recovery, and fine particle dose using validated laboratory equipment and methods (e.g., cascade impactors, chemical analysis) as per FDA/CDRH guidance.
- Standardized Protocols: For biocompatibility, adherence to and successful completion of tests defined by ISO 10993 standards (e.g., in vitro cytotoxicity, in vivo sensitization).
- Engineering Specifications/Industry Standards: For mechanical testing (e.g., environmental, flow performance, life cycle, drop, resistivity), performance against pre-defined engineering specifications or relevant industry standards.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #8.
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(486 days)
NVP
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healthcare professional.
The Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The device consists of a collapsible paperboard housing and 2 one-way valves to control the direction of air flow when the patient inhales and exhales through the device. The LiteAire is not sterile, but clean and ready to use right out of the package. The LiteAire can be assembled by gently pushing in the edges of the device. The holding chamber can also be collapsed flat between uses and is anti-static.
The provided text describes modifications to a medical device (LiteAire Dual-Valved, Collapsible MDI Holding Chamber) and evaluates its substantial equivalence to a predicate device. The information presented focuses on non-clinical performance testing rather than a clinical study involving human readers or AI.
Here's an analysis of the provided text in the context of your questions:
1. A table of acceptance criteria and the reported device performance.
The document discusses performance in the context of non-clinical testing, specifically regarding the aerosolization efficiency of the device with different MDI products. The "acceptance criteria" are implied by the comparison to the predicate and the general expectation for an MDI holding chamber to deliver appropriate doses. The "reported device performance" is given in tables for Total Delivered Dose, Coarse Particle Dose, Fine Particle Dose, MMAD, and GSD.
Acceptance Criteria (Implied / Functional Requirements):
- Aerosol Delivery Performance: The ability to effectively deliver the prescribed dose from an MDI, with appropriate particle size distribution, comparable to or better than predicate devices. This is assessed via "Total Emitted Dose, Course Particle Dose or Fine Particle Dose."
- Mechanical Integrity: Maintain structural integrity and functionality (pop-ability, collapsibility, valve resistance) over expected shelf-life and under environmental stresses.
- Biocompatibility: No adverse biological reactions when in contact with lung tissue, skin, and mucosal membranes.
- Anti-static Properties: Exhibit anti-static properties to minimize drug adherence to the chamber walls.
Reported Device Performance:
The document provides specific data in Tables 2 and 3 for the subject device (K160109) with three different MDI products (Proventil HFA, Atrovent HFA, QVAR 80 mcg) at adult (28 L/min) and pediatric (12 L/min) flow rates. The values reported are 95% confidence intervals.
Table 1: Device Performance (Excerpts from Tables 2 & 3 Combined)
| Performance Metric | MDI Product Tested (Example Range) | Flow Rate |
|---|---|---|
| Total Delivered Dose (µg/actuation) | 39.77 – 77.62 | Adult/Pediatric |
| Coarse Particle Dose (>4.7 µm) (µg/actuation) | 0 – 3.42 | Adult/Pediatric |
| Fine Particle Dose ( |
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(403 days)
NVP
The antistatic Compact Space Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The device is intended for use in neonates, infants, children, adolescents and adults. The intended environments for use include home, hospitals and clinics.
Antistatic Compact Space Chamber
The provided document is a 510(k) premarket notification letter from the FDA regarding an "Antistatic Compact Space Chamber" (K143615), which is a nebulizer. It indicates the device has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria for device performance, outcomes from a study proving it meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
The letter is a regulatory approval document and focuses on the administrative aspects of FDA clearance, such as:
- Trade/Device Name: Antistatic Compact Space Chamber
- Regulation Number/Name: 21 CFR 868.5630, Nebulizer
- Regulatory Class: Class II
- Product Code: NVP
- Indications for Use: Administer aerosolized medication from most pressurized Metered Dose Inhalers to neonates, infants, children, adolescents, and adults in home, hospitals, and clinics.
To answer your request, information regarding the device's technical performance and the studies demonstrating it would need to be found in the original 510(k) submission itself or in relevant performance data documents, which are not included in this provided text.
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(266 days)
NVP
The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - Home, hospitals and clinics.
This product is intended for patients who can follow verbal instructions.
The FSC Anti-Static Valved Collapsible Holding Chamber is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a collapsible housing and mouth piece and a one-way valve to prevent exhaling into the chamber.
The FSC Anti-Static Valved Holding Chamber is intended to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilator medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
The provided text describes a 510(k) summary for the FSC Anti-Static Valved Collapsible Holding Chamber, which is a medical device used to administer aerosolized medication from Metered Dose Inhalers (pMDIs). The summary focuses on demonstrating substantial equivalence to predicate devices, namely the AeroChamber Plus Z-stat (K052332) and the E-Z Spacer (K933090).
However, the document does not outline specific, quantifiable acceptance criteria in the format of a table, nor does it provide a study that explicitly 'proves' the device meets such criteria in a typical clinical trial sense. Instead, it demonstrates equivalence to a predicate device through various non-clinical performance tests.
Therefore, the following information is extracted and presented as closely as possible to the requested format, acknowledging the limitations of the provided text.
Acceptance Criteria and Device Performance (Based on Equivalence Testing)
The document doesn't explicitly state numerical "acceptance criteria" but rather demonstrates performance that is "equivalent" or "better than" the predicate device, specifically the AeroChamber Plus Z-Stat (K052332), for particle characterization. For other tests, it states the device "passed or met its performance specifications."
| Acceptance Criteria Category | Specific Performance Parameter | Predicate Performance (K052332 or general) | Reported Device Performance (FSC Anti-Static Valved Collapsible Holding Chamber) |
|---|---|---|---|
| Particle Characterization | Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (Ventolin HFA) | 37.5-46.8 ug/burst (MDI only for comparison) | 50.6-55.0 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. |
| Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (Atrovent HFA) | 7.5-8.1 ug/burst (MDI only) | 6.3-8.3 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. | |
| Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (QVAR 40) | 12.1-14.8 ug/burst (MDI only) | 10.7-15.4 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. | |
| Material Biocompatibility | Cytotoxicity, Sensitization, Genotoxicity, Exhaustive Leachable/Extractable Testing | (Standard ISO 10993 requirements) | Passed required tests for External Communicating and Surface Contact classifications. |
| Simulated Lifetime | Pre and post-exposure, Cleaning | (Not specified, but predicate performance implied baseline) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Environmental & Mechanical | High and Low temperature, Drop test | (Not specified) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Anti-static Property | Surface resistivity | "Yes" (for K052332) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Differential Pressure | Comparative testing | (Not specified) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size for Particle Characterization:
- @ 28 lpm flow rate: 3 samples of the device, tested with 3 different drugs, 3 times each, for a total of 9 sample points for MDI-Spacer data. "MDI only" data used 3 samples tested with 3 drugs (number of times not specified, but implied to be comparable for a total of 9 tests or fewer for baseline).
- @ 12 lpm flow rate: 3 samples of the device, tested with 3 different drugs, 3 times each, for a total of 9 sample points.
- Data Provenance: Not explicitly stated, but the context of a 510(k) submission implies that these were laboratory-based, non-clinical tests conducted by or for FSC Laboratories, Inc. (the submitter). Therefore, it is prospective in the sense that it was conducted for this submission, and the country of origin would likely be the USA, where the company is based.
- Test Set Sample Size for Particle Characterization:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a non-clinical, in-vitro performance study. There were no human "experts" establishing a "ground truth" for a test set in the sense of medical diagnosis or interpretation. The ground truth was based on objective physical measurements (e.g., particle size, dose delivered) using a cascade impactor and established testing protocols.
-
Adjudication method for the test set:
- Not applicable as this was a non-clinical, in-vitro performance test based on objective measurements rather than subjective assessment requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, along with the effect size:
- No. This was a non-clinical device performance study, not a clinical study involving human readers or cases.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- "Standalone performance" in this context refers to the device's performance without a human in the loop, which is exactly what the non-clinical particle characterization and other mechanical/environmental tests represent. The data provided (Tables 4, 5, 6) are the results of the device performing its intended function in a laboratory setting. So, yes, standalone performance was assessed.
-
The type of ground truth used:
- The "ground truth" for the particle characterization and dose delivery tests was based on direct, objective physical measurements obtained through standard laboratory techniques, such as using an 8-stage cascade impactor and measuring drug quantities. For other tests (like biocompatibility, anti-static properties), the ground truth was defined by meeting specific ISO standards or internal performance specifications.
-
The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set." The tests described are to validate the physical performance of the manufactured device.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set for a physical device.
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(474 days)
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The Space Chamber Plus and Compact Space Chamber Plus are intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The devices are intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include home, hospitals and clinics.
The Space Chamber Plus and Compact Space Chamber Plus are devices designed to assist patients with inhaling aerosolized medication dispensed through a Metered Dose Inhaler. The devices consist of a cylindrical chamber with an opening at each end. One opening is for the aerosol medication to be inserted, the other is tapered into a mouthpiece for inhalation. The mouthpiece can be used with or without a mask. The Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.
Here's a breakdown of the acceptance criteria and the study details for the Space Chamber Plus and Compact Space Chamber Plus devices, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria for the Space Chamber Plus and Compact Space Chamber Plus devices are based on demonstrating substantial equivalence to the predicate device, AeroChamber Plus aVHC with Flow-Vu IFI (K070674), particularly with respect to particle size distribution and respirable dose. The study performed involved non-clinical testing of particle size distribution.
Table of Acceptance Criteria and Reported Device Performance (Summary of Equivalence)
| Performance Metric | Acceptance Criteria (Demonstrate Equivalence to Predicate) | Space Chamber Plus Reported Performance | Compact Space Chamber Plus Reported Performance |
|---|---|---|---|
| Particle Size, Mean MMAD, μm | Demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 2.5 (0.04) | |
| Ipratropium Bromide: 0.93 (0.05) | |||
| Beclomethasone Dipropionate: 1.3 (0.02) | |||
| (All values are within a narrow 95% CI and comparable to the predicate's MMAD values: Albuterol 2.4 (0.03), Ipratropium Bromide 0.76 (0.05), Beclomethasone Dipropionate 1.3 (0.03)) | Albuterol: 2.3 (0.05) | ||
| Ipratropium Bromide: 0.80 (0.02) | |||
| Beclomethasone Dipropionate: 1.3 (NA^) | |||
| (All values are within a narrow 95% CI (where applicable) and comparable to the predicate's MMAD values: Albuterol 2.4 (0.03), Ipratropium Bromide 0.76 (0.05), Beclomethasone Dipropionate 1.3 (0.03)) | |||
| Mean Total Respirable Dose, μg | Demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 286.9 (36.3) | |
| Ipratropium Bromide: 85.26 (3.3) | |||
| Beclomethasone Dipropionate: 328.05 (9.9) | |||
| (Comparable to predicate's values: Albuterol 292.2 (19.2), Ipratropium Bromide 55.28 (3.0), Beclomethasone Dipropionate 316.25 (17.6)) | Albuterol: 253.4 (38.7) | ||
| Ipratropium Bromide: 65.19 (2.1) | |||
| Beclomethasone Dipropionate: 308.29 (12.7) | |||
| (Comparable to predicate's values: Albuterol 292.2 (19.2), Ipratropium Bromide 55.28 (3.0), Beclomethasone Dipropionate 316.25 (17.6)) | |||
| Mean Respirable Fraction PF% (0.5-4.7) | Greater than pMDI alone and demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 86.1 (0.9) | |
| (Predicate: 87.6 (0.7), pMDI alone: 79.7 (3.3)) | |||
| Ipratropium Bromide: 65.3 (0.9) | |||
| (Predicate: 60.0 (1.8), pMDI alone: 54.7 (1.7)) | |||
| Beclomethasone Dipropionate: 82.7 (0.8) | |||
| (Predicate: 83.9 (1.1), pMDI alone: 77.3 (2.4)) | Albuterol: 88.0 (0.6) | ||
| (Predicate: 87.6 (0.7), pMDI alone: 79.7 (3.3)) | |||
| Ipratropium Bromide: 61.9 (0.7) | |||
| (Predicate: 60.0 (1.8), pMDI alone: 54.7 (1.7)) | |||
| Beclomethasone Dipropionate: 83.7 (1.0) | |||
| (Predicate: 83.9 (1.1), pMDI alone: 77.3 (2.4)) |
^(NA: Not applicable when results for each individual run are the same)
Study Details Proving Acceptance Criteria
The study performed was a non-clinical performance study focused on the particle size distribution of aerosolized medication delivered by the Space Chamber Plus and Compact Space Chamber Plus, in comparison to the predicate device and the pMDI alone.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific numerical sample size for each test run (e.g., number of inhalations tested, number of devices tested). However, the presence of 95% Confidence Intervals (CI) suggests multiple replicates were performed for each measurement.
- Data Provenance: The study was conducted by Medical Developments International Limited, an Australian company. The testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODF/DCRD/ADDB -1993), implying a controlled laboratory environment. The data is retrospective to the submission date.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical performance study involving physical measurements of particle size distribution, not an evaluation requiring expert interpretation of clinical images or patient data. The "ground truth" was established by the physical testing methodology itself, following established guidance.
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Adjudication method for the test set:
- Not Applicable. As this was a non-clinical, objective measurement study, there was no need for expert adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was a non-clinical performance study of a medical device (spacer/valved holding chamber) focused on drug delivery characteristics, not an AI-based diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This study assessed the physical performance of a mechanical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" was established through objective physical measurements using scientific instruments (e.g., cascade impactors for particle size distribution) following the methodology outlined in the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" and generating quantitative data for MMAD, respirable dose, and respirable fraction.
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The sample size for the training set:
- Not Applicable. This was a non-clinical performance validation against a predicate device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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(90 days)
NVP
The InspiraChamber® Anti-Static Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - Home, hospitals and clinics where patients may require the use of a holding chamber with pMDIs.
The intended patient population is 3 years and older who have been prescribed pMDI medications.
The InspiraChamber® is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber.
The InspiraChamber® is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
This document describes the InspiraChamber® Anti-Static Valved Holding Chamber, a device designed to assist in the inhalation of medications delivered via Metered Dose Inhalers (MDIs). The device's performance was evaluated through non-clinical testing, primarily focusing on comparative particle characterization.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the comparison to the predicate device, K872037 - Trudell AeroChamber. The presented data demonstrates the InspiraChamber's performance in terms of aerosol characteristics, aiming for equivalence with or suitable performance compared to MDI only or the predicate.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (InspiraChamber® - 95% Confidence Intervals) | Comments |
|---|---|---|---|
| Particle Characterization (28 lpm) | Equivalent to MDI only or predicate device | Particle size and dose metrics reported for three drugs. See Tables 1, 2, 3 below. | |
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (ProAir HFA) | Implied to be effective for drug delivery | 40.9 - 59.3 (MDI-Spacer) vs. 37.5 - 46.8 (MDI only) | Improved or comparable respirable dose with spacer. |
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (Atrovent HFA) | Implied to be effective for drug delivery | 5.3 - 7.0 (MDI-Spacer) vs. 7.5 - 8.1 (MDI only) | Slightly lower but potentially acceptable respirable dose with spacer. |
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (QVAR 40) | Implied to be effective for drug delivery | 9.4 - 11.7 (MDI-Spacer) vs. 12.1 - 14.8 (MDI only) | Slightly lower but potentially acceptable respirable dose with spacer. |
| Total Delivered Dose - ug/burst (ProAir HFA) | Similar to MDI only or predicate device | 55.0-69.4 (MDI-Spacer) vs. 102.7-104.8 (MDI only) | Expected reduction in total dose with spacer, as some drug deposits in chamber. |
| Total Delivered Dose - ug/burst (Atrovent HFA) | Similar to MDI only or predicate device | 11.2-13.3 (MDI-Spacer) vs. 19.0-21.0 (MDI only) | Expected reduction in total dose with spacer. |
| Total Delivered Dose - ug/burst (QVAR 40) | Similar to MDI only or predicate device | 21.4-25.3 (MDI-Spacer) vs. 33.6-38.4 (MDI only) | Expected reduction in total dose with spacer. |
| Particle Size (MMAD) (um) (ProAir HFA, 28lpm) | Within acceptable range for respiratory delivery | 1.52-1.68 | Fine particle size, suitable for lung deposition. |
| Particle Size (MMAD) (um) (Atrovent HFA, 28lpm) | Within acceptable range for respiratory delivery | 1.54-1.77 | Fine particle size, suitable for lung deposition. |
| Particle Size (MMAD) (um) (QVAR 40, 28lpm) | Within acceptable range for respiratory delivery | 0.44-0.52 | Very fine particle size, suitable for deep lung deposition. |
| Particle Characterization (12 lpm) | Equivalent to MDI only or predicate device | Particle size and dose metrics reported for three drugs. See Table 4 below. | |
| Mechanical Testing | Meets relevant standards for durability | Performed as part of Simulated life cycle testing | Includes high/low temperature, drop test. Implied successful. |
| Environmental Testing | Meets relevant standards for environmental conditions | Performed as part of Simulated life cycle testing | Implied successful. |
| Simulated Life Cycle (Cleaning) | Maintains performance after repeated cleaning | Performed (Pre and post-exposure) | Implied successful. |
| ISO 10993 Testing (Biocompatibility) | Meets ISO 10993 for indirect contact (aerosol) and direct (skin) contact | Cytotoxicity, Sensitization, Intracutaneous Irritation. BPA extractables - non-BPA. | Implied successful, indicating biocompatibility. |
| Anti-static surface resistivity | Within acceptable range | Performed | Implied successful. |
| Differential Pressure | Comparable to predicate | Performed (comparative) | Implied successful, indicating proper valve function. |
| Performance of Auditory alert | Functional and effective | Performed | Implied successful. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- For particle characterization at 28 lpm: 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
- For particle characterization at 12 lpm: 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
- For MDI only tests: 3 samples were tested with 3 drugs.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission, this is typically new data generated specifically for the submission and would be considered prospective for the purpose of demonstrating substantial equivalence. The testing was performed internally or by a contracted lab for InspiRx, Inc., a company based in New Brunswick, NJ, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (valved holding chamber) does not typically involve expert ground truth establishment in the same way an imaging AI device would. The "ground truth" for its performance is established through quantitative physical and chemical measurements (e.g., particle size, dose delivery) using standardized laboratory methods (e.g., cascade impaction, ISO 10993 biocompatibility tests). Therefore, there were no "experts" in the clinical sense establishing ground truth in terms of diagnoses or interpretations. The expertise lies in the certified laboratory technicians and engineers who performed the tests and analyzed the data according to established protocols.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the "ground truth" is based on objective laboratory measurements, not expert consensus or clinical adjudication.
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 accessory (valved holding chamber) and not an AI-powered diagnostic or interpretive device that would involve human readers or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as it is not an algorithm-based device. The device's performance is standalone in the sense that it mechanically modifies aerosol delivery.
7. The Type of Ground Truth Used
The ground truth used for this study is based on objective, quantitative laboratory measurements using established scientific and engineering methodologies, including:
- Particle Characterization: Measured using an 8-stage cascade impactor according to standard protocols (e.g., those referenced in USP ). This provides quantitative data on particle size distribution (MMAD, GSD) and dose delivery (total dose, respirable dose).
- Biocompatibility: Evaluated against ISO 10993 standards, using tests like cytotoxicity, sensitization, and intracutaneous irritation.
- Mechanical and Environmental Testing: Standardized tests for durability, temperature stability, drop resistance, etc.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The development of the device would involve engineering design and iterative physical testing, but not data-driven training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth to be established for it.
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(363 days)
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(189 days)
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The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. The intended environments for use include the home, hospitals and clinics.
For Single Patient Use .
Recommended Patient Population:
OptiChamber Diamond: Age 5 and up
OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months
OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years
OptiChamber Diamond with Large LiteTouch mask: 5 years +
The OptiChamber Diamond Valved Holding Chamber (VHC) is a Class II device. It is intended to be used in combination with most pressurized Metered Dose Inhalers (pMDIs) to assist in respiratory drug delivery.
The OptiChamber Diamond Valved Holding Chamber is a device utilizing the same operating principles as the AeroChamber Plus Z-Stat Valved Holding Chamber (K052332). Both the AeroChamber Plus Z-Stat and the OptiChamber Diamond are available with and without mask.
The valved holding chamber (VHC) is designed to assist patients who cannot correctly coordinate actuation of the pressurized metered dose inhaler (pMDIs) with inhalation. The VHC works by 'holding' the aerosol cloud emitted from the pMDI inside the chamber so that the larger aerosol particles are removed from the aerosol cloud by impaction into the chamber walls and sedimentation under the influence of gravity.
The OptiChamber Diamond Valved Holding Chamber is made of antistatic plastic materials alleviating any need to wash prior to first use. OptiChamber Diamond is comprised of: the mouthpiece, the chamber, the adapter (end cap) with inhalation flow alert, the exhaust valve, the inhalation valve, the valve retaining ring, and the cap.
The provided text describes testing conducted for the OptiChamber Diamond Valved Holding Chamber, a device intended to assist in respiratory drug delivery with pressurized Metered Dose Inhalers (pMDIs).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to the predicate device AeroChamber Plus Z-Stat Valved Holding Chamber (K052332) based on in vitro testing. The acceptance criteria are implicitly that the OptiChamber Diamond's performance (MMAD, GSD, FPD, FPF) should be comparable to or within acceptable limits relative to a pMDI alone and presumably similar to the predicate device, although direct comparative values for the predicate are not specified in this summary.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Fine Particle Dose (FPD) | Determined for categories: >4.7um, ≤4.7um, and ≤1.0um. Specific values for the OptiChamber Diamond with pMDI were measured and used to demonstrate performance. |
| Fine Particle Fraction (FPF) | Fraction of dose entering impactor ≤ 4.7um. Specific values were measured and used to demonstrate performance. |
| Mass Medium Aerodynamic Diameter (MMAD) | Geometric mean aerodynamic diameter. Specific values were measured and used to demonstrate performance. |
| Geometric Standard Deviation (GSD) | Measure of dispersion in lognormal distribution. Specific values were measured and used to demonstrate performance. |
| Comparison to pMDI Alone | Performance with OptiChamber Diamond VHC was compared to a pMDI alone. |
| Drug Formulations | Evaluated with albuterol, fluticasone propionate, and ipratropium bromide. |
| Simulated Breathing Patterns | Tested at 15 LPM (pediatric) and 30 LPM (adult). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The pMDI was actuated 10 times into each device (OptiChamber Diamond VHC and pMDI alone) for each test. With three drug formulations and two flow rates, this implies a total of 60 actuations for the OptiChamber Diamond (10 actuations * 3 formulations * 2 flow rates) and another 60 for the pMDI alone.
- Data Provenance: The study was an in vitro test, meaning it was conducted in a lab setting, not on human or animal subjects. Details on the country of origin are not explicitly stated, but the submitter is "Respironics New Jersey, Inc." in Parsippany, New Jersey, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of in vitro performance testing. The "ground truth" is established through standardized laboratory measurements and analytical techniques (HPLC assays, NGI analysis).
4. Adjudication Method for the Test Set
Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert adjudication of patient outcomes or imaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This was an in vitro performance study of a physical device, not an AI or diagnostic imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone in vitro performance study was done. The device's performance was evaluated independently without human interaction influencing the drug delivery mechanics during the measurement.
7. The Type of Ground Truth Used
The "ground truth" for this in vitro study was based on analytical measurements and established standards for aerosol drug delivery. This includes:
- HPLC assays: Quantifying drug deposition in various parts of the Next Generation Impactor (NGI).
- Next Generation Impactor (NGI): A standardized instrument used to measure the aerodynamic particle size distribution of aerosols, which forms the basis for MMAD, GSD, FPD, and FPF calculations.
- CITDAS software: Used for the calculation and analysis of aerosol performance parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning or AI algorithm, so there is no "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.
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