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Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.

Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.

Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.

Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.

Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.

Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.

Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called the MiniSpacer Dual Spray MDI Adapter. This document is a regulatory submission for a device, which typically describes an engineering verification and validation study rather than a clinical study for AI software.

Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially details such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set information (which are all highly relevant to AI/ML device evaluations), is not present in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and general performance, rather than AI-specific metrics.

However, I can extract the following relevant information based on the request, reinterpreting some categories in the context of a non-AI medical device submission:

Acceptance Criteria and Device Performance

• Product: MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
• Study Type: This document describes a premarket notification (510(k)) to establish substantial equivalence to predicate devices, not a clinical trial or AI performance study. The "study" here refers to the engineering verification and biocompatibility assessment for the physical device.

Additional Requested Information (as applicable to this document):

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

   • Test Set Sample Size: Not specified in the document. The testing described appears to be bench testing for material and functional equivalence.
   • Data Provenance: Not explicitly stated, but the toxicological assessment and comparisons against predicate devices would be based on internal testing and regulatory standards. It's a regulatory submission, not a clinical trial, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for patient data.

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

   • Not applicable in the context of this device. Ground truth is established through engineering specifications, material standards, and regulatory requirements (e.g., biocompatibility testing interpreted by toxicologists) rather than expert consensus on medical images or patient outcomes.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of expert interpretations. Compliance is determined by engineering testing and regulatory assessment.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

   • No, an MRMC study was not done. This device is a physical medical component (an actuator for MDI medication), not an AI diagnostic or treatment planning system that would involve human readers interpreting data.

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

   • Not applicable. This device does not involve an algorithm or AI component.

6. The type of ground truth used:

   • For material and functional performance, the "ground truth" is defined by established engineering specifications, performance standards, mechanical testing results, and toxicological assessment standards. For regulatory approval, the ultimate "ground truth" is established by demonstrating substantial equivalence to legally marketed predicate devices through comparative analysis and testing.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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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)

(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

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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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)

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The MINISPACER® 1024A, 1025A and 1543A adapters are single patient, disposable devices for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner.

The MINISPACER® 1024A, 1025A and 1543A adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments.

Not Found

My deepest apologies, but the provided text does not contain specific acceptance criteria or the details of a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the MiniSpacer® 1024A, 1025A, and 1543A MDI Adapters.

This type of document is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. It confirms that the FDA has reviewed the manufacturer's submission and found it acceptable for market, but it does not typically include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specifics about the type of ground truth used or the size and establishment of ground truth for a training set.

These details would normally be found in the V&V (Verification and Validation) reports or clinical study summaries submitted by the manufacturer to the FDA as part of their 510(k) application, but they are not typically included in the public-facing clearance letter itself.

Therefore, I cannot fulfill your request for this specific document. If you have a different document that details performance studies, I would be happy to analyze it.

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The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner.

The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments.

The device is intended for sale by or on the order of a physician.

MiniSpacer® Dual Spray MDI Adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit.

This looks like a 510(k) clearance letter from the FDA for a medical device called "MiniSpacer® Dual Spray MDI Adapter."

Based on the provided text, it's a clearance letter, not a study report. Therefore, none of the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies can be extracted from this document.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It does not contain any details about performance criteria or the studies used to demonstrate those criteria.

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The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three major functions:

• To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects.
• To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation.
• To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.

The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber.

This document is a 510(k) premarket notification approval letter from the FDA to Thayer Medical Corporation for a device called "LiteAire," which is a collapsible, disposable accessory device for use with metered dose inhalers (MDIs). The document does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details.

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The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,

The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use.

This document is a 510(k) premarket notification from the FDA regarding the "PrimeAire" device. It is a letter confirming that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter, not a performance study report.

Therefore, I cannot provide the requested information based on the input.

To answer your request, I would need a document that describes the design verification and validation testing for the PrimeAire device, including its performance characteristics and the studies conducted to demonstrate its safety and effectiveness.

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