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1 - Intended Use: The DHD TRUST is intended for use as a nebulizer.

• 2 Indications:
• The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
• The DHD TRUST delivers aerosolized medications and diagnostic formulations.
• 3 Target Patient Population
  Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.

The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.

The provided text describes a 510(k) premarket notification for the DHD Healthcare Corporation's "TRUST" nebulizer. It details the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or software. The study mentioned relates to particle size delivery for a physical medical device (nebulizer) and aims to show equivalence to a predicate device, not performance benchmarks for an AI system.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I discuss sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.

The "Summary of Studies" section only states:
"Testing of particle size delivery was performed in accordance with the guidance document "REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS". The results of this testing shows particle size delivery to be equivalent between TRUST and the predicate."

This describes a physical performance test for a nebulizer, not an AI/ML model.

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The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device.
Claims:

• The use of DHD Roadrunner improves clearance of secretions
• The use of DHD Roadrunner may reduce the need for postural drainage
• DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
• The DHD Roadrunner may be used to prevent or reverse atelectasis

The DHD Roadrunner is indicated for use as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device.

The provided text describes the DHD Roadrunner, a Positive Expiratory Pressure (PEP) device, and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria or provide a detailed study report that proves the device meets those criteria with numerical performance metrics. Instead, it broadly claims that the device "met its specifications" and was "substantially equivalent."

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific quantitative values from the provided text.

However, I can extract the available information regarding the "Summary of Studies" and other relevant details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document mentions "bench & human testing" but does not provide the number of participants or samples.
• Data Provenance: Not specified (e.g., country of origin). The document implies the testing was conducted by DHD Healthcare Corporation. It's unclear if the "human testing" involved a retrospective or prospective study design.

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

Not applicable. This device is a mechanical medical device, not a diagnostic algorithm. Ground truth for performance would typically be established through engineering specifications, physical measurements, and clinical outcomes/physiological effects, rather than expert consensus on interpretations of data.

4. Adjudication method for the test set

Not applicable. As a mechanical device performance evaluation, adjudication would typically involve adherence to test protocols and measurement standards rather than expert consensus on interpretations.

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, not an AI or imaging diagnostic tool. An MRMC study is inappropriate for evaluating a PEP device.

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

The device is a physical, human-operated medical device. The concept of "standalone" performance (algorithm only) does not apply. The device's performance is inherently tied to a human user's exhalation. The "bench testing" component could be considered "standalone" in the sense of evaluating the device's physical output independent of a patient, but this is a different context than algorithm performance.

7. The type of ground truth used

The ground truth for the device's performance is implied to be based on:

• Engineering Specifications: The device "met its specifications."
• Comparison to Predicate Devices: Performance was compared to the Flutter® and TheraPEP® devices to establish "substantial equivalence" in terms of mechanisms (creating vibrating positive expiratory pressure) and intended physiological effects (secretion clearance, airway opening, preventing/reversing atelectasis). The predicates' established performance and safety serve implicitly as a form of ground truth for what is considered an effective PEP device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

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Boeing is indicated for the treatment and prevention of atelectasis. Boeing facilitates opening of airways in patients requiring prevention or treatment of atelectasis. Boeing also has the ability to provide supplemental oxygen when used with compressed oxygen.

The DHD Boeing is a single-patient-use Respiratory Therapy device. The standard system consists of a flow amplification body, compressed oxygen/air tubing, pressure port cap, and mouthpiece. The mouthpiece can be replaced with a mask.

The DHD Boeing device (Positive Airway Pressure (PAP) Device) was determined to be substantially equivalent to the predicate device, TheraPEP, based on non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• The submission does not specify the exact sample sizes used for each bench test. However, it states that the non-clinical bench testing compared the DHD Boeing against the predicate device and against its own performance specifications.
• Data Provenance: The tests were non-clinical bench tests performed by the manufacturer, DHD Healthcare Corporation. No information is provided regarding data provenance in terms of country of origin or whether it was retrospective or prospective, as it pertains to bench testing.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not applicable for this submission. The "ground truth" in this context refers to established performance specifications and the performance of the predicate device, which are determined through engineering principles and existing regulatory decisions rather than expert consensus on individual cases.

4. Adjudication Method for Test Set:

• Not applicable as this was non-clinical bench testing comparing against specifications and a predicate device.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices involving human interpretation of results, which is not applicable to a Positive Airway Pressure (PAP) device.

6. Standalone Performance Study (Algorithm Only):

• Yes, a form of standalone performance study was done through the "non-clinical bench testing" which compared the DHD Boeing against its "own performance specifications." This indicates the device's technical performance was evaluated independently of human-in-the-loop operation, reflecting its inherent functionality.

7. Type of Ground Truth Used:

• The ground truth used was based on:
  • Performance Specifications: The device met its own predefined performance specifications for airway pressure (expiratory and inspiratory) and supplemental oxygen delivery.
  • Predicate Device Performance: The Boeing's performance was compared to and found substantially equivalent to the legally marketed predicate device, TheraPEP, regarding these performance characteristics.

8. Sample Size for Training Set:

• This information is not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development would involve engineering prototypes and iterative testing, but not a "training set" as understood in machine learning.

9. How Ground Truth for Training Set was Established:

• Not applicable, as there is no "training set" for this type of medical device. The "ground truth" for its design and testing would be derived from engineering standards, material properties, physiological requirements for PAP therapy, and the performance characteristics of existing predicate devices.

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The DHD TheraPEP® is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis. The device may be used in conjuction with aerosol drug therapy.
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.

The DHD TheraPEP® is a single-patient-use Respiratory Therapy device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable.
Air and aerosolized drugs are drawn in through the inlet of TheraPEP, which is opposite the mouthpiece end of the device. The air and aerosolized drug passes by the inlet valve which baffles out some of the medication, primarily large diameter particles of aerosolized drug which can not be absorbed by the patient's lung tissue. The air and respirable diameter particles of the aerosolized drug continue undeterred past the inlet device and through the device past the mouthpiece and into the patient's body. As the user begins exhaling, the inlet valve closes, forcing all of the air from the lungs out the selected orifice in the selector dial.
The MDI with spacer or Nebulizer may be connected directly or by means of an adapter to the 22mm O.D. inlet end (opposite mouthpiece end) of the TheraPEP device. Positive Expiratory Pressure (PEP) occurs during exhalation and aerosol drug delivery occurs during inspiration. Use of an MDI Spacer and/or Nebulizer requires the same technique of breathing for inhalation and breath hold as does PEP therapy. A patient would be instructed by a clinician to take in a larger than normal breath for PEP Therapy or Aerosol Drug delivery followed by a short breath hold prior to exhalation. PEP occurs during exhalation and helps prolong exhalation plus keeps airways open longer thereby helping to move secretions, increase the transpulmonary pressure gradient, and resolve atelectasis.

The provided text describes modifications to the TheraPEP device and studies conducted to support an added claim regarding its use with aerosol drug therapy. However, it does not detail specific "acceptance criteria" in the form of numerical performance targets (e.g., minimum sensitivity or specificity) or a formal "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or screening device.

Instead, the studies summarized aim to demonstrate substantial equivalence to existing devices and that the added claim does not negatively impact safety and effectiveness. The "acceptance criteria" here appear to be more about demonstrating equivalency and non-inferiority in terms of drug delivery characteristics, rather than meeting predefined performance thresholds for a new clinical outcome.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations regarding explicit acceptance criteria and a structured "proving" study:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list numerical "acceptance criteria" in the traditional sense for a diagnostic or screening device (e.g., specific thresholds for sensitivity, specificity, or accuracy). Instead, the performance evaluation in this submission focuses on demonstrating equivalence in drug delivery performance to predicate devices and that the new configurations (with nebulizer and MDI spacer) do not negatively impact performance.

The implicit acceptance criteria seem to be:

1. No significant difference in aerosolized drug delivery when the TheraPEP is used with MDIs (with spacer) or SVNs, compared to existing market products or the predicate device.
2. No statistically significant difference in total drug mass delivered or respirable drug mass delivered for different medications when compared to the predicate device in combination with nebulizers.
3. The added claim (combination with aerosol drug delivery) will not adversely affect the safety and effectiveness of the TheraPEP device.

Therefore, the "reported device performance" is largely framed in terms of "no difference" compared to predicate devices or current market offerings.

Study Information Details:

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

   • Phase I Testing: Not explicitly stated for each comparison, but the overall context of 510(k) submissions for such devices often involves in vitro laboratory testing rather than human subject trials. The phrasing "various products currently on the market" suggests comparative testing.
   • Phase II Testing: "small sample size (n=3)" was explicitly mentioned for the comparison between TheraPEP® and Resistex® for Intal® and Alupent® drug delivery.
   • Data Provenance: The studies appear to be laboratory-based in vitro evaluations of particle size distribution using cascade impaction measurement. Therefore, there is no "country of origin of the data" or "retrospective/prospective" context in the typical clinical study sense.

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

   • Not applicable as the studies were in vitro laboratory tests measuring particle size distribution and drug mass, not clinical evaluations requiring human expert interpretation for ground truth. The "ground truth" was established by the physical measurements themselves.

3. Adjudication method for the test set:

   • Not applicable. The studies involved quantitative physical measurements, not human interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This was not an MRMC study. The studies evaluated device performance in terms of drug delivery characteristics, not reader performance with or without AI assistance.

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

   • Yes, in a sense. The studies were "standalone" in that they evaluated the physical performance of the device and its compatibility with other components (nebulizers, MDIs) without human operation or interpretation as a variable in the outcome measurements. This aligns with the "algorithm only" concept for a physical device, where its intrinsic function is tested.

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

   • The "ground truth" for these studies was based on quantitative physical measurements using a cascade impactor to determine particle size distribution and total drug mass delivered. This is an objective measurement rather than an interpretive or clinical ground truth.

7. The sample size for the training set:

   • Not applicable. These were in vitro verification and validation studies, not machine learning model development. Therefore, there is no concept of a "training set."

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

   • Not applicable, as there was no training set.

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The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipment attachments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the reuse of aneroid gauges and pressure indicators from patient to patient per your institution's protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges.

The DHD Lichen Product is a kit consisting of a hydrophobic bi-directional filter with tubing that is connected to each side of the hydrophobic bi-directional filter. This assembled filter kit is a single-patient-use device intended for infection control for use with low flow pressure indicators and both inspiratory and expiratory maneuvers with low flow pressure indicators and gauges where the patient exhales at a pressure of less than 120cm H20.

The provided document, K980662, is a 510(k) summary for the DHD Healthcare Lichen Filter Kit. It explicitly states that "There were no specific studies completed in association with this submission." As a result, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted because such a study was not performed and therefore not submitted.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable, as no studies were performed or submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no studies were performed or submitted.

4. Adjudication method for the test set
Not applicable, as no studies were performed or submitted.

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 physical filter, not an AI-assisted diagnostic tool, and no studies were performed or submitted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical filter, not an algorithm, and no studies were performed or submitted.

7. The type of ground truth used
Not applicable, as no studies were performed or submitted.

8. The sample size for the training set
Not applicable, as no studies were performed or submitted.

9. How the ground truth for the training set was established
Not applicable, as no studies were performed or submitted.

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The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region.

The Pilot device is a mask attachment for the Stealth Metered Dose Inhaler (MDI) Spacer. The Pilot mask fits directly onto the Stealth MDI Spacer. Pilot is a single piece, injection molded, silicone rubber piece. It is intended for single patient use and may be disassembled from the Stealth MDI for convenient cleaning the device, by hand, in warm soapy water. The Pilot mask will be available in several sizes. and large masks. The mask sizes are designed to fit comfortably to a users face. The masks also include a tapered fitting designed to mate with the Stealth mouthpiece. The tapered fitting includes a small ledge which serves as a stop, preventing the mask from being advanced too far onto the Stealth mouthpiece.

The provided 510(k) summary for the "Stealth/Pilot (Final Name to Be Determined) MDI Spacer with Facemask" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be described. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and addressing technological characteristics with "no testing required" for most points.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "There were no specific studies completed in association with this submission."

Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable, as no studies involving a test set and ground truth establishment were described.

4. Adjudication method for the test set

Not applicable, as no studies involving a test set were described.

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 mechanical medical device (MDI spacer with a facemask), not an AI-powered diagnostic or assistive technology.

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

Not applicable, as this is a mechanical device, not an algorithm.

7. The type of ground truth used

Not applicable, as no studies involving ground truth were described.

8. The sample size for the training set

Not applicable, as no training set was used (e.g., for an AI algorithm).

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

Not applicable, as no training set was used.

Summary of the Study and Device Acceptance:

The submission for the "Stealth/Pilot" facemask does not include any performance studies or clinical trials with acceptance criteria and measured device performance in the traditional sense. Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices ("ACE" MDI Spacer and "Stealth" MDI Spacer) and confirming that its technological characteristics meet basic design requirements without interfering with the primary function of the MDI spacer.

The "Summary of Studies" section explicitly states, "There were no specific studies completed in association with this submission," and the "Conclusions Drawn from Studies" section states "None."

The acceptance criteria listed in Section 6 ("Technological Information") are essentially design requirements that the manufacturer asserts are met by the Pilot mask's design, materials, and intended function. The FDA's 510(k) clearance process often allows for substantial equivalence determinations without new clinical or performance data if the new device is sufficiently similar to legally marketed predicate devices. In this case, the Pilot mask is an accessory that interfaces with an already cleared MDI spacer, and the manufacturer argued successfully that its design characteristics inherently met the stated requirements, thus "no testing is required."

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