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EZ-Sprayer is intended to apply topically by spray or atomizing an oil or water base solution to either the nose and / or throat, for example, topical anesthetics solutions of lidocaine or xylocaine.

The device will not be supplied with water or oil base solutions.

The disposable, air or gas powered venturi sprayer / atomizer with reservoir and spring loaded flow control button, with an adjustable spray nozzle.

A disposable, nose or throat atomizer for either oil or water base solutions.

The provided text describes the "EZ Spray" powered atomizer and its substantial equivalence to a predicate device, the DeVilbiss Atomizer Model 5005. It does not contain information about a study proving the device meets acceptance criteria in the manner typically associated with AI/ML device evaluations (i.e., performance metrics, sample sizes, ground truth establishment, or expert reviews).

The document is a 510(k) submission summary for a medical device (EZ Spray) and focuses on demonstrating substantial equivalence to a pre-amendment predicate device, the DeVilbiss Atomizer Model 5005. The "acceptance criteria" here refer to design and performance specifications intended to show that the EZ Spray functions similarly to the predicate, and these are compared directly against the predicate device's characteristics rather than against a predefined set of independent performance benchmarks with associated statistical studies for standalone or human-assisted AI.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of medical device submission.

Here's the relevant information that can be extracted, framed within the requested structure where possible, and noting where information is not applicable:

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

The acceptance criteria are implicitly defined by the characteristics of the predicate device. The "reported device performance" is the EZ Spray's characteristics, which are claimed to be equivalent.

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

• Sample Size: Not applicable. This is not an AI/ML device. The "test set" in this context refers to the device itself being compared against a predicate, not a dataset for performance evaluation.
• Data Provenance: Not applicable. The comparison is based on the functional and material characteristics of the EZ Spray and the predicate device.

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

• Number of Experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the comparison is the established characteristics and performance of the predicate device.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no need for adjudication as the comparison was made against the known properties of the predicate device.

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

• MRMC Study: No. This is not an AI-assisted device. Therefore, no MRMC study or effect size calculation for human readers with/without AI assistance was performed.

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

• Standalone Performance Study: Not applicable. This device is a mechanical atomizer, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" used for this submission is the established characteristics, materials, and performance specifications of the predicate device (DeVilbiss Atomizer Model 5005), which was pre-amendment and legally marketed. The submission asserts that the EZ Spray is substantially equivalent to this predicate based on these established attributes.

8. The sample size for the training set

• Training Set Size: Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Ground Truth Establishment for Training Set: Not applicable. There is no training set for this type of device.

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The E-Z SPACER® Mask (Small) uses FDA approved materials: Dynaflex G2706 Kraton thermoplasiic rubber designed for medical applications, and 21 CFR 178.3297 colorant pigments as specified by the Food and Drug Administration (Colorants for polymers). The E-Z SPACER Mask is injected molded with cavity I.D. mask (E-Z SPACER®MASK (Small) for identification.

This document is a "Summary of Safety and Effectiveness" for the E-Z SPACER® Mask (Small). It describes the materials used, some testing conducted, and general compliance with regulations.

However, it does not provide the type of information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of typical medical device performance evaluation (e.g., diagnostic accuracy, sensitivity, specificity, or other quantitative performance metrics).

Here's why and what information is missing:

• No explicit "acceptance criteria" table: The document doesn't define specific numerical targets or thresholds for performance that the device is intended to meet.
• No "reported device performance" metrics: While it mentions "fatigue testing" and "particle size studies," it doesn't provide quantitative results or a comparison against predefined criteria for these studies.
• No diagnostic or clinical efficacy study: The document focuses on material safety, manufacturing compliance, and durability. It does not describe a study to evaluate the clinical effectiveness or diagnostic accuracy of the spacer mask in a patient population.
• No information on "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," or "ground truth for training set." These are all relevant to studies evaluating the performance of a medical device, especially those involving algorithms or diagnostic capabilities, which this device does not appear to have.

Summary of missing information based on your request:

What the document does describe in terms of "testing":

• Fatigue Testing:
  • Test performed: E-Z SPACER Mask attached to E-Z SPACER device, opened and closed 1,460 times (based on 4 uses/day for a year). Washed following patient instructions (once a week).
  • Evaluation: Mask evaluated every 50 cycles.
  • Result: "There were no signs of breakdown."
  • Discussion: This is a durability/material integrity test, not a performance study in the sense of clinical efficacy or diagnostic accuracy. There are no explicit acceptance criteria stated ("no signs of breakdown" is a qualitative observation, not a quantitative metric).
• Particle Size Studies:
  • Mentioned: "Particle size studies are submitted showing E-Z SPACER with Mask and without."
  • Discussion: The results of these studies are not included in this summary. It only states they were submitted. To meet your request, the results and their comparison to acceptance criteria would need to be provided.

In conclusion, this document primarily serves as a declaration of material safety, manufacturing compliance, and some durability testing for the E-Z SPACER Mask. It does not contain the detailed performance study information with explicit acceptance criteria and quantitative results typically found for devices requiring clinical or diagnostic efficacy data.

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The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDIs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.

The device is a simple plastic cylinder designed to fit flush over the mouthpieces of inhalers supplied by Schering (Proventil and Vanceril), Allen and Hanburys (Ventolin and Serevent), and Warrick (Albuterol). A whistle mechanism on the device is activated by the user during inspiration. The accessory device does not introduce additional space to the metered dose inhaler or interfere with the performance of the inhaler. The whistle reminds the user to sustain a slow continuous inspiration when using the metered dose inhaler.

The provided text describes the MDI Tutor, a device designed to assist metered dose inhaler users by providing an auditory whistle during correct inspiratory technique. The information available focuses on the device's function and a single performance test.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a sample size for the performance testing. It simply states "Performance testing for the MDI Tutor was designed to determine the threshold pressure required to evoke the whistle (.13 L/sec)."

The data provenance is not explicitly stated but appears to be a laboratory test conducted by the device manufacturer ("MDI Tutor Inc."). It is a retrospective test to verify a design parameter.

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

Not applicable. The ground truth for this specific performance test was a physical property measurement (threshold pressure/flow rate) of the device itself, not an interpretation requiring human expertise.

4. Adjudication Method for the Test Set:

Not applicable. The test described is a direct measurement of a physical parameter, not an assessment requiring adjudication by multiple readers.

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

No. The provided text does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a physical accessory, not an AI system in the traditional sense of image analysis or diagnostic aid.

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

The device itself is a standalone accessory. The performance test conducted ("determine the threshold pressure required to evoke the whistle") is a standalone assessment of the device's physical function. There is no "algorithm" in the context of AI being tested here.

7. The Type of Ground Truth Used:

The ground truth used for the described performance test was a physical measurement/specimen characteristic. Specifically, the flow rate (expressed as pressure threshold) at which the device's whistle mechanism activates.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical accessory, not an AI algorithm that requires a training set.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.

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The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.

The MedShield product reduces drug deposition in the tongue when used in conjunction with metered dose inhaler (MDI) medications. The device attaches to an MDI elbow and shields the tongue of the user from the medication spray. Drug that deposits on the device would otherwise be on the users tongue. Based on this, the taste effect of the medications is reduced. This simple device includes two different features. 1. The patient end of the device covers the tongue. The patient end may vary to maximize the comfort of a wide range of users. 2. The elbow end of the device includes a universal clip, which attaches the device to all MDI elbows. To satisfy the preferences of various customers, the force required to separate (or attach) the device to various elbows can be modified by adjusting the clip or modifying the taper around the clip. The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard. The MedShield is designed for single patient use. Patients may be given the product for use either in a hospital or home environment for extended time periods. Recommendations for cleaning, in cases of extended time, are included in the instructions for use.

This K961455 submission describes the MedShield, a tongue cover or guard designed to reduce drug deposition on the tongue when used with Metered-Dose Inhalers (MDIs). The device functions by shielding the tongue from the medication spray, thereby reducing the taste effect of the medications. The data provided focuses on the physical and chemical integrity of the device material (Celcon M90 Acetal resin) rather than clinical performance metrics related to drug deposition or taste reduction.

1. Table of Acceptance Criteria and Reported Device Performance

• Alcohols (Ethyl, Methyl, Propyl), Freon, Sodium Sulfate, Trisodium Phosphate: Excellent resistance.
• Oleic Acid, Sodium Carbonate: Good resistance.
• Extensive table of "Chemical Resistance of 'Celcon' Acetal Copolymer Resin" at 72°F and 140°F (see full table in original document). |
  | Durability (Cleaning) | No physical or cosmetic degradation after typical cleaning agents/conditions (e.g., alcohol, dishwashing liquid, vinegar, standard dishwasher cycles). | Cleaning Test: MedShield units were soaked for 5 days in alcohol, dishwashing liquid, and vinegar with no physical or cosmetic degradation noted. Units were subjected to 5 cycles of a standard dishwasher with no physical or cosmetic degradation noted. (Considered typical cleaning agents/conditions). |
  | Durability (Impact) | Withstand repeated drops from a reasonable height without breakage. | Drop Test: MedShield units were dropped 10 times from a height of 1 meter onto a tile-covered cement floor without breakage. |
  | Performance (Drug Deposition Reduction) | Reduce drug deposition on the tongue compared to no device or other devices. (Implied primary function, though not a quantifiable acceptance criterion with a specific threshold in the provided text). | Comparative Performance Testing: "In each instance tested, the medication deposited on the MedShield was less than that with other devices are cylindrical providing significantly more surface area to collect medication. The lower values for MedShield indicate that only medication that would be deposited on the tongue is affected." (Qualitative statement, no quantitative data or specific comparison devices mentioned). |
  | Equivalence to Predicate Devices | Substantially equivalent to Micro Spacer and AeroChamber in terms of safety and effectiveness. | DHD believes the MedShield performs substantially equivalent to the predicate device(s) and does not adversely affect safety and effectiveness compared to the predicate device. (Conclusion based on the above tests and feature descriptions). |

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

The document does not explicitly state the number of samples (MedShield units) used for each specific test (e.g., Cleaning Test, Drop Test, Comparative Performance Testing). It refers to "MedShield units" in plural for these tests. For the chemical resistance of the raw material (Celcon M90), the data provenance is "Hoeschet Celanese Corp." (the manufacturer of the resin). For the other tests (cleaning, drop, comparative performance), the data appears to be internally generated by DHD. The data is retrospective, as it's being presented as part of a 510(k) submission after the tests were conducted.

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

Not applicable. This submission focuses on the material and physical properties of the device, not on clinical interpretation or diagnosis that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests performed (chemical resistance, cleaning, drop, comparative performance) are objective physical/chemical tests, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The comparative performance testing was qualitative and focused on drug deposition on the device itself, not on human reader performance or clinical outcomes.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the material properties (chemical resistance) is based on manufacturer's specifications and test results for the raw material (Celcon M90 Acetal resin). For the in-house tests (cleaning, drop), the ground truth is the direct observation of physical and cosmetic degradation of the device under specific test conditions. For the "Comparative Performance Testing," the ground truth for "medication deposited" would likely be quantitative measurement of drug residue from the test setup, though specific methods are not detailed.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no AI algorithm or "training set" in the context of machine learning.

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

Not applicable (as above).

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The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.

The Aradigm Corporation SmartMist™ Asthma Management System is a single patient use prescribed metered dose inhaler (MDI) accessory and peak flow meter. The SmartMist™ is composed of the non-disposable, battery powered, portable SmartMist™ Controller and the SmartMist™ Spirometry Airway. In addition to it; primary purpose of assisting with drug delivery and its secondary purpose of monitoring lung function of patient compliance monitoring is available.

The SmartMist™ Asthma Management System is designed to work with a particular style of MDI, without modification. The entire MDI-canister and plastic actuator-is inserted into the SmartMist™ without the introduction of any flaps or valves. The MDI is easily removed for cleaning or for manual dosing should the SmartMist™ become inoperable.

As the patient inhales through their prescribed MDI that they have inserted into the SmartMist™, the device's microprocessor monitors the inhalation flow rate and volume detected by the system's pressure transducer. If the inhalation flow rate and volume fall within the factory programmed parameters, the microprocessor triggers its mechanism to actuate the MDI canister; aerosol medication is delivered to the patient.

Feedback regarding the inhalation flow rate is provided to the patient in the form of red and green LEDs. When the green LED is illuminated, the patient is breathing at the recommended inhalation rate for aerosol drug delivery.

The SmartMist™ Asthma Management System also functions as an electronic peak flow meter. When the user exhales through the Spirometry Airway, the device's microprocessor determines the peak expiratory flow rate (PEFR) and forced expiratory volume in one second (FEV). The peak flow rate is displayed to the patient in the liquid crystal display window.

A record of PEFR, FEV , and dosing (inhalation) events is stored in the SmartMist™ memory for later retrieval, if desired, by a trained medical practitioner. Therefore, the SmartMist™ also provides patient compliance monitoring at the option of the practitioner.

Use of MDI medications with the SmartMist™ provides to the patient continual inhalation technique training. Since the SmartMist™ will not deliver the medication unless the patient's inhalation is at the proper flow rate, the patient eceives technique feedback each time the SmartMist™ is used for delivery of medication. Red and green indicators provide easily understood flow rate feedback to the patient.

This document appears to be a 510(k) summary for the Aradigm SmartMist™ Asthma Management System, not a study report per se. Therefore, it primarily describes the device and its intended use, and generally states that testing was performed and met standards, rather than providing detailed results of a specific clinical trial with acceptance criteria for device performance.

Based on the information provided, here's an attempt to answer your questions to the best of what's available in the text:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. It states that:

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

This information is not provided in the document. The text refers to "testing" performed but does not specify the sample size of participants or devices, nor whether the data was retrospective or prospective, or its origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The context of this device (medical device for patient use, not an AI diagnostic tool) does not typically involve expert consensus for ground truth in the same way an image analysis algorithm might. Ground truth for spirometry and spray delivery would typically be established by calibrated reference equipment, not expert opinion.

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

This information is not provided and is not applicable in the context of this device's testing described. Adjudication methods like 2+1 or 3+1 are typically used in studies where human experts are making subjective assessments that need to be reconciled (e.g., in reading medical images). The testing described for the SmartMist™ appears to involve objective measurements against established technical standards (ATS recommendations, accepted spray delivery standards).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted or reported. This type of study is relevant for AI diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The SmartMist™ is an assistive device for drug delivery and monitoring, not an AI diagnostic tool that human "readers" would use to make interpretations.

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

The document describes testing of the device itself (SmartMist™), which inherently includes its internal algorithms for monitoring and actuating based on patient inhalation. Therefore, the "testing" mentioned for spirometry and spray delivery accuracy would reflect standalone performance of the device's functions. The entire device, including its algorithms, was tested against ATS recommendations and accepted spray delivery standards.

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

The ground truth for the testing appears to be based on:

• ATS (American Thoracic Society) recommended standards for spirometry monitoring. These are established physiologic and technical standards.
• Accepted standards for the average weight of a metered spray from an MDI. These are likely regulatory or industry-accepted physical measurement standards.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this device. The SmartMist™ is not an AI/ML algorithm that undergoes "training" in the data science sense. Its "factory programmed parameters" for inhalation flow rate are pre-set based on medical and engineering principles, not learned from a dataset.

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

Not applicable as there is no "training set" for this device in the machine learning sense. The device's operational parameters (e.g., "factory programmed parameters" for inhalation flow rate and volume) would be established through engineering design, clinical understanding of optimal inhalation techniques, and potentially in-vitro testing, rather than a data-driven training process with established ground truth.

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