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The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.

The DDI Ultrasonic Nebulizer System is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The DDI Ultrasonic Nebulizer System is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries.

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details for the DDI Ultrasonic Nebulizer System:

The provided document (K090307) is a 510(k) summary for a Medical Device. For 510(k) submissions, the primary "study" is often a comparison of technical characteristics and performance to a legally marketed predicate device, rather than a traditional clinical trial with acceptance criteria for new device performance metrics. The goal of a 510(k) is to demonstrate substantial equivalence, not necessarily to prove absolute efficacy or safety with new, independent studies.

Therefore, the "acceptance criteria" for this device are implicitly the performance specifications and safety standards met by its predicate devices, and the "study" is the comparison against those predicates to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in the document. Instead, the DDI Ultrasonic Nebulizer System is deemed acceptable because its performance parameters are "statistically identical" to the predicate devices. The table below presents the key performance characteristics reported for the new device and its predicates, implying that matching or being substantially similar to these predicate values constitutes acceptance.

Study Details Proving Acceptance

The "study" for this 510(k) submission is primarily a nonclinical comparison of technical characteristics and performance against two legally marketed predicate devices:

1. Omron Micro-Air Vibrating Mesh Nebulizer (K062263)
2. Health & Life Co. Ultrasonic Nebulizer System Model HL 100 (K081738)

The conclusion states that "All of the performance parameters of the devices are statistically identical, and do not raise any new safety or efficacy." This forms the basis of the substantial equivalence determination.

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

   • The document does not describe a clinical "test set" in the traditional sense of patient data. The evaluation appears to be based on bench testing of the device's technical specifications and electrical safety.
   • Data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing as part of their regulatory submission. The data is retrospective in the sense that it's comparing a new device against established predicate device specifications, and the testing of the new device likely occurred prior to the submission date.

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

   • This is not applicable as there was no "test set" requiring expert ground truth in the context of diagnostic interpretation. Ground truth for device performance parameters (e.g., nebulization rate, particle size) would have been established through standardized engineering and laboratory testing protocols.

3. Adjudication method for the test set:

   • Not applicable, as there was no "test set" requiring human adjudication in the context of interpretation.

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

   • No, a MRMC comparative effectiveness study was not done. This submission is for a medical device (nebulizer) that delivers medication, not a diagnostic imaging or screening tool that would involve human readers interpreting cases.

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

   • This is not applicable, as the device is a physical medical device (nebulizer), not an algorithm or AI system. Its performance is inherent to its design and mechanical/electrical operation.

6. The type of ground truth used:

   • The "ground truth" for the device's performance characteristics (e.g., nebulization rate, particle size, battery life, dimensions) would have been established through laboratory measurements and engineering specifications. For electrical safety, the ground truth is defined by compliance with the referenced international standards (IEC 60601, EN 60601-1, EN 60 601-1-2).

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning system, so there is no concept of a "training set" in this context.

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

   • Not applicable as there is no training set.

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The Prodigy Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Prodigy Voice Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

This system contains speaker function which provides step by step instructions.

The provided text offers minimal details regarding the acceptance criteria and the study that proves the device meets those criteria. Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide specific acceptance criteria (e.g., accuracy percentages, precision metrics, bias limits) nor detailed performance results to populate such a table.

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

• Test Set Sample Size: Not specified.
• Data Provenance: The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." There is no mention of the country of origin or whether the studies were retrospective or prospective.

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

Not specified. The document only mentions "healthcare professionals" conducted studies.

4. Adjudication Method for the Test Set:

Not specified.

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

Not mentioned or implied. The focus appears to be on the device's standalone performance rather than comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):

Yes, this was undoubtedly done. The "Performance Studies" section states, "The performance of Prodigy Voice Blood Glucose Monitoring System was studied in the laboratory and in clinical settings..." This implies the device was tested as a standalone system.

7. Type of Ground Truth Used:

While not explicitly stated, for a blood glucose monitoring system, the ground truth would typically be established by a reference method (e.g., a laboratory-grade blood glucose analyzer that is traceable to an international standard). The text mentions "quantitative measurement of glucose," which necessitates a highly accurate reference for comparison.

8. Sample Size for the Training Set:

Not specified.

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

Not specified.

Summary of Available Information from the Provided Text:

• Reported Device Performance: NOT DETAILED. No specific metrics (e.g., accuracy, precision) or numerical results are provided. |
  | Test Set Sample Size | NOT SPECIFIED. |
  | Data Provenance (Test Set) | "in the laboratory and in clinical settings by healthcare professionals and lay users."
• Country of Origin: Not specified.
• Retrospective/Prospective: Not specified. |
  | Number & Qualifications of Experts (Ground Truth - Test Set) | NOT SPECIFIED. Mentions "healthcare professionals" but no details on number, specialties, or experience. |
  | Adjudication Method (Test Set) | NOT SPECIFIED. |
  | MRMC Comparative Effectiveness Study | NO. Not mentioned or implied. |
  | Standalone Performance | YES. Implied by "Performance Studies... in the laboratory and in clinical settings." |
  | Type of Ground Truth Used | Reference Method (e.g., laboratory-grade glucose analyzer). While not explicitly named, the nature of glucose measurement requires a highly accurate and precise reference method for comparative ground truth. |
  | Training Set Sample Size | NOT SPECIFIED. |
  | How Ground Truth for Training Set Was Established | NOT SPECIFIED. |

Conclusion:

The provided 510(k) summary (a premarket notification for demonstrating substantial equivalence to a predicate device) is high-level. It confirms that performance studies were conducted and that the device met its intended use, which is sufficient for 510(k) clearance. However, it does not provide the detailed scientific and clinical evidence, including specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would typically be contained in the full submission to the FDA. The purpose of this summary is to briefly introduce the device and its regulatory status, not to serve as a comprehensive research paper.

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The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in capillary whole blood from the fingertip and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Prodigy glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. The system also provides voice broadcast function when the meter is used to test.

The provided document (K060467) pertains to the 510(k) summary for the Prodigy Blood Glucose System. After careful review, the document does not contain the detailed acceptance criteria or the specific study results that would allow for a complete description of the device's performance against such criteria.

The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (TaiDoc Technology Corporation, K042005) rather than providing a detailed performance study against pre-defined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information regarding sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

Here's what can be extracted and inferred from the text regarding safety and effectiveness:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states: "The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate." However, it does not detail what specific acceptance criteria were used or the quantitative performance results against them.

2. Sample sized 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.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.

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:
This information is not applicable/provided. The Prodigy Blood Glucose System is an in-vitro diagnostic device for measuring glucose, not an AI-assisted diagnostic tool requiring multi-reader studies with human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The Prodigy Blood Glucose System is an electrochemical method-based meter. Its performance is inherent to the device itself (strip and meter interaction). The concept of "standalone algorithm only" is not directly applicable in the same way it would be for image analysis AI. The "standalone" performance would be its accuracy in measuring glucose values, which is generally evaluated in clinical trials using reference methods. However, the details of such a trial are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood glucose measurement systems, the "ground truth" is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer) with high accuracy and precision. While the document mentions "clinical and non-clinical testing data," it does not explicitly state the type of ground truth method used.

8. The sample size for the training set:
This information is not provided in the document. (Note: For a traditional electrochemical blood glucose meter, the concept of a "training set" as understood in machine learning is not directly applicable. Calibration data and internal validation data would be collected during development and manufacturing, but specific "training set" size for an algorithm is not relevant here).

9. How the ground truth for the training set was established:
As above, this information is not provided and the concept of "training set ground truth" is not directly applicable in the context of this device type.

Summary of available device performance information (from the "Similarities" table):

This table highlights technical specifications and equivalence, but not detailed accuracy performance against clinical acceptance criteria.

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The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.

The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

The Prodigy glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This document primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market. It often doesn't contain detailed, standalone clinical trial reports with full statistical breakdowns, specific acceptance criteria for performance metrics (like accuracy targets), or comprehensive study methodologies. As such, some of the requested information (especially quantitative acceptance criteria, exact sample sizes for training, and specific details about ground truth establishment for training data) is not explicitly stated in this type of document. I will extract what is available and clearly state what is not present.

Acceptance Criteria and Device Performance

The 510(k) summary primarily establishes substantial equivalence by demonstrating that the new device, the Prodigy Blood Glucose Test System, is similar to its predicate device (TaiDoc Technology Corporation, K042005) in terms of technology and performance. While specific numerical acceptance criteria (e.g., "95% of readings must be within ±X% of reference") are not explicitly listed in the provided text for device performance, the overall acceptance criterion for the submission is that the device is "as safe and effective as the predicate."

The text states: "The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate." This implies that the device met performance standards comparable to those accepted for the predicate.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Study Details:

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

   • Sample Size: The exact sample size for the test set (clinical study group) is not explicitly stated in the provided document. The document mentions "clinical and non-clinical testing data," but does not give numerical figures for the number of patients or samples.
   • Data Provenance: The document does not specify the country of origin of the data. It mentions "Diagnostic Devices, Inc.,Inc. Address: 8935 NW 27th street, Miami, FL 33172. U.S.A.", which implies the company is based in the US, but this doesn't confirm the origin of the clinical data. The data is retrospective or prospective is not explicitly stated, though clinical studies for 510(k) are typically prospective.

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

   • This information is not provided in the 510(k) summary. For a blood glucose meter, the "ground truth" would typically come from a laboratory reference method (e.g., YSI analyzer), not expert human adjudication in the way it might for imaging.

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

   • This concept of "adjudication" is generally relevant for subjective assessments (like interpreting medical images). For a quantitative device like a blood glucose meter, the ground truth is established by a more accurate reference method, not by expert adjudication. Therefore, an adjudication method is not applicable and not mentioned.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is used for diagnostic imaging systems where human readers interpret cases, often with and without AI assistance, to measure the AI's impact on human performance. The Prodigy Blood Glucose Test System is a direct quantitative measurement device, not an image interpretation aid. Therefore, this question is not applicable to this device.

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

   • Yes, implicitly. A blood glucose meter inherently operates as a "standalone" algorithm/device in that it directly measures glucose and provides a numerical output without requiring human interpretation or decision-making in its core function. The "clinical and non-clinical testing data" mentioned refers to the performance of the device itself.

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

   • The document does not explicitly state the ground truth method. However, for blood glucose meters, the standard ground truth is typically a laboratory reference method (e.g., hexokinase method on a YSI analyzer or similar highly accurate laboratory instrument).

7. The sample size for the training set:

   • This information is not provided in the 510(k) summary. Given that this is a relatively older electrochemical biosensor, the concept of a "training set" for a machine learning algorithm in the modern sense (with large datasets) might not be directly applicable as it would be for AI/ML-driven devices. Device development often involves calibration data, but it's not usually referred to as a "training set" in this context or documented with specific sizes in 510(k) summaries.

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

   • As with the training set details, this is not explicitly provided and not typically detailed in 510(k) summaries for this type of device. If there was a "training" or calibration phase, the ground truth would likely have been established using a highly accurate laboratory reference method, similar to the test set.

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