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DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress).

DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.

DANA is a mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments to aid in the assessment of an individual's medical or psychological state. DANA results should be interpreted only by qualified professionals.

DANA was developed on a mobile platform to improve the access and availability of reaction time tests and standardized health assessments through (1) custom configuration of the system by clinicians based on their need and discretion; and (2) allowing for objective health assessments both in-clinic and out-of-clinic settings.

The provided document is a 510(k) summary for the DANA device, an unclassified mobile-based task performance recorder. It compares DANA to a predicate device (QbTest) and mentions software testing, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall for diagnostic devices, or specific reaction time performance metrics like mean, standard deviation, error rate, etc.).
• Details on sample size for a test set, data provenance, ground truth establishment for a test set, or adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance studies.
• Details on sample size for the training set or how ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to the predicate device based on intended use and technological characteristics, and mentions general software testing.

Given the limitations of the provided text, I will answer the questions to the best of my ability, indicating where information is not present.

Acceptance Criteria and Study Details for DANA Device

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

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics for the DANA device (e.g., accuracy of reaction time measurement, consistency, precision, etc.). The 510(k) summary states that "Differences in the design and performance of DANA from the QbTest do not affect either the safety or effectiveness of DANA for its intended use," which is a high-level statement for substantial equivalence, but it does not quantify performance.

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

The document does not specify a sample size for a "test set" or provide details on data provenance (country of origin, retrospective/prospective study design). The summary mentions "Software testing was conducted in accordance with FDA's May 2005 guidance document," which relates to software validation rather than clinical performance testing with a specific test set.

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)

The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The DANA device is described as providing "objective measurements of reaction time (speed and accuracy)" and scoring "standardized psychological questionnaires." These types of measurements typically rely on predefined algorithms and the user's interaction directly with the device, rather than subjective expert interpretation for ground truth. The interpretation of DANA results is specified to be done by "qualified professionals," but this is about result usage, not ground truth establishment for performance validation of the device itself.

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

The document does not describe any adjudication method as no specific test set requiring such expert adjudication is detailed.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The DANA device provides objective measurements and scores questionnaires, it is not described as an AI-driven assistive tool for human readers in a diagnostic context that would typically warrant an MRMC study to measure improvement with AI assistance.

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

The document describes DANA as a "mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments." This implies a standalone (algorithm-only) performance in terms of generating these raw measurements and scores. The device takes inputs (user interactions) and produces outputs (reaction time data, questionnaire scores) without a specific "human-in-the-loop" component in the measurement generation process itself, though human interpretation of the results is required. However, no specific "standalone study" with detailed metrics is described.

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

The document does not explicitly state the type of ground truth used for validating the device's performance because the nature of the device (measuring reaction time and scoring questionnaires) implies that its "ground truth" relates to the accuracy and reliability of its internal clock, input detection, and scoring algorithms, rather than a diagnostic 'truth' like pathology. For reaction time, the ground truth would be the actual time elapsed between stimulus and response, measured by highly accurate timing mechanisms. For questionnaires, the ground truth would be the correct application of the scoring rules. No validation study details are provided to elaborate on how these internal "ground truths" were confirmed.

8. The sample size for the training set

The document does not mention a training set sample size. AI/ML software often uses training sets, but the description of DANA focuses on objective measurement and standardized questionnaire scoring, which may not heavily rely on complex supervised machine learning models requiring large labeled training sets in the same way an image recognition AI would. The software testing mentioned is more likely related to functional and performance testing against specifications rather than AI model training.

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

Since no training set is mentioned (see point 8), the document does not provide information on how ground truth for a training set was established.

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Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Dana Reusable Test Pack." It primarily discusses regulatory compliance and does not contain scientific study details, acceptance criteria, or performance data beyond the statement of substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided document. The document confirms that the device is cleared for marketing based on substantial equivalence, but it does not include the specifics of performance metrics, study designs, sample sizes, or ground truth establishment that would typically be found in a study report.

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Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Dana Reusable Test Pack." While it states the intended use and regulation information, it does not contain the detailed acceptance criteria or a study that proves the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
5. Information about standalone algorithm performance.
6. The type of ground truth used.
7. Training set sample size or how its ground truth was established.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance, but it does not provide the underlying performance study details that would typically include acceptance criteria and specific performance metrics.

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The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators". This document typically outlines the FDA's decision on substantial equivalence based on data submitted by the manufacturer. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study results.

The document states:

• Device Name: Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators
• Intended Use: For testing the air removal efficiency of pre-vacuum steam sterilizers.
• Performance Claim: The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window).
• Test Parameters for Validation: 134℃ for 3.5 minutes with a 2-minute dry time.

Based on the information provided in the given document, I cannot provide a complete answer to your request. The document is a regulatory approval letter, not a detailed scientific study report. It states that the device is "substantially equivalent" to predicate devices, implying that testing was conducted, but it does not include the specifics of that testing.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided document):

• 2. Sample size used for the test set and the data provenance: Not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. The ground truth here is a physical condition (temperature difference, vacuum presence/absence) measured by instruments, not expert interpretation of an image or signal.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (ground truth is instrumental/physical).
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is a chemical indicator, not an AI or imaging device requiring human interpretation for its primary function.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone indicator. Its "performance" is whether the dye changes correctly. There's no AI algorithm or human-in-the-loop for its direct function.
• 7. The type of ground truth used: Based on the description, the ground truth is physical measurement of sterilization conditions, specifically the temperature difference in a standard test pack and the presence/absence of proper vacuum, conforming to ANSVAAMI/ISO 11140-5:2007 Standard. This is not expert consensus, pathology, or outcomes data in the traditional sense.
• 8. The sample size for the training set: Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model. The device's performance is based on its chemical and physical properties.
• 9. How the ground truth for the training set was established: Not applicable.

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Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum 4 minute steam sterilization cycles with the Dana Emulating Indicator cleared by FDA under K100891.

Reusable Integrator Test Pack for Dana Emulating Indicator.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Reusable Integrator Test Pack for Dana Emulating Indicator." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance. It is a regulatory clearance, not a scientific study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

To obtain this information, you would typically need to refer to the original 510(k) submission (K110253) made by Dana Products, Inc. to the FDA. Such submissions contain the technical data, study protocols, and results that demonstrate the device meets its intended performance and regulatory requirements. These documents are usually not publicly available in full detail through a simple clearance letter.

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The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.

Reusable Biological Indicator Test Pack for Steam Sterilization.

The provided document (K103321) is a 510(k) clearance letter from the FDA for a Reusable Biological Indicator Test Pack for Steam Sterilization. It indicates substantial equivalence to a predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a summary or report of a scientific study.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed technical report would be needed to answer these questions.

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Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature : 270°F (132°C) Time: 4 Minutes

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The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device called "Dana Emulating Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not present in the FDA letter. The letter only refers to "indications for use" as stated in the enclosure, but the details of performance criteria and actual test results are absent.
• Sample size and data provenance: Not mentioned.
• Number of experts and qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone performance: Not mentioned.
• Type of ground truth: Not mentioned.
• Sample size for training set: Not applicable for this type of device (it's a physical indicator, not an AI/software device).
• Ground truth for training set: Not applicable.

The "Indications for Use" section (page 2) describes what the device is intended to do and the specific parameters it's designed to monitor in a sterilization process:

Device Name: Dana Emulating Indicator

Indications For Use: "Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met."

Critical Parameters:

• Temperature: 270°F (132°C)
• Time: 4 Minutes

While these are the conditions the device is designed to indicate, the document does not provide the specific performance acceptance criteria (e.g., how accurate is the "dark bar travel" or what tolerance it has) nor does it provide a study report demonstrating its performance against such criteria. This kind of detail would typically be found in the actual 510(k) submission document or a separate test report, not in the FDA's decision letter.

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Dana reusable challenge test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SteriScan Integrators.

Reusable SteriScan Integrator Test Pack for Steam

This document is a 510(k) clearance letter from the FDA for a medical device (Reusable SteriScan Integrator Test Pack for Steam Sterilization). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria. The FDA determined that the new device is as safe and effective as a legally marketed predicate device, therefore a detailed performance study as you've requested is typically not included or required for a 510(k) clearance.

Therefore, I cannot provide the requested information from the given input.

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Dana reusable test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with 3M's 1292 Rapid Readout Biological Indicators along with or without SteriScan Integrators.

Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization.

Unfortunately, the provided document is a letter from the FDA regarding a 510(k) clearance for a Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization. It confirms substantial equivalence to a predicate device and provides information on regulatory compliance.

However, the document does not contain any information about the acceptance criteria and the study that proves the device meets those criteria. Specifically, the request asks for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance study details
7. Type of ground truth used
8. Sample size for the training set
9. How training set ground truth was established

None of this information is present in the provided text. To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or similar technical documentation that details the testing performed for the device.

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The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets.

The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps are external programmable syringe infusion pumps used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.

The DANA 3cc Syringe Insulin Reservoir is a sterile, single-use, non-pyrogenic, syringe that is designed for use with all versions of the DANA Diabcare® Insulin pump that have been cleared for marketing in the U.S. (K001604, K022317, and K063126). The syringe reservoir is a 3 ml polypropylene syringe with a 300 unit insulin capacity that is supplied with a 22 gauge, 12.7 mm straight needle. The reservoir is filled similarly to filling an insulin syringe. Once filled and inspected for entrapped air, the needle is removed and the syringe reservoir is inserted into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin pump. The syringe has groves cut into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin Pump.

The proposed DANA 3cc Syringe Insulin Reservoir is a modification of the insulin reservoir accessory described in K001604, the original 510(k) premarket notification for the DANA Diabecare® Insulin Pump. The modification was limited to a change in the gasket configuration and material. The proposed DANA 3cc Syringe Insulin Reservoir has a ring shape gasket that is manufactured from silicone.

The provided text describes a 510(k) submission for the DANA 3cc Syringe Insulin Reservoir, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not explicitly detail specific, quantified acceptance criteria or a comprehensive study report with detailed methodologies and results as one might expect from a formal performance study section.

Based on the provided information, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantified acceptance criteria with pass/fail thresholds for specific performance metrics. Instead, it broadly states that "Design verification activities... included evaluation of physical and functional characteristics, and shelf-life testing. The results confirm that the DANA 3cc Syringe Insulin Reservoir showing to may insulin reservoir for all legally marketed versions of the DANA Diabecare® Insulin Pumps and support the claimed shelf life."

This indicates that the device met internal performance standards, but those specific standards and their numerical results are not provided in this summary. The "Comparison Chart for Determination of Substantial Equivalence" focuses on shared design features rather than performance metrics.

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

The document does not provide specific details on the sample sizes used for the design verification tests (physical, functional, shelf-life). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). The tests were conducted internally by Sooil Development Co., Ltd. as part of their "Design verification activities."

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

This type of information is not applicable and not provided in the context of this device. The "ground truth" for an insulin reservoir's performance would typically be established through engineering tests measuring physical and functional attributes against predefined specifications, rather than expert consensus on subjective assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment where discrepancies need resolution, such as in image analysis or clinical trials. Performance testing for a medical device like an insulin reservoir involves objective measurements, not human adjudication of subjective data.

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

No. An MRMC study is not relevant for this type of device. MRMC studies are used to evaluate the diagnostic performance of human readers (e.g., radiologists) in interpreting medical images, often comparing performance with and without AI assistance. This device is an insulin reservoir, not a diagnostic imaging AI.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a "standalone" performance evaluation was conducted in the sense that the device's physical and functional characteristics were tested independently. The "Design verification activities" were focused on the device itself. While the device is an accessory intended for human use with an insulin pump, the performance reported here is of the reservoir itself, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing would be established by predefined engineering specifications, design requirements, and recognized industry standards for insulin delivery devices and sterile medical components. For example, a "ground truth" for capacity would be 300 units as measured by calibrated equipment, or for sterility, it would be the absence of microbial growth as per validated sterilization methods.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (an insulin reservoir), not an AI algorithm or a diagnostic tool that requires a "training set" of data in the machine learning sense.

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

Not applicable, as there is no training set for this type of device.

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