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510(k) Data Aggregation
(97 days)
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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(110 days)
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.
Not Found
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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(311 days)
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.
Not Found
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:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- The type of ground truth used.
- 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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(365 days)
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:
| Acceptance Criteria | Reported Device Performance (from document) |
|---|---|
| Complete Dye Migration (Positive Result): Demonstrates proper sterilization conditions and proper vacuum when used in a pre-vacuum steam sterilizer. | The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. |
| Incomplete Dye Migration (Negative Result): Demonstrates inadequate vacuum resulting 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. | 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). |
| Validation Test Parameters: 134℃ for 3.5 minutes with a 2-minute dry time. | The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time. |
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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(96 days)
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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(288 days)
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
Not Found
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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(88 days)
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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(175 days)
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:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- 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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(105 days)
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.
| Performance Metric/Characteristic | Acceptance Criteria (Not explicitly quantified in text) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | (Implied: Meet design specifications)e.g., integrity of syringe, gasket fit, needle attachment. | Confirmed to meet design specifications during "evaluation of physical and functional characteristics." |
| Functional Characteristics | (Implied: Proper insulin delivery, no leakage, compatibility with DANA Diabecare® pumps) | Confirmed through "evaluation of physical and functional characteristics" to function as an insulin reservoir for DANA Diabecare® Insulin Pumps. |
| Shelf-life | (Implied: Maintain integrity and function for claimed shelf-life duration) | "Support the claimed shelf life." (Specific duration not provided in this snippet). |
| Sterility Status | Supplied Sterile | "Supplied sterile" |
| Single Use | Designed for single use | "Single use" |
| Capacity | 3ml syringe 300 unit capacity | "3 ml syringe" "300 unit capacity" |
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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(112 days)
The DANA Diabecare® IIS is an external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products.
The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.
The DANA Diabecare® IIS insulin pump is a modification of the device described in K022317, the DANA Diabecare® II Insulin Pump.
The DANA Diabecare® IIS insulin pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The DANA Diabecare® IIS insulin pump has two insulin delivery modes, the basal infusion rate and meal bolus injections. The user can program up to 24 basal infusion dosages in one-hour increments and three bolus injections daily. The basal infusion rate can be temporarily increased or reduced to accommodate changes in activity levels.
The DANA Diabecare® IIS insulin pump is battery powered, water resistant, compact, and lightweight. The pump is equipped with safety systems, acoustic signals, and an LCD display that reads "SE" for a system error. The data that can be stored and retrieved from the DANA Diabecare® IIS insulin pump software includes the following: 100 alarms, 500 bolus doses, 500 daily insulin dosages, and 500 prime histories. The pump also has an error log.
DANA Diabecare® IIS is intended to be used with a proprietary insulin reservoir and the infusion set. The insulin reservoir is a 3mL plastic syringe with a 300-unit insulin capacity. Accessories for the device include the SUPERLINE, SUPERLINE-Easy Release, Soft-Release-R and Soft-Release-ST, which are identical to those included with the DANA Diabecare® II Insulin Pump, and consist of a 55cm/(70cm)/110cm length of tubing with a luer-lock connector on the proximal end for attachment to the insulin syringe and a 27G needle on the distal end. Additional accessories necessary for operation and maintenance of the pump, syringe, and infusion set are provided with the DANA Diabecare® IIS pump.
The provided document is a 510(k) summary for the DANA Diabecare® IIS Insulin Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that are typically found in studies for diagnostic or AI-driven medical devices.
Instead, the "Performance Testing" section states: "Module and system verification and validation testing was performed on the modified software for the DANA Diabecare® IIS insulin pump. The verification and validation testing confirmed that all new and modified subroutines performed as designed and conformed to the software requirement specifications. The modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump. A risk analysis was also performed in accordance with the requirements of Medical Device Directive 93/42/EEC and ISO 14971 which confirmed that the modified DANA Diabecare® IIS insulin pump is safe and effective for its intended use for the subcutaneous delivery of insulin for the treatment of diabetes mellitus."
This indicates that the "acceptance criteria" were related to software requirements and safety standards, not statistical performance metrics against a medical ground truth in the way a diagnostic AI would be evaluated. The "study" mentioned is the internal verification and validation testing and risk analysis, which confirmed compliance with these engineering and regulatory standards.
Therefore, many of the requested elements for a deep learning/AI device evaluation cannot be extracted from this document because it describes an insulin pump, not an AI or diagnostic tool.
Here's a breakdown of the information that can be extracted and an explanation for why other requested information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from text) | Reported Device Performance (Implied from text) |
|---|---|
| New and modified software subroutines perform as designed. | Confirmed: All new and modified subroutines performed as designed. |
| Software conforms to specifications. | Confirmed: Software conformed to the software requirement specifications. |
| Software is safe and effective for controlling and monitoring the pump. | Confirmed: Modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump. |
| Device complies with risk analysis requirements (e.g., ISO 14971, MDD 93/42/EEC). | Confirmed: Risk analysis performed, confirming safety and effectiveness for intended use. |
| Device maintains substantial equivalence to predicate device. | Confirmed by FDA 510(k) clearance (K063126). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This device is an insulin pump, not a diagnostic AI system that uses patient data for a "test set" in the common AI sense. The "verification and validation testing" would have involved internal software testing and hardware testing, not a clinical study on a patient test set in the same way.
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)
- Not Applicable / Not Provided: Ground truth in the context of an insulin pump's software validation would relate to whether the code executed correctly and met specifications, not to clinical diagnoses requiring expert medical review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: As above, this concept does not apply to the software verification and validation of an insulin pump.
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
- No: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: The device is an insulin pump; its function is to deliver insulin, not to provide an algorithm-only diagnostic output. Its performance is inherent in its operation, which is always with a human user in the loop providing inputs and monitoring. The "algorithm" here refers to the pump's control software, not a diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Software Requirements Specifications / Engineering Standards: The "ground truth" for the performance testing of the pump's software would have been the predefined requirements and specifications outlined during its development, as well as relevant safety and performance standards (e.g., ISO 14971, Medical Device Directive 93/42/EEC).
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI system that undergoes "training" on a data set. Its software is programmed and validated.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As above, the concept of a training set and its ground truth does not apply to this type of device.
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