Search Results

For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The provided text is a 510(k) summary for the ALEVE® Direct Therapy® medical device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Based on the provided document, the device is a TENS unit, and the acceptance criteria and study proving it meets these criteria are related to its safety and performance based on engineering and laboratory testing, rather than clinical efficacy studies for AI/ML performance.

Therefore, I cannot provide information on AI/ML specific criteria such as:

• A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets in an AI/ML context.
• Number of experts and their qualifications for ground truth establishment for an AI/ML test set.
• Adjudication methods for an AI/ML test set.
• MRMC comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used in an AI/ML context.
• Sample size for a training set (AI/ML).
• How ground truth for a training set was established (AI/ML).

Here's a breakdown of what can be extracted from the document regarding the device's acceptance criteria and the study that proves it meets them, framed in the context of a medical device submission (Premarket Notification 510(k)) that relies on substantial equivalence to predicate devices:

Device: ALEVE® Direct Therapy® (Second Generation) - Transcutaneous Electrical Nerve Stimulator (TENS) for Pain Relief

1. Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing):

The document does not present a formal table of explicit acceptance criteria with numerical performance targets for a new device. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicates through a series of non-clinical tests and shows comparable technological characteristics.

• Unit level testing
• System testing
• Software verification and validation |
  | Usability Engineering | Testing performed and results contributed to meeting established specifications. |
  | Biocompatibility | Met requirements per ISO 10993-1. |
  | Electrical Safety | IEC 60601-1:2005 Ed. 3 + C1:2009 + A1:2012 (FDA Recognition Number 19-4) compliant. |
  | Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 Ed. 4 (FDA Recognition 19-8) compliant. |
  | Home Healthcare Environment | IEC 60601-1-11 Edition 2.0 2015-01 (FDA Recognition Number 19-14) compliant. |
  | TENS Specific Safety | IEC 60601-2-10 Edition 2.0 2012.06 (FDA Recognition Number 17-11) compliant. |
  | Risk Management | ISO 14971 Second edition 2007-03-01 (FDA Recognition Number 5-40) compliant. |
  | Software Life Cycle Processes | IEC 62304 Edition 1.1 2015-06 (FDA Recognition Number 13-79) compliant. |
  | Chemical Characterization (Materials) | AAMI/ANSI/ISO 10993-10:2010 (FDA Recognition Number 2-173) compliant (implied by biocompatibility). |

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

• Sample Size: The document does not specify a "sample size" in the conventional sense of a clinical trial or a machine learning test set. The validation is based on non-clinical bench and safety testing of the device itself (e.g., electrical safety, software validation, biocompatibility), not a dataset of patient data or clinical images. Therefore, the "test set" would refer to the physical units of the device tested in the laboratory. The document does not specify how many units were tested.
• Data Provenance: Not applicable in the context of patient data. The data provenance is from laboratory testing performed by the manufacturer, Bayer HealthCare LLC. The document does not specify the country where these tests were conducted, but the company is based in Whippany, New Jersey, USA. The testing is retrospectively reported as part of the 510(k) submission.

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

• Not applicable. Ground truth for a TENS device's safety and performance in the context of a 510(k) is established through adherence to recognized international and national standards (e.g., IEC, ISO, ANSI/AAMI) verified by laboratory testing, not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set:

• Not applicable. There is no human adjudication process involved in verifying the compliance of a TENS device with electrical safety, EMC, or biocompatibility standards.

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

• No. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a therapeutic TENS unit.

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

• Not applicable in the context of an AI/ML algorithm. The "standalone" performance here refers to the device's ability to operate according to its specifications (e.g., output electrical pulses within specified parameters) without human intervention during its operational cycle, which is verified through bench testing. The mobile app controls the device, but the "performance" validated is of the TENS output, not the app's diagnostic or interpretive capabilities.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is its compliance with pre-defined technical specifications, safety standards, and performance characteristics as demonstrated through non-clinical bench testing, software verification/validation, and adherence to recognized standards (e.g., electrical safety, EMC, biocompatibility, risk management). It is essentially engineering and regulatory standard compliance.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Not applicable. As above, this is not an AI/ML device.

Ask a specific question about this device

Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back.

The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.

This document is a 510(k) summary for the ALEVE Direct Therapy TENS device, claiming substantial equivalence to a predicate device (Pain Pilot™ / WiTouch® K120500). As such, it focuses on demonstrating similarity rather than presenting a detailed de novo study with specific acceptance criteria and performance against those criteria in the way a novel device might.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for the device's clinical performance (e.g., pain reduction scores). Instead, it relies on demonstrating substantial equivalence to a predicate device, meaning its performance is expected to be similar or identical.

The performance data primarily focuses on engineering and safety standards, and a single usability study.

• ISO 14971:2007 (risk management)
• AAMI/ANSI ES60601-1:2005/(R)2012 (general basic safety and essential performance)
• IEC 60601-1-2 Ed 4.0 2014-02 (EMC)
• IEC 60601-1-11 Ed 1.0 2010-04 (home healthcare environment)
• IEC 60601-2-10 Ed 2.0 2012-06 (nerve and muscle stimulators) |
  | Biocompatibility Standards Compliance | Conformance with ISO standards:
• AAMI/ANSI/ISO 10993-1:2009/(R) 2013 (biological evaluation, risk management)
• AAMI/ANSI/ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity)
• AAMI/ANSI/ISO 10993-10:2010 (irritation and skin sensitization)
  (Note: The document states "The safety of this colorant has been demonstrated (Section 12, Biocompatibility).") |
  | Software Verification and Validation (Moderate Level Concern) | Software verification and validation testing conducted, documentation provided in accordance with FDA's guidance for "Moderate level concern device." |
  | Device Output Characteristics | Data in support of the device waveform and verification of output characteristics provided. (The specific characteristics are listed in the "Basic Unit Characteristics Comparison" table on page 5, which are all "IDENTICAL" or "Substantially Equivalent" to the predicate, implying conformity to the predicate's established performance). |
  | Usability | A 15-subject usability study was conducted for the predicate device (K120500) and reported to the FDA. The submitter (Bayer HealthCare, LLC) references this study due to the devices and labeling being "sufficiently similar." This implies the predicate device met usability criteria, and by extension, the new device is considered to meet them. |
  | Substantial Equivalence | The overall acceptance criterion is "substantial equivalence" to the predicate device (Pain Pilot™ / WiTouch® K120500). The document concludes: "The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided in the 510(k) submission is sufficient to demonstrate substantial equivalence to the predicate device. As the ALEVE Direct Therapy TENS device is nearly identical to the predicate device, with identical indications for use and essentially identical technological characteristics, the ALEVE Direct Therapy TENS device is substantially equivalent to the predicate device." |

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

• Test Set Sample Size:
  • For the usability study (which is the only human-based performance data mentioned), the sample size was 15 subjects.
  • No other human clinical "test set" data is explicitly described for performance on the primary indication (pain relief). The submission relies on the predicate device's established effectiveness.
• Data Provenance: The usability study was conducted by Hollywog (the original manufacturer of the predicate device). The document doesn't specify the country of origin for this study, nor does it explicitly state if it was retrospective or prospective, though usability studies are typically prospective.

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. This device is a TENS unit for pain relief, not an AI/imaging diagnostic device. Ground truth, in the sense of expert annotation, is not relevant to the usability study or the engineering/safety tests described. Pain relief, if directly measured in a clinical trial, would typically rely on patient-reported outcomes, not expert-established ground truth.

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

Not applicable, as described in point 3.

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

Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (TENS unit), not a software algorithm or AI.

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

For the usability study, the "ground truth" would be the direct experience and feedback of the 15 subjects regarding the device's ease of use and functionality. For the safety and engineering tests, the "ground truth" is compliance with recognized standards or objective measurements of electrical characteristics. For the primary indication (pain relief), the justification relies on the predicate device's established clinical effectiveness, which would have been based on patient outcomes data (e.g., pain scores) in its original approval.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Not applicable, as described in point 8.

Ask a specific question about this device

The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole patient use only, and should not be shared.

The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.

The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System.

The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

Here's a breakdown of the acceptance criteria and study information for the Contour Next EZ Blood Glucose Meter (K130265):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Contour Next EZ Blood Glucose Monitoring System are based on ISO 15197:2003 standards for accuracy, repeatability, linearity, and intermediate precision. The provided document details the performance of the Contour Plus System as a proxy for the Contour Next EZ system, along with specific additional testing for the modified Contour Next EZ meter.

Ask a specific question about this device

The CONTOUR®NEXT Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only.

CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR®NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR® NEXT Blood Glucose Monitoring System consists of a small handheld blood glucose meter that utilizes dry reagent test strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. The meter together with the test strips and control solutions is referred to as the CONTOUR® NEXT Blood Glucose Monitoring System.

The CONTOUR® NEXT Blood Glucose Monitoring System underwent various verification and validation activities to demonstrate its substantial equivalence to the predicate device. Details regarding acceptance criteria and study results are provided below based on the information extracted:

Acceptance Criteria and Device Performance

• Meter shall not experience permanent damage or present hazard such as excessive temperature or heat due to overvoltage. | - All blood glucose tests attempted while connected to PC generated "Do not Test, Connected" error screen.
• All results maintained correct voltage regulation within limits and did not present temperature hazard near or above the specified limit. |
  | Biocontamination – exposure to blood-borne pathogens via device | - Must meet requirements set forth in IEC 61010-1:2001 (2nd Edition).
• No residual blood or control solution to be observed on any of the meters after cleaning.
• No virus must be detected on any surface after 60s of cleaning with specified wipes. | - Compliance with IEC 61010-1:2001 requirements confirmed via testing by an external lab.
• There was no residual blood or control solution observed on any of the meters after soiling and cleaning.
• The specified disinfectant passed the virus elimination effectiveness test for all tested meter device surfaces. |
  | Material degradation due to cleaning and disinfection | - Plastic parts were not to exhibit any cracking, glazing, discoloration or expansion after being exposed to cleaning agents.
• Metallic parts were to exhibit little or no corrosion (evaluated as low, medium, or high). | - All results for plastic and metallic parts met the specified criteria for each solution tested. |
  | Choking/toxicity dangers from small parts (batteries) | - Reagent insert shall warn users of accidental swallowing of test strip.
• User Guide shall warn users of accidental swallowing of assembly components.
• Assembly components are not required to be unscrewed for any reason.
• Design will utilize a non-ordinary screw and require uncommon tools to remove. | - Test strip insert already warns against swallowing test strips.
• System User Guide warns: "Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed." and "Keep batteries away from children. Lithium batteries are poisonous. If swallowed, immediately contact your poison..."
• Device designed so that no hazardous assembly parts are easily accessible to user. |
  | Meter malfunction - incorrect reading or does not function properly | - The accuracy of the test strip driving voltage of the Analog Front End at operating temperature range shall be assessed under various test temperatures.
• The CONTOUR®NEXT meter data port shall withstand multiple cycles (insertions/removals).
• The meter shall perform an electronics self test to verify proper function of the meter electronics. | - All results for each test temperature were within the required mV range set forth in the testing.
• All results for the meter data port were within the specified limits after multiple test strip insertion/removal cycles.
• All software test conditions in validation testing passed acceptance criteria. |
  | Erroneous data transfer from meter to PC | - The CONTOUR®NEXT meter's computer interface shall detect and correct communication errors. | - All software test conditions in validation testing passed acceptance criteria. |
  | User unable to properly use meter or follow its instructions for use | - Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result. | - Completing initial setup task was successful.
• Study subjects successfully completed a mock blood glucose test and marked the reading. |
  | User misinterprets meter readings | - Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result. | - Completing initial setup task was successful.
• Study subjects successfully completed a mock blood glucose test and marked the reading. |
  | User mishandles meter (i.e., drops meter, spills liquid on meter) | - Meter must be designed to withstand drop and show no signs of damage to any components.
• Meter must also be designed to withstand Spill Test after exposure to various test solutions. | - All results withstood the stated Drop test and Spill challenges. |

Study Details

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

   • Biocontamination: "One set of meters were soiled with CONTOUR®NEXT liquid control and another set of meters were soiled with 5 uL of venous blood." "Test meters received contact with an EPA-approved surrogate for a human virus for 24 hours on various test surfaces." The exact number of meters in each set is not specified.
   • Usability Study: The document refers to a "customer focus study (summative usability study)" but does not specify the number of participants.
   • Other tests: For other technical performance tests (e.g., electrical safety, material degradation, meter malfunction, data transfer, drop/spill), the sample size of meters or components tested is not explicitly stated, but the results indicate "All results" for the tested items met criteria.
   • Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The studies appear to be internal verification and validation tests conducted by the manufacturer as part of the device development and submission process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are engineering and usability focused, not involving expert interpretation of medical images or diagnostic results. The "ground truth" for these tests are objective engineering specifications or direct observation of user behavior (for usability).

3. Adjudication method for the test set: Not applicable. The tests performed are objective, involving mechanical stress, electrical measurement, or direct observation of adherence to instructions. There is no mention of a need for adjudication.

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: Not applicable. This device is a blood glucose monitoring system, not an AI-based diagnostic imaging tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its glucose measurement algorithm. The various tests described assess the device's standalone performance across different parameters (electrical, mechanical, software, etc.). The usability studies indirectly evaluate human-in-the-loop performance in terms of whether users can operate the device correctly.

6. The type of ground truth used:

   • Objective Engineering Specifications: For risks like electric shock, material degradation, meter malfunction, erroneous data transfer, and user mishandling, "ground truth" is defined by established engineering standards (e.g., IEC 61010-1:2001, specified mV ranges, withstand limits for drop/spill).
   • Direct Observation/Absence of Failure: For biocontamination, the ground truth is the absence of observed residual blood/control solution or detected virus.
   • Successful Task Completion: For user inability to use the meter or misinterpreting readings, the ground truth is the successful completion of specific tasks by study participants as observed in the usability study.

7. The sample size for the training set: Not applicable based on the provided document. The document describes validation and verification studies for a medical device (blood glucose meter), not an AI algorithm requiring a training set. The device utilizes a "blood glucose measurement algorithm and automatic calibration," but details about the development or training of this algorithm are not provided in this 510(k) summary.

8. How the ground truth for the training set was established: Not applicable, as no training set for an AI algorithm is described.

Ask a specific question about this device

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only.

CONTOUR® test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication.

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR LINK Wireless Blood Glucose Monitoring System features the CONTOUR LINK Wireless Blood Glucose Monitor and the currently marketed CONTOUR Blood Glucose Test Strips, among other components (e.g., lancing device, lancets and control solution)

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Repeatability Test: 10 meters, 10 replicates per meter. Total n=100.
  • Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
• Intermediate Precision Test: 10 meters tested over 10 days, one measurement per meter per lot per control solution per day.
  • Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
• System Accuracy Evaluation (ISO 15197): 100 fresh capillary blood samples tested using 2 test strip lots on 2 CONTOUR LINK meters. Total of 400 readings.
  • Data Provenance: Fresh capillary blood samples (prospective). Country of origin not specified, but typically conducted in the submitting company's R&D facilities or contracted labs.
• Linearity/Assay Reportable Range (Predicate K062058 data cited):
  • Study 1: Blood with 40% hematocrit, 5 glucose concentrations, 3 CONTOUR lots, 24 sensors per lot.
  • Study 2: 8 meters, 3 sensors per lot tested on each.
  • Data Provenance: Unspecified, but derived from the predicate device's 510(k) submission (K062058), so likely both in-house lab testing (prospective) and potentially some clinical data.
• Detection Limit: 3 production lots of CONTOUR sensors, 24 sensors per sample for manipulated blood samples.
  • Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
• Analytical Specificity (Interferences): Not explicitly stated how many samples or replicates were performed for each compound.
  • Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
• Method Comparison with Predicate Device (Linearity/Assay Reportable Range comparison): 444 paired readings collected.
  • Data Provenance: Fresh venous blood; likely prospective in-house lab testing.
• Method Comparison with Predicate Device (CONTOUR LINK vs. CONTOUR meters): 111 subjects (fingerstick study). Two lots of CONTOUR sensors, four CONTOUR meters. RF function of CONTOUR LINK left on.
  • Data Provenance: Fresh capillary blood samples from 111 subjects. Likely prospective clinical or usability study. Country unspecified.
• Clinical Study (Usability and Accuracy - New Device): 77 adults.
  • Data Provenance: Adults aged 20-85 (fresh capillary blood, self-test and HCP-test results). Likely prospective clinical or usability study. Country unspecified.
• Clinical Study (Usability and Accuracy - Predicate K062058 cited): 109 adults.
  • Data Provenance: Adults aged 20-75 (self-testing). Derived from predicate device's 510(k) submission (K062058). Likely prospective clinical or usability study. Country unspecified.

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

• No human experts were used for establishing ground truth. The ground truth in these studies was established using a high-precision laboratory reference method.

4. Adjudication Method for the Test Set

• Not applicable. Since the ground truth was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer) rather than human experts, there was no need for an adjudication method.

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

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers (interpreting images/cases) with and without AI assistance. This device is a blood glucose meter, and its performance is assessed against a laboratory reference standard, not against human interpretation of images.
• A comparative performance study was done between the new device (CONTOUR LINK) and the predicate device (CONTOUR) using blood samples, showing equivalence.

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

• Yes, the device's accuracy tests (Precision, System Accuracy, Linearity, Detection Limit, Analytical Specificity) represent standalone performance, as these evaluate the device's ability to measure glucose values compared to a reference method, without human intervention in the measurement process itself beyond standard operation. The clinical study also included "HCP-test results" which implies professional use, which would also be standalone.
• The clinical usability studies involved human users (self-testers and HCPs) operating the device, but the accuracy assessment within these studies is still primarily evaluating the device's standalone measurement capability under real-world usage conditions.

7. The Type of Ground Truth Used

• Laboratory Reference Method: The primary and most frequently cited ground truth was the YSI 2300 STAT PLUS glucose analyzer.
• Traceability: The YSI analyzer is traceable to the hexokinase method, which was developed collaboratively by the FDA, CDC, NIST, and AACC. This method utilizes NIST Standard Reference Material 917, dry D-glucose.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. Blood glucose meters typically do not involve "training sets" in the same way AI algorithms do unless specific machine learning components are involved (which is not described here). The development and calibration of such devices usually rely on extensive internal R&D test data and validated chemical/electrical principles, rather than a publicly reported "training set."

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

• As the document does not explicitly mention a training set in the context of an AI/ML model, it also does not describe how ground truth for such a set was established. Device calibration and internal validation would rely on the same laboratory reference methods described for the performance studies (e.g., YSI 2300 STAT PLUS traceable to hexokinase method).

Ask a specific question about this device

DIDGET® World Reports Diabetes Management Software is an over-the-counter software program for use by healthcare professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Bayer's DIDGET® blood glucose meter.

This software application allows the transfer of blood glucose results, along with time, date, and certain data markers, from Bayer's DIDGET® blood glucose meter to the DIDGET®World Reports web server through the use of a USB cable. Data analysis includes allowing the home-user or healthcare professional to view the data in five different ways:
Electronic logbook where all of the data can be seen
Glucose trend of the results by date
Daily blood glucose trend (standard day)
Weekly blood glucose trend (standard week)
Summary chart (histogram or pie chart)

The DIDGET® World Reports Diabetes Management Software is a diabetes data management software program. The performance assessment focused on its ease of use and understandability of results.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Fifty (50) subjects.
  • 3 healthcare professionals (HCPs)
  • 47 lay users (35 young adults with diabetes and 12 parents or legal guardians of children with diabetes).
• Data Provenance: The document does not specify the country of origin. The study was a "Performance Assessment," implying it was a prospective study designed specifically to evaluate this software.

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

This device is software for viewing and printing blood sugar readings. The performance assessment was about usability and understandability rather than diagnostic accuracy against a "ground truth" established by experts in the typical clinical sense (e.g., radiologists interpreting images). The "ground truth" in this context was subjective user feedback on ease of use and understandability of the presented data. The study included 3 healthcare professionals, but their role was as participants providing feedback, not as independent adjudicators establishing a gold standard for the data.

4. Adjudication method for the test set:

Not applicable. The study assessed subjective user experience (ease of use and understandability) rather than objective clinical outcomes requiring adjudication.

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

Not applicable. This is a data management software, not an AI-powered diagnostic tool, and the study did not involve human readers interpreting cases or AI assistance for diagnosis.

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

The performance assessment focused on the human-in-the-loop experience (users interacting with the software). A standalone performance of the algorithm itself (e.g., data transfer accuracy, report generation accuracy) is implied by the "verification and validation studies" mentioned, but specific details of such standalone tests are not provided in this summary. The stated performance assessment is user-centric.

7. The type of ground truth used:

The "ground truth" for this performance study was subjective user feedback and experience regarding the software's ease of use and the understandability of its presented data.

8. The sample size for the training set:

Not applicable. This regulatory submission concerns a diabetes data management software. There is no mention of a machine learning or AI model being trained, thus no "training set" in that context. The software's functionality is based on displaying and organizing existing data, not on learning from data to make predictions or classifications.

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

Not applicable, as there is no training set for a machine learning model.

Ask a specific question about this device

The Didget blood glucose monitoring system (meter, strips, and controls) is intended for self-testing by people with diabetes to monitor glucose concentrations in fresh capillary whole blood samples drawn from the fingertip only. It is intended for those ages four and older, with adult supervision as needed. The Didget blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The Didget Blood Glucose Monitoring System consists of:

1. Didget Blood Glucose Monitor
2. Contour Blood Glucose Test Strips
3. Contour Control Solution

The provided text describes a 510(k) summary for the Didget Blood Glucose Monitoring System. It outlines the device, its intended use, and a performance assessment, but does not specify numerical acceptance criteria or detail the study results required to prove these criteria were met. The document states that "The studies showed equivalent performance with the current Contour system." and "The results of clinical evaluations... demonstrated that the device can produce blood glucose results that are substantially equivalent to results obtained on the predicate device." However, specific metrics, thresholds, and statistical analyses are not provided.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Note: The document does not provide specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) or the detailed numerical results from the Didget system's performance. It broadly states "equivalent performance".

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

• Sample Size for Test Set: Not specified. The document states "a clinical setting using persons with diabetes, ages 5 through 24," but does not give a number of participants.
• Data Provenance:
  • Country of origin of the data: Not specified.
  • Retrospective or prospective: Not specified, but "studied in the laboratory and in a clinical setting" suggests a prospective study.

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

• Not applicable. This study is for a blood glucose meter, which typically uses a highly accurate laboratory reference method (e.g., YSI analyzer) as the "ground truth" rather than expert interpretation of images or other data. The text mentions "compared to a laboratory method."

4. Adjudication method for the test set:

• Not applicable. (See point 3)

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 relevant to a blood glucose meter study. This type of study is typically done for diagnostic imaging or interpretation tasks involving human readers.

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

• Yes, effectively. The performance assessment of a blood glucose meter is inherently a standalone assessment of the device's accuracy against a reference method. The Didget system's performance was compared to the Contour system and "a laboratory method."

7. The type of ground truth used:

• Laboratory Method: The document states the results were "compared to... a laboratory method." This typically refers to a highly accurate and precise analytical instrument considered the gold standard for glucose measurement.

8. The sample size for the training set:

• Not applicable / Not specified. Blood glucose meters are not typically "trained" in the same way machine learning algorithms are. Their performance is based on the chemical and electrochemical reactions of the test strip and the meter's electronics.

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

• Not applicable / Not specified. (See point 8)

Ask a specific question about this device

The AlCNow multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbAIc, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.

The A1CNow+ tests provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used to monitor glycemic control in people with diabetes. A1cNow+ consists of 1) a semi-disposable plastic-encased device (the monitor), 2) a plastic cartridge enclosing dry reagent strips, and 3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge. When testing with A1CNow+, an unmeasured whole blood mixture (diluted) is directly applied to the sample port, and the results are displayed in numeric form on the Monitor's liquid crystal display after 5 minutes.

The provided text describes a 510(k) submission for a device modification (AlcNow® Multi-Use) and does not contain detailed acceptance criteria and performance data in a tabular format typically found in clinical study reports. It broadly states that the device is "safe and effective" and "substantially equivalent" to its predicate.

Based on the provided document, here's what can be extracted and what information is not available:

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

The document does not provide specific numerical acceptance criteria or detailed performance metrics. It generally states that "The performance was assessed in two separate clinical validation studies. The studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy."

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 the sample size used for the test set(s) or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions "two separate clinical validation studies."

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 provide information on the number or qualifications of experts used to establish ground truth.

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

The document does not describe any adjudication methods used for the test set.

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 device (A1CNow®) is a diagnostic assay for measuring glycated hemoglobin, not an AI-assisted imaging device or one involving "human readers" in the context of MRMC studies typical for image-based diagnostic aids. Therefore, an MRMC comparative effectiveness study, as described, is not applicable or mentioned for this device.

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

The A1CNow® device is an automated in vitro diagnostic device. Its performance is inherently "standalone" in that it directly measures %A1C from a blood sample. The "studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy" implies standalone performance evaluation of the device's accuracy and reliability. However, the document does not explicitly use the term "standalone performance study" in the context of algorithm-only performance. It notes that the product is "safe and effective in the hands of lay users and healthcare professionals," suggesting evaluation of its overall use, not just the technical core.

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

For an A1C measurement device, the "ground truth" would typically be established by a reference method for A1C measurement (e.g., HPLC methods that are traceable to the DCCT reference method) in a clinical laboratory. The document does not explicitly state how the ground truth was established, but this is the standard approach for such assays.

8. The sample size for the training set

The document does not mention the concept of a "training set" as it would apply to machine learning algorithms. This device is a biochemical assay, not an AI/ML-based diagnostic. Therefore, information on a "training set" is not relevant or provided.

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

As there is no mention of a "training set" for an AI/ML model, this information is not applicable or provided.

Summary of what is available vs. missing:

The provided text serves as a 510(k) summary for a device modification, focusing on establishing substantial equivalence. It describes the device, its intended use, and states that performance was assessed through clinical validation studies, concluding "no negative impact on product safety and efficacy" and "substantially equivalent." However, it lacks the detailed quantitative performance metrics, sample sizes, ground truth methodologies, and specific study designs that would typically constitute a comprehensive report of acceptance criteria and proven performance for a clinical study.

Ask a specific question about this device

GLUCOFACTS® Express Diabetes Management Software is an over-the-counter software program for use by health care professionals and patients with diabetes for transferring blood glucose data from a blood glucose meter to a personal computer for the purpose of viewing and printing reports that display blood glucose readings from Bayer's CONTOUR®, CONTOUR® TS, BREEZE®, and BREEZE®2 blood glucose meters.

GLUCOFACTS® Express Diabetes Management Software is an overthe-counter software program for use by persons with diabetes in the home and by healthcare professionals in healthcare facilities to assist with transferring blood glucose data from a blood glucose monitor to a personal computer to allow reviewing and analyzing the data to support effective diabetes management.

This software application allows the transfer of blood glucose results, along with time, date, and certain data markers, from a Bayer blood glucose meter to a personal computer through the use of a serial or USB cable. Data analysis includes allowing the home-user or healthcare professional to view the data in five different ways: 1. Electronic logbook where all of the data can be seen 2. Glucose trend of the results by date 3. Daily blood glucose trend (standard day) 4. Weekly blood glucose trend (standard week) 5. Summary chart (histogram or pie chart)

The provided text describes the 510(k) summary for the GLUCOFACTS® Express Data Management Software. This document focuses on establishing substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria or a comprehensive study design with technical performance metrics.

Therefore, much of the requested information (like specific quantitative acceptance criteria, detailed performance metrics, sample sizes for test and training sets, ground truth establishment methods in a technical sense, expert qualifications, adjudication methods, or MRMC studies) is not present in the provided text. The "Performance Assessment" section is qualitative and user-focused.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document emphasizes ease of use and understandability as the key performance indicators for this software. It does not provide numerical or statistical acceptance criteria typical for diagnostic devices (e.g., sensitivity, specificity, accuracy).

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

• Sample Size for the Test Set: 51 people
  • 43 lay users
  • 8 healthcare professionals
• Data Provenance (Country of Origin): Not specified.
• Retrospective or Prospective: Not specified, but given the nature of a user study assessing "ease of use" and "understandability," it would most likely be a prospective study where users interact with the software.

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

• Number of Experts: Not applicable in the context of this study. The "ground truth" for ease of use and understandability is derived from the users' experience and perceptions, not from expert consensus on a diagnostic outcome. The study involved 8 healthcare professionals, but their role was as study participants providing feedback, not as adjudicators establishing a "ground truth" for diagnostic accuracy.
• Qualifications of Experts: Not applicable for establishing ground truth. The 8 healthcare professionals were participants, but their specific qualifications beyond being "healthcare professionals" are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a user-focused study assessing subjective metrics (ease of use, understandability), not a diagnostic performance study requiring adjudication of results against a reference standard.

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

• MRMC Study Done: No. The text does not describe an MRMC study. The study focused on user experience with the software itself, not on comparing human reader performance with or without AI assistance for a diagnostic task.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed.

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

• Standalone Study Done: Yes, in a sense. The software itself is the "device," and its standalone performance (ease of use, understandability of reports) was assessed by users interacting directly with it. However, this is not a "standalone performance" in the typical diagnostic AI context, which would involve algorithmic accuracy against a ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: User feedback and perception regarding "ease of use" and "understandability" served as the primary "ground truth" for this software's performance assessment. It did not involve expert consensus, pathology, or outcomes data in the traditional sense for diagnostic accuracy.

8. Sample Size for the Training Set

• Sample Size for the Training Set: Not applicable. This software is described as a "data management software program" that allows "viewing and printing reports." It is not an AI/ML model that would typically have a "training set" in the context of learning patterns for prediction or diagnosis.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set or an AI/ML model being trained.

Ask a specific question about this device

For in vitro diagnostic use in the quantitative determination of total billrubin in human serum and plasma on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.

The ADVIA Chemistry Total Bilirubin_2 is used for the in vitro quantitative determination of total bilirubin in human serum and plasma on the ADVIA® Chemistry Systems. The proposed labeling indicates the ADVIA Chemistry Total Bilirubin_2 reagents can be used on the ADVIA Chemistry Systems 1650, 1800, 2400, and 1200. The Total Bilirubin_2 assay is based on a chemical oxidation method, utilizing vanadate as the oxidizing agent. Total bilirubin (conjugated and unconjugated) is oxidized by vanadate at about pH 2.9 to produce biliverdin. In the presence of detergent and vanadate, both conjugated and unconjugated bilirubin are oxidized. This oxidation causes a decrease in optical density of the yellow color, which is specific to bilirubin. The decrease in optical density at 451/545 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.

Here's an analysis of the provided 510(k) summary regarding the ADVIA® Chemistry Total Bilirubin_2 device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state formal "acceptance criteria" in terms of pre-defined thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to a predicate device (ADVIA® IMS Total Bilirubin) by comparing performance characteristics. The implied acceptance criterion is that the new device's performance is comparable to or better than the predicate device's performance, and within generally accepted analytical standards for clinical laboratory assays.

2. Sample Size and Data Provenance for the Test Set

• Imprecision Study (Test Set):

  • The sample size for the imprecision study is not explicitly stated as a single "test set" size. Instead, it reports CVs at multiple bilirubin levels. The common practice for imprecision studies involves running samples (controls or patient pools) multiple times over several days. The table shows 3-5 different bilirubin levels tested on each of the four ADVIA Chemistry Systems.
  • Data Provenance: Not specified in the summary (e.g., country of origin). The studies appear to be prospective as they were conducted specifically for this 510(k) submission to evaluate the performance of the new device.

• Correlation (Method Comparison) Study (Test Set):

  • Sample Size:
    • Serum, ADVIA 1650 vs ADVIA IMS: 118 samples (N=118)
    • Serum, ADVIA 2400 vs ADVIA 1650: 119 samples (N=119)
    • Serum, ADVIA 1200 vs ADVIA 1650: 119 samples (N=119)
  • Data Provenance: Not specified (e.g., country of origin). Appears to be prospective as these studies would have been designed to compare the new device against existing methods.

• Interfering Substances Study (Test Set):

  • The sample size for the interfering substances experiment is not explicitly stated. Typically, a small number of samples (e.g., one or two per interference level) are spiked with the interfering substance and tested.
  • Data Provenance: Not specified. Appears to be prospective.

• Analytical Range Study (Test Set):

  • The sample size used to establish the analytical range (linearity) is not explicitly stated. These studies typically use a series of diluted/spiked samples to cover the claimed range.
  • Data Provenance: Not specified. Appears to be prospective.

3. Number of Experts and Qualifications for Ground Truth

• No external "experts" (e.g., radiologists) were explicitly used to establish ground truth for these analytical performance studies.
• For an in vitro diagnostic (IVD) device like a bilirubin assay, "ground truth" is typically established by:
  • Reference Methods: The "AACC Reference Method" is stated as the standardization method for both the new device and the predicate. This is a highly standardized and validated analytical method.
  • Predicate Device: The predicate device itself (ADVIA IMS Total Bilirubin) serves as a gold standard or "truth" for comparison in the method correlation studies. Its results are assumed to be accurate.
  • Known Concentrations: For studies like imprecision, interfering substances, and analytical range, commercial controls or spiked samples with known, verified concentrations are used.

4. Adjudication Method for the Test Set

• Not applicable. This product is an in vitro diagnostic (IVD) lab assay. Adjudication, particularly multi-reader methods (e.g., 2+1, 3+1), is typically relevant for interpretative devices like imaging diagnostics where human readers make a judgment, and their discrepancies need to be resolved. For a quantitative chemical assay, the measurement itself is the output, and any discrepancies would be resolved through re-testing, calibration checks, or investigation into analytical errors, rather than expert adjudication of a qualitative result.

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

• No MRMC study was done. This type of study is for interpretative devices involving human perception (e.g., radiology AI). The ADVIA Chemistry Total Bilirubin_2 is a quantitative analytical device that produces numerical results, not images or qualitative interpretations that a human reads. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (Algorithm Only) Performance Study

• Yes, this entire submission is a standalone performance study in the context of an IVD. The device is the algorithm/reagent system that performs the measurement without human interpretation of the primary data (other than reading the final numerical output). The performance data (imprecision, correlation, etc.) reflects the algorithm/reagent system's capabilities without human-in-the-loop directly influencing the outputted bilirubin concentration. Human interaction is limited to operating the instrument, loading samples, and interpreting the final numerical result in a clinical context.

7. Type of Ground Truth Used

• Reference Methods and Predicate Device:
  • For standardization, the AACC Reference Method is explicitly stated as the ground truth.
  • For method comparison/correlation, the ADVIA IMS Total Bilirubin assay (predicate device) served as the comparison method, implicitly representing the accepted "truth" for validating the new device's accuracy.
  • For imprecision, analytical range, and interfering substances, the ground truth would have been established using calibrated materials, known-concentration controls, and carefully prepared spiked samples.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated for algorithm training. This device is a traditional chemical assay, not an AI/ML-based device that undergoes a distinct "training" phase with a large dataset in the sense of machine learning algorithms. The development of such an assay involves chemical formulation, optimization, and extensive analytical validation in a laboratory setting, but not typically "training data" as would be used for neural networks or similar AI.

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

• Not applicable. As explained above, this is not an AI/ML device with a training set in the conventional sense. The "ground truth" for the device's development and optimization would have been established through standard chemical and laboratory practices, utilizing reference methods, standards, and control materials to ensure the reagents and measurement principles were accurate and robust.

Ask a specific question about this device