Search Results
Found 5 results
510(k) Data Aggregation
(261 days)
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.
| Acceptance Criteria Category (Implied by 510(k) Process) | Reported Device Performance / How Met (Based on Non-Clinical Testing and Comparison) |
|---|---|
| Safety & Effectiveness (Overall) | Demonstrated by substantial equivalence to legally marketed predicate devices. "does not raise new or different questions about safety or effectiveness." |
| Technological Characteristics | Very similar to Predicate 1 (ALEVE Direct Therapy TENS, first-generation) in intended use, outer dimensions, buttons, electrodes, materials, remote control, RF communication, pulse amplitude. |
| Similar to Predicate 2 (Chattem SmartRelief) in indications for use and output specifications (pulse amplitude, frequency, duration). | |
| Performance Verification | Met established specifications through: - 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
(504 days)
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.
| Test Type | Acceptance Criteria | Reported Device Performance (Contour Plus System, unless otherwise noted) |
|---|---|---|
| Accuracy (Analytical) | Glucose < 75 mg/dL: - Within ±5 mg/dL (unspecified %) - Within ±10 mg/dL (unspecified %) - Within ±15 mg/dL (unspecified %) Glucose ≥ 75 mg/dL: - Within ±5% (unspecified %) - Within ±10% (unspecified %) - Within ±15% (unspecified %) - Within ±20% (unspecified %) | Glucose < 75 mg/dL (combined lots): - Within ±5 mg/dL: 75 of 78 (96.2%) - Within ±10 mg/dL: 78 of 78 (100%) - Within ±15 mg/dL: 78 of 78 (100%) Glucose ≥ 75 mg/dL (combined lots): - Within ±5%: 454 of 522 (87.0%) - Within ±10%: 519 of 522 (99.4%) - Within ±15%: 522 of 522 (100%) - Within ±20%: 522 of 522 (100%) |
| Accuracy (Clinical Trial) | Glucose < 75 mg/dL: - Within ±5 mg/dL (unspecified %) - Within ±10 mg/dL (unspecified %) - Within ±15 mg/dL (unspecified %) Glucose ≥ 75 mg/dL: - Within ±5% (unspecified %) - Within ±10% (unspecified %) - Within ±15% (unspecified %) - Within ±20% (unspecified %) | Glucose < 75 mg/dL: - Within ±5 mg/dL: 3 of 7 (42.9%) - Within ±10 mg/dL: 4 of 7 (57.1%) - Within ±15 mg/dL: 7 of 7 (100%) Glucose ≥ 75 mg/dL: - Within ±5%: 119 of 209 (56.9%) - Within ±10%: 186 of 209 (89.0%) - Within ±15%: 205 of 209 (98.1%) - Within ±20%: 209 of 209 (100%) |
| Repeatability | Not explicitly stated as a pass/fail criterion in the summary, but data provided for comparison. | Mean, Pooled Standard Deviation, and Coefficient of Variation provided for five glucose levels (e.g., at 42.2 mg/dL, CV was 2.8%; at 323 mg/dL, CV was 1.5%). |
| Linearity | Results within ±10 mg/dL for glucose values < 100 mg/dL and results within ±10% for glucose values ≥ 100 mg/dL. | 100% of results met the acceptance criteria. Additionally, 100% of tests for 0.1 mg/dL and 692 mg/dL samples yielded "LO" and "HI" messages, respectively. Range 10-600 mg/dL covered. |
| Intermediate Precision | Cp values ≥ 0.65. | All results generated Cp values > 1.0, meeting the acceptance criteria. |
| EMC and Electrical Safety | Compliance with IEC 62316-2-6:2005, IEC 61010-1:2001, and IEC 61010-2-101:2002. | Evaluated and found to be compliant. |
| Hematocrit + Temp Study | Bias from YSI < 10 mg/dL (glucose < 100 mg/dL) or < 10% (glucose ≥ 100 mg/dL). | Acceptance criteria met using both current and modified meters. Modified meter showed narrower bias range at low temperatures. |
| Hematocrit Dependency | Bias from YSI < 10 mg/dL (glucose < 100 mg/dL) or < 10% (glucose ≥ 100 mg/dL). | Acceptance criteria met. |
| Temperature Dependency | Bias from YSI < 10 mg/dL (glucose < 100 mg/dL) or < 10% (glucose ≥ 100 mg/dL). | Acceptance criteria met. |
| Temp and Humidity Comb. | ±10 mg/dL or ±10% of the reference method. | Results met acceptance criteria. |
| Sample Re-application (Lab) | 95% of results fall within ±15 mg/dL (glucose < 100 mg/dL) or within 15% (glucose ≥ 100 mg/dL) of the reference assay. | When severely under-filled: both current and modified meters met criteria. When moderately under-filled: current meter generated E2 error (100%), modified meter generated accurate results meeting criteria. |
| Sample Re-application (Lay User) | ISO 15197:2013 accuracy criteria (implied to be within ±15mg/dL or ±15% of the YSI reference for glucose levels, as per stated performance). | Lay users trained to underfill: 100% of results following re-application met ISO 15197:2013 accuracy criteria (within 15% of YSI reference). R&D lay user studies (58 instances): 98% of data met ISO 15197:2013 accuracy criteria (within ±15mg/dL or ±15% of YSI reference). |
| Moisture Damaged Test Strips | Increased detection of damaged test strips compared to predicate device. | Modified Contour Next EZ meters were capable of detecting damaged test strips more frequently than the current Contour Next EZ meter and generated an E11 error code. |
2. Sample Size Used for the Test Set and Data Provenance
- Much of the analytical testing (Accuracy, Repeatability, Linearity, Intermediate Precision, EMC, Electrical Safety) was performed using the Contour Plus Blood Glucose Monitoring System and test strips, which is stated to be representative.
- Analytical Accuracy:
- Glucose < 75 mg/dL: Three lots of test strips, with 26 measurements per lot. Total: 78 unique measurements.
- Glucose ≥ 75 mg/dL: Three lots of test strips, with 174 measurements per lot. Total: 522 unique measurements.
- Repeatability: Not explicitly stated, but data is given for 5 glucose levels across 3 lots of test strips.
- Linearity: Blood glucose samples ranged from 0.1 mg/dL to 692 mg/dL. No specific number of samples is given, but it implies a range of concentrations were tested.
- Intermediate Precision: 300 control tests (using three lots of test strips and three levels of control solution).
- Clinical Trial (Accuracy): 220 persons with diabetes were enrolled.
- Glucose < 75 mg/dL: 7 instances (across the 220 subjects).
- Glucose ≥ 75 mg/dL: 209 instances (across the 220 subjects).
- Hematocrit and Temperature Combination Study: Not explicitly quantified, but performed with "Three glucose concentrations and four hematocrit levels... at temperatures of 5, 10, 22, 35, 40 and 45℃."
- Hematocrit Dependency Study: Not explicitly quantified, but performed with "Four glucose concentrations and five hematocrit levels."
- Temperature Dependency Study: Not explicitly quantified, but performed with "Three glucose concentrations were tested at temperatures of 5, 10, 15 and 22°C."
- Temperature and Humidity Combination Study: Not explicitly quantified, but tested across 5 different environmental conditions.
- Blood Sample Re-application (Lab Personnel): Not explicitly quantified, but involved "inoculated with blood to simulate severely under-filled and moderately under-filled conditions."
- Blood Sample Re-application (Lay Users):
- Feasibility Study: Not explicitly quantified, but lay users were "trained to underfill the test strips."
- R&D Lay User Studies: 58 instances of under-filled test strips from multiple studies.
- Error Detection of Moisture Damaged Test Strips: Not explicitly quantified, but test strips "stressed by leaving the bottles open for 23 days inside a 30°C80% RH environmental chamber."
Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Bayer Healthcare LLC" submitter, it is likely that parts of the studies, especially regulatory submissions, involve US-based data or adherence to international standards globally. The studies appear to be prospective in nature, as they involve active testing and clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for all glucose measurements was established using a YSI reference method. This is a laboratory-based, highly accurate method for measuring glucose, often considered the gold standard in such studies. The number and qualifications of experts performing the YSI reference measurements are not specified in the document, but it's implied to be performed by qualified laboratory personnel.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method for the test set. Given that the ground truth is established by a YSI reference method, which is an objective measurement, an adjudication process involving human reviewers for interpretation of results is generally not applicable in this context. The comparison is directly between the device reading and the YSI reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done in the conventional sense (i.e., comparing human readers' performance with and without AI assistance). This device is a blood glucose meter, and the primary assessment is its analytical accuracy against a reference standard, not its impact on human interpretation of images or other subjective data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance was done. All the analytical accuracy, repeatability, linearity, intermediate precision, and various environmental/interference studies (hematocrit, temperature, humidity) reflect the standalone performance of the device (system/algorithm). The clinical trial also evaluates the system's accuracy "in the hands of intended users," which still primarily assesses the device's output against the ground truth, rather than human diagnostic performance. The "Blood Sample Re-application (Lab)" and "Error Detection of Moisture Damaged Test Strips" studies directly test the algorithmic improvements implemented in the modified device.
7. The Type of Ground Truth Used
The primary ground truth used for glucose measurements throughout the studies is the YSI reference method. This is an objective, laboratory-based measurement of glucose concentration, considered a highly accurate standard.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is typical for a 510(k) submission for a blood glucose meter where the device's underlying chemistry and algorithms are often developed and validated over time, with the submission focusing on performance testing for the final product and its modifications, rather than detailing the initial machine learning model training (if any complex machine learning was even involved, which is less common for these types of electrochemical devices). The modifications described (glucose calculation algorithm, improved blood detection, error detection for damaged strips) would likely have been developed and refined using internal data before the formal validation studies presented here.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided in the document.
Ask a specific question about this device
(98 days)
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
| Risk | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| User injury from electric shock | - Meter shall not allow a test to initiate when connected to an external device (e.g., computer).- 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
-
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.
-
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).
-
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.
-
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.
-
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.
-
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.
-
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.
-
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
(80 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Program is easy to use | The study showed that the program is easy to use |
| Results are understandable by users | The study showed that the results are understandable by the users |
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
(47 days)
The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
Here's the analysis of the provided text regarding the ADVIA® Chemistry Microalbumin Controls:
Acceptance Criteria and Study for ADVIA® Chemistry Microalbumin Controls
This device is a Quality Control Material, and the "acceptance criteria" and "study" are focused on its stability and performance as a control, establishing substantial equivalence to a predicate device rather than a clinical efficacy study typically seen for diagnostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (quality control material), the "acceptance criteria" revolve around its stability and intended function, demonstrating it performs as expected for quality control. The provided information focuses on aspects related to its stability and composition compared to a predicate.
| Feature | Acceptance Criteria (Implied / Predicate) | Reported Device Performance (ADVIA® Chemistry Microalbumin Controls) |
|---|---|---|
| Stability (Shelf-life) | Reconstituted urine controls stable for 8 hours at 25°C, 5 days at 4°C, or 14 days at -20°C (Predicate) | Reconstituted, capped, and stored at 2-8°C stable for 28 days |
| Shelf Life (Unreconstituted) | Not explicitly stated for predicate in this context | 24 month shelf life |
| Constituent Analytes | Multiple analytes (Predicate) | Microalbumin values only (This is a differentiating feature, not a failure to meet criteria) |
| Format | Lyophilized mixture of human urine base with added constituents (Predicate) | Same (Lyophilized mixture of human urine base with added constituents) |
| Levels | Two levels (Predicate) | Same (Two levels) |
| Overall Performance | Similar to other products in commercial distribution intended for similar use (Predicate implication) | The performance of the control is similar to other products in commercial distribution intended for similar use. Values validated according to established procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the traditional sense of a patient cohort. For this quality control material, the "test" primarily refers to stability studies. The actual number of control vials or batches tested for stability is not provided.
- Data Provenance: The stability validation was performed at the manufacturing site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK. The data is retrospective in the sense that the studies were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and not provided. For a quality control material, "ground truth" is established by laboratory analytical methods to determine its stated values and stability characteristics, not by expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies where human readers interpret data (e.g., images) and their interpretations need to be reconciled for ground truth. This is not relevant for a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic algorithms or imaging devices to assess how AI impacts human reader performance, which is not relevant for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
No, a standalone (algorithm-only) study was not performed. The device itself is a physical quality control material, not a software algorithm. Its "performance" is its inherent stability and stated values, validated through laboratory procedures.
7. The Type of Ground Truth Used
The "ground truth" for the ADVIA® Chemistry Microalbumin Controls is established through laboratory analytical testing (e.g., using a reference method or validated assays) to determine the concentration of microalbumin and to confirm the stability of these concentrations over time and under various storage conditions. This is considered a form of analytical truth.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1