Search Results

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.

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® 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

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

The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips.

This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH. Protein, Protein-to-Creatinine Ratio, Specific Gravity, and Urobilinogen. These measurements are used to assist diagnosis in the following areas:

• Kidney Function .
• Urinary tract infections .
• Metabolic disorders (e.g. diabetes mellitus) .
• . Liver Function

Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use.

The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and Bayer MULTISTIX PRO® Reagent Strips.

The analyzer is a reflectance spectrophotometer that analyzes the color and intensity of the light reflected from the reagent area and reports the results in clinically meaningful units. The analyzer can determine and report the color of the urine.

All testing takes place on the fixed platform. The fixed platform consists of 3 sections: the strip loading station, the incubation/read station, and the waste bin. Strips are placed on the strip loading station. The push bar moves the strips to the incubation/read station, where they are tested. When testing is complete, the strips drop into the waste bin. When testing is complete, an internal thermal printer prints the test results.

The provided text describes the CLINITEK Advantus™ Urinalysis analyzer and its performance assessment for 510(k) submission. However, it does not explicitly provide a table of acceptance criteria with reported device performance or detailed information about the studies. Here's what can be extracted and inferred:

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

The document states, "Studies were conducted as internal laboratory setting and in clinical settings to demonstrate the performance of the CLINITEK Advantus™ analyzer and assess its substantial equivalence against the predicate devices and where applicable the referenced laboratory methods." It also highlights the device's ability to "preserve reagent algorithms and performance parameters."

While specific numerical acceptance criteria (e.g., accuracy percentages, sensitivity/specificity thresholds) and a direct performance comparison table are not provided in this summary, the core acceptance criterion is substantial equivalence to the predicate devices (CLINITEK 500 and CLINITEK 200+).

Inferred Table of Acceptance Criteria & Reported Performance:

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The studies were conducted in "internal laboratory setting and in clinical settings." This implies both controlled lab environments and real-world clinical usage. The country of origin is not explicitly stated, but the manufacturer is Bayer HealthCare, LLC, located in Norwood, MA, USA, suggesting the studies likely occurred in the US. The studies appear to be prospective to demonstrate device performance.

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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "referenced laboratory methods" for comparison, which would imply the use of validated, possibly expert-performed, gold standard methods.

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

• Adjudication Method: Not specified. The comparison is against predicate devices and "referenced laboratory methods," suggesting a direct comparison rather than a human adjudication process for image interpretation.

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:

• MRMC Study: Not applicable. This device is an automated urinalysis analyzer, not an AI-assisted diagnostic tool for human readers interpreting complex images. Its function is to read reagent strips, and the comparison is largely against other automated or reference methods, not human interpretation improvement.

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

• Standalone Performance: Yes, the device itself is a standalone automated system. The performance assessment would inherently be of the "algorithm only" (the reflectance spectrophotometer and its interpretation logic) without continuous human intervention during the reading process. Humans load the strips and review results, but the reading itself is automated.

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

• Type of Ground Truth: The ground truth would have been established by the performance of the predicate devices (CLINITEK 500 and CLINITEK 200+) and "referenced laboratory methods." For urinalysis, these reference methods typically include established manual chemical tests, microscopy, or other validated laboratory analyzers. It implies a comparison to established, accepted diagnostic methods for each analyte.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified. The document states "reagent algorithms and performance parameters" are preserved, suggesting a legacy of development, but details on specific training sets for new algorithms in this device are not provided.

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

• Ground Truth for Training Set: Not specified. Given the nature of a spectrophotometric reader, the "training" (calibration, algorithm development) would typically involve known concentrations of analytes and corresponding reflectance values to build the correlation between color intensity and analyte concentration. This would be established using highly accurate laboratory standards and methods.

Ask a specific question about this device

The Ascensia BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia "BREEZE"2 Blood Glucose Meter, Ascensia" BREEZE® Reagent Strips and Ascensia BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia BREEZE® 2 Gonton Solution in of the measurement of glucose in whole blood. The Ascensia® BREEZE® 2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE 2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

The Ascensia® BREEZE®2 Blood Glucose Monitoring System consists of:

1. Ascensia® BREEZE®2 Blood Glucose Monitor
2. Ascensia BREEZE®2 Blood Glucose Test Strips
3. Ascensia BREEZE®2 Control Solution

The provided text describes the Ascensia® BREEZE®2 Blood Glucose Monitoring System. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in a table format with specific performance metrics (e.g., accuracy percentages, limits of agreement). Instead, it makes a general statement about performance.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "subject meter results for capillary blood samples" and "a validation... performed in a clinical setting by persons with diabetes." However, the exact number of participants or samples is not provided.
• Data Provenance: Prospective and clinical. The study was "performed in a clinical setting by persons with diabetes," suggesting a prospective clinical trial. The country of origin is not specified but given the submitter's address (Mishawaka, IN, USA) and FDA submission, it likely involved data from the USA.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The ground truth was established by "results of a laboratory glucose analyzer" and "BREEZE®2 results obtained by a healthcare professional." The specific qualifications of the healthcare professional are not detailed, nor are the specific details of the laboratory glucose analyzer.

4. Adjudication Method for the Test Set

Not specified. The document states that "subject meter results for capillary blood samples were compared with BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer." This implies a comparison against these two reference methods, but no adjudication process for discrepancies is described.

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

No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an imaging device that would typically involve multiple human readers interpreting cases.

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

Yes, a standalone performance assessment was effectively done. The device's results (from the Ascensia® BREEZE®2 Blood Glucose Monitor used by subjects) were compared directly against reference methods ("BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer"). This evaluates the device's performance independently.

7. The Type of Ground Truth Used

The ground truth for the test set was established by:

• Comparison with laboratory glucose analyzer results. This is considered a high-fidelity reference standard for blood glucose measurement.
• Comparison with BREEZE®2 results obtained by a healthcare professional. This serves as another point of comparison, likely using the device itself but operated by a trained professional.

8. The Sample Size for the Training Set

Not applicable/Not provided. The text describes a validation study, but there is no mention of a separate "training set" in the context of an AI/ML algorithm development, as this device predates widespread regulatory submissions for such technologies in medical devices. This is a traditional medical device submission for a blood glucose monitor.

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

Not applicable. As noted above, this device predates the typical AI/ML development paradigms involving distinct training sets requiring ground truth establishment in that context.

Ask a specific question about this device

For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.

The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The analytes currently in the control material are: cPSA

This document is a 510(k) summary for the ADVIA® IMS cPSA Control, a quality control material. It describes the device, its intended use, and its substantial equivalence to a predicate device. As a quality control material used to monitor the performance of other assays, the acceptance criteria and study design are different from those for diagnostic devices that detect a disease. This document does not describe a clinical study in the typical sense with patient data, expert readers, or AI performance metrics.

Here's an analysis of the provided text based on the requested information:

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

The document does not explicitly state "acceptance criteria" in the context of performance specifications for the ADVIA® IMS cPSA Control itself. Instead, it describes its intended use as a quality control material "to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems."

The "reported device performance" of the ADVIA® IMS cPSA Control is implied by its function as a control. The key performance characteristics for such a control material would typically be its assigned values (which establish accuracy) and its stability (which ensures its continued utility for precision monitoring over time). However, these specific values or stability data are not provided in this summary.

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

This information is not applicable and not provided. The device is a quality control material, not a diagnostic device that processes patient samples or generates diagnostic data. There is no "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. As explained above, there is no "test set" of patient data requiring expert-established ground truth. The "ground truth" for a quality control material would be its manufacturing specifications and assigned analyte values, determined through laboratory methods, not expert consensus on patient cases.

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

This information is not applicable and not provided for the same reasons as above.

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

This information is not applicable and not provided. This device is a quality control material, not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness study was performed or is relevant.

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

This information is not applicable and not provided. This device is a quality control material, not an algorithm.

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

For a quality control material, the "ground truth" refers to its assigned analyte values (in this case, cPSA concentration) and its manufacturing specifications. These are established through rigorous laboratory testing during the development and manufacturing process, comparing it against reference materials and methods. The document does not detail how these specific values were established but implies they are part of the product specifications.

8. The sample size for the training set

This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm, and therefore has no "training set."

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

This information is not applicable and not provided for the same reasons as above.

Ask a specific question about this device

For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system.
For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

The Bayer ADVIA® IMS PSA Calibrators and ADVIA® IMS cPSA Calibrators are for values of calibrator material prepared in bovine serum with non-serum constituents added.
The analytes currently in the calibrator material are: PSA in the ADVIA® IMS PSA Calibrator cPSA in ADVIA® IMS cPSA Calibrator

This document is a 510(k) summary for the ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator. It establishes substantial equivalence to a predicate device but does not describe a study that involves performance acceptance criteria against which devices are measured. This type of device (calibrator) would typically undergo studies related to its stability, traceability, and commutability, rather than efficacy studies with clinical endpoints.

Therefore, many of the requested elements for describing an acceptance criteria study are not applicable to the information provided in this document.

Here's a breakdown of the applicable information:

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

   • Not applicable. This document does not present specific performance acceptance criteria for the calibrator itself, nor does it report performance against such criteria. The 510(k) submission focuses on substantial equivalence to a predicate calibrator and its intended use for calibration. Performance of the calibrator would be assessed through its ability to enable accurate and precise measurements by the ADVIA® IMS system when assaying patient samples, which is not detailed here.

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

   • Not applicable. There is no "test set" in the context of device performance evaluation described in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. Ground truth establishment by experts is generally not relevant for calibrator devices.

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

   • Not applicable.

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 device.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

Summary of Relevant Information from the Provided Text:

• Device Type: In vitro diagnostic calibrator material.
• Intended Use: For in vitro diagnostic use in the calibration of quantitative PSA and complexed PSA assays on the ADVIA® IMS system.
• Substantial Equivalence: The device is deemed substantially equivalent in intended use, storage and handling, stability, source material, and instructions for use to the previously cleared Bayer Lipoprotein Calibrators (K051619). This is the primary "proof" for this type of device according to the 510(k) process – demonstrating it is as safe and effective as a legally marketed predicate device.
• Device Description: Prepared in bovine serum with non-serum constituents added. The analytes are PSA and cPSA.

Ask a specific question about this device