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510(k) Data Aggregation
(60 days)
The OneTouch Verio Reflect Blood Glucose Monitoring System is composed of the OneTouch Verio Reflect Meter and OneTouch Verio Test Strips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The OneTouch Verio Reflect Blood Glucose Monitoring System consists of the OneTouch Verio Reflect Blood Glucose Meter, OneTouch Verio Test Strips, OneTouch Verio Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Reflect Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. The OneTouch Verio Reflect meter also contains tools to aid diabetes management which include a dynamic range indicator, test tracker, blood sugar mentor, trend90 average blood glucose and meal and advanced tagging.
The OneTouch Verio Reflect Blood Glucose Monitoring System was evaluated for its accuracy in a Lay User Method Comparison Study. The study assessed the device's performance against a laboratory reference method, the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016)) | Reported Device Performance (OneTouch Verio Reflect Blood Glucose Monitoring System) |
|---|---|
| For glucose concentrations ≥ 75 mg/dL: At least 95% of results must be within ±15% of the reference method. | 99.2% of results were within ±15% of the YSI 2300 reference instrument. |
| For glucose concentrations < 75 mg/dL: At least 95% of results must be within ±15 mg/dL of the reference method. | No specific detailed breakdown for concentrations < 75 mg/dL provided in the summary table, but the overall 99.2% within ±15% performance suggests this criterion was met. |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: 354 lay persons (fingertip capillary blood samples).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a "Lay User Method Comparison Study" conducted for regulatory submission, it is highly likely to be a prospective study.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable in this context. The ground truth for glucose concentration was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer), not human expert interpretation.
4. Adjudication Method:
Not applicable. The ground truth was established by a laboratory instrument, not human review requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a blood glucose monitoring system, and its performance is assessed against a laboratory reference standard, not through a comparative study with human readers (with or without AI assistance).
6. Standalone (Algorithm Only) Performance:
The reported performance is the standalone performance of the device as used by lay users, essentially the algorithm's performance in determining glucose levels from the test strip sample. No "human-in-the-loop" was involved in the measurement process for the reported accuracy.
7. Type of Ground Truth Used:
Instrument-based reference measurement: Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).
8. Sample Size for Training Set:
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as would typically be described for image analysis devices. The "blood glucose algorithm" mentioned is likely part of the device's core operating principle, which would be developed and validated through extensive R&D and analytical studies rather than a distinct training set for a machine learning model.
9. How Ground Truth for Training Set was Established:
Not explicitly stated regarding a distinct "training set" as commonly understood in AI/ML. The device's underlying algorithm development would have relied on a combination of chemical principles, laboratory measurements, and potentially large datasets of glucose readings and interfering substances to refine its accuracy and interference reduction capabilities.
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(189 days)
The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive.
The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
The provided text describes a 510(k) summary for the One Touch Via™ On-Demand Insulin Delivery System (K163357). This document focuses on demonstrating substantial equivalence to a predicate device (FINESSE™ Personal Insulin Delivery System, K111924) rather than presenting a study to prove acceptance criteria for a novel device's performance characteristics.
Therefore, the information requested can only be partially addressed based on the provided text. The document states that the new device has "minor modifications in component design for improved manufacturability associated with the relocation and increased automation of the manufacturing" and "minor changes to labeling content and format". It explicitly states that "The System technological characteristics, performance characteristics, and the user interface remain unchanged" and "No clinical performance data is required to validate the intended uses and user needs of the system."
Given these statements, the "acceptance criteria" discussed are primarily related to ensuring the modified device performs comparably to the predicate device and meets established safety and performance standards for infusion pumps.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results for the device itself in a typical "device meets acceptance criteria" format. Instead, it states that "Design verification studies per test methods and acceptance criteria previously established for the predicate device were conducted on finished devices which were representative of commercial device have demonstrated the function, wear and mechanical reliability of the device for the intended period of time."
It also states: "Performance bench testing demonstrated that the subject device met all the existing device specifications, thereby demonstrating that the device is as safe, as effective, and performs as well as the predicate device (K111924)."
This implies that the acceptance criteria are the "existing device specifications" (presumably inherited from the predicate device) and the "test methods" used to verify them. However, these specific criteria and the detailed performance against them are not provided in this summary.
The document lists categories of testing performed:
- Insulin compatibility and stability studies
- Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Material Mediated Pyrogen, Hemolysis)
- Design verification studies for function, wear, and mechanical reliability (including dimensional inspection, IDD performance testing at nominal and extreme environmental conditions, alarm function, leak testing, cannula function, needle function, chemical compatibility, packaging testing, fluid ingress, and adhesive performance)
- Design verification studies for Inserter and Fill Syringe accessories (including chemical exposure, cleanability, and functional testing)
- Human factors studies (labeling comprehension and usability)
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 sample sizes for the "test set" (i.e., the samples used for the non-clinical performance data). It only mentions that "finished devices which were representative of commercial device" were used.
The data provenance (country of origin, retrospective/prospective) is not mentioned.
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 is not applicable as the study described is non-clinical performance testing (bench testing, biocompatibility, human factors) and does not involve "ground truth" derived from expert review in the context of clinical observations or diagnostics. Human factors studies are mentioned, which would involve users, but details on "experts" for ground truth are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study described is non-clinical performance testing.
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 is not applicable. The device is an insulin delivery system, not an AI-assisted diagnostic or imaging device. The document explicitly states: "No clinical performance data is required to validate the intended uses and user needs of the system."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a mechanical insulin delivery system, not an algorithm. It is a "manual, user filled, positive volume displacement, bolus dosing pump" and "insulin delivery requires competent human interaction to actuate the buttons to deliver insulin."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable for this type of non-clinical device testing. The "ground truth" for non-clinical performance testing would be established engineering specifications, physical/chemical standards, and recognized biological response criteria (e.g., for biocompatibility).
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" for an algorithm, as the device is a mechanical insulin delivery system.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set."
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of a modified medical device (an insulin delivery system) to an existing predicate device. It relies heavily on non-clinical performance data (bench testing, biocompatibility, human factors) to show that the modifications do not negatively impact safety or effectiveness. The specific numerical acceptance criteria and detailed performance results are not included, nor are clinical trial details or AI-related study design elements.
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(182 days)
The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus Flex Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
The OneTouch Ultra Plus Flex Blood Glucose Monitoring System consists of the OneTouch Ultra Plus Flex Blood Glucose Meter, OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The provided text describes the performance of the OneTouch Ultra Plus Flex Blood Glucose Monitoring System, particularly its accuracy against specific criteria and a reference method.
Here's an analysis based on the provided text to address your points:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is assessed in accordance with ISO 15197:2013(E) Clause 6.3 (System Accuracy) and Clause 8 (User Performance Evaluation). The acceptance criteria for blood glucose monitoring systems, as per ISO 15197:2013, dictate that for glucose concentrations <100 mg/dL, 95% of the values must fall within ±15 mg/dL of the reference measurement, and for glucose concentrations ≥100 mg/dL, 95% of the values must fall within ±15% of the reference measurement.
| Metric / Glucose Range | Acceptance Criteria (ISO 15197:2013) | Reported Device Performance (System Accuracy, Healthcare Professionals) (Page 14) | Reported Device Performance (Lay User Performance) (Page 15-16) |
|---|---|---|---|
| System Accuracy (<100 mg/dL) | ≥95% within ±15 mg/dL | 100% within ±15 mg/dL (Pooled Results for Lots A-C) | 96.8% within ±15 mg/dL |
| System Accuracy (≥100 mg/dL) | ≥95% within ±15% | 98.8% within ±15% (Pooled Results for Lots A-C) | 97.0% within ±15% |
| System Accuracy (Overall Glucose Range) | Not explicitly stated as overall, but implied by above | 99.2% within ±15mg/dL or ±15% (Pooled Results for A-C) | 97.0% within ±15 mg/dL or ±15% |
2. Sample Size Used for the Test Set and Data Provenance
-
System Accuracy (Healthcare Professionals):
- Sample Size: 100 subjects (Page 13) resulting in 600 total meter results (200 per test strip lot across 3 lots) (Page 14).
- Data Provenance: The study was conducted on "fingertip capillary blood samples obtained by healthcare professionals". The country of origin is not explicitly stated, but the company is based in Switzerland with a consultant in the UK, suggesting European data. The nature is prospective, as samples were "obtained by healthcare professionals" for the study.
-
Lay User Performance Evaluation:
- Sample Size: 166 lay persons (Page 15).
- Data Provenance: "fingertip capillary blood samples obtained by 166 lay persons". Country of origin not specified, but likely similar to the professional study. The nature is prospective.
-
Method Comparison Performance (initial study with healthcare professionals):
- Sample Size: 113 subjects (Page 9) focusing on "first test sample data".
- Data Provenance: "glucose values from the OneTouch Ultra Plus Flex Blood Glucose Monitoring System (obtained by healthcare professional fingersick samples from diabetic subjects)". Prospective data, likely similar geographical origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by a laboratory reference method, the Yellow Springs Instrument (YSI) 2300 STAT PLUS glucose analyzer. This is an automated analytical instrument, not human experts. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment does not apply in this context.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth is an objective laboratory reference measurement (YSI analyzer), not human readers 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
An MRMC study was not conducted. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. The effectiveness is measured by the device's accuracy against a laboratory reference.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This is an inherent aspect of the device's design. The system automatically measures glucose and provides a reading. The "System Accuracy" and "Lay User Performance Evaluation" studies demonstrate the standalone performance of the device (meter and test strips) in conjunction with samples from healthcare professionals or lay users, respectively. It is an "algorithm only" performance in the sense that the device performs the measurement autonomously following sample application.
7. The Type of Ground Truth Used
The ground truth used in these studies is a recognized laboratory reference method: the Yellow Springs Instrument (YSI) 2300 STAT PLUS glucose analyzer. This is an objective, quantitative measurement, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a traditional electrochemical blood glucose meter. Its "training" or development would involve engineering design, calibration, and extensive analytical testing (e.g., repeatability, linearity, interference) rather than machine learning on a large dataset. Therefore, a specific "training set sample size" as is common with AI/ML devices is not provided or applicable in the traditional sense. The development of the device would have involved internal validation and calibration procedures.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of AI/ML is not directly applicable. The device's foundational accuracy and calibration would have been established through rigorous analytical testing during its development, likely using traceable glucose standards and established laboratory methods. The document mentions that the system was "designed and tested in accordance with ISO 15197:2013(E)." This standard outlines requirements for system accuracy, which inherently relies on comparison to a recognized reference method (like YSI).
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(182 days)
The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared.
OneTouch Verio Flex™ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch Verio Flex™ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use.
The OneTouch® Verio Test Strips are for use with the OneTouch Verio Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
The OneTouch Verio Flex Blood Glucose Monitoring System consists of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Flex Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
OneTouch Verio Flex™ Blood Glucose Monitoring System Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The OneTouch Verio Flex™ Blood Glucose Monitoring System was designed and tested in accordance with ISO 15197:2013(E) guidelines for system accuracy. The key acceptance criteria and reported performance from the device's system accuracy study are summarized below.
Acceptance Criteria per ISO 15197:2013(E) Clause 6.3 - System Accuracy (Healthcare Professional Use):
| Glucose Concentration Range | Acceptance Criterion (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | ≥ 95% of results within ±15 mg/dL |
| ≥ 100 mg/dL | ≥ 95% of results within ±15% |
| Overall (Combined) | ≥ 95% of results within ±15 mg/dL or ±15% |
Reported Device Performance (Healthcare Professional Use):
| Glucose Concentration Range | Reported Performance (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | 100% of results within ±15 mg/dL (Pooled Lots A-C) |
| ≥ 100 mg/dL | 99.3% of results within ±15% (Pooled Lots A-C) |
| Overall (Combined) | 99.5% of results within ±15 mg/dL or ±15% (Pooled Lots A-C) |
Acceptance Criteria per ISO 15197:2013(E) Clause 8 - User Performance Evaluation (Lay User):
| Glucose Concentration Range | Acceptance Criterion (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | ≥ 95% of results within ±15 mg/dL |
| ≥ 100 mg/dL | ≥ 95% of results within ±15% |
| Overall (Combined) | ≥ 95% of results within ±15 mg/dL or ±15% |
Reported Device Performance (Lay User Performance Evaluation):
| Glucose Concentration Range | Reported Performance (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | 93.1% of results within ±15 mg/dL (Note: This is below the ISO 95% criterion) |
| ≥ 100 mg/dL | 98.6% of results within ±15% |
| Overall (Combined) | 97.6% of results within ±15 mg/dL or ±15% |
Note on Lay User Performance: While the overall and ≥100 mg/dL results met the ISO 15197:2013(E) Clause 8 criteria, the performance for glucose concentrations <100 mg/dL was 93.1%, which is below the 95% acceptance criterion mentioned in the ISO standard for this range. However, the summary statement on page 15 still concludes that the system meets "all design input specifications" and ISO 15197:2013 requirements, suggesting that possibly the specific internal acceptance criteria for this portion might have been different or considered acceptable within the context of the overall system accuracy. Without further information, this discrepancy for the <100 mg/dL range in lay user performance is noted.
2. Sample size used for the test set and the data provenance
Method Comparison Performance (Healthcare Professional Use):
- Sample Size: 115 subjects
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingersick samples from diabetic subjects" and testing against a reference method. The location is not specified.
System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3 (Healthcare Professional Use):
- Sample Size: 100 subjects
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingertip capillary blood samples obtained by healthcare professionals". The location is not specified.
Lay User Performance Evaluation (Clause 8, first study summary):
- Sample Size: 172 lay persons
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingertip capillary blood samples obtained by lay persons". The location is not specified.
User Performance Evaluation in compliance with ISO 15197:2013(E) Clause 8 (second study summary):
- Sample Size: 167 lay persons
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingertip capillary blood samples obtained by lay persons". The location is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth. Instead, the ground truth was established using a recognized laboratory reference method: the Yellow Springs Instrument (YSI) 2300 (or YSI 2300 STAT PLUS) glucose analyzer. This instrument itself is considered the "expert" for generating accurate glucose measurements.
4. Adjudication method for the test set
Not applicable. The ground truth was established by a laboratory reference instrument (YSI analyzer), not by human experts 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 device is a blood glucose monitoring system, not an AI-powered diagnostic imaging or interpretation tool that involves "human readers." Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The "Method Comparison Performance" study and the "System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3" study assessed the device's accuracy when operated by healthcare professionals, comparing its readings directly to the laboratory reference method (YSI). This represents the algorithm's performance with trained users, effectively functioning as a standalone assessment of the device's accuracy in a controlled environment. The "Lay User Performance Evaluation" also assessed the device's accuracy when operated by intended users, albeit with human interaction in using the device.
7. The type of ground truth used
The ground truth used was laboratory reference measurements obtained from a Yellow Springs Instrument (YSI) 2300 (or YSI 2300 STAT PLUS) glucose analyzer. This is considered a highly accurate and recognized method for determining glucose concentrations.
8. The sample size for the training set
The document does not provide a sample size specifically for a "training set." Blood glucose monitoring systems like the OneTouch Verio Flex™ typically do not use machine learning models that require a separate training set in the same way AI algorithms do. The development process would involve calibration and optimization based on chemical and electrical principles rather than iterative training on a dataset. The studies described are validation studies.
9. How the ground truth for the training set was established
As noted above, the concept of a "training set" in the context of machine learning does not directly apply to this device. For the development and calibration of the glucose monitoring system, the ground truth would have been established through highly accurate laboratory reference methods (like those provided by a YSI analyzer) during the chemical and electrical engineering phases, prior to the validation studies described in the document. The document doesn't detail these initial development and calibration phases.
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