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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:

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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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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

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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):

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