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Medisign MM1000 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).

The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Medisign MM1100 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).

The Medisign MM1100 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Medisign MM1200 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).

The Medisign MM1200 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Smart Diabetes Bluetooth Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (invitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).

The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Smart Diabetes Glucose Control Solutions are intended for use with Smart Diabetes Bluetooth meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.

Medisign MM1000 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.

The Medisign MM1000 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Medisign MM1100 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.

The Medisign MM1100 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Medisign MM1200 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.

The Medisign MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.

The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Smart Diabetes Glucose Control Solutions are for use with the Smart Diabetes Bluetooth Pro meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.

Medisign® Blood Glucose Monitoring System measures the glucose in the fresh capillary whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips.

Medisign® MM 1000 BT Blood Glucose Monitoring System, Medisign® MM 1100 BT Blood Glucose Monitoring System, Medisign® MM1200 BT and Smart Diabetes Bluetooth Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), lancing device, lancets, batteries (CR2032), diabetes management software, and data transporting cable are sold separately.

Medisign® MM1000 BT MULTI Blood Glucose Monitoring System, Medisign® MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign® MM1200 BT MULTI and Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual. Disposable lancing device, blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), batteries (CR2032) diabetes management software, and data transporting cable are sold separately.

Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3 µg and buffer & non-reactant - 50.5µg

Each box of control solutions (Level 1, Level 2 and Level 3) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL), Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).

The system contains Bluetooth wireless technology. This device complies with U.S. federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Operation is subject to the following two conditions:

• This device may not cause harmful interference.
• · This device must accept any interference received, including interference that may cause undesirable operation.

The Bluetooth wireless technology is used to transfer meter test results to a mobile APP.

The provided text describes several Medisign and Smart Diabetes Bluetooth Blood Glucose Monitoring Systems, all under K152534. The submission claims substantial equivalence to a predicate device (K111456 Medisign® Blood Glucose Monitoring System) and includes performance testing of the modified device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly states that the modified devices aim to demonstrate substantial equivalence to the predicate device, implying that the performance of the modified device should align with that of the predicate. It then lists "Similarities" and "Differences" between the candidate device (the various Medisign and Smart Diabetes systems) and the predicate device (K111456). While it doesn't present a formal acceptance criteria table with numerical targets, it lists the characteristics that are considered "Same" as the predicate device.

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

The document mentions "verification tests were conducted" (page 16) but does not provide any specific details about the sample sizes used for these tests. There is also no explicit mention of data provenance (country of origin) or whether the studies were retrospective or 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)

For a blood glucose monitoring system, the "ground truth" is typically an established laboratory reference method (e.g., using a YSI glucose analyzer) rather than expert consensus on images or clinical assessments. The document does not mention the involvement of experts for establishing ground truth in the context of radiologists or similar clinical reviewers. The ground truth for glucose measurements would be provided by a highly accurate laboratory instrument.

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

Given that the device measures a quantitative value (glucose concentration) against an established reference method, an adjudication method like 2+1 or 3+1 (which are typically used for qualitative or subjective assessments in imaging or pathology) is not applicable or mentioned in the context of this device. The comparison would be a direct quantitative comparison between the device reading and the reference method reading.

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 type of study (MRMC, measuring improvement with AI assistance) is not relevant to a blood glucose monitoring system, which is a standalone diagnostic device, not an AI-assisted diagnostic imaging tool. Therefore, no such study was done or reported here.

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

Yes, the performance testing described implicitly as "verification tests" (page 16) would be a standalone performance evaluation of the device (meter and test strip system) measuring glucose concentrations. The device itself (the algorithm within the meter) provides the result without human interpretation of raw data, beyond operating the device. While "algorithm only" implies a pure software evaluation, this would be the closest analogue for a medical device that produces a direct numerical output.

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

For a blood glucose monitoring system, the ground truth is established by a reference laboratory method for glucose measurement, typically a highly accurate and precise enzymatic method often run on a laboratory analyzer (e.g., YSI glucose analyzer). While not explicitly stated, this is the standard for validating such devices. The document mentions "Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips," which further indicates a comparison to a standardized laboratory method that often reports plasma glucose.

8. The sample size for the training set

The document describes a 510(k) submission for modified devices, claiming substantial equivalence. It refers to "verification tests" for the modified device based on its similarity to a predicate device. No mention is made of a "training set" as would be used for machine learning. The device operates based on established electrochemical principles, not a learnable algorithm that requires training data in the AI sense.

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

As there is no mention of a training set in the context of an AI/machine learning model, this question is not applicable. The device's operation relies on chemical reactions and electrical current measurements, calibrated against reference glucose values derived from a laboratory method.

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The Medisign® MM3000 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, forearm or palm. The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.

The Medisign® MM3000 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 Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Medisign® Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.

The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.

The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Medisign® Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.

The Medisign® MM3000 Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.

The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.

Medisign Blood Glucose Monitoring System measures the glucose in the whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase (GOD) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips.

Medisign MM3000 Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Blood glucose test strips, blood glucose control solutions (1, 2, 3 levels), diabetes management software, and data transporting cable are sold separately.

Medisign MM3000 Multi Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Disposable lancing device, blood glucose test strips, blood glucose control solutions (1,2,3 levels), diabetes management software, and data transporting cable are sold separately.

Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Also, each box may contain 25 test strips packed with single aluminum foiled pack or 50 test strips packed with single aluminum foiled pack. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3ug and buffer & non-reactant - 50.5uq.

Each box of control solutions (1, 2, 3 levels) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL) and Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).

Here's the information about the acceptance criteria and study for the Medisign MM3000 Blood Glucose Monitoring System, extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria for the Medisign MM3000 Blood Glucose Monitoring System performance (e.g., accuracy percentages or error ranges). Instead, it states that "all tests have been proved satisfactory according to the predetermined acceptance criteria." It also does not present a table of specific reported device performance metrics in relation to these criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against predefined quantitative targets.

However, based on general expectations for blood glucose monitoring systems, acceptance criteria typically revolve around accuracy relative to a laboratory reference method. The measuring range is reported as 20 - 600 mg/dL.

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

The document mentions that a "system performance test including human factor study was conducted." However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established by comparative measurements using a laboratory reference method.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method. In the context of blood glucose monitoring systems, "adjudication" usually refers to how discrepancies between the device and the reference method are handled or how multiple readers for a test are reconciled. Since this is an in-vitro diagnostic device measuring a quantitative value, adjudication in the sense of expert consensus on qualitative interpretation is not typically 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:

This question is not applicable to the Medisign MM3000 Blood Glucose Monitoring System. This device is an in-vitro diagnostic device for quantitative blood glucose measurement, not an AI-assisted diagnostic imaging or interpretation system that would involve human "readers" or an MRMC study design.

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

The device is a standalone system for measuring blood glucose. Its performance is evaluated as the algorithm/system without human intervention in the measurement process itself, beyond the user applying the sample. The document states a "system performance test" was conducted, implying standalone performance evaluation.

7. The Type of Ground Truth Used:

While not explicitly stated in detail, the ground truth for blood glucose monitoring systems is invariably established through comparison with a laboratory reference method. The phrase "Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips" implies that plasma-equivalent values (likely derived from a laboratory reference) are the standard against which the device's measurements are calibrated and compared.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. Blood glucose meters do not typically undergo a "training" phase in the same way machine learning algorithms do. Their performance is based on the chemical and electrical properties of the test strips and meter, which are developed and validated.

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

As mentioned above, the concept of a "training set" and associated ground truth establishment is not directly applicable to this type of medical device in the same way it would be for an AI/machine learning system. The device's fundamental performance is based on its electrochemical methodology and calibration, not on learning from a dataset.

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Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for selftesting by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions.

The Medisign™ MM1000 test strip is to be used with Medisign™ MM1000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1100 test strip is to be used with Medisign™ MM1100 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1200 test strip is to be used with Medisign™ MM1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in clinical settings. It is intended for use outside of the body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.

The Medisign™ MM1000 Multi Blood Glucose Test strip is to be used with Medisign™ MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing, The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1100 Multi Blood Glucose Test strip is to be used with Medisign™ MM1100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1200 Multi Blood Glucose Test strip is to be used with Medisign™ MM1200 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign™ Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (10T), and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data transporting cable are sold separately.

Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (107), and a carrying bag including user manual, quick reference manual and log book. Disposable lancing device, blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data transporting cable are sold separately.

Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) - 2.5 units, redox mediator - 32.3µg and buffer & non-reactant - 50.5µg.

Each box of control solutions (Level A and Level B) contains one vial of aqueous control solution (4ml each): Level A contains 0.11% concentrations of glucose (approximately 120 mg/dL) and Level B contains 0.23% concentrations of glucose (approximately 320 mg/dL).

Only the difference among six blood glucose monitoring systems above is the appearance of the top cases of the meters. Six blood glucose monitoring systems use the same PCB, the same LCD, the same Software, the same test strip, and the same control solution.

This is a 510(k) premarket notification for Medisign MM1000, MM1100, and MM1200 Blood Glucose Monitoring Systems, and their "Multi" versions. The document states that "clinical data demonstrate the performance of the subject devices well with the laboratory glucose reference test equipment. All predetermined acceptance criteria were satisfied." However, the document does not provide specific acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document only states that "All predetermined acceptance criteria were satisfied" and the "clinical data demonstrate the performance of the subject devices well with the laboratory glucose reference test equipment." This is a general statement and lacks the specificity required to answer your questions.

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