Search Results

The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.

The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 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 system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.

The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh.

The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the qlucose meter and test strips are working properly and that the measurement is accurate.

The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.

The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical iudgment or recommendations for treatment. This device is not intended as a substitute for medical care.

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucose meter, single use test strips and control solution. The new device IDEAL LIFE Gluco-Manager™, Model GMM0002 is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device. The IDEAL LIFE Gluco-Manager™ can be used alone to measure your blood glucose. If the user would like to transmit blood glucose information for display on a personal computer, the IDEAL LIFE Gluco-Manager™ can wirelessly communicate with a communication gateway (the optional IDEAL LIFE Pod™) or by using the Gateway Application, a mobile medical application.

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002, demonstrates its performance through compliance with ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. While the document asserts compliance with this standard, it does not explicitly state specific acceptance criteria values or detailed performance results in the provided text.

Therefore, I cannot directly complete Table 1 with specific acceptance criteria and reported device performance values from the provided text. The document refers to the ISO standard as the basis for performance.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for the test set or any performance study.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document mentions it's for self-testing at home and the submitter is in Toronto, ON, Canada, but this doesn't clarify the study's data origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not stated. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) rather than expert consensus.

4. Adjudication method for the test set:

• Not applicable/Not stated. Given the nature of blood glucose measurements, an adjudication method like 2+1 or 3+1 for image interpretation is not relevant. The ground truth would be based on a laboratory reference method.

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 standalone blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers.

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

• Yes. The document describes the IDEAL LIFE Gluco-Manager™ as a blood glucose monitoring system that measures glucose in fresh capillary whole blood and displays the result. It states it "can be used alone to measure your blood glucose." The wireless communication and Gateway Application are for transmitting and reviewing data, not for making interpretations, evaluations, or medical judgments. The core measurement is standalone.

7. The type of ground truth used:

• Not explicitly stated, but for a blood glucose monitoring system claiming conformance to ISO 15197, the ground truth would invariably be established using a laboratory reference method (e.g., a YSI Glucose Analyzer) which is considered the gold standard for glucose measurement in blood.

8. The sample size for the training set:

• Not applicable/Not stated. As a biosensor-based system, it likely does not involve a "training set" in the machine learning sense. Its performance is based on its electrochemical design and calibration, not a trained algorithm.

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

• Not applicable. (See point 8).

In summary: The provided 510(k) summary for the IDEAL LIFE Gluco-Manager™ states that the device conforms to ISO 15197, which serves as the primary evidence of meeting acceptance criteria. However, explicit numerical performance data (e.g., accuracy percentages, precision metrics) and details about the study design, sample sizes, and ground truth methodology are not provided within this specific document, beyond the general statement of ISO compliance.

Ask a specific question about this device

The IDEAL LIFE Pod™ receives data wirelessly from IDEAL LIFE devices to transmit over the Internet or common telephone lines from the user's home. The Pod is an optional accessory to IDEAL LIFE devices, including the GlucoManager™, the BP-Manager™ and/or the Body Manager™. The Pod is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.

The IDEAL LIFE Pod is a simple, user-friendly wireless modem accessory that wirelessly receives data from IDEAL LIFE devices and transmits the data to the IDEAL LIFE website. The IDEAL LIFE database is updated securely with the user's information, which is available for review via secure Internet access. Using the Pod, an individual can more easily view and track their blood pressure, blood glucose, and/or body weight information.

The provided text describes a 510(k) submission for the IDEAL LIFE Pod™ Model ILP 0001, which is an accessory designed to wirelessly transmit data from other IDEAL LIFE devices (like GlucoManager™, BP-Manager™, and Body Manager™) to a website for review.

Crucially, this submission does not include a study with acceptance criteria and a detailed description of device performance in a clinical or analytical setting. The IDEAL LIFE Pod is a data transmission device, not a diagnostic or therapeutic device that directly measures physiological parameters. Its function is to transmit data, and the provided document focuses on demonstrating substantial equivalence to predicate devices based on software, hardware, and user experience, rather than performance against a specific clinical metric.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample size for test set, expert involvement, adjudication method, MCMC study, standalone performance, type of ground truth, training set details) cannot be extracted from the given text because such information is not present or relevant to the device's function as described.

The document states:

• "Differences with the new Pod have been demonstrated not to affect safety or effectiveness of the device, using software design controls, V&V testing, and user testing of the device."
• "Hardware, software, and the manufacturing processes are the same as the predicate Pod. Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance."
• "Since the Pod is a wireless device, the radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards."
• "User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting."

This indicates that the "study" was primarily focused on software validation and verification (V&V), hardware testing (specifically RF interference and emissions), and user testing/historical experience to confirm that the updated version of the Pod maintains its intended function and safety without introducing new risks compared to its predicate. There is no mention of performance metrics like accuracy, sensitivity, or specificity, which would typically be associated with diagnostic devices.

Summary of available information:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of clinical or analytical performance metrics. The implied criteria revolve around maintaining software and hardware functionality, compliance with FCC standards, and user-friendliness, equivalent to the predicate device.
   • Reported Device Performance: The text states, "Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance." Also, "radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards." And "User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting." No quantitative performance metrics (e.g., accuracy, reliability of data transmission rate, error rates) are provided.

2. Sample size used for the test set and the data provenance: Not mentioned. The testing described (software V&V, FCC compliance, user testing) does not detail sample sizes. Data provenance is not specified beyond "user testing and historical experience."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned. The device transmits data rather than making a diagnosis or measurement that would require expert ground truth.

4. Adjudication method for the test set: Not applicable or mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This type of study is for diagnostic devices where human readers interpret results.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is an "algorithm only" in the sense that its function is data transmission. The "testing" mentioned is its standalone functionality and compliance, but not in the context of diagnostic performance.

7. The type of ground truth used: Not applicable. The device's function doesn't involve generating data that requires a ground truth in a clinical sense. The "ground truth" for its operation would be successful data transmission and proper function.

8. The sample size for the training set: Not applicable or mentioned, as this is not a machine learning-based diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the 510(k) summary for the IDEAL LIFE Pod™ ILP 0001 details its function as a data transmission accessory and demonstrates its substantial equivalence to predicate devices through software/hardware validation, FCC compliance, and user testing. It does not provide information related to clinical or diagnostic performance studies with specific acceptance criteria or detailed results, as those are not within the scope of this device's intended use.

Ask a specific question about this device

The IDEAL LIFE BP-MANAGER™ is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric technique.

The IDEAL LIFE BP-MANAGER™ should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER ™ should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgeners or recommendations for treatment. Clinical judgment and experience are required for interpretation of information. This device is not intended as a substitute for reedical care.

The IDEAL LIFE POD™ is an optional accessory to the IDEAL LIFE BPMANAGER TM and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting. The IDEAL LIFE POD™ is an optional accessory designed to ssist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intepded as a substitute for medical care.

The IDEAL LIFE BP-MANAGER™ is a single unit software-controlled device with a blood pressure cuff, and operation is automatic. The IDEAL LIFE BP-MANAGFER™ can bc used alone without any other accessories. Blood pressure and heart rate results are displayed on the screen of the IDEAL LIFE BP-MANAGER™. Up to 70 blood pressure readings are stored in the blood pressure computer processor. The device is not intended for self-diagnosis of discase and it is expected that individuals using the IDEAL LIFE BP-MANAGER™ will consult with a physician for interpretation of results.

If an individual desires automated graphical presentation of their blood pressure and heart rate data, the IDEAL LIFE POD™ may be purchased separately and used with the IDEAL LIFE BP-MANAGER™ as an optional accessory. The IDEAL LIFE POD™ is not required for operation of the IDEAL LIFE BP-MANAGER™ . The IDEAL LIFE POD™ is a simple transmitter (i.e., a wireless router) that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting.

The provided text describes the IDEAL LIFE BP-MANAGER™ and IDEAL LIFE POD™ devices. However, it does not contain specific acceptance criteria or detailed results from a study that definitively proves the device meets such criteria in a quantitative manner as requested in the input format.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that the performance testing was conducted "in accordance with the guidance document entitled 'Non-Invasive Blood Pressure (NIBP) Monitor Guidance' dated March 10, 1997." This guidance document would contain the actual acceptance criteria (e.g., accuracy ranges for blood pressure measurements).

However, the provided text does not explicitly list these acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure readings compared to a reference standard). It only provides a general statement: "Results of these tests confirm the appropriate performance of both the IDEAL LIFE BP-MANAGER™ and the IDEAL LIFE POD™."

Therefore, a table cannot be fully constructed from the provided text.

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing in human volunteers" but does not specify the sample size for this test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document states that performance testing included "performance testing in human volunteers." For a blood pressure monitor, the ground truth is typically established by trained medical professionals using a reference blood pressure measurement method (e.g., auscultation with a sphygmomanometer). However, the document does not specify the number of experts used or their qualifications.

4. Adjudication method for the test set:

The document does not mention any adjudication method 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 is a blood pressure monitor and a data transmitter, not an AI-powered diagnostic tool requiring human interpretation of images or complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

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

The IDEAL LIFE BP-MANAGER™ is a standalone device for measuring blood pressure. The performance testing "in human volunteers" would inherently be a standalone performance evaluation of the algorithm's ability to measure blood pressure. However, the document does not explicitly label it as a "standalone" study in contrast to human-in-the-loop. The IDEAL LIFE POD™ is a data transmitter and doesn't have an "algorithm-only" performance in the sense of making medical judgments.

7. The type of ground truth used:

For the blood pressure measurements, the ground truth would typically be established by concurrent measurements using a validated reference method (e.g., auscultation by trained observers). While not explicitly stated as "ground truth," performance testing in human volunteers for a blood pressure monitor implies comparison against such a standard.

8. The sample size for the training set:

The document does not mention a training set or its sample size. Given the device's function as a blood pressure monitor, it's unlikely to have a "training set" in the context of machine learning. The device's calibration and algorithm development might have used a dataset, but it's not referred to as a "training set" in the provided text.

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

Since no training set is described, this information is not available.

In summary:

The provided document, a 510(k) summary, focuses on establishing substantial equivalence to predicate devices and generally stating that performance tests were conducted according to guidance. It lacks the specific quantitative details requested regarding acceptance criteria, sample sizes for testing, expert qualifications, or detailed study methodology. To obtain such information, one would typically need to refer to the full study reports that were submitted to the FDA, which are not included in this summary.

Ask a specific question about this device