(128 days)
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:
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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.
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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."
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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.
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Adjudication method for the test set: Not applicable or mentioned.
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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.
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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.
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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.
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The sample size for the training set: Not applicable or mentioned, as this is not a machine learning-based diagnostic device.
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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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.