(51 days)
The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.
The PILL PHONE software device will be sold to users of cell phones (or other communication devices) through their cell phone service. The software will have a feature to send out reminders to a cell phone owner of the dosing schedule that has been programmed into the phone, whether the dosing schedule is for the user, a child, or an elderly parent. The software will also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills. The PILL PHONE software is a Minor Level of Concern.
The provided text primarily focuses on the 510(k) summary and FDA clearance for the PILL PHONE medication reminder software device. It details the device's classification, predicate devices, and a brief description of its features. However, it does not include any information about formal acceptance criteria or a study proving the device meets specific performance criteria.
The document is a regulatory submission for market clearance based on substantial equivalence to existing devices, not a scientific study reporting performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, expert qualifications, or ground truth establishment.
The relevant sections are:
- 1. A table of acceptance criteria and the reported device performance: Not found in the document.
- 2. Sample sized used for the test set and the data provenance: Not found in the document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found in the document.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found in the document.
- 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 found in the document. The device is a standalone software, not an AI assistance tool for human readers in a diagnostic context.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "software that operates on a user's cell phone or other wireless device" and is a "medication reminder and information system." This strongly implies a standalone algorithm providing reminders and information. However, no specific performance study is mentioned.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study is described.
- 8. The sample size for the training set: Not found in the document.
- 9. How the ground truth for the training set was established: Not applicable, as no training set or ground truth for it is described.
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.