(90 days)
Potty Pal: This device is indicated as a daytime enuresis alarm that may be used by a parent or caregiver to assist toddlers in toilet training.
Forevery Dry: This device is indicated as nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem.
The Forever Dry and Potty Pal consist of: Training parts, which has sewn in mylas conductive strips. The strips are connected to an audible alarm. Powered by a 9V battery
This is a tricky request as the provided text doesn't describe a study to prove acceptance criteria for a device in the traditional sense of an AI/software device. The document is an FDA 510(k) clearance letter for two physical devices: "Potty Pal" and "Forever-Dry," which are enuresis alarms. The clearance is based on substantial equivalence to devices marketed before May 28, 1976, not on performance metrics from a specific study against acceptance criteria as one would expect for an AI algorithm.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will explain where the information is missing or not applicable within the context of these documents.
Acceptance Criteria and Device Performance
Since this is a 510(k) clearance based on substantial equivalence for physical enuresis alarms, there aren't explicit, quantified "acceptance criteria" and "reported device performance" in the same way an AI algorithm might have. The "performance" is implicitly tied to the predicate devices and the functionality described.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the context):
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Functional Equivalence: Device effectively functions as an enuresis alarm. | The device consists of "Training parts, which has sewn in mylar conductive strips. The strips are connected to an audible alarm." It is "Powered by a 9V battery," implying functionality similar to predicate enuresis alarms. |
| Intended Use: Device is suitable for its stated indications. | "Potty Pal: ...daytime enuresis alarm... to assist toddlers in toilet training." "Forever Dry: ...nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem." This aligns with the fundamental purpose of enuresis alarms. |
| Safety: Device operates without undue harm. | (Not explicitly stated in the provided text, but assumed under general regulatory requirements for medical devices). |
| Predicate Equivalence: Device is substantially equivalent to a legally marketed predicate device. | The FDA letter states: "we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." The product code 78 KPN for "Enuresis Alarm" indicates it falls into an established category. |
Study Details (Based on available information and the nature of a 510(k) for these devices)
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The provided documents describe a 510(k) clearance for physical devices based on substantial equivalence, not a testing study with a "test set" in the context of an AI algorithm. There is no mention of clinical data or performance testing in terms of patient sample sizes.
- Data Provenance: Not applicable for a test set. The determination is based on a comparison to predicate devices legally marketed prior to May 28, 1976, as well as the device's design description.
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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. There was no "ground truth" established by experts for a "test set" in the context of these physical devices. The FDA's review process involves regulatory experts evaluating the submission against existing regulations and predicate devices.
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Adjudication method for the test set:
- Not applicable. No "test set" or adjudication method described for performance evaluation.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for evaluating human reader performance, often with or without AI assistance. This is a clearance for physical enuresis alarms, not an AI software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are physical, non-AI devices.
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The type of ground truth used:
- For the substantially equivalent determination, the "ground truth" is adherence to existing regulatory standards and the known performance characteristics of legally marketed predicate enuresis alarms. There's no specific "ground truth" in terms of pathology or clinical outcomes data described for this 510(k) submission. The devices' efficacy is implied by their classification and equivalence to established technologies.
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The sample size for the training set:
- Not applicable. These are not AI/machine learning devices, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable as there is no training set.
Summary: The provided documents pertain to an FDA 510(k) clearance for two physical enuresis alarm devices ("Potty Pal" and "Forever-Dry") based on substantial equivalence to predicate devices. This regulatory pathway does not typically involve the kind of detailed performance study with acceptance criteria, test/training sets, expert ground truth, or MRMC studies that would be associated with evaluating an AI algorithm. The clearance signifies that the FDA has determined the device is as safe and effective as a legally marketed predicate device.
§ 876.2040 Enuresis alarm.
(a)
Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.