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SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.

SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.

The provided text does not contain information regarding specific acceptance criteria for device performance or a detailed study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the Simavita SIM™ System, which outlines the device's substantial equivalence to a predicate device and its intended use, but does not provide quantitative performance metrics or a detailed study description with ground truth and expert involvement.

Here's a breakdown of what is and is not available in the provided text, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available. The document states that "SIM™ was subjected to biocompatibility testing, electrical safety and electromagnetic safety testing, standard testing for electrical equipment intended for measurement purposes, safety testing for information technology equipment, and other relevant performance testing. In all instances, SIM™ functioned as intended and the results observed were as expected." However, it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance results for the device's primary function of monitoring wetness events.

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

• Not available. The document states "SIM™ functioned as intended and the results observed were as expected" for various tests, but it does not specify any sample sizes for these tests, nor does it mention data provenance (e.g., country of origin, retrospective/prospective).

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

• Not available. There is no mention of a test set requiring expert-established ground truth for performance evaluation of the wetness monitoring function. The reported testing focuses on safety and general functionality.

4. Adjudication method for the test set:

• Not available. This information is typically relevant when multiple experts are involved in establishing ground truth or reviewing cases, which is not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• Not available. The document does not describe any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is an "Enuresis Alarm" for remote monitoring of wetness, not a diagnostic imaging AI system that typically involves human readers in an MRMC study.

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

• Not available in the sense of a detailed performance study. The device's function is standalone in terms of detecting wetness events, but the document doesn't provide a rigorous, quantitative standalone performance study with metrics like sensitivity, specificity, etc. It only states that the device "functioned as intended."

7. The type of ground truth used:

• Not explicitly stated for the core function of wetness detection. For the safety and electrical performance tests, the "ground truth" would be established by the adherence to regulatory standards and expected performance. However, for the primary function of wetness detection, no specific ground truth methodology (e.g., actual wetness measured by a different method, expert observation) is described in the provided text.

8. The sample size for the training set:

• Not applicable/Not available. The document describes a medical device for wetness monitoring, not an AI/machine learning system that typically requires a training set of data.

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

• Not applicable/Not available. As above, this is not relevant for the type of device and information provided in the 510(k) summary.

In summary, the provided 510(k) summary for the Simavita SIM™ System focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and general safety/performance testing that "functioned as intended." It does not include the detailed quantitative performance metrics, study designs (e.g., sample sizes, expert involvement, ground truth methodologies), or comparative effectiveness studies that your request pertains to.

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The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.

Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.

Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.

The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.

The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.

The provided document is a 510(k) summary for the Hughes Bowel and Bladder System Model MeD-18. This document, primarily from 1997, is concerned with establishing substantial equivalence to a predicate device for regulatory clearance, rather than detailing a clinical study with acceptance criteria and performance metrics in the way a modern AI/ML device submission would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in the provided text. The device described is a physical enuresis alarm, not an AI/ML diagnostic or predictive device.

The document states:

• The device is an "enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected..."
• It "helps persons with incontinence manage or overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins."
• It "functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage."

This type of device would typically rely on engineering specifications for its components (e.g., sensor sensitivity, vibration motor reliability, battery life, material biocompatibility, electromagnetic compatibility) and perhaps user studies for usability and effectiveness in real-world scenarios. However, none of these details are available in the provided FDA 510(k) summary.

In summary, the provided text does not contain the information necessary to describe acceptance criteria and associated study details as requested for an AI/ML device.

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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):

Study Details (Based on available information and the nature of a 510(k) for these devices)

1. 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.

2. 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.

3. Adjudication method for the test set:

   • Not applicable. No "test set" or adjudication method described for performance evaluation.

4. 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.

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

   • Not applicable. These are physical, non-AI devices.

6. 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.

7. 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."

8. 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.

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The proposed device, DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist the control of incontinence. It is designed and used in a manner consistent with the predicate device (l.e., the emission of bodily fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm).

The proposed device. DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist in controlling incontinence. It is designed and used in a manner consistent with the predicate device (i.e., the emission of bodly fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm). DryTime for Bladder Control Silent contains the identical components used in the Health Sense International predicate device, DryTime for Potty Training, except that DryTime® for Bladder Control Silent uses a silent vibrator alarm in place of the audio buzzer alarm of DryTime® for Potty Training.

DryTime for Bladder Control Silent is comprised of a disposable fluid sensor strip unit (Sense'R Strip") attached to a silent vibrator alarm unit, which, in turn, clips via a soft vinyl strap to the front of the undergarment about two inches below the outside of the walstband (fabric is pinched to allow the jaws of clip to attach). The sensor strip unit is the Identical Sense 'R Strip® of the approved DryTime® for Potty Training predicate device, and includes two parallel vertical aluminized mylar sensor strips which are spaced a short distance apart from each other and which are electrically connected to the silent vibrator alarm unit. These aluminized mylar sensor strips are encased inside a disposable soft, absorbent paper sheath; the outer portion of the paper sheath is composed of apertured paper and the inner portion is made of a highly absorbent paper which is in contact with the aluminized mylar sensor strips. When the sensor unit is attached to the undergarment, the sensor strip unlt is extended downward inside the undergarment to lay over the groin. The top side of the paper sheath surrounding the two aluminized mylar sensor strips has an adhesive which secures the strip to the undergarment. The adhesive is exposed by peeling a paper backing from the sensor strip unit.

When the subject urinates or defecates, the released fluid is absorbed by the inner portion of the sensor strip unit through the holes of the outer apertured paper. The absorbed fluid contacts the aluminized mylar sensor strips encased within the paper sheath, and creates a "bridge" between the two conductive strips so that the electrolytes in the fluid complete an electrical circuit with those strips. Once the circuit is completed by the fluid, the alarm is activated to indicate that the person wearing the device has elther urinated or defecated.

At the same time the circuit is completed, a transistor in the alarm unit switches the current to another circuit, thereafter bypassing the aluminized mylar sensor strips. This ensures that the alarm will remain activated once fluld has been detected, regardless of any movements by the subject that might otherwise break the initial circuit created by the fluid bridge between the mylar sensor strips. The activation of the transistor also ensures that current no longer flows through the aluminized mylar sensor strips.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. In fact, it explicitly states the following:

• "Because of the strong similarity between DryTime® for Bladder Control Silent and the predicate device, there has been no nonclinical testing of DryTime® for Bladder Control Silent to demonstrate safety and effectiveness." (Page 4)
• "Because of the strong similarity between DryTime® for Bladder Control Silent and the predicate device, the determination of substantial equivalence does not include an assessment of performance data, and there has been no clinical testing of DryTime for Bladder Control Silent to demonstrate safety and effectiveness." (Page 5)

Therefore, I cannot provide a response with the requested details as they are not present in the given document.

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