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The Perifit Pump is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Perifit Pump is an electrically powered wearable single breast pump consisting of the following key components: a housing ("hub") containing pump electronics (motor, valve, PCB, rechargeable battery and associated components), and detachable milk-contacting components: a silicone flange (breast shield), a plastic (polypropylene) connector, silicone diaphragm, a silicone duckbill valve, a plastic bottle. Accessories provided with the Perifit Pump include a screw-on container lid, a USB charging cable, and bra adjustment buckle. The Perifit pump is a closed-system breast pump.

The hub user interface allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 8 vacuum levels, capable of providing suction from 30 to 285 mmHg, with cycle speeds ranging from 68 to 120 cycles per minute in stimulation mode and 28 to 80 cycles per minute in expression mode.

The Perifit Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1500mAh). The breast pump cannot be operated while it is being charged. The Perifit Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment.

An optional smartphone app may be used with the Perifit Pump. The app may be used to control the operation of the breast pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Perifit Pump.

The Perifit Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.

The Perifit Pump, a wearable electric breast pump, underwent various non-clinical performance tests to demonstrate its substantial equivalence to the predicate device, the Elvie Stride (K210936). The acceptance criteria for these tests were based on relevant international and national standards, as well as FDA guidance documents.

Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size for any of the non-clinical tests conducted. It generally states that "Performance testing... included" these tests, implying empirical evaluation. The data provenance is also not explicitly stated regarding whether it was retrospective or prospective, or country of origin. However, given the nature of the tests (biocompatibility, electrical safety, mechanical performance), they are typically conducted prospectively in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable to the described non-clinical performance and safety testing. These tests rely on established scientific and engineering standards and measurements, not expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for human interpretation of medical images or data. The described tests are based on objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not explicitly stated or described. The document focuses on non-clinical performance and safety testing to demonstrate substantial equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.

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

This question is largely not applicable in the context of the Perifit Pump as a physical medical device. While the device does use embedded software and has an optional smartphone app, the "standalone performance" typically refers to the diagnostic accuracy of AI algorithms without human intervention. The software in the Perifit Pump is for controlling pump operations, saving history, and estimating milk volume, not for diagnostic purposes. The software verification and validation would confirm its functionality and adherence to specifications, which is a form of standalone testing for the software component.

7. The type of ground truth used

The ground truth for the non-clinical tests was based on established physical, chemical, and electrical standards and specifications. For instance:

• Biocompatibility: In vitro and in vivo testing against established criteria for cytotoxicity, sensitization, and irritation.
• Electrical Safety & EMC: Compliance with limits and requirements defined in IEC and AAMI standards.
• Material Compliance: Adherence to specific chemical composition and safety requirements outlined in 21 CFR.
• Performance Testing: Measured vacuum levels, cycle speeds, and other operational parameters against predefined engineering specifications. For backflow protection, the ground truth is the absence of liquid in the air-pumping system. For use life, it's maintaining performance over a specified duration.

8. The Sample Size for the Training Set

This information is not applicable as the document describes non-clinical performance and safety testing, not the development or evaluation of a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as the document describes non-clinical performance and safety testing, not the development or evaluation of a machine learning algorithm.

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The Perifit Care+ is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Perifit Care+ is indicated for an adult female.

The Perifit Care+ device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.

The provided document is a 510(k) summary for the Perifit Care+ device. It outlines the device's indications for use, technological characteristics, and comparison to a predicate device (Perifit K221476) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (Perifit K221476) through similarity in indications for use, technological characteristics, and safety testing.

The "reported device performance" is largely described through the completion of various non-clinical performance tests, indicating the device met the standards for safety and functionality, rather than achieving specific quantitative performance metrics against a defined acceptance criterion.

However, based on the provided text, we can infer some "acceptance criteria" from the testing performed and the comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical performance test (e.g., number of units dropped, number of users for the questionnaire). It also does not explicitly state the provenance (country of origin, retrospective/prospective) for these tests, except that they were conducted to a standard (e.g., ISO, IEC). User testing via a questionnaire is mentioned, implying a human subject component, but details are absent.

This type of information is usually detailed in the full 510(k) submission, not typically in the public summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies described are primarily non-clinical, involving engineering and materials testing, and software validation, rather than clinical studies requiring expert ground truth for diagnostic accuracy. The "user testing through a questionnaire" is a form of user experience or usability testing, not typically a "ground truth" establishment in a diagnostic context.

4. Adjudication Method for the Test Set

Since there's no mention of a diagnostic accuracy study or establishment of "ground truth" by experts, an adjudication method (like 2+1 or 3+1) is not applicable and not mentioned in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. The Perifit Care+ is a patient-operated perineometer providing biofeedback, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output with or without AI assistance. The effectiveness is primarily linked to the patient's own exercise and biofeedback, not an external reader's interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The device is a perineometer that provides biofeedback for pelvic floor muscle exercise via a smartphone app. Its "performance" is based on its ability to accurately sense muscle contractions and transmit that data, along with the functionality of the app itself. The software verification and validation (and "sensor behavior testing") would assess its standalone performance in these aspects. There's no "algorithm only" performance reported in the sense of an AI model making a diagnosis or prediction without human input, as this is not the nature of the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be established by:

• Engineering specifications and standards: For mechanical, electrical, and sensor performance (e.g., a drop test either meets or fails a predetermined physical integrity standard).
• Reference materials/methods: For biocompatibility testing (e.g., cell cultures, animal models for irritation).
• Software requirements and design specifications: For software V&V (the software performs as designed and meets requirements).
• User feedback/comprehension: For the user questionnaire (users correctly understand labeling and operation).

There is no mention of ground truth established by expert consensus, pathology, or outcomes data related to diagnostic accuracy, as it's not a diagnostic device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in this context. The device is not an AI/ML model that is "trained" on a dataset in the conventional sense for making diagnostic predictions. Its software includes an application and embedded firmware, which are developed and validated against requirements, not "trained."

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a "training set" in the context of machine learning, this information is not applicable and not provided. Software "ground truth" would be established by its adherence to design specifications and user requirements during the development and validation phases.

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The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Perifit is indicated for an adult female.

The Perifit device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.

The Perifit is a perineometer designed to treat stress, mild-moderate urge, and mixed urinary incontinence in women by strengthening pelvic floor muscles through exercise. It provides biofeedback via smartphone technology. The Perifit is indicated for adult females and is available over-the-counter.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" in the context of clinical performance data in the typical sense of evaluating diagnostic accuracy or treatment efficacy with patient outcomes. The performance data focuses on device safety, electrical safety, biocompatibility, software validation, and mechanical durability, which are typically evaluated through engineering tests and specific standards.

• Biocompatibility: The ISO 10993 tests would involve specific biological samples or animal models depending on the sub-part (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation/toxicity). The sample sizes for these specific tests are not detailed.
• Mechanical Tests: The number of devices subjected to mechanical drop and durability testing is not specified.
• Sensor Behavior/User Comprehension: A "questionnaire" was used, but the sample size of users and data provenance (e.g., country of origin, retrospective/prospective) for this survey are not stated.

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

This information is not applicable or provided in the document. The document describes a 510(k) submission for a perineometer, which is a biofeedback device, not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth for a test set. The "ground truth" for this device relates to its adherence to safety and performance standards (e.g., biocompatibility standards, electrical safety standards, mechanical performance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. The document does not describe a clinical study requiring adjudication of expert interpretations or diagnoses.

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. The Perifit is a perineometer for pelvic floor muscle exercise and biofeedback, not an AI-assisted diagnostic or interpretation system that would involve human "readers" or an MRMC study.

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

Not applicable. The Perifit is a physical device that works with a smartphone app for biofeedback. Its performance is intrinsically linked to user interaction and physical measurements. It is not an algorithm that operates "standalone" in a diagnostic or interpretive capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the Perifit's performance is its compliance with established engineering and safety standards and its ability to provide biofeedback, rather than a clinical ground truth like pathology or expert consensus on a diagnosis.

• Biocompatibility: ISO 10993 standards define the "ground truth" for material biological safety.
• Electrical Safety: IEC 60601 standards define the "ground truth" for electrical safety.
• Software Validation: FDA guidance and IEC 62304 define the "ground truth" for software quality and safety.
• Mechanical Performance: Internal specifications and durability testing protocols define the "ground truth" for mechanical integrity.
• Functionality (Biofeedback): The device's ability to accurately sense pelvic floor muscle contractions and transmit them to the app for user feedback is the functional ground truth, demonstrated through sensor behavior testing.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML model that undergoes "training" in the traditional sense. The development and verification process involves engineering design, testing against standards, and software validation.

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

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

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