(157 days)
The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Electric Breast Pump Model: YM-8166 is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
The provided text is a 510(k) summary for an Electric Breast Pump Model: YM-8166. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing related to safety and effectiveness, rather than a clinical study evaluating the accuracy or performance of an AI/ML algorithm with human-in-the-loop.
Therefore, the specific information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets (in the context of AI models), expert ground truth, multi-reader multi-case studies, and training set information for AI, is not applicable to this device and the provided document.
The document describes the device's technical specifications and how they compare to a predicate device, along with the results of various engineering and biological safety tests.
Here's the relevant information that can be extracted from the provided text, framed in the context of device performance, rather than AI performance:
Acceptance Criteria and Device Performance (Non-AI/ML Device)
This device, an Electric Breast Pump, is a mechanical and electrical medical device. Its "performance" is assessed based on its ability to effectively and safely express milk, primarily through its engineering specifications and biological material compatibility, not through an AI algorithm's diagnostic or predictive accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Aspect | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (from "Summary of Non-Clinical Performance Testing") |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing (per ISO 10993-5, -10, -23) | "The patient-contacting components of the subject device were shown to be non-cytotoxic, non-irritating, and non-sensitizing." |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2 | "Electrical safety and EMC testing was performed per the following standards:" (followed by a list of standards met) |
| Software Verification & Validation | Consistent with "basic level of concern" per FDA guidance, all software requirement specifications met, all software hazards mitigated. | "System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels." |
| Suction Strength & Cycle Speed | Complied with design specifications throughout use life. | "Suction strength and cycle speed of subject devices were tested. All the test results complied with the design specifications of the subject device throughout the use life." |
| Backflow Prevention | No liquid backflow into tubing/motor. | "Backflow testing was conducted... The test results showed that there was no backflow during the test." |
| Battery Performance | Remains functional during stated use-life. | "Battery performance testing was conducted to demonstrate that the battery remains functional during its stated use-life." |
| Battery Status Indicator | Remains functional during stated battery life. | "Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life." |
| Intended Use | Express milk from lactating women for collection (consistent with predicate). | "The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts." (Matches predicate's intended use). |
| Operational Characteristics | Similar to predicate, with differences not raising new safety/effectiveness questions (e.g., suction range, cycle speed). | "The Electric Breast Pump Model: YM-8166 has the same intended use, mode of action and similar operational characteristics as the predicate device... The different technological characteristics... do not raise different questions of safety and effectiveness." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of an AI algorithm. For non-clinical performance testing (e.g., biocompatibility samples, electrical safety tests, functional tests), the sample sizes are implicitly defined by the testing standards and protocols used. These are typically engineering samples of the device, not a "data set" of patient cases.
- Data Provenance: The testing was conducted by the manufacturer, Guangdong Youmeng Electrical Technology Co., Ltd., based in China. The nature of these tests (e.g., bench testing, material testing) means there's no patient data involved, hence no "retrospective or prospective" designation in the AI sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device does not use an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for this device's performance is objective measurements (e.g., electrical readings, vacuum pressure, material properties) and laboratory test results as per established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication is described or required for the type of non-clinical, objective performance testing conducted for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant or performed.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. There is no standalone AI algorithm for medical interpretation being evaluated. The device has embedded software for controlling the pump's functions (e.g., vacuum pressure, cycle speed), and its verification and validation are noted, but this is functional software, not an AI for diagnosis or treatment decision support.
7. The Type of Ground Truth Used
- Objective Measurements and Standard Compliance: The "ground truth" for this device's performance is based on established engineering specifications, published international standards (e.g., IEC for electrical safety, ISO for biocompatibility), and bench test results (e.g., vacuum pressure readings, cycle speeds, observing no backflow). It is not expert consensus, pathology, or outcomes data in the sense of clinical decision-making.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set of data for model development. The software is noted as having "Verification and Validation" but this refers to traditional software engineering processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, this question is not relevant. Software "ground truth" or correct functionality is established through design specifications, requirements, and traditional software testing methodologies.
In summary, the provided document is a regulatory submission for a standard medical device (an electric breast pump) that relies on non-clinical performance testing and substantial equivalence to a predicate device, not on AI/ML algorithm performance. Therefore, many of the questions related to AI evaluation criteria are not applicable.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).