(88 days)
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
The subject devices are electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage. The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.
The provided text describes the 510(k) summary for the Philips Avent Comfort Single/Twin Electric Breast Pump (K161532). It outlines performance testing, but it does not contain information about acceptance criteria or a study proving that a "device" (in the context of an AI/ML medical device) meets specific performance criteria like sensitivity, specificity, or accuracy. This document is for a traditional medical device (a breast pump), not an AI/ML algorithm. Therefore, many of the requested fields are not applicable.
However, I can provide information based on the performance testing that was conducted for this breast pump, mapping it to the closest relevant categories where possible.
Acceptance Criteria and Device Performance (Breast Pump)
Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" are related to safety, electrical performance, software validation, usability, biocompatibility, and vacuum performance, rather than diagnostic accuracy metrics.
1. Table of Acceptance Criteria and the Reported Device Performance
| Category / Test Type | Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|---|
| Electrical Safety and EMC | Compliance with AAMI / ANSI ES60601-1:2005 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) and AAMI / ANSI / IEC 60601-1-2:2007 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests). | The device complies with the stated standards. Specific values are not provided, but compliance implies meeting safety thresholds for electrical hazards and electromagnetic interference/emission. |
| Software Verification and Validation | Compliance with AAMI / ANSI / IEC 62304:2006 (Medical device software - Software life cycle processes) and FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". | Software V&V testing was conducted complying to the stated standard and guidance. This implies the software functions as intended and is safe. |
| Usability Testing | Adherence to FDA Guidance 1497, Medical Device Use-Safety Incorporating Human Factors into Risk Management. The implicit criterion is that the device is safe and effective for its intended user population, preventing use errors, and is at least substantially equivalent in usability to the predicate device. | Testing demonstrated that the usability of the subject device is substantially equivalent to the predicate device. |
| Biocompatibility Testing | Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process), ANSI / AMI / ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity), and ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization). The implicit criterion is that patient-contacting materials do not pose unacceptable biological risks (e.g., cytotoxicity, irritation, sensitization). | The testing demonstrated that the patient contacting materials are biocompatible. |
| Vacuum Performance Test (Key Performance Specs) | - Suction levels (stimulation): within acceptable ranges and comparable to predicate (e.g., 127mmHg +/- 15mmHg compared to 40 - 140mmHg for predicate). |
- Cycles per second (stimulation): within acceptable ranges and comparable to predicate (e.g., 1.42 - 2.0 compared to 1.7 - 1.93 for predicate).
- Suction levels (expression): within acceptable ranges and comparable to predicate (e.g., 168 – 250mmHg compared to 45 - 245mmHg for predicate).
- Cycles per second (expression): within acceptable ranges and comparable to predicate (e.g., 0.70 - 0.87 compared to 0.83 – 1.36 for predicate).
- Maximum Vacuum: comparable to predicate (e.g., 250mmHg compared to 270mmHg for predicate).
- Vacuum stability, durability, pump temperatures during operation. | - Suction levels (stimulation): 127mmHg +/- 15mmHg
- Cycles per second (stimulation): 1.42 - 2.0
- Suction levels (expression): 168 – 250mmHg
- Cycles per second (expression): 0.70 - 0.87
- Maximum Vacuum: 250mmHg
The testing demonstrated the mechanical performance and performance specifications of the subject device and validated that the performance of the subject device is substantially equivalent to the predicate device. |
Regarding AI/ML specific questions:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device is a breast pump, not an AI/ML algorithm. Performance testing was conducted on hardware, software functionality, and physical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of diagnostic accuracy for AI/ML does not apply here. Experts involved in testing would be engineers, usability specialists, and potentially clinicians for biocompatibility or usability assessments, but not to establish "ground truth" for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for diagnostic outcomes. Testing involved validation against standards and comparison to a predicate device.
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. No MRMC study was conducted as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical breast pump; there is no standalone algorithm in the sense of an AI/ML diagnostic or assistive tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/ML diagnostic sense. For this device, "ground truth" equates to established engineering specifications, safety standards (e.g., electrical safety, EMC, biocompatibility), and the performance characteristics of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of AI/ML for this device. Software verification and validation would use test cases, not a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).