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The Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, and AOV6852) is a powered breast pump to be used by lactating women to express and collect milk from their breast Pump is intended for a single user.

The subject devices, Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, AOV6852), are powered breast pumps to be used by lactating women to express and collect milk from their breast. The proposed devices are battery powered, software-controlled, and intended for a single user. The devices are intended for home use. The subject devices have the following modes: Massage mode, Expression mode, Bionic mode, Frequency Conversion mode A, Frequency Conversion mode B, Continuous suck mode and Mixed mode; each mode has multiple levels. Massage mode is for stimulating breast milk secretion. Expression mode is for pumping breast milk. Bionic mode cycles between massaging for 2 cycles and expressing for 2 cycles. Frequency Conversion mode A cycles between massaging for 3 cycles and expressing for 1 cycle. Frequency Conversion mode B cycles between massaging for 3 cycles and expressing for 2 cycles. Continuous suck mode applies a lower suction followed by a hold and then a second increase in suction before release as a cycle. Finally, Mixed mode cycles between massaging for 3 cycles and expressing for 1 cycle at levels 1-6, then cycles between massaging for 3 cycles and expressing for 2 cycles at levels 7-9. The subject devices can be used in a single or double pumping configuration and have anti-backflow protection. The subject devices have a USB connecting cable and matching power adapter to supply power to the device. The subject devices are provided non-sterile and are not to be sterilized by the user prior to use. Each device includes a breast shield assembly, collection bottles, tubing set, feeding accessories, power adapter (for charging), and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body, which contacts the user's breast.

This is a 510(k) premarket notification for an Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) and not a study detailing the development and validation of an AI/ML powered device. As such, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is not applicable or available within this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Electric Breast Pump Models 918, HF918, K211024) through non-clinical testing. It highlights that the subject and predicate devices have the same indications for use and intended use. The non-clinical tests performed are related to the safety and performance of the physical device components, not AI/ML algorithm performance.

Here's a breakdown of the available information regarding device performance and acceptance criteria from the provided text, adapted to your table format where possible, and noting what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Massage mode: AOV6818: 80-200, AOV6821: 100-200, AOV6826: 80-180, AOV6830: 80-200, AOV6852: 80-200 (mmHg ±5 mmHg)
• Expression mode: AOV6818: 150-280, AOV6821: 160-280, AOV6826: 120-280, AOV6830: 120-280, AOV6852: 100-260 (mmHg ±5 mmHg) |
  | Backflow and Overflow | No liquid backflow into tubing and motor even if bottle is over-filled. | "The test results showed that there was no backflow during the test." |
  | Cycle Speed | Compliance with the design specifications of the subject devices throughout the use life. Ranges for various modes and models are listed. | "All the test results complied with the design specifications of the subject devices throughout the use life." Sample ranges include:
• Massage mode: AOV6818: 39-95, AOV6821: 36-55, AOV6826: 42-91, AOV6830: 30-98, AOV6852: 59-128 (times/Min ±2 times/Min) |
  | Battery Indicator | The battery status indicator remains functional during its stated battery life. | Battery indicator testing was conducted to demonstrate functionality. |

Since this document is a 510(k) summary for a powered breast pump (a traditional medical device), and not an AI/ML device, the following points are not applicable or derivable from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable for a physical device's non-clinical safety/performance testing. The "test set" would be the manufactured devices and their components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering specifications and objective measurements against those specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance would be objective measurements against engineering design specifications and relevant international standards (e.g., IEC standards for electrical safety, ISO 10993 for biocompatibility).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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