Search Results

The Ameda Mya Joy PLUS breast pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The Mya Joy PLUS Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The Mya Joy PLUS Breast Pump utilizes a DC-powered motor driving a diaphragm-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies. The Mya Joy PLUS Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes and control vacuum strength within each mode, 6 levels of vacuum strength in stimulation and 12 levels in expression. The Mya Joy PLUS Breast Pump is intended for a single user in the home environment. When properly connected, the Ameda Hygienikit pumping kit transfers the vacuum generated by the powered pump to the breast enabling expression and collection of milk. A diaphragm in the breast flange assembly physically isolates pump and tubing from the space where milk is expressed, flows and is collected, effectively protecting the breast milk from contamination. The pump allows lactating women to express milk at their own convenience and maintain their milk supply. The base model of the Mya Joy PLUS Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard. Optional accessories, such as a carrying bag or spare parts for the pumping kit, may be included in the packaging of other product offerings.

I am sorry, but the provided text describes the 510(k) premarket notification for a breast pump, not an AI/ML-enabled medical device. Therefore, the document does not contain the information needed to answer your request regarding acceptance criteria and study details for an AI/ML device.

The document discusses:

• Device: Mya Joy PLUS Breast Pump (a powered breast pump)
• Predicate Device: Cimilre F1 powered breast pump
• Acceptance Criteria: Related to physical and electrical performance of the breast pump (e.g., vacuum range, cycle range, noise level, battery performance, electrical safety, EMC, biocompatibility, device life, packaging integrity).
• Study Proving Acceptance: Non-clinical tests involving measurements of vacuum, noise, and environmental tolerance, and safety testing against recognized standards (e.g., ISO, IEC). No clinical testing was required or performed for this submission.

Thus, I cannot extract information about:

1. A table of acceptance criteria for an AI/ML device or its reported performance.
2. Sample sizes for test sets (as there's no AI/ML model being tested).
3. Number of experts or their qualifications for ground truth (as there's no AI/ML model for which ground truth is established).
4. Adjudication methods.
5. MRMC comparative effectiveness studies or human reader improvement with AI assistance.
6. Standalone AI algorithm performance.
7. Type of ground truth (e.g., expert consensus, pathology, outcomes data).
8. Training set sample size.
9. How ground truth for a training set was established.

To answer your request, I would need a document related to an AI/ML medical device submission.

Ask a specific question about this device