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510(k) Data Aggregation
(133 days)
The Ameda Pearl Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ameda Pearl Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
The Ameda Pearl Electric Breast Pump is an electric breast pump powered by an external AC-DC power supply or its 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 Ameda Pearl Electric 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 and pumping (cycle) speeds. Vacuum is monitored continuously by a sensor mounted on an internal printed circuit board. The Ameda Pearl Electric Breast Pump has a backlit LCD display, which shows pumping mode, suction level, cycle speed level, timer, and battery charge level. Surrounding the front panel display are eight soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, control vacuum strength and cycle speed, and adjust the lighting intensity of the LCD display and of a nightlight which shines from the underside of the pump handle. There are 6 levels of suction strength in stimulation mode and 12 levels in expression mode. While the user can select any of 6 available cycle speeds at each of the 12 vacuum levels in expression mode, the cycle speed in stimulation mode is pre-set at each of the 6 vacuum levels available in that mode. At minimum vacuum, level 1, the cycle speed is highest, 120 CPM (cycles per minute). Medium vacuum levels 2 and 3 are cycled at 100 CPM, and the highest 3 vacuum levels are delivered at 80 CPM. The Ameda Pearl Electric Breast Pump is primarily intended for multiple users in a hospital environment. Use is also expected 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 air space where milk is expressed and collected, protecting the breast milk from contamination. The Ameda Pearl Electric Breast Pump is supplied with an AC adapter. HygieniKit is not included.
The Ameda Pearl Electric Breast Pump is a powered breast pump intended for lactating women to express and collect milk. It is designed for multiple users in a hospital setting and single-user home use.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics (like vacuum pressure accuracy or cycle speed consistency) with their corresponding reported device performance values. Instead, it states that "Specifications were met under all conditions" for vacuum pressure and cycle speed.
However, a comparison table with the predicate device (Spectra S3 Plus Breast Pump) provides insights into the operational characteristics and implicit performance expectations. While not formal 'acceptance criteria' in the strict sense, these values reflect the operational range and expected performance of the device.
| Feature | Acceptance Criteria (Implicit from design/comparison) | Reported Device Performance (from summary) | Notes |
|---|---|---|---|
| Power Source (External) | AC/DC adapter supporting 15V, 2A DC operation | AC/DC adapter 15V, 2A DC | Meets its own designed power input. |
| Power Source (Internal) | Rechargeable lithium-ion battery, 10.8V, 2600 mAh | Rechargeable lithium-ion battery, 10.8V, 2600 mAh | Matches its own design specifications. |
| Battery Performance | ≥ 4 hours on full charge | 4 hours on full charge | Meets specified battery life. This is an improvement over the predicate device (3 hours). |
| Auto Power-off | After 60 minutes in expression mode | After 60 minutes in expression mode | Meets specified auto-off duration. This is a longer duration than the predicate (30 minutes), indicating a design choice. |
| Pump Type | Diaphragm | Diaphragm | Matches its own design. |
| Modes | Stimulation and Expression | Stimulation and Expression | Matches its own design. |
| Vacuum Levels | 6 in stimulation mode, 12 in expression mode | 6 in stimulation mode, 12 in expression mode | Matches its own design. The predicate has 5 in massage mode and 12 in expression mode, suggesting a slight difference in stimulation/massage phase granularity. |
| Vacuum Range | 30 – 250 mm Hg | 30 – 250 mm Hg | Matches its own design specifications. The predicate device has a slightly different range (50 – 270 mm Hg), indicating a different operational characteristic that the submission implicitly argues does not raise new safety/effectiveness questions. |
| Cycle Speed Range (Stimulation) | 80, 100, 120 cycles/minute | 80, 100, 120 cycles/minute | Matches its own design. The predicate has a fixed 70 cycles/minute in massage mode. The difference here is a key technological characteristic that was assessed for safety and effectiveness during the substantial equivalence determination. |
| Cycle Speed Range (Expression) | 30 – 48 cycles/minute | 30 – 48 cycles/minute | Matches its own design. The predicate has 38 – 54 cycles/minute in expression mode. Similar to vacuum range, this difference was assessed for substantial equivalence. |
| LCD Display | Mode, Time, Vacuum Level, Battery Status, Cycle speed | Mode, Time, Vacuum Level, Battery Status, Cycle speed | Matches essential display elements of the predicate. |
| LCD Brightness | 3-level adjustable | 3-level adjustable | This is an improvement over the predicate (non-adjustable). |
| Night Light Brightness | 3-level adjustable | 3-level adjustable | This is an improvement over the predicate (2-level adjustable). |
| Button Controls | 8 buttons (Power, Mode, Suction, Cycle Speed, LCD, Night light) | 8: Power, Mode, Suction increase and decrease, Cycle Speed increase and decrease, LCD brightness, Night light brightness | More granular control options compared to the predicate (7 buttons) by including a dedicated LCD brightness control. |
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Risk Analysis in accordance with ISO 14971:2019, Electrical safety testing per IEC 60601-1, Electromagnetic compatibility testing per IEC 60601-1-2, Use in home healthcare per IEC 60601-1-11 | Fully compliant with relevant safety standards. This is a critical component of establishing safety for substantial equivalence. |
| Software | Verification and validation per FDA guidance | Software verification and validation conducted; Moderate level of concern. | Complies with FDA guidance for software in medical devices. |
| Backflow/Overflow Protection | Adequate protection demonstrated | Testing confirmed device life and battery operating time, battery indicator accuracy, and protection against backflow and overflow. | This is a critical safety feature for breast pumps. The confirmation of its efficacy is a key performance criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of subject data (e.g., lactating women). The testing described is bench performance testing and non-clinical engineering tests. Therefore, specific sample sizes for human subjects or data provenance (country of origin, retrospective/prospective) are not applicable or provided in this context. The testing involved the device units themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The study primarily describes non-clinical engineering and bench performance testing. There is no mention of human expert-established ground truth related to clinical outcomes or interpretation of data in the provided text, as this is a device performance test, not a diagnostic or interpretative AI study.
4. Adjudication Method for the Test Set
Not applicable, as the testing described is non-clinical bench testing and does not involve human interpretation or subjective assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, often with and without AI assistance, to assess performance and impact on human decision-making. The Ameda Pearl Electric Breast Pump is a mechanical device, and its evaluation focuses on physical performance parameters and safety, not diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, in a sense. The bench performance testing evaluates the device's inherent mechanical and electrical performance (e.g., vacuum pressure generation, cycle speed consistency) without human interaction or interpretation as part of the primary outcome. This type of testing is analogous to "standalone" performance for mechanical devices, demonstrating the device's capabilities on its own.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing was based on:
- Engineering Specifications: The device's designed vacuum pressure range, cycle speeds, battery life, and other operational parameters.
- International Standards: Compliance with recognized standards such as ISO 14971 (Risk Analysis), IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and IEC 60601-1-11 (Home Healthcare).
- FDA Guidance: Software verification and validation followed the 2005 FDA guidance document.
- Functional Verification: Confirmation of features like backflow/overflow protection and battery indicator accuracy.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for an AI/ML algorithm mentioned in the context of this device.
Ask a specific question about this device
(136 days)
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:
- A table of acceptance criteria for an AI/ML device or its reported performance.
- Sample sizes for test sets (as there's no AI/ML model being tested).
- Number of experts or their qualifications for ground truth (as there's no AI/ML model for which ground truth is established).
- Adjudication methods.
- MRMC comparative effectiveness studies or human reader improvement with AI assistance.
- Standalone AI algorithm performance.
- Type of ground truth (e.g., expert consensus, pathology, outcomes data).
- Training set sample size.
- 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.
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