(90 days)
The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
The ARDO Calypso Pro Powered Breast Pump is a single piston pump for hospital, rental and personal use. The unit is equipped with a robust plastic housing and a simplified, logically-organized keyboard with an LCD display readout. The electrical equipment is designed for outlet and for car battery-operation, or for (optional) battery use. The controls allow each mother to customize the settings through a flexible system for adjusting vacuum and cycles. The ARDO Calypso Pro breast pump's vacuum level remains stable when the user changes the cycle setting. Likewise, the cycle level remains stable when the user changes the vacuum setting.
The provided text is a 510(k) summary for a breast pump, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study for acceptance criteria. As such, it does not contain the information requested for acceptance criteria and a study proving a device meets those criteria.
Specifically, the document states:
"The ARDO Calypso Pro breast pump is identical to the previously cleared ARDO Calypso breast pump, except for a minor difference in the indications for use. There have been no device changes since the last 510(k) notification. Thus, further performance testing was not necessary." and "The ARDO Calypso Pro breast pump is substantially equivalent to the ARDO Calypso breast pump. The ARDO Calypso Pro breast pump is identical to the predicate device except for a minor difference in the indications for use. The minor difference in the indications for use between the ARDO Calypso Pro breast pump and the ARDO Calypso breast pump does not raise new issues of safety or effectiveness. There have been no device changes since the last 510(k) notification. Thus, the ARDO Calypso Pro breast pump is substantially equivalent to the predicate."
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria or study results are presented. The document relies on the predicate device's performance.
- Sample sized used for the test set and the data provenance: No test set was used as no further performance testing was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was used.
- Adjudication method for the test set: Not applicable as no test set was used.
- 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. This device is a breast pump, not an AI-powered diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a breast pump, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for performance testing.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device requiring a training set.
The document primarily provides a Substantial Equivalence Chart comparing the new device (Calypso Pro) to its predicate device (Calypso) based on technological characteristics. This chart indicates that the new device is identical to the predicate device across all listed features except for a minor difference in the "Indication for use" (specifically, the predicate indicated "single users" for indoor use, while the new device indicates "multiple users").
The relevant comparative information from the provided text is included below, but it does not represent acceptance criteria and performance data from a specific study of the new device.
Substantial Equivalence Chart (Modified to reflect acceptance criteria focus, though not explicitly stated as such in the original document):
| Feature | Predicate Device Performance (Implied Acceptance Criteria for New Device) | Reported New Device Performance |
|---|---|---|
| Indication for use | The ARDO Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. | The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users. |
| Suction Connection | 1 suction connection, suitable for double pumping mode via Y connector | same |
| Power Supply | Adaptor: 100 V - 240 V, 50/60 Hz | same |
| Electrical Safety | IEC 60601-1 | same |
| EMC Emitted Interference | Complies with IEC 60601-1-2 | same |
| EMC Interference Resistance | Complies with IEC 60601-1-2 | same |
| Battery | Battery 6 x 1,5 V; 9 V, 1200 mA | same |
| Noise Level |
§ 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).