(112 days)
The ARDO Carum powered 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 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 Pumpset should be used in combination with ARDO breast pumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset.
ARDO Carum and Calypso Powered Breast Pumps consist of the breast milk pump and a pump set (single or double pump set). They are double piston or reciprocating pumps for hospital, rental and personal use. The units are 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. For both the Carum and Calypso breast pumps, the vacuum level remains stable when the user changes the cycle setting. Likewise, the cycle level remains stable when the user changes the vacuum setting. A non-sterile pump set is included for collection and storage of milk.
Three models of ARDO Powered Breast Pumps are available:
- -Calvpso with battery compartment and outlet adapter:
- -Carum with outlet cord: and
- -Carum with built in rechargeable battery and outlet cord.
Accessories for Carum include:
- -Power cord:
- -Protective carrying case;
- Car adapter (12VDC); -
- -Trolley;
- Bottle holder: -
- -EasvFreeze holder:
- EasyFreeze bag; and -
- -PumpSets.
Accessories for Calvpso include:
- Power cord; -
- Bottle holder; -
- Nylon bags for accessories and for the PumpSet; -
- -EasyFreeze bag;
- -Breastfeeding bag (Shoulder Bag consisting of cold bag, cooling elements, Calvpso bag and Pumpset bag); and
- -Pumpsets.
The provided text is a 510(k) summary for the ARDO Carum and Calypso Powered Breast Pumps. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device. However, it does not describe an AI/ML powered device, nor does it detail acceptance criteria and a study proving an AI device meets those criteria in the typical sense of diagnostic performance metrics like sensitivity or specificity.
Therefore, many of the requested points are not applicable as they relate to AI/ML device performance studies. I will address the points that can be inferred from the document regarding the performance tests conducted on the breast pumps.
Here's an analysis based on the provided text, with "N/A" for sections not applicable to this document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted, but it doesn't explicitly define "acceptance criteria" as pass/fail thresholds with numerical targets for each. Instead, it states that the devices "functioned as intended" or that testing "support[s] the safety profile and performance."
| Performance Test Category | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Compliance with relevant ISO and IEC standards; no adverse findings. | - Microbiological Tightness (ISO 11737-1:2006): Performed. |
| - Biocompatibility: | ||
| - Cytotoxicity (ISO 10993-5:2009/(R)2014): Performed. | ||
| - Irritation (ISO 10993-10:2010): Performed. | ||
| - Sensitization (ISO 10993-10:2010): Performed. | ||
| - Acute systemic toxicity (ISO 10993-11:2006/(R)2010): Performed. | ||
| Conclusion: Device materials were demonstrated to be biocompatible for intended use. | ||
| Electrical & Mechanical Functionality | Compliance with relevant IEC standards; device functions as specified. | - Electromagnetic Safety (IEC 60601-1-2:2007): Performed. |
| - Electrical Safety (IEC 60601-1:2005): Performed. | ||
| - Battery Safety (IEC 62133:2003, EN 60068-2-27:2009, EN 60068-2-6:2008): Performed. | ||
| - Max vacuum pressure during a simulated 20-min session meets specifications. | - Vacuum Pressure over Time: Evaluation conducted to determine max vacuum pressure during a simulated 20-minute pumping session. | |
| Conclusion: In all instances, the ARDO Carum and Calypso Powered Breast Pumps functioned as intended. | ||
| Software Performance | Software verified and validated. | - Software: Verified and validated. |
| Overall Performance & Substantial Equivalence | Performs as intended, safe, and effective, demonstrating substantial equivalence to predicate. | Conclusion: Performed as intended and in a manner substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML model's performance. The "tests" mentioned are engineering and safety tests on the physical breast pump devices. The sample size for these engineering tests is not explicitly stated but would typically involve a certain number of manufactured units or material samples. The data provenance is not described in terms of country of origin or retrospective/prospective for typical medical device performance studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This information is relevant for AI/ML diagnostic or prognostic studies, not for the physical device performance testing described.
4. Adjudication method for the test set
N/A. Not applicable to the type of device and testing described.
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
N/A. This is a breast pump, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device (breast pump), not an algorithm.
7. The type of ground truth used
For the safety and performance tests:
- Safety & Biocompatibility: Ground truth is established by the specified ISO and IEC standards and their defined methodologies for evaluation.
- Electrical & Mechanical Functionality: Ground truth is established by the defined specifications of the device (e.g., intended vacuum pressure range, cycle range) and compliance with IEC standards for electrical and battery safety. "Functioned as intended" implies comparison against design specifications.
- Software Performance: "Verified and validated" against software requirements and design specifications.
8. The sample size for the training set
N/A. There is no AI/ML model training discussed in this document.
9. How the ground truth for the training set was established
N/A. There is no AI/ML model training discussed in this document.
§ 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).