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510(k) Data Aggregation
(27 days)
The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.
The Ardo Bellis is a breast pump unit for collecting breast milk by application of a defined vacuum with a defined frequency on a woman's breast. The pump needs to be connected to a single or double pump set (Carum and Calypso Powered Breast Pumps, cleared under K141742) to be used on one or two breasts. The case and controls of the pump unit have limited contact with the user and are intended only to control the activities of the device parts that contact the user's breast. The device is comprised of an ON/OFF button and two +/- buttons for adjusting (increasing or decreasing) the vacuum and cycle speed. The pump can also be operated using the accompanying mobile application. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. An integrated battery allows for portable use of the device. With the supplied power adapter, the device can be recharged.
Ardo Bellis can be used indoors in professional as well as home care environments.
This is a 510(k) premarket notification for the Ardo Bellis powered breast pump (K230590). The 510(k) summary explicitly states that the purpose of this submission is not to test a new device or its performance, but to modify the indications for use statement of an existing device (Ardo Bellis) to include "multiple users." The Ardo Bellis itself appears to be a modification of the predicate device, Ardo Alyssa (K212773).
Therefore, this document does not contain an independent study designed to prove that the Ardo Bellis meets specific acceptance criteria based on performance data generated for this 510(k) submission. Instead, it leverages the performance testing done for the predicate device, Ardo Alyssa (K212773), and argues that the changes in the Ardo Bellis (primarily case design and the multiple-user indication) do not raise new questions of safety or effectiveness.
Because there is no new, independent study described in this document for the Ardo Bellis (K230590), most of the requested information regarding acceptance criteria and study particulars cannot be extracted. The document specifically states:
"The changes made to the design and indications for use of the subject device do not raise different questions of safety and effectiveness. Therefore, the performance testing included in K212773 can be leveraged to support the safety and effectiveness of the subject device."
Therefore, I cannot populate the requested information. The document explicitly indicates that the performance data from K212773 (Ardo Alyssa) is being leveraged, not that new performance data was generated for K230590.
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(227 days)
The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa is intended for a single user.
The Ardo Alyssa is a powered breast pump that generates negative pressure to express millt from the breasts of lactating women. It is intended for a single user and can be used in professional healthcare and home environments. The pump can be used for single or double breast pumping. To operate as a single or double pumping system, the pump needs to be connected to a single or double pump sets to be provided with the Ardo Alyssa are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump. The Ardo Alyssa has two operational modes (stimulation and expression), with eight vacuum levels in each mode. The device comprises an ON/OFF button and two +/- buttons for independently adjusting (increasing or decreasing) vacuum and cycle. The user also has an option to operate the device via the mobile app, MyArdoApp. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. The pump can be powered using the supplied power adapter or by an integrated rechargeable battery.
The provided text is a 510(k) summary for the Ardo Alyssa powered breast pump. It details the device, its intended use, comparison to a predicate device, and the results of non-clinical performance testing.
However, the questions posed relate to the acceptance criteria and study proving a device meets acceptance criteria, specifically in the context of AI/ML performance metrics like sensitivity, specificity, or AUC, and the human expert involvement in ground truth establishment and MRMC studies. The Ardo Alyssa is a powered breast pump, not an AI/ML powered device, and the provided document does not contain information about AI-related performance metrics or studies involving human readers/experts in the way your questions imply.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the format you expect for an AI/ML device. The "performance testing" section in the document refers to engineering and safety performance testing (e.g., vacuum pressure, electrical safety, battery life), not diagnostic performance based on AI algorithms.
The questions regarding sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to the information provided in this 510(k) summary for a powered breast pump.
To reiterate, the provided document does not contain the type of AI/ML-related study information needed to answer most of your detailed questions. The acceptance criteria listed are primarily for physical and electrical performance, and the "study" is a series of non-clinical engineering and safety tests rather than a clinical performance study involving AI analysis of medical images or data.
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(125 days)
The powered Melodi Prime Breast Pump is intended to express and collect milk from the breast of a lactating woman. This device is a double pump with a single pumping option; it is intended for a single user.
The Melodi Prime breast pump is a battery operated breast pump. It operates with 4 AA size batteries. It comes with a power adapter as it can be used with a power adapter without batteries as well. The power adapter does not charge the batteries.
The Melodi Prime breast pump is designed to be a single patient use device. It consists of a LCD display that allows the user to see the current settings of the device. It is an easy to use device, consist of 5 buttons (On/Off, + , - , Phase 1/ Phase 2, & Single/ Double Pumping).
The breast pump allows for single pumping and double pumping options. The suction hose connections are independent of each other. Inside the device, it consists of a PCB, motor and valve.
The accessories that comes with the device are from Ardo Medical AG. The PumpSets are approved under K141742.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Melodi Prime Breast Pump:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a tabulated format. However, it describes performance characteristics that were tested and deemed acceptable for demonstrating substantial equivalence.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Consistent Pressure and Cycles | The pressure level and cycles per minute remain consistent throughout the bench test and show a constant and uniform behavior. |
| Back-flow Prevention (Pump to Tubing) | Back-flow tests confirm that the Melodi Prime Breast Pump can prevent back-flow of the liquid from the Pump Set into the tubing. |
| Back-flow Prevention (Bottle to Pump) | The Pump Sets are also able to prevent liquid going out from the bottle to the pump. |
| Durability / Reliability | The system was tested for more than 72 hours without any problems or errors. |
| Suction Pressure Range | 60-250 mmHg (This is a specification, also serving as an implicit criterion. The reported performance implies it meets this range, as it's directly compared to the predicate's 50-250 mmHg, with the subject device's range being within acceptable physiological limits.) |
| Electrical Safety | Passed electrical safety testing. (Implicit criterion related to the difference in power source from the predicate). |
| Electromagnetic Compatibility (EMC) | Passed electromagnetic compatibility (EMC) testing. (Implicit criterion related to the difference in power source from the predicate). |
| Biocompatibility/Food Safety | PumpSets used in the subject device are a cleared device, therefore, no concerns on biocompatibility and food safety. (Implicit criterion, relies on prior clearance of components). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench tests" and "back flow tests" but does not detail the number of units or test repetitions.
- Data Provenance: Not explicitly stated, but the context indicates these were conducted internally by the manufacturer or a contract lab as part of the 510(k) submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective, though bench testing is inherently prospective experimentation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. The "ground truth" for technical performance criteria (like pressure consistency, back-flow prevention, and durability) is typically established through objective measurements and engineering standards, not expert clinical consensus in this context.
- Qualifications of Experts: Not applicable for the described tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests described are objective bench tests, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a breast pump, and its effectiveness is determined by mechanical performance, safety, and functionality, not by interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Standalone Study: Yes, in essence, the "Performance Data" section describes standalone testing of the device's mechanical and functional characteristics without human intervention influencing the fundamental performance results. It's not an "algorithm" in the typical software sense, but the device's inherent operation was tested.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance tests was based on objective measurements against engineering specifications and physical principles. For example, pressure levels are measured by sensors, back-flow is visually or mechanically confirmed, and durability is timed.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a mechanical breast pump, not an AI/ML algorithm that requires a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.
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