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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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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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The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.

The One Mum Pumpset is a sterile pumpset accessory used by a single user in conjunction with the Ardo breastpumps. The Pumpset has nearly identical technological characteristics and identical principles of operation as the non-sterile pumpset previously cleared in the Ardo Carum and Calypso Powered Breast Pumps (K141742), with the minor difference being that the Pumpset is sterilized using an ethylene oxide gas cycle. Like the predicate device non-sterile pumpset, the One Mum Pumpset consists of multiple components including a bottle, bottle cap, polypropylene breast shell, and silicon tubing kit that connects to the breast pump for the removal, collection, and storage of the mother's breast milk. The Pumpset can be used both as a single pumpset and as a double pumpset and may be used in indoor settings including hospital and home.

The provided text is a 510(k) summary for the Ardo Medical AG's One Mum Pumpset. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. This document does not describe the acceptance criteria of an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The information provided pertains to a physical medical device (a breast pump accessory) and its sterilization and biocompatibility testing. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.

However, based on the content related to the One Mum Pumpset, I can extract information relevant to its performance testing, which serves a similar purpose to acceptance criteria for a physical device:

1. A table of acceptance criteria and the reported device performance:

Regarding the other requested points (2-9), these are entirely focused on AI/ML device studies and are not applicable to the submitted document as it discusses a physical breast pump accessory:

• No AI/ML device is mentioned.
• No test set for an algorithm is described.
• No experts for ground truth establishment for an AI algorithm are mentioned.
• No adjudication method for an AI test set is discussed.
• No multi-reader/multi-case comparative effectiveness study for AI assistance is mentioned.
• No standalone AI algorithm performance is discussed.
• No AI ground truth type is mentioned.
• No training set size or ground truth establishment for a training set is relevant to this document.

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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:

1. 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.
2. Sample sized used for the test set and the data provenance: No test set was used as no further performance testing was conducted.
3. 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.
4. Adjudication method for the test set: Not applicable as no test set was used.
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: Not applicable. This device is a breast pump, not an AI-powered diagnostic tool involving human readers.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for performance testing.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
9. 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):

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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."

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.

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The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles. The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob. The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent.

The provided text does not contain detailed information regarding acceptance criteria for device performance or a specific study that proves the device meets those criteria in the context of clinical or diagnostic accuracy. Instead, it describes a medical device, the Ardo Suction Pumps (master and senator), and its regulatory submission (510(k)).

The document states that the device was tested against recognized international standards for medical suction equipment and general safety:

• ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction equipment
• ISO 10079-3: Medical Suction Equipment -- Part 1: Suction equipment powered from a vacuum or pressure source
• IEC 601-1: Medical Electrical Equipment -- Part 1: General requirements for safety

These standards typically define performance requirements (e.g., maximum vacuum pressure, flow rate, safety features) and testing methodologies for such devices. Therefore, the "acceptance criteria" are implied to be compliance with these standards, and the "study" is the testing performed against these standards.

Here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information for AI/diagnostic devices is not applicable to this type of medical hardware submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device "was tested" against these standards, implying compliance, as the FDA granted 510(k) clearance based on these tests.

2. Sample size used for the test set and the data provenance

• This information is not explicitly stated. For a hardware device like a suction pump, "sample size" typically refers to the number of units tested, which is not detailed.
• Data provenance: Not applicable in the context of clinical data. The tests were likely conducted in a laboratory setting by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable. The "ground truth" for a mechanical device is its adherence to engineering specifications and safety requirements defined by the standards. No clinical experts were involved in establishing a diagnostic ground truth for this type of device.

4. Adjudication method for the test set

• Not applicable. The tests against the standards are objective measurements, not subjective evaluations requiring adjudication.

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

• Not applicable. This is a medical hardware device, not an AI/diagnostic imaging system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a medical hardware device, not an algorithm. The device functions independently in its suction capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device is based on engineering specifications and safety standards (ISO 10079-1, ISO 10079-3, IEC 601-1). Compliance with these standards confirms the device's functional and safety performance.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. There is no training set for this type of device.

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