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The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user.

The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user. This is accomplished by an electrical pump system generating a suck and release vacuum pattern. The suction strength is adjustable. The cycles per minute are adjustable. The electrical pumping unit of the device is connected to the breast shields via silicone tubing. The breast shield and screw housing is equipped with a flap valve separating the breast shield from the NUK breast milk container. The system is assembled in an airtight way to ensure that the system can build up vacuum when the breast shield is connected to the breast. The milk will flow through the flap back flow valve into the bottle. A voltage adaptor is provided with the device.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: NUK Expressive Double Electric Breast Pump

Intended Use: To express milk from the breasts, intended for use by a single user.

Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than setting new, explicit acceptance criteria for performance beyond what is comparable to the predicate. The "acceptance criteria" can be inferred from the comparison points and the tests conducted to show equivalence.

Here's a table based on the comparison and performance sections:

Table: Acceptance Criteria (Inferred from Predicate Equivalence) and Reported Device Performance

Study Details

The document describes device verification testing to demonstrate conformance with specifications and equivalence to the predicate device. This is typical for a 510(k) submission.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of number of devices or number of human participants. The document mentions "device verification testing" and tests for "suction pressure," "biocompatibility," and "electrical safety." These typically involve testing multiple units of the device and material samples, but specific numbers are not provided.
   • Data Provenance: The tests were conducted internally by MAPA GmbH ("the company's Design Control Process"). The country of origin for the data is Germany (MAPA GmbH is in Zeven, Germany). The nature of the studies (e.g., suction pressure testing, electrical safety testing) is an engineering and material compliance assessment, not a clinical trial in the traditional sense. It's an internal verification process.

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

   • Not applicable in the context of this device's verification. The "ground truth" for electrical safety is defined by IEC standards, for biocompatibility by ISO 10993, and for suction pressure by engineering specifications and comparison to the predicate device's measured parameters. These are objective engineering and regulatory standards, not subjective expert consensus on clinical findings.

3. Adjudication method for the test set:

   • Not applicable. The tests involve objective measurements against established specifications/standards, not subjective assessments requiring expert adjudication.

4. 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 or assistive tool for human readers. No MRMC study was conducted.

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

   • Not applicable. This is a mechanical/electrical medical device, not an algorithm. The device performance (e.g., suction pressure) is inherent to its design and operation.

6. The type of ground truth used:

   • Objective Engineering Specifications and Standards:
     • Suction pressure: Measured values compared against the predicate device's established range and the device's own internal specifications.
     • Biocompatibility: Results of tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 standards.
     • Electrical Safety: Conformance with IEC 60601-1 and IEC 60601-1-2 standards.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

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The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. These condoms have a length of ≥175mm, a width of 52mm. The thickness is 0.10 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm. The primary packaging material is a foil package. The on surface lubricant is silicon oil. The term Dotted refers to the irregular surface of the condom. The irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The New Condom is defined as a condom of increased thickness relative to some of the other BillyBoy types.

The provided document describes a 510(k) summary for BillyBoy Dotted (Beaded) Condoms and BillyBoy New Condoms. This summary focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a device meets acceptance criteria through a clinical study with human or image data. Therefore, many of the requested categories regarding clinical studies, expert involvement, and ground truth are not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

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

The document states that the device's performance was evaluated against specific standards. The acceptance criteria are essentially defined by these standards, and the reported performance is "passed all."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact sample size used for the performance testing. It generally refers to "the devices" being evaluated.
• Data Provenance: The testing was conducted by MAPA GmbH in Zeven, Germany. The data provenance is from internal testing reports and certificates. The studies were likely prospective, as they involved testing newly manufactured condoms to ensure compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device (condom), and its performance is assessed against engineering and biological standards, not through expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Performance testing for condoms involves objective measurements and adherence to specifications, not adjudications by experts.

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 not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this device's performance is established by the specified requirements and methodologies outlined in the ASTM D3492 standard for male latex condoms and the ISO 10993 standard for biocompatibility. These standards define the acceptable physical and biological properties.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. No training set exists for this device.

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The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.

The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single use. This is accomplished by an electrical diaphragm pump generating a suck and release vacuum pattern. The suction strength is adjustable. The pumping device is sealed via a connection ring to a breast shield equipped with a valve separating the breast shield from the bottle.

Here's an analysis of the provided text regarding the NUK Breast Pump (K101157) and its acceptance criteria, focusing on the requested information.

It's important to note that the provided 510(k) summary is for a medical device that does not involve an AI/ML algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this type of document. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards.

Acceptance Criteria and Reported Device Performance for NUK Easy-Flow Single Electric Breast Pump (K101157)

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The document states: "The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicate. Additional performance testing was completed for biocompatibility and electrical safety to recognized standards."

This indicates that internal verification and validation studies were conducted according to the company's design control processes and relevant recognized standards. The 510(k) process primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than entirely novel clinical efficacy studies.

Specifically:

• Substantial Equivalence Comparison: A detailed table compares the subject device (NUK Easy-Flow Electric Breast Pump) to the predicate device (miPump Electric Breast Pump K082802) across various specifications (FDA classification, intended use, users, portability, vacuum range, suction mode, pump type, closed system, biocompatibility, electrical safety). The conclusion is that they have "substantially equivalent intended use and technological specifications."
• Biocompatibility Testing: Confirmed compliance with ISO 10993.
• Electrical Safety Testing: Confirmed compliance with ISO 60601-1.

2. Sample Size Used for the Test Set and Data Provenance

Given this is a 510(k) for a hardware medical device (breast pump) and not an AI/ML diagnostic, there isn't a "test set" in the sense of a dataset for an algorithm. The "testing" refers to physical product testing and design verification.

• Sample Size for Test Set: Not specified in terms of a "data set" for an algorithm. It would refer to the number of physical units tested for engineering specifications, durability, etc., but this detail is not provided in a 510(k) summary (which focuses on the conclusion of testing).
• Data Provenance: Not applicable in the context of an AI/ML algorithm's dataset. The "data" here would be test results from manufacturing and engineering verification, originating from the manufacturer's (MAPA GmbH, Germany) internal testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not an AI/ML device requiring expert consensus for a "ground truth" dataset. The "truth" for device performance is established through engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication for a data set is mentioned or relevant for this type of device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device does not incorporate AI, therefore, no studies comparing human readers with and without AI assistance were conducted.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device does not incorporate an AI algorithm.

7. Type of Ground Truth Used

Not applicable in the context of an AI/ML algorithm. The "ground truth" for this device's performance is established by engineering specifications, recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 60601-1 for electrical safety), and the functional requirements for a breast pump.

8. Sample Size for the Training Set

Not applicable. This device does not use a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not use a training set for an AI/ML algorithm.

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