Search Results

The MilkMate Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for multiple users in places of work, shared spaces, healthcare facilities, hospitals, and the home.

The MilkMate Breast Pump includes a multi-user breast pump and disposable breast pump kits for the convenience of pumping in the workplace, shared spaces, healthcare facilities, hospitals, or the home environment. The breast pump provides two modes: stimulation and expression mode. It can be operated using AC power or a built-in rechargeable li-ion cylindrical battery. The kits are comprised of two each of a breast shield, breast shield body, backflow protector, valve and membrane, standard neck bottle pouch with cap, tubing, and tubing connector. Five breast shield sizes are offered (21 mm, 27 mm, 27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.

The provided text describes a 510(k) premarket notification for the MilkMate Breast Pump, focusing on the substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and study information, based on the input provided:

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

The document does not explicitly state formal "acceptance criteria" for clinical performance in a quantifiable manner (e.g., specific thresholds for milk production increase or user satisfaction ratings). Instead, the performance testing focused on demonstrating that the new breast shield sizes perform comparably to the predicate device in terms of vacuum and cycle settings.

However, based on the non-clinical performance testing summary, here's what can be inferred as performance metrics evaluated:

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

The document does not provide details on the sample size for the test set or the data provenance. The testing appears to be primarily non-clinical performance testing of the device's physical characteristics (vacuum and cycle behavior) rather than real-world user data. Therefore, concepts like country of origin or retrospective/prospective are not directly applicable in the way they would be for clinical studies involving human subjects.

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):

This information is not applicable to the type of non-clinical performance testing described. Ground truth in this context would be the objective measurements of vacuum and cycle settings, typically established by engineering standards and calibrated equipment. There is no mention of human experts establishing "ground truth" for these technical measurements.

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

This is not applicable as the testing described is non-clinical performance testing, not a study evaluating interpretations or conditions that would require adjudication among human reviewers.

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:

This is not applicable. The device is a breast pump, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant.

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

This is not applicable. The device is a physical breast pump, not an algorithm.

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

The "ground truth" for the non-clinical performance testing would be the engineering specifications and objective measurements of vacuum pressure and cycle speed using calibrated instruments. The goal was to confirm that the modified device's performance aligns with these objective specifications and the performance of the predicate device.

8. The sample size for the training set:

This is not applicable. The document describes a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable, as there is no training set for an algorithm.

Ask a specific question about this device

The MilkMate Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for multiple users in places of work, shared spaces, healthcare facilities, hospitals, and the home.

The MilkMate Breast Pump includes a multi-user breast pump and disposable breast pump kits for the convenience of pumping in the workplace, shared spaces, healthcare facilities, hospitals, or the home environment.

The breast pump provides two modes: stimulation and expression mode. It can be operated using AC power or a built-in rechargeable li-ion cylindrical battery.

The kits are comprised of two each of a breast shield, breast shield body, backflow protector, valve and membrane, standard neck bottle pouch with cap, tubing, and tubing connector. Three breast shield sizes are offered (27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.

The provided document outlines the substantial equivalence determination for the MilkMate Breast Pump (K223084) to a predicate device (Electric Breast Pump, Model XN/MS-2224B, K201152). As such, the acceptance criteria are primarily focused on demonstrating that the new device is as safe and effective as the predicate device, relying heavily on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The device's acceptance criteria are primarily met through a series of non-clinical performance tests. These tests are designed to evaluate the safety and effectiveness of the MilkMate Breast Pump, especially given certain technological differences from the predicate device (e.g., suction strength, use of a single-use sterilized kit) and broader intended use (multi-user, various environments). The "SUMMARY OF NON-CLINICAL PERFORMANCE TESTING" section explicitly lists these studies.

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

The document does not specify exact numerical sample sizes for the test sets (e.g., number of kits tested for biocompatibility, number of aging units, number of pumps in performance tests). The studies involve material, sterilization, and mechanical performance testing, not human subjects.

The data provenance is not explicitly stated in terms of country of origin of the data. However, the tests are conducted according to internationally recognized standards (ISO, ASTM), implying standard laboratory conditions. These are retrospective tests on manufactured devices and components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the evaluation is based on non-clinical performance testing against established standards and specifications, not on expert interpretation of medical images or patient data to establish a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation is based on objective, quantifiable non-clinical performance test results against specified criteria in standards (e.g., pass/fail for biocompatibility, specific numerical ranges for vacuum/cycle, sterility assurance level). There is no "adjudication" in the sense of resolving disagreements among human reviewers of qualitative data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases with and without AI assistance. The MilkMate Breast Pump is a mechanical and electrical device for breast milk expression; therefore, an MRMC study is not applicable.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This concept is not applicable in the traditional sense for a breast pump. The device has "software" as indicated in the comparison table, which would control its mechanical functions (vacuum, cycle speed, modes). The performance tests described evaluate the device's functional integrity as a complete system. The "algorithm" itself (i.e., the software's functional logic) is tested as part of the overall pump's performance rather than isolated standalone algorithm performance typical of AI/CADe devices.

7. Type of Ground Truth Used:

The ground truth used in these non-clinical studies is based on:

• International Standards: ISO 10993 (biocompatibility, EO residue), ISO 11135, ISO 11737 (sterilization), ASTM F1980 (accelerated aging), ASTM F2096-11 (leak testing).
• Device Specifications: Internal design specifications for vacuum strength, cycle speed, battery life, and other functional parameters.
• Predicate Device Characteristics: Comparison of technological features and performance parameters to the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set:

This information is not applicable. The MilkMate Breast Pump is a mechanical/electrical device, not a machine learning or AI-driven diagnostic tool that requires a "training set" of data in the common sense for model development.

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

This information is not applicable as there is no "training set" in the context of this device.

Ask a specific question about this device