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The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.

The Spectra Series Breast Pump is operated by AC motor, The device's motor drives a Piston pump, creating a vacuum to express breast milk. Passing through an air tubing to breast shield, the vacuum is used to comfortably draw out the breast milk.

This device operates with power ON at the same time. Also, vacuum regulate operates, and I adjust a vacuum. ON, OFF of a device means opening of absorption and end.

Regular this which is international or foods of FDA shall obey it to safe sanitary rules etc. related to contacts of mother's milk that I faced it to things come in contact on matter or human chest etc.

The provided document is a 510(k) summary for the UZINMEDICARE CO. Spectra Series Breast Pump. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets those criteria in the way a clinical trial for a diagnostic algorithm would.

Therefore, many of the requested sections about acceptance criteria and study details (like sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not explicitly provided in this type of regulatory submission for a breast pump.

Here's the information that can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance

The "acceptance criteria" for this device, in the context of a 510(k) submission for a breast pump, are primarily related to its functional specifications and ensuring it performs similarly to legally marketed predicate devices without raising new questions of safety or effectiveness. The comparison chart among devices serves as a de facto demonstration of performance against these implied criteria.

Table of Acceptance Criteria (Implied by Predicate Device Comparison) and Reported Device Performance:

Note: The reported performance for the Spectra Series Breast Pump is presented against specifications of predicate devices rather than against explicit, quantified acceptance criteria like sensitivity/specificity for a diagnostic device. The "Highest Vacuum Setting" for the Spectra is stated as "400 Less than," which seems to be a typo and likely means a maximum of 400 mmHg or less than 400 mmHg. Given the other predicate values, it's probably intended to mean its maximum vacuum is less than 400 mmHg.

Study Details

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

   • Not Applicable / Not Provided. This document describes a 510(k) premarket notification, which relies on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than a clinical study with a "test set" of patients in the context of, for example, a diagnostic algorithm. The testing mentioned is "non-clinical."

   • Data Provenance: Not applicable.

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

   • Not Applicable / Not Provided. No human ground truth establishment for a test set is described.

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

   • Not Applicable / Not Provided. No human adjudication process is described.

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 / Not Provided. This device is a breast pump, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are irrelevant in this context.

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

   • Not Applicable / Not Provided. This device is a mechanical breast pump. "Standalone performance" in the context of an algorithm is not relevant. The device operates independently to express milk.

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

   • Not Applicable / Not Provided. The "truth" for a breast pump is its functional operation (e.g., vacuum levels, cycle speed, safety features) to express milk, rather than a diagnostic ground truth like pathology. The "ground truth" here is adherence to engineering specifications and safety standards, demonstrated through non-clinical testing.

7. The sample size for the training set:

   • Not Applicable / Not Provided. There is no "training set" in the context of an AI/machine learning algorithm for this mechanical device.

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

   • Not Applicable / Not Provided. No training set or associated ground truth establishment is relevant for this mechanical device.

Summary regarding the study:

The document states under "Discussion of Non Clinical Tests": "All testing of this subject device has demonstrated that the Spectra Series breast pump meets established requirements when used in the manner and environment specified in product labeling."

This implies that standard non-clinical performance and safety testing (e.g., electrical safety, electromagnetic compatibility, material biocompatibility, vacuum accuracy, durability, and functional testing to ensure it meets its specifications and performs similarly to predicate devices) was performed. However, the document does not provide details of these specific tests, their methodologies, or the precise results beyond the comparative table. The study is a "non-clinical" comprehensive device evaluation against engineering and safety standards, not a human reader or AI performance study.

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