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The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.

The SPECTRA WEARABLE is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). It is designed to work in the user's bra and is battery operated so it can be used hands-free without external power cords. The device is provided non-sterile. The SPECTRA WEARABLE allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh).

The provided text describes the 510(k) summary for the SPECTRA WEARABLE powered breast pump (K220926). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones and ensuring it meets safety and performance standards, rather than proving its effectiveness through clinical trials with specific acceptance criteria in the way a new therapeutic drug or medical imaging AI might.

Therefore, the requested information regarding acceptance criteria and studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not typically found in these types of submissions for a device like a powered breast pump. The focus is on technical performance, safety, and substantial equivalence to a predicate device, rather than a clinical effectiveness study with defined endpoints and ground truth.

However, based on the provided text, I can extract the following relevant information regarding the non-clinical tests conducted to demonstrate substantial equivalence and general performance.

Acceptance Criteria and Device Performance (Inferred from Non-Clinical Tests)

Here's a breakdown of the specific points requested, based on the absence or presence of information in the document:

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

   • See table above. The "acceptance criteria" are inferred from the standards and tests performed, which aim to ensure safety and performance equivalence to the predicate device. The "reported device performance" is the summary of the test results indicating that these criteria were met.

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

   • This information is not provided in the document. The testing described is primarily engineering and bench testing (e.g., electrical safety, EMC, biocompatibility, vacuum performance), not a clinical study involving a "test set" of patients or data in the typical sense.

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 provided and is not applicable to the types of non-clinical, bench testing performed for this device. "Ground truth" in this context would refer to objective measurements and compliance with established engineering and safety standards.

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

   • This information is not provided and is not applicable to the types of non-clinical tests performed.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of imaging, often with AI assistance. The SPECTRA WEARABLE is a powered breast pump, a mechanical device, not a diagnostic tool where "human readers" would be involved in interpreting results.

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

   • This question is not applicable as the device is a mechanical breast pump and does not involve an "algorithm only" or AI component in the sense of image analysis or diagnostic prediction. Its performance is evaluated through physical and electrical testing.

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

   • The "ground truth" for the non-clinical tests described is based on established engineering specifications, regulatory standards, and objective measurements. For example, a vacuum gauge would objectively measure vacuum strength against a specified range, and a timer would measure cycle speed. Biocompatibility is assessed against ISO standard criteria.

8. The sample size for the training set

   • This information is not provided and is not applicable. The device is a mechanical breast pump; it does not utilize a machine learning model that requires a "training set."

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

   • This information is not applicable as there is no training set for this device.

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