Search Results

The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Spectra S3 Plus is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to switch from massage mode to expression mode, and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S3 Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute. The Spectra S3 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S3 Plus breast pump can be used by multiple users. Kits used with the Spectra S3 Plus breast pump, however, are labeled for a single user.

This is a summary of the provided text, focusing on acceptance criteria and study details.

The document is a 510(k) premarket notification for the Spectra S3 Plus Breast Pump. It aims to demonstrate substantial equivalence to a predicate device (Spectra S1 Plus Breast Pump, K150476).

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly outline specific "acceptance criteria" in a quantitative, pass/fail table format with reported performance. Instead, it states that the conducted tests demonstrate the device "meets specifications" or "demonstrates" certain functionalities. The comparison table with the predicate device implies that functional equivalence to the predicate is the primary acceptance criterion for most features, with specific new tests for the multi-user aspect.

Here's an interpreted table based on the provided "Summary of Non-Clinical Tests" and the predicate comparison:

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

The document does not specify the sample size for any of the non-clinical tests performed. It also does not directly state the data provenance (e.g., country of origin, retrospective/prospective). However, given that Uzinmedicare Co. is located in South Korea and it's a 510(k) submission to the FDA, the testing was likely conducted by or for the manufacturer. The tests are non-clinical (engineering/performance tests), not human clinical trials.

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

Not applicable. The tests performed are non-clinical engineering/performance tests, not studies requiring expert interpretation of ground truth in a clinical context (e.g., image reading).

4. Adjudication Method for the Test Set:

Not applicable. As these are non-clinical performance tests, there's no "adjudication method" in the sense of resolving conflicting expert opinions. The tests would likely involve measuring physical parameters against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study is a non-clinical evaluation of a breast pump, not an AI-assisted diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

Not applicable. This is a physical medical device (breast pump), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established specifications and physical measurements, rather than clinical outcomes or expert consensus. For example, a vacuum test would measure the actual vacuum generated and compare it to the specified range (50-270 mmHg).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so 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 device.

Ask a specific question about this device