(416 days)
The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps 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 S1 Plus and Spectra S2 Plus are capable of providing vacuum levels from 50-280 mmHg with cycling rates up to 70 cycles per minute. The Spectra S1 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S2 Plus is powered only by a 12V DC adaptor.
The provided document is a 510(k) summary for the Spectra S1 Plus and Spectra S2 Plus powered breast pumps. As such, it reports on a comparison to a predicate device and does not describe a study to prove a device meets acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools. The acceptance criteria here are related to regulatory compliance and equivalence to a predicate, rather than performance metrics like sensitivity, specificity, or AUC for a diagnostic task.
Therefore, many of the requested fields cannot be directly answered because the type of study described in the document is a regulatory submission for substantial equivalence based on non-clinical testing, not a performance study of a device that "reports device performance" in a quantitative diagnostic sense.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and performance in a standard table format for diagnostic accuracy. Instead, it describes compliance with various standards and successful operation within specified ranges, demonstrating equivalence to the predicate device.
| "Acceptance Criteria" (based on non-clinical testing and equivalence to predicate) | Reported Device Performance |
|---|---|
| Compliance with ISO 14971:2007 (Risk Analysis) | Risk analysis developed in accordance with ISO 14971:2007 |
| Compliance with IEC 60601-1:2005 (Electrical Safety) with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 | Electrical Safety Testing in accordance with specified standards. |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Electromagnetic Compatibility Testing in accordance with specified standards. |
| Compliance with IEC 60601-1-11:2010 (Safety for home use) | Safety Testing for use in the home in accordance with specified standards. |
| Compliance with ISO-10993 (Biocompatibility) for cytotoxicity, sensitization, and irritation | Biocompatibility Tests in accordance with specified standards. |
| Compliance with FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005) for software verification and validation | Software verification and validation testing as recommended. |
| Compliance with IEC 62304 (Medical Device Software - Software Life Cycle Processes) | Medical Device Software - Software Life Cycle Processes in accordance with specified standards. |
| Performance within specified vacuum and cycle rate ranges, backflow protection, and battery operation time (compared to predicate) | Performance testing conducted at minimum and maximum vacuum settings for 20 minutes (simulating a pumping session). Specifications were met for vacuum level, cycle rate, backflow protection, and battery operation time. Results held under single/double pumping and varying power sources (for Spectra S1 Plus). |
| Substantial equivalence to predicate device (Limerick PJ's Comfort) | The devices share the same intended use, technological characteristics (diaphragm pump, single/double options), and similar specifications (e.g., suction strength 50-280 mmHg vs. 40-270 mmHg for predicate; cycle speed 38-70 cycles/min vs. 16-70 cycles/min for predicate). Differences do not introduce new intended use or raise safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical testing of the physical device and its software, not a study involving patient data or a "test set" in the context of diagnostic performance. There is no patient sample size or data provenance in this context. The tests performed are engineering and safety tests.
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. "Ground truth" in the diagnostic sense is not relevant for this type of regulatory submission for a breast pump. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring adjudication in a clinical or diagnostic sense for this device.
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/ML device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance testing was for the physical device's specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests involves established international and national standards for electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software development, as well as the manufacturer's own design specifications (e.g., vacuum level ranges, cycle rates).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, this question is not relevant.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).