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

Device Description

The Sonata™ breast pump and kit are used to express and collect mills from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. The system is not designed for mobile use. Pumping with the Sonata™ breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The Sonata™ breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.

AI/ML Overview

The provided document is a 510(k) summary for the Medela Sonata™ breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device (Medela Symphony Breast Pump) rather than detailing a study that meets specific acceptance criteria for a device performance. Therefore, most of the requested information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of clinical performance or algorithm performance is not present in this regulatory document.

However, I can extract information related to non-clinical tests conducted to support substantial equivalence.

Here's the breakdown of what can be inferred and what is not available from the document:

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

The document does not provide a formal table of acceptance criteria for a clinical performance study or an algorithm; instead, it lists non-clinical tests performed to demonstrate safety and performance compared to a predicate device. The "acceptance criteria" here are implicitly tied to meeting the standards of these non-clinical tests and demonstrating comparable performance to the predicate.

Here's a summary of performance-related information:

Aspect	Acceptance Criteria (Implied / Comparator)	Reported Device Performance (Sonata™)
Pumping Mechanism	Equivalent function to predicate	Linear piston, microprocessor-controlled DC motor drives linear element to create volumetric expansion and vacuum.
Vacuum Range (Double)	Similar to predicate	-50 to -240mmHg ± 10 mmHg / -7 to -32 kPa ± 3 kPa (with 21, 24, 27, 30, and 36mm breast shield sizes)
Vacuum Range (Single)	Similar to predicate	-50 to -240mmHg ± 10 mmHg / -7 to -32 kPa ± 3 kPa (with 21, 24, 27, 30, and 36mm breast shield sizes)
Adjustable Suction Levels	Numeric comparison to predicate	10 levels
Cycle Speed	Similar to predicate	54 – 120 Cycles/Minute
Overflow Protection	Effective milk separation	A Protection Membrane on the kit side acts as a media separation and prevents milk from going into the pump.
Operation Time (Battery)	Similar to predicate	Approx. 60 minutes
Charging Time	Similar to predicate	Approx. 4 hours
Electrical Safety	Compliance with IEC 60601-1:2005 (3rd Ed.) & AAMI/ANSI ES60601-1:2005/(R)2012 & A1:2012	Complies with specified standards
EMC	Compliance with IEC 60601-1-2: 2014	Complies with specified standards
Home Healthcare Safety	Compliance with IEC 60601-1-11: 2010	Complies with specified standards
Risk Management	Compliance with ISO 14971:2007	Risk Analysis developed in accordance with ISO 14971:2007
Biocompatibility	No new testing required per ISO 10993	Patient contacting materials are identical to those used in the predicate Symphony Breast Pump, thus no new testing.
Software V&V	Compliance with FDA Guidance for Software in Medical Devices	Conducted, documentation provided; software considered "moderate" level of concern.
Performance Testing	Ensure comparable vacuum performance, stability, battery, overflow, design life, durability, acoustic	Performed to determine vacuum performance (min/max), vacuum stability, battery performance, overflow performance, design life, durability, and acoustic testing.

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, as it outlines non-clinical testing rather than a clinical study with a "test set" of patient data. The tests refer to device-specific performance evaluations.

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 non-clinical tests described. No "ground truth" established by human experts is mentioned for a test set in the context of clinical performance.

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

This information is not applicable to the non-clinical tests described.

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 information is not applicable. The device is a breast pump, not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance is mentioned.

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

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

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

This information is not applicable to the non-clinical tests described. The "ground truth" for the non-clinical tests is based on objective measurements against engineering specifications and voluntary standards.

8. The sample size for the training set

This information is not applicable. This is a physical device, not an AI model requiring a training set of data.

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

This information is not applicable for the same reason as point 8.

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