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

Elvie Stride is an electric breast pump that is intended for lactating women to express and collect breast milk. It is intended for a single user. It may be operated as a single or double pumping system. Elvie Stride has adopted the in-bra aesthetic. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without any external power cords. The pump is located off the body and the milk collection bottle is located on the breast. It expresses milk by applying negative pressure to the nipple so that expressed milk may collect in the milk collection bottle. It can be controlled through the physical interface on the pump or through a mobile companion app. Elvie Stride consists of 15 components: Hub, Breast Shield, Cup Front, Diaphragm Seal, Valve, Stopper, Tubing, Tube Splitter, Hub Connector, Cover, Cup Seal, Cap, Cap Seal, Clip and USB Charging Cable. All components are reusable and may be manually cleaned or placed on the top shelf of a dish washer.

This document is a 510(k) premarket notification for the Elvie Stride, a powered breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device (Elvie Pump K181863), not on clinical performance studies that would typically involve acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the provided text does not contain the information required to answer the prompt regarding acceptance criteria and the study proving a device meets those criteria, specifically in the context of an AI/SaMD.

The document details:

• Device Type: Powered breast pump (hardware device, not an AI/SaMD).
• Approval Type: 510(k) Premarket Notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical performance against pre-defined acceptance criteria for, say, diagnostic accuracy.
• Non-Clinical Testing: Biocompatibility, electrical safety, electromagnetic compatibility, wireless technology, software verification (for the breast pump's internal software, not an AI for diagnosis), and performance testing (e.g., vacuum pressure, cycle rate, backflow, battery life).

To illustrate, if this were an AI/SaMD for, for example, breast cancer detection, the information I would expect to find (but is absent here) would be:

1. A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, or F1-score with defined thresholds and the actual values achieved in a clinical study.
2. Sample size and data provenance: Details on the number of images/cases in the test set, their origin (e.g., US hospitals, European clinics), and whether the data was collected retrospectively or prospectively.
3. Number of experts and qualifications for ground truth: How many radiologists or pathologists reviewed the data to establish the definitive diagnosis, and their experience levels.
4. Adjudication method: How disagreements among experts were resolved (e.g., majority vote, senior expert review).
5. MRMC study and effect size: If human performance with and without AI assistance was compared, and the quantitative improvement.
6. Standalone performance: The AI's performance without human intervention.
7. Type of ground truth: Whether it was expert consensus, biopsy-confirmed pathology, or long-term clinical outcomes.
8. Training set sample size: How many cases were used to train the AI.
9. Ground truth for training set: How the training data labels were established.

Since the provided document is for a physical breast pump and not an AI/SaMD, none of this detailed information about AI performance or clinical study design elements for AI validation is present. The "Testing" section refers to engineering and safety tests for the breast pump itself, not diagnostic performance of an AI.

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

The Elvie Pump is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout and bra adjustor. All components (minus the pump) are reusable and may be manually cleaned. The kit components may be purchased separately and are available in different sizes and configurations.
The Elvie Pump includes piezoelectric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes.
The Elvie Pump is a battery-powered electro-mechanical device that contains software. It can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed and pumping history information.
All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.

This document is a 510(k) summary for the Elvie Pump and does not describe acceptance criteria or a study that proves the device meets specific performance criteria through clinical trials or comparative effectiveness studies. Instead, it outlines the device's characteristics, its intended use, and its substantial equivalence to a predicate device based on non-clinical performance tests.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text.

However, I can provide the information available from the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a formal way for a clinical study comparing the Elvie Pump against specific performance metrics linked to patient outcomes or clinical effectiveness. Instead, it lists non-clinical performance tests that demonstrate the device meets its own specifications, which serve as internal "acceptance criteria" for engineering and safety.

2. Sample sized used for the test set and the data provenance

Not mentioned in the document. The listed tests are non-clinical (e.g., biocompatibility on materials, software validation, electrical safety), not clinical studies with human test sets.

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

Not applicable. The document describes non-clinical engineering and safety tests, not studies requiring expert-established ground truths for clinical evaluation.

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

Not applicable. This is not a clinical study.

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 MRMC comparative effectiveness study was mentioned. The device is a powered breast pump, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.

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

While the device includes software and has a "milk measurement algorithm," the document only states that the "milk measurement algorithm" was validated as part of software validation. It does not provide details of a standalone performance study for this specific algorithm or its performance metrics.

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

For the non-clinical tests:

• Biocompatibility: Standards (ISO 10993) and established laboratory protocols.
• Software Validation: Requirements specifications, internal validation protocols, and FDA guidance.
• Usability: IEC 62366-1 standard.
• Electrical Safety/EMC: Relevant IEC 60601 series standards.
• Cleaning Validation: Effectiveness against microbial load reduction/soil removal as per internal protocols.
• Device Performance (Vacuum/Backflow): Engineering specifications for the Elvie Pump.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning model's development with a training set for clinical applications. The "software" and "microcontroller" mentioned are likely for controlling the pump's mechanical functions and user interface, not for AI-based analysis requiring training data in the traditional sense.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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