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The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The VIVACE is intended for single user and multiple users in home and healthcare environments.

The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home or health care and by a single user and multiple users. VIVACE is both AC- powered battery-powered. The AC adapter uses a 100-240 VAC, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.

I am sorry, but the provided text is a 510(k) summary for a powered breast pump (VIVACE) and does not contain the specific information requested about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML or diagnostic performance.

The document focuses on:

• Regulatory clearance (510(k) for a medical device).
• Comparison to a predicate device (OPERA) for substantial equivalence.
• Non-clinical performance testing: Biocompatibility, electrical safety, electromagnetic compatibility, software evaluation, and general performance tests (vacuum level, backflow protection, use life, battery performance, multi-user cross-contamination).

It does not include:

• A table of acceptance criteria and reported device performance for a diagnostic or AI-driven system.
• Details about sample sizes for test sets, data provenance, or ground truth establishment for AI/ML performance.
• Information about expert adjudication, MRMC studies, standalone AI performance, or training set details.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

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

VIVACE is an electric breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home environment by a single user. VIVACE is both AC-powered/battery-powered. The AC adapter uses a 100-240 V a.c, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA regarding a powered breast pump called VIVACE. It details the device's characteristics, comparison to a predicate device, and a summary of non-clinical performance testing.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the device's effectiveness in terms of milk expression efficiency, comfort, or user experience (e.g., a multi-reader multi-case study for an AI-powered device).

The "performance testing" section (Section 9) focuses on:

• Biocompatibility: Testing materials for cytotoxicity, sensitization, and irritation.
• Electrical Safety: Conformance to IEC standards.
• Electromagnetic Compatibility: Conformance to IEC standards.
• Software: Evaluation based on FDA guidance.
• Other performance testing:
  • Vacuum level verification: Ensures the device meets mode/cycle specifications.
  • Backflow protection: Verifies no liquid backflow into tubing.
  • Use life testing: Demonstrates maintained specifications throughout proposed use life.
  • Battery performance testing: Demonstrates functionality during stated use-life.
  • Battery status indicator testing: Demonstrates functionality during stated battery life.

These are primarily safety and basic functional performance tests to ensure the device operates as intended and is safe for the user, rather than a clinical study evaluating its effectiveness in milk expression compared to a gold standard or human performance. The document focuses on showing substantial equivalence to an existing predicate device based on these engineering and safety parameters.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of effectiveness or superiority, as there is no mention of such a study in the provided text. The device is a powered breast pump, not an AI-powered diagnostic device, so concepts like "multi-reader multi-case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone performance," or "ground truth for the test set" are not applicable to the information given in this document.

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