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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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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The VIVACE Electrosurgical System is comprised of the following components:

• . The system main body, consisting of:
  • LCD touch screen control panel O
  • High-frequency generating output section (main P.C.B board or RF Generator) O
  • Power supply component Switch Mode Power Supply (SMPS) O
• The accessories to the device include: ●
  • Handpiece with Handpiece Connector o
  • Disposable micro-needle cartridge (electrode) for insertion into Handpiece O
  • Foot switch O
    Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

The provided text is a 510(k) Summary for the VIVACE Electrosurgical System. It outlines the device's technical specifications and the performance data submitted to the FDA to establish its safety and efficacy and demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device, which is what your request implies.

The "Performance Data" section (Page 6 of the input) lists various tests that were conducted (electrical testing, biocompatibility testing, sterility testing, shelf life/packaging, software verification/validation, and thermal testing) and states that "All acceptance criteria were met." However, it does not define these acceptance criteria, nor does it provide detailed results or specific studies that you've requested (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI/ML performance studies).

The "Thermal Testing" section briefly mentions:

• An ex vivo animal study using a porcine tissue model.
• Standardized H&E staining techniques to visualize and measure thermally damaged profile data through Nitro Blue Tetra Chlorine (NBTC) and H&E histological evaluation.
• The finding that the vivace microneedling device showed consistent formation of measurable thermal lesions for highest energy level settings in the treatment porcine tissue at a temperature close to physiological.

This is a performance test, not a study to establish clinical effectiveness or compare AI performance against a human or a human-assisted AI.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study proving the device meets them as described in your prompt (which is structured for an AI/ML device performance study) because this regulatory document for the VIVACE Electrosurgical System does not contain such information. It focuses on demonstrating substantial equivalence through engineering and biological performance testing, not AI model performance.

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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.

The VIVACE Electrosurgical System is comprised of the following components: the system main body of the device which consists of the LCD touch screen control panel, the high frequency generating output section (main P.C.B board or RF Generator), and the power supply component, the Switching Power Supply (SMPS). The accessories to the device include the handpiece with disposable micro-need le cartridge (electrode) insertion, and foot switch. Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. The hand piece being held at right angles, the tip is placed in light contact with the epidermis. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator, hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be resterilized.

Here's a breakdown of the acceptance criteria and study information for the VIVACE Electrosurgical System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Study): 31 participants were enrolled, with 28 subjects completing all three sessions and included in the final study analysis.
• Data Provenance: The study was a "31 patient US study," indicating the data was collected in the United States and was prospective as it involved tracking subjects over time after treatment.

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

• Number of Experts: Three, blinded, independent licensed physicians.
• Qualifications: "Licensed physicians" is the only qualification explicitly stated. No specific experience level (e.g., "radiologist with 10 years of experience") is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "By 2/3 evaluator agreement (≥ 1 point change) criteria." This means that for a subject to be considered to have improved, at least two out of the three blinded evaluators had to agree on at least a one-point improvement on the score.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported in this summary. The study focused on the device's standalone clinical efficacy.

6. Standalone (Algorithm Only) Performance Study

• This device is an electrosurgical system, not an AI algorithm. Therefore, a standalone (algorithm only without human-in-the-loop performance) study in the context of AI is not applicable. The clinical study described evaluates the device's performance when used by clinicians.

7. Type of Ground Truth Used

• Clinical Ground Truth: Expert consensus of three blinded physicians using a validated clinical scoring methodology (9-point Fitzpatrick Wrinkle and Elastosis Scale).

8. Sample Size for the Training Set

• Not Applicable / Not Provided: This device is a medical instrument (electrosurgical system), not an AI algorithm that requires a training set in the typical sense. The summary describes a clinical study to validate the device's performance, not to train a predictive model.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable / Not Provided: As in point 8, this is not an AI algorithm with a training set. The "ground truth" (clinical outcomes) described in the performance section was established by expert evaluation.

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