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The XP3000 RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The XP3000 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The XP3000 is a state-of-the-art radiofrequency device with massage attachments that enables the application of therapy by a non-invasive, high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpieces are equipped with buttons, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip. Contact quality monitoring system is present for monitoring of the contact quality under the patch electrode. An easy-to-read handpiece displays show the selected treatment parameters. Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data. The XP3000 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, handpiece XP (215/3), two massage attachments for the XP handpiece, large handpiece (215/1) with integrated massage part, large handpiece (215/1).

The provided document is a 510(k) premarket notification for the XP3000 device. It states that the device is substantially equivalent to a predicate device (Exilis XP, K143040) and includes information about non-clinical testing and a clinical performance test.

However, the document does NOT contain the specific details requested regarding acceptance criteria, reported device performance measurements, sample sizes, data provenance, expert qualifications, or adjudication methods for the clinical study.

The clinical testing section only states: "The substantial equivalence determination for the XP3000 is based on clinical performance testing. The aim of the performance test was to prove that XP3000 device reaches the effective treatment temperature and maintain it for required time." It then provides a table comparing the XP3000 to the predicate device, but this table lists device specifications (like temperature range, power, dimensions) rather than specific performance metrics from a study that would demonstrate meeting acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a study, nor can I provide answers to most of the specific questions about the study design that would prove the device meets acceptance criteria.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria (Indirect/Implied): The document implies an acceptance criterion for the clinical performance test: that the XP3000 device "reaches the effective treatment temperature and maintain it for required time." The "Effective Treatment Temperature" is listed as 40 - 45 °C in the comparison table for both the XP3000 and the predicate device.
• Reported Device Performance: The document states that the substantial equivalence is based on clinical performance testing, but it does not report the specific results from that testing (e.g., "95% of treatments achieved 40-45°C for X minutes," or specific data points). It only lists the target effective treatment temperature.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not specify the sample size or data provenance for the clinical performance test.

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/provided. The clinical performance test was focused on reaching and maintaining temperature, not on interpretations requiring expert ground truth (like image analysis for cellulite reduction efficacy where experts might be needed to rate appearance changes). No information on experts is provided.

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

• Not applicable/provided. Given the focus on temperature reaching and maintenance, a typical adjudication method for interpretation would not be relevant. The document provides no information on any such method.

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. This type of study (MRMC for human readers with/without AI assistance) is not mentioned and is not relevant to the described clinical performance test for a radiofrequency device that aims to elevate tissue temperature.

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

• Not applicable/provided. The device is a physical RF device. The mention of "Software Life Cycle Processes" (IEC 62304) suggests software is involved in control, but a standalone algorithm performance without human-in-the-loop is not described for a diagnostic or interpretative task. The "clinical performance testing" refers to the device's ability to achieve a physical effect.

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

• Ground Truth (Implied): The "ground truth" for the clinical performance test was likely the actual tissue temperature measured during the treatment, compared against the target effective treatment temperature of 40-45°C. The document does not explicitly state the measurement method or its validation.

8. The sample size for the training set

• Not applicable/provided. The document does not describe AI/ML components requiring a training set in the conventional sense for diagnostic or predictive tasks. The software mentioned (IEC 62304) is for device control, not for learning from a dataset to perform a task.

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

• Not applicable/provided. See point 8.

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The XP300 device is indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids.

The XP300 system is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field. The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables the operator to see the on-screen information from various angles during the procedure. In addition, the brightness of the screen can be set to match the lighting in the room. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. The XP300 device incorporates the ultrasonic feature for added patient comfort. Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data. The XP300 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic generator and ultrasonic element, user interface with 8.4" colour touch screen, applicator with colour screen and control buttons. The main change between this device and the predicate is the inclusion of the Ultrasonic convenience function which is intended to improve patient's comfort during the procedure.

This document is a FDA 510(k) summary for the BTL Industries XP300 device, an electrosurgical cutting and coagulation device and accessories indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids. The submission is for a modification to the XP200 device, specifically the inclusion of an ultrasonic element to improve patient comfort.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" as performance metrics for clinical efficacy in a table format with reported performance. This 510(k) is a submission for a modification to an already cleared device (XP200), and the primary focus is on demonstrating that the modification (ultrasonic element for patient comfort) does not negatively impact the existing safety and effectiveness, and that the device still meets relevant safety and performance standards.

Instead of clinical performance acceptance criteria, the document focuses on compliance with various electrical, mechanical, and biocompatibility safety standards, and confirms that the technical specifications of the XP300 are equivalent to the predicate XP200, with the only notable difference being the addition of the ultrasonic feature.

Here's a table based on the non-clinical performance data and comparison to the predicate:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "There was no clinical testing required to support the XP 300 medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical test set, sample size, or clinical data provenance discussed for the XP300's primary indication.

The "testing" mentioned refers to non-clinical performance and safety testing (electrical, EMC, biocompatibility, software validation, and tissue heating related to the combined RF and ultrasound). These tests are typically conducted in a laboratory setting, not with human subjects, and thus terms like "sample size" for a test set in the clinical sense are not applicable. The document does not specify the number of units or test configurations used for these non-clinical 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. As no clinical test set was required or performed, there was no need for experts to establish ground truth in a clinical context. The "ground truth" for non-clinical testing is established by compliance with international standards and engineering specifications.

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

Not applicable, as no clinical test set was used.

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. The XP300 is an electrosurgical device for dermatological procedures, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this device.

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

Not applicable. The XP300 is a hardware device with software controls, not an algorithm for standalone performance evaluation in the context of diagnostics or AI. Its performance is evaluated through compliance with electrical, mechanical, and safety standards, and its ability to deliver specified energy (RF and ultrasound) safely.

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

For this submission, the "ground truth" is primarily based on:

• Compliance with international and national safety standards: IEC 60601 series, ISO 14971, ISO 10993 series, etc.
• Engineering specifications and design inputs: The device's electrical, mechanical, and software parameters conforming to its intended design.
• Performance confirmation of the physical outputs: E.g., accurate frequency, nominal output power, power fluency, and safe tissue heating.

8. The sample size for the training set

Not applicable. This is a hardware device; "training set" typically refers to data used to train machine learning models, which is not relevant here.

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

Not applicable, as there is no training set mentioned or implied for this device.

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