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The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Reverso Pro System, positioned on a rolling cart, is a computerized system comprised of a console (main unit) and two Applicators: The Reverso Applicator with detachable single-use tips and the Quadro RF Applicator. The system using the Reverso Applicator delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin, or using the Quadro RF Applicator in a continuous wave manner to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Reverso Pro System provides individual adjustments of energy settings and treatment time, and, in the Reverso mode, it also enables the adjustment of tip pattern and pulse profile, to achieve appropriate efficiency and safety for each eligible patient. The system console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso Pro System Applicators are designed for use in dermatological procedures, they are hand-held and ergonomically designed for the treatment requirements. The applicators are connected to the system via a separate cable, each. When not in use, the applicators can be placed within the applicator holder, where the Reverso Applicator is positioned on the system console and the Quadro RF Applicator is positioned on the rolling cart. The Reverso Applicator is compatible with five types of fractional RF tip heads: 44, 80, 88, 160 pin tip head and 176 pin tip head. The Quadro RF Applicator is emitting continues RF energy through a set of two pairs of stainless steel, RF electrodes. The applicator is hand-held and ergonomically designed to induce heat of the skin and beneath tissues for topical heating sensation.

This document is a 510(k) summary for the Indiba S.A.U. Reverso Pro System (K243139). It details the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is an electrosurgical cutting and coagulation device. The information provided outlines the non-clinical (bench) performance data for the device, and a qualitative assessment of its similarities to predicate devices to establish substantial equivalence. However, there is no detailed clinical study or acceptance criteria table in the format requested, nor is there information about AI/ML algorithm performance.

The document states:

• "Clinical Performance Data: Not Applicable" (Page 8)
• The "Non-Clinical (Bench) Performance Data" section primarily discusses the device's RF performance specifications and thermal effects. It does not describe a study involving human or expert evaluation for determining accuracy or clinical efficacy in the context of an AI/ML device.
• The entire submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than proving the device meets specific performance criteria through a rigorous clinical trial or AI/ML validation study.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML algorithm with human-in-the-loop performance, ground truth establishment, or sample sizes for test/training sets, because this submission is for a medical device that does not appear to involve an AI/ML component or a clinical performance study in the way typically required for AI/ML-driven devices.

The information provided relates to the physical device's electrical and mechanical safety, electromagnetic compatibility, and thermal performance.

Based on the provided text, the device is a radiofrequency aesthetic device, not an AI/ML-driven diagnostic or therapeutic device. As such, the types of studies and acceptance criteria you've asked about (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information presented in this 510(k) summary. The "study" mentioned for performance is a skin temperature test on 3 human volunteers for the Quadro RF Applicator, which is a very different type of study than an AI/ML validation.

Therefore, providing a specific table and detailed answers to your questions on AI/ML performance would be misleading as the document does not contain this information.

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The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

The Reverso device is a tabletop computerized system comprised a console (main unit) and Applicator with detachable single-use tips. The system delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin. The Reverso device provides individual adjustments of energy settings, tip pattern, pulse profile to achieve appropriate efficiency and safety for each eligible patient. The device console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso device Applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. The applicator is hand- held and ergonomically designed for the treatment requiring ablation and resurfacing of the skin. The applicator is connected to the system via a cable. When not in use, the applicator can be placed within the applicator holder positioned on the system console. The Reverso Applicator is compatible with two types of fractional RF tip heads; 80 pin tip head and 160 pin tip head.

The provided text is a 510(k) summary for the Reverso device, which is an electrosurgical device for dermatological ablation and resurfacing. It aims to prove substantial equivalence to a predicate device, the Venus Viva MD.

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

Key Takeaway: This document is not about an AI/ML device where acceptance criteria would involve performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts. Instead, it's a traditional medical device 510(k) focused on demonstrating substantial equivalence to an existing cleared device through engineering and performance testing, primarily with bench and ex-vivo studies. Therefore, many of the typical AI/ML-specific questions (number of experts, adjudication methods, MRMC studies, standalone performance metrics) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are not presented as a table of numerical thresholds for AI performance, but rather as meeting the design requirements and demonstrating similar performance characteristics to the predicate device. The primary goal is to show the Reverso device is "as safe and effective as the predicate device, and that no new safety or effectiveness issues are raised."

The document focuses on comparing the Reverso with the predicate device (Venus Viva MD) across various technical specifications and performance aspects.

Here's a table summarizing the "acceptance criteria" (implied equivalence to predicate) and the reported performance:

Study Details (Applicable to this type of device)

The studies conducted are primarily for engineering validation and comparison to a predicate device, not for typical AI/ML performance evaluation.

1. Sample Size and Data Provenance for Test Set:

   • Bench Tests: No specific "sample size" for a data set in the AI sense is mentioned. These are engineering measurements.
   • Ex-Vivo Tissue Testing: "The study was conducted on human abdomen tissues following an abdominoplasty surgery". A "single treatment" was performed. While it doesn't state the number of tissue samples or individual treatments, it implies a small, illustrative set rather than a large statistical sample.
   • Data Provenance: Not specified, but standard for ex-vivo human tissue. Retrospective/Prospective is not applicable here as it's not a clinical study on living subjects. The tissues were obtained after abdominoplasty surgery.

2. Number of Experts and Qualifications for Ground Truth:

   • Experts: Not explicitly stated as "experts" for ground truth adjudication in the AI sense.
   • Qualifications: The histology section mentions "biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by H&E staining to visualize the tissue ablation and coagulation patterns." This implies histopathological analysis, which would typically be performed by trained personnel (e.g., pathologists or histotechnicians). There is no expert consensus or panel adjudication as would be common for subjective AI image analysis.
   • Ground Truth Type: For the ex-vivo study, the ground truth was histology (H&E staining) to observe ablation and coagulation patterns. This is an objective measurement of tissue response.

3. Adjudication Method for Test Set:

   • Method: Not applicable. There was no expert panel or subjective assessment requiring adjudication. The comparison was based on objective histological findings.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Performed? No. This device is not an AI/ML diagnostic aid, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or required.

5. Standalone (Algorithm Only) Performance:

   • Performed? Not applicable. This is a physical electrosurgical device, not a software algorithm providing diagnostic output.

6. Type of Ground Truth Used:

   • For the ex-vivo study, the ground truth was histology (H&E stained samples) to visually assess and compare tissue ablation and coagulation patterns between the subject and predicate devices.

7. Sample Size for Training Set & How Ground Truth Was Established (for AI/ML):

   • Not applicable. This document describes a traditional medical device, not an AI/ML algorithm that requires training data and ground truth labeling. The "training" here refers to the device's design, manufacturing, and internal testing, not machine learning model training.

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Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows:
a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines.
b. The Recirculation Connector is indicated for use as a male to male Luer adaptor.
c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system.
d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.

A series of blood tubing set accessories to be used as part of the extracorporeal circuit.
A. Medisystems Blood Tubing Set Accessory, Access Flow Reversing Valve, (Reverso): The technical characteristics of the device consist of a manually operated valve with a gasket to prevent leakage. The device is also equipped with tubing and Luer connectors to allow it to interconnect between the blood tubing set and the blood access devices. The device allows reversal to the arterial and venous blood access without the need to disconnect the blood tubing set from the access devices. The reversal of the arterial and venous accesses is necessary to facilitate certain common diagnostic procedures and can be used to reverse flow in central venous or femoral catheters that have patency problems.
B. Medisystems Blood Tubing Set Accessory, Recirculation Connector: The device is a singly packed recirculation connector (male-to male Luer adaptor) used to interconnect the arterial and venous bloodlines.
C. Medisystems Blood Tubing Set Accessory, Parallel Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in parallel into the extracorporeal circuit.
D. Medisystems Blood Tubing Set Accessory, Series Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in series into the extracorporeal circuit.

The provided text describes a 510(k) submission for "Blood Tubing Set Accessories" by Medisystems Corporation. The document outlines the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar measures typically found in AI/ML device submissions.

Instead, the submission focuses on establishing substantial equivalence to a legally marketed predicate device (Medisystems' Blood Tubing Sets described in K953823) and details the safety and effectiveness measures in terms of manufacturing processes and quality control.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for K994306 (Medisystems Blood Tubing Set Accessories)

Given the nature of the device (blood tubing set accessories for hemodialysis) and the regulatory context (510(k) submission from 2000), the testing described is primarily for manufacturing quality assurance and functional integrity rather than AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not specify quantitative acceptance criteria for device performance (e.g., "leakage rate must be

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