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The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients.

The Rigel Medical UniPulse 400 is a portable, rechargeable battery operated (with AC Adapter) defibrillator tester used to determine that a defibrillator and a defibrillator with a transcutaneous pacemaker function perform to their published performance specifications. The UniPulse 400 is connected to a defibrillator output and is used to measure the output energy delivered from the device into a standard resistive test load. It also provides waveform information on its integrated display. For pacemaker testing, a variable load from 50 to 1600 ohms is available in 50-ohm steps. Defibrillator paddles are connected directly to the UniPulse 400 for hands free operation, or to contact plates if using the paddles. When the defibrillator is discharged, the UniPulse 400 will display the energy delivered. Included in the UniPulse 400 is an ECG simulator with normal sinus rhythm and arrhythmia simulation to trigger automated defibrillation.

UniPulse 400 is used by biomedical and/or clinical engineers to verify performance of defibrillators used in their hospital. The UniPulse 400 provides statistical data measured from the device and can communicate to an external Bluetooth printer and a PC / Laptop via Bluetooth and USB.

The provided text describes the UniPulse 400 Defibrillator/Pacemaker Analyzer, a device used to verify the performance of defibrillators. However, it does not include detailed acceptance criteria or a study proving the device meets those criteria in a format directly addressing typical AI/ML device study parameters.

The document discusses performance testing, but focuses on compliance with general safety and EMC standards rather than specific analytical performance metrics and their acceptance thresholds. It also states the device is not an AI/ML product, and thus many of the requested criteria (like ground truth, expert adjudication, MRMC studies) are not applicable.

Here's a breakdown based on the provided text, and where gaps exist because the device is not an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the device was tested to comply with its specifications, but it does not explicitly list quantitative performance acceptance criteria for measuring energy output or pacemaker analysis, nor does it report specific numerical performance results against such criteria. The "Summary of Performance Testing" refers to compliance with safety (Electrical Safety, Electromagnetic Compatibility) and software development standards, not analytical performance accuracy or precision with defined thresholds relevant to a diagnostic AI/ML device.

2. Sample Size for Test Set and Data Provenance

This information is not applicable/provided in the context of an AI/ML test set. The UniPulse 400 is an analyzer for other medical devices, not a diagnostic tool that processes patient data. Performance testing appears to involve laboratory bench testing against standards, not a patient-based test set.

3. Number of Experts for Ground Truth and Qualifications

This is not applicable as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Its performance evaluation would involve comparing its measurements against known, calibrated inputs or reference devices, not expert consensus on medical images or signals.

4. Adjudication Method for Test Set

This is not applicable for the same reasons as (3).

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

This is not applicable. The UniPulse 400 is a measurement device for defibrillators, not an AI-assisted diagnostic tool that aids human readers in interpreting clinical cases. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only) Performance Study

While the device's "performance testing" assesses its standalone function, it's not a standalone algorithm in the sense of an AI/ML diagnostic tool. The document states its performance was tested against its predetermined specifications, indicating standalone functionality, but does not provide details of this testing beyond compliance.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML diagnostic devices (e.g., pathology, outcomes data) is not applicable here. For the UniPulse 400, "ground truth" would likely involve highly accurate and calibrated reference measurements from specialized lab equipment or known, precise outputs from simulated defibrillator discharges. The document does not specify how the accuracy of these reference measurements was established.

8. Sample Size for Training Set

This is not applicable. The UniPulse 400 is a hardware and software device following traditional engineering principles, not an AI/ML algorithm that is 'trained' on a dataset.

9. How Ground Truth for Training Set was Established

This is not applicable for the same reasons as (8).

Conclusion from the document:

The K182905 510(k) summary for the UniPulse 400 primarily focuses on demonstrating substantial equivalence to a predicate device (Fluke Biomedical Impulse 7000dp Defibrillator Analyzer) by showing similar technological characteristics and compliance with general safety and electromagnetic compatibility (EMC) standards. The "Performance Testing - Bench" section states that the device was tested according to "predetermined specifications" and that the results show compliance, but it does not elaborate on what these specific performance specifications are (e.g., accuracy, precision of energy measurement), nor does it present the numerical results of these tests.

The document is a regulatory clearance for a physical measurement device, not an AI/ML diagnostic algorithm, hence the lack of information pertinent to AI/ML specific study requirements.

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Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.
Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.

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The provided text is related to a 510(k) clearance for the Nidek UniPulse CO2 Surgical Laser System. It is an administrative document confirming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance as typically expected for in-vitro diagnostic (IVD) devices or AI/ML-driven medical devices.

Therefore, most of the requested information regarding acceptance criteria, study details, expert consensus, and training/test set specifics for an AI/ML device is not applicable to this document. This document primarily focuses on regulatory clearance based on substantial equivalence to an already marketed device.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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

• Not Applicable. The document does not describe specific performance-based acceptance criteria for the Nidek UniPulse CO2 Laser System in terms of classification metrics (e.g., sensitivity, specificity, AUC) or quantitative measurements. Instead, it relies on substantial equivalence to a predicate device. The "performance" assessment here is conceptual, relating to the device's ability to perform its intended function safely and effectively, similar 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)

• Not Applicable. No explicit test set or clinical study data (in the sense of a controlled trial with a defined sample size for performance evaluation) is described. The clearance is based on the comparison to a predicate device, not on new clinical performance data from a specific test set.

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. Since there is no described test set or performance study, there is no mention of experts establishing ground truth for such a set.

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

• Not Applicable. No test set or corresponding adjudication method is discussed.

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. This is a laser surgical system, not an AI-driven diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. As no specific performance study is detailed, no ground truth methodology is described. The "ground truth" for the clearance is essentially the established safety and efficacy profile of the predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

Summary of Relevant Information from the Document:

While most of the requested information for an AI/ML device is not applicable, here's what can be gleaned about the regulatory approach:

• Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
• Device Trade Name: UniPulse CO2 Laser System
• Device Common Name: CO2 Surgical Laser System
• Device Classification: Class II
• Performance Standards (Regulatory Compliance, not performance metrics): The laser systems comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
• Indications for Use: Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows, and acne scar revision.
• Basis for Clearance: Substantial equivalence to the Coherent CO2 laser system (the predicate device). The document states: "The Nidek CO2 system is substantially equivalent to Coherent's CO2 laser system. The risks and benefits of the Nidek UniPulse CO2 are comparable to the predicate device when used for similar clinical applications."

The clearance is granted because the Nidek UniPulse CO2 laser system is "substantially equivalent with respect to indications for use, materials, method of operation and physical construction" to the predicate device, thereby assuring safety and effectiveness. This is a common pathway for medical device clearance, especially for non-novel technologies like surgical lasers.

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