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Intended use

This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions:

• Ventilation monitoring
• Inspiratory 02 measurement
• Device monitoring
• Anesthetic gas receiving system

The following options are additionally available:

• Patient-gas measurement module for 02, CO2, N2O, and anesthetic gases
• 02 insufflation

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.

Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube.

The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).

Indications

The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

The Atlan anesthesia workstation was developed and is manufactured by Dräger in Lübeck, Germany. The anesthesia workstation is specified for inhalational anesthesia using volatile anesthetic agents and/or patient ventilation, including the delivery of oxygen and the monitoring of device functions as well as the patient's and/or anesthetic parameters. Atlan is available in different device variants and can be upgraded by software and hardware options as well as attachable accessories.

The Atlan anesthesia workstation consists of four major subsystems, each of which operates on its own specific principle while interacting with the other subsystems to achieve the intended use. These major subsystems include:

• Gas reception and delivery, i.e., gas mixer o
• o Anesthetic breathing system
• o Anesthetic ventilator
• o Anesthetic gas scavenger

The Atlan anesthesia workstation receives medical gases from a cylinder or central gas supply, creates a gas mixture, or composition, and delivers this mixture at a determined flow rate to the anesthetic breathing system.

Atlan's anesthetic breathing system is the interface between the anesthesia workstation and the patient. Its purpose is to deliver the gas composition to the patient. While doing so, the anesthetic breathing system converts the continuous gas flow to the patient's intermittent respiratory flow, supports controlled or assisted ventilation, and allows for gas sampling and pressure measurements. Furthermore, the anesthetic breathing system conditions the inspiratory gas by means of a heater and removes carbon dioxides from the patient's expired qas.

The anesthetic ventilator drives fresh gas from the anesthetic breathing system to the patient and expired gas to the anesthetic gas scavenger.

Atlan's integrated anesthetic gas scavenger collects all waste anesthetic gases received from the breathing circuit and passes it on to a hospital disposal system.

The anesthesia workstation is also comprised of several minor subsystems whose interactions with the main subsystems help to address considerations of patient safety and system integrity. The minor subsystems include:

• o Gas monitoring
• o Ventilation and airway monitoring
• Device monitoring, including system self test o
• Embedded control display o
• RFID capabilities o

The provided text is a 510(k) Premarket Notification Summary for the "Atlan" anesthesia workstation. It describes the device, its intended use, and compares it to a predicate device (Perseus A500, K133886) and several reference devices.

However, the document does not contain specific acceptance criteria tables, reported device performance metrics, sample sizes for test sets, data provenance, information about expert ground truth establishment, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance data, or details about training set ground truth establishment.

Instead, it states that "The Atlan anesthesia workstation is a new device and has undergone extensive testing to qualify it with e.g., national and international consensus standards, technical system requirements and other requirements." It then lists the types of verification and validation activities performed, such as:

• Sterilization
• Biocompatibility
• Software, including cybersecurity
• Electrical safety
• Electromagnetic compatibility (EMC)
• Compliance with various IEC and ISO standards (e.g., IEC 60601-1-8 for alarm systems, ISO 80601-2-13 for anesthetic workstations, ISO 80601-2-55 for respiratory gas monitors)
• Waveforms, including comparisons to the predicate device and performance as per ASTM-F1101
• Technical System Requirements (risk control measures, technical data, essential safety and performance)
• Accessories compatibility
• Human factors engineering (IEC 60601-1-6 for Usability, IEC 62366-1 for the application of usability engineering to medical devices)

The document concludes that "The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Atlan is as safe, as effective and performs as well as or better than the legally marketed device Perseus K133886 as identified in this section of the submission."

Therefore, I cannot provide the requested table and detailed study information because it is not present in the provided text. The document summarizes the types of testing performed and the conclusion of those tests but does not offer the specific data points requested in your prompt.

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The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".

The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.

The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria for the "Fourth Gas Module with CO2 for Primus US 'Apollo' Anesthesia machine."

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:

• "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."

However, it does not provide details about specific acceptance criteria or the study data that supports this assurance.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

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The TROJAN SUPRA® Lubricate Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricant coating. The condom is a straight-walled, nipple-end condom with a nominal length of 190 mm and an approximate flatwidth of 58 mm.

This document describes a 510(k) premarket notification for the TROJAN SUPRA® Lubricated Polyurethane Male Condom. The acceptance criteria and the study that proves the device meets those criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Users/Cases): 206 couples.
• Data Provenance: Prospective, conducted in France.

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

This information is not explicitly provided in the document. The study involved "an In-Use Study" following an FDA guidance, and the outcomes were "clinical breakage rate" and "clinically significant slippage." It's customary for such clinical studies to involve medical professionals in assessing and recording these events, but the specific number and qualifications of experts are not detailed.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Clinical studies often have adjudication committees for adverse events or endpoint assessment, but the document does not specify if one was used or the method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not conducted as this is a medical device (condom) and not an imaging-based diagnostic or AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical medical device (condom) and does not involve AI algorithms.

7. The Type of Ground Truth Used

The ground truth used was clinical observation and user reporting of objective outcomes, specifically:

• Clinical Breakage Rate: Direct observation/reporting of condom breakage during intercourse.
• Clinically Significant Slippage Rate: Direct observation/reporting of condom slippage during intercourse.

8. The Sample Size for the Training Set

No training set information is applicable or provided as this is a physical medical device, not an AI-based system.

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

Not applicable as there is no training set for this type of medical device.

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