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The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.

The provided document focuses on the substantial equivalence of the Noah Medical Galaxy System to a predicate device (Monarch Endoscopy Platform) and a reference device (superDimension Navigation System). It details various performance tests conducted to support this claim, but it does not explicitly define specific acceptance criteria with numerical thresholds for device performance, nor does it present a study that reports numerical device performance against such criteria.

Instead, the document broadly states that the device has been "successfully tested" and "meets the intended user needs". It also mentions a simulated use study where users were able to "navigate to within 30 mm of the lesion, complete tomosynthesis, and acquire tissue". However, this is described as a capability demonstrated rather than a performance metric achieved against a pre-defined acceptance criterion.

Therefore, I cannot fully complete the table for acceptance criteria and reported device performance as requested, as these specific numerical values and direct comparisons are not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit numerical acceptance criteria or corresponding reported device performance metrics are provided in the document. The performance data section describes general testing and findings without quantifiable acceptance thresholds.

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

The document mentions "human cadaver and animal models" for "Design Validation testing" and "Simulated Use" testing. It also refers to "representative users" for "Human Factor Usability Testing."

• Test Set Sample Size: Not explicitly stated as a number. The document refers to "human cadaver and animal models" and "representative users" without specifying the quantity.
• Data Provenance: The testing was performed by Noah Medical, implying it's internal study data. The document does not specify the country of origin of the cadavers or animals, nor does it explicitly state whether the study was retrospective or prospective, though design validation and usability testing are typically prospective.

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

The document does not describe a process for establishing ground truth for a test set through expert consensus in the context of clinical performance evaluation against a specific gold standard. The focus of the performance testing described is on functional verification, safety, and usability.

• For the simulated use, "The user group included physicians who have been trained and are actively using the predicate and reference devices." The number of these physicians is not specified, and their specific role in establishing "ground truth" (as opposed to being subjects performing tasks) is not detailed.
• Qualifications of these physicians are generally described as "trained and actively using the predicate and reference devices," suggesting experience with similar bronchoscopic navigation systems.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing focuses on functional and usability aspects rather than diagnostic or clinical accuracy requiring expert review and adjudication of findings.

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

The document does not mention a MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The performance data focuses on the device's functionality, safety, and usability, demonstrating substantial equivalence to predicate devices, not on the comparative effectiveness of AI-assisted vs. unassisted human performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly describe a standalone algorithm performance study. The Galaxy System's navigation component is integrated and described as used by physicians: "The Galaxy System enables a physician to utilize electro-mechanical articulation for precise control... By utilizing electromagnetic field-based sensors on the tip of the endoscope tip location relative to the pre-operative scan anatomy is continuously displayed." The software verification and validation section confirms that "Galaxy System software conforms to the design specifications and meets the intended use and needs of the intended users," but this is about software correctness rather than a standalone performance metric against a clinical ground truth.

7. Type of Ground Truth Used

For the simulated use testing, the "ground truth" for navigation was implicitly the ability to "successfully navigate to a peripheral lung lesion" and reach "within 30 mm of the lesion." This appears to be based on an expected outcome in the cadaver/animal models, rather than a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests the described performance testing is for validation, not for the training of a machine learning model, or if there was training, its details are not included in this summary.

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

As no information about a training set is provided, how its ground truth was established is also not available in this document.

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The Galaxy System (which includes the Jupiter amplifier and Galaxy software) is intended for use as a polysomnographic system to acquire record, display, print and store physiological parameters to assist clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers, clinics or other test environments where adults or infants require the documentation of sleep or other physiological disorders. The Galaxy system does not provide alarms and is not intended for use as an automated apnea monitor.

The Galaxy system (which includes the Jupiter and Galaxy software) is a Polysomnography System that is intended to acquire, record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.

The system can record, monitor, store and transfer of up to 42 channels of biophysical parameters. Generally the device is capable of acquiring and displaying the following parameters:

• EEG .
• EOG (eye movement) ●
• Chin EMG .
• . Leg EMG (leg movement)
• ECG (single channel) ●
• . Chest respiratory effort
• . Abdomen respiratory effort
• . Nasal Flow Thermistor
• . Nasal Flow Pressure
• . Body position
• . Snoring
• Oximeter .
• . Patient "Event" button

The components of the Galaxy system include:

• Headbox/Amplifiers (i.e., "BrainBox EEG amplifier, "Touchproof connector box", "Jupiter 1. amplifier") – Galaxy can support two amplifier/headbox models, 1166 and 1142. Both models are electrically exactly the same, except for the differences between the number of channels.
• Ethernet Interface
• Isolator (ISO101)
• Connecting Wires
• Desktop Computer
• Electrodes Third party electrodes and sensors such as surface electrodes compatible with 32 AC inputs by means of touch-proof connectors, "Nonin oximeter (XPOD3012)," and "respiratory effort sensors" can be used with the system, but these sensors are not provided with the device. Only sensors specifically tested and verified for use with the device should be used and are listed in the user's manual.
• Galaxy Software The Galaxy software's main functionalities include the following:
  • a. Record and display signals Collect and display PSG parameters. Plot acquired data on screen (within a time window of 30 seconds) and store on hard-disk of computer.
  • b. Provide tools for Manual Review of Data Allow the user to review and manually analyze data, edit this analysis and delete the entered events if needed. Software also displays the user annotations along with the signal traces, as trend overview over the night and as a list, and allows the user to review the acquired data after the completion of the recording to examine and annotate afterwards (offline).
  • c. Generate Patient Reports The software calculates summaries of the manually scored data and print them as tabulated reports and shows simple computer calculations like average value, rates etc ...

Galaxy also has the following additional functions:

• changing the mode of the amplifier for calibration, impedance check or data acquisition .
• sending commands to set sample rate of the digitization, to specify the recording montage . and to receive data from the Jupiter amplifier via Ethernet interface.

The device does not provide any automatic scoring algorithms.

I am programmed to be an obedient and helpful AI assistant. I will do my best to fulfill your request.

The provided document describes a 510(k) premarket notification for the Galaxy System, a Polysomnography (PSG) System. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance metrics through a clinical study with acceptance criteria in the typical sense of algorithm performance. The device itself (Galaxy System) is a data acquisition and display system for physiological parameters, not an automated diagnostic algorithm. Thus, the "acceptance criteria" and "study" are focused on safety, effectiveness, and functional equivalence to existing legally marketed devices, rather than a clinical performance study with predefined statistical endpoints for an AI algorithm.

However, I will extract the information that aligns closest to your request, interpreting "acceptance criteria" as the comparable characteristics to predicate devices that demonstrate safety and effectiveness for its intended use, and "study" as the testing and verification performed to support these claims.

Here's a breakdown of the information based on your request, as much as can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for substantial equivalence of a polysomnograph system (not an AI algorithm with specific performance metrics like sensitivity/specificity), the "acceptance criteria" are interpreted as the functional and technical characteristics deemed equivalent to the predicate devices. The "reported device performance" is essentially the detailed specification of the Galaxy System, demonstrating its equivalence to the predicate devices.

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

The document does not describe a clinical study with a "test set" of patient data for evaluating an algorithm's performance. The testing mentioned in the document is primarily hardware and software verification and validation, safety testing, and compliance with standards.

• Test Set Sample Size: Not applicable in the context of an algorithm's performance on patient data.
• Data Provenance: Not applicable. The device itself records physiological data; it does not process pre-existing data or make interpretations. The testing involved "work-bench by developers, in the factory by developers and in the field by sleep-technicians and researchers." This suggests functional testing, not a clinical trial on a specific dataset.

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

This is not applicable. The device does not involve an AI algorithm that requires expert-established ground truth on a test set. It's a data acquisition and display system. Clinicians/physicians use the displayed parameters for "diagnostic review," but the device itself does not provide automated diagnoses or interpretations that would require ground truth for validation.

4. Adjudication Method for the Test Set

This is not applicable, as there is no test set in the sense of a dataset requiring expert adjudication for algorithm performance evaluation.

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 such study was done or is mentioned. The Galaxy System "does not provide any automatic scoring algorithms" and "does not provide alarms and is not intended for use as an automated apnea monitor." Therefore, there is no AI component for human readers to interact with or improve upon.

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

No. The device "does not provide any automatic scoring algorithms." Its function is to "acquire, record, display, print and store physiological parameters to assist clinicians/physicians."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. As highlighted, this device is a data acquisition and display system, not an AI diagnostic tool. Its validation focuses on accurate signal acquisition, display, and compliance with safety and electrical standards.

8. The Sample Size for the Training Set

Not applicable. The document describes a traditional medical device (polysomnograph system) that acquires and displays physiological data. It is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary of Device Nature and 510(k) Context:

This 510(k) submission is for a Polysomnography (PSG) System, which is a device designed to collect, display, and store physiological signals for manual review by clinicians. It explicitly states it does not contain automatic scoring algorithms, alarms, or automated apnea monitoring. The "testing" described is focused on:

• Hardware verification and validation: Ensuring the amplifier, interfaces, and other physical components function correctly and meet specifications.
• Software verification and validation: Ensuring the software accurately records, displays, stores, and allows for manual review and reporting of data.
• Safety and EMC compliance: Adhering to relevant IEC and EN standards for medical electrical equipment.
• Substantial Equivalence: Demonstrating that its technological characteristics and intended use are similar to legally marketed predicate devices (Natus Neurolink IP Model PK1117 and Alice 5 by Respironics), thereby establishing its safety and effectiveness without requiring a new clinical performance study for an AI component.

Therefore, the types of "acceptance criteria" and "studies" you are asking about, which are typical for AI/ML-based diagnostic devices, are not relevant or present in this specific 510(k) document because the device does not incorporate AI or automated diagnostic functions.

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