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STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery.

STARDUST MED is indicated for hair removal and permanent hair reduction.

Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime

STARDUST MED is a laser emitting device that is operated with handpiece in contact with the skin.

STARSDUST MED comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch.

A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpiece:

• -808 nm Laser diode.

The provided text is a 510(k) summary for the STARDUST MED device and focuses on establishing substantial equivalence to a predicate device (MT ONE DIAMOND - K191942). It relies heavily on comparing technical specifications and intended use, and states that non-clinical testing supports the device's technological characteristics and performance.

However, the document does not contain information about:

• Acceptance criteria for a specific performance study.
• The device's reported performance against such criteria.
• Sample sizes used for a test set or data provenance for any clinical performance study.
• The number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Any Multi Reader Multi Case (MRMC) comparative effectiveness study.
• Any standalone performance study (algorithm only).
• The type of ground truth used for any performance study.
• Sample size for the training set or how ground truth was established for a training set.

The "Performance data" section only mentions:

• Safety and electromagnetic compatibility (EMC) testing: Compliance with IEC 60601-2-22 and IEC 60601-1-2 standards. This is a regulatory compliance, not a performance study as typically understood for a medical device's intended use (e.g., hair removal efficacy).
• Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance. This also relates to regulatory compliance and software quality, not a direct measure of hair removal performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the detailed information points you listed, because this information is not present in the provided document. The 510(k) summary emphasizes the device's similarity to a predicate device and adherence to safety and software standards, rather than presenting a clinical performance study with specific acceptance criteria related to its intended use (hair removal).

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The Stardust II is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders. The Stardust II is only to be used under the direction and supervision of a physician, technologist or clinician.

The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:

• Airflow (acquired with a pressure cannula or thermistor sensor) .
• Effort .
• SpO2 .
• . Pulse rate
• Apnea ●
• Hypopnea ♥
• Desaturation .
• Snore .

The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.

This looks like a medical device submission, specifically a 510(k) summary for the Stardust II device. The provided text does not contain specific acceptance criteria or the details of a study demonstrating the device meets those criteria, nor does it provide performance data, sample sizes, ground truth establishment, or information on reader studies.

The submission focuses on establishing substantial equivalence to a predicate device and describing the intended use and device functionality. It states that "Design verification tests were performed on the Respironics Stardust II as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not elaborate on what those criteria were, what the "reported device performance" was, or the details of the study.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for test sets.
• Information on MRMC comparative effectiveness studies or standalone studies.
• Details on the type of ground truth used or how it was established for training and test sets.

The provided text only contains the following relevant information regarding your request:

• Device Name: Stardust II Ventilatory Effort Recorder
• Intended Use: To collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders.
• Key Functionality: Records physiological signals and uses proprietary algorithms to determine and report respiratory waveforms and events (Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation, Snore).
• Statement on Testing: "Design verification tests were performed on the Respironics Stardust II... All tests were verified to meet the required acceptance criteria."

Without additional documentation (e.g., from an appendix or supporting study report that would typically be part of a full 510(k) submission but are not included in this summary), I cannot provide the specific details you've requested.

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The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting.

The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).

The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:

Airflow* Effort SpO2 Pulse rate Apnea Hypopnea Desaturation

*Nasal airflow can be acquired with a pressure cannula or thermistor sensor.

The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.

The provided document for the Respironics Stardust II (K021845) does not contain detailed information about specific acceptance criteria or the study that proves the device meets these criteria in the format requested. The document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Design verification tests were performed on the Respironics Stardust II as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, it does not provide a table with specific acceptance criteria (e.g., accuracy thresholds for SpO2, airflow, etc.) nor the reported device performance measurements against those criteria.

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

This information is not provided in the document. The document mentions "design verification tests," but does not specify the sample size of patients or data samples used for these tests, nor the country of origin of the data, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The document refers to the device aiding "Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders," implying clinical validation, but it doesn't detail how ground truth was established for any test sets.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

This information is not provided in the document. The filing is for a device to aid in diagnosis, but it does not detail any studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document states: "The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events: Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation."

This indicates that the device has an algorithmic component that processes signals and determines events, suggesting a standalone algorithmic function. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are not provided for these algorithms.

7. Type of Ground Truth Used:

This information is not explicitly stated in the document for any test sets. Given the device's intended use for diagnosing sleep-related breathing disorders, ground truth would typically be established by polysomnography (PSG) scored by a sleep expert, or clinical diagnosis. However, this is not described as part of the "design verification tests."

8. Sample Size for the Training Set:

This information is not provided in the document. The document mentions "proprietary algorithms" but does not detail their development or any training data used.

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

This information is not provided in the document.

Summary of available information regarding acceptance criteria and studies:

The provided 510(k) summary indicates that design verification tests were conducted, and "All tests were verified to meet the required acceptance criteria." However, the document does not disclose the specific acceptance criteria themselves, nor the detailed results of these tests, nor the methodologies, sample sizes, or ground truth establishment relevant to those tests.

The focus of this 510(k) is demonstrating substantial equivalence to predicate devices (Respironics Stardust and Respironics REMstar Auto) based on similar operating principles, technology, and manufacturing processes, rather than providing detailed clinical performance data from new studies.

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Intended Use:
The Stardust is a respiratory disorder diagnostic device that is intended to measure and record five parameters. These parameters are percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort, and body position (i.e., supine or non-supine). It can also be connected to a Respironics Virtuoso Smart CPAP System to record and display continuous positive airway pressure (CPAP) and ainway index level.

The Stardust can be used as a stand-alone unit for recording data. It also interfaces with a commercially available IEC 950 compliant computer, which enables you to view data real-lime in a recording mode. The Stardust does not have any audible alarms and, therefore, should not be used for continuous monitoring of oxygen saturation or as a replacement for pulse oximeter monitors.

Indications for Use: The Stardust is indicated for use in the diagnosis of respiratory disorders, such as sleep apnea.

A low-power, diagnostic, recording device that interfaces with predefined sensors, and processes and records physiologic patient data.

The Stardust is a respiratory disorder diagnostic device that is intended to be used to measure and record five parameters. These parameters are:

• D percent SpO, (functional)
• 0 pulse rate
• oral/nasal airflow
• 0 respiratory effort
• body position (i.e., supine or non-supine) o

It can also be connected to a Respironics Virtuoso Smart CPAP System to record and display continuous positive airway pressure (CPAP) and airway index level. The Stardust can be used as a stand alone unit for recording data. It also interfaces with a commercially available IEC 950 compliant computer and can be used to view data real-time in a recording mode. The Stardust does not have any audible alarms and, therefore, should not be used for continuous monitoring.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it describes the Stardust device, its intended use, software capabilities, and general safety and effectiveness testing to demonstrate substantial equivalence to predicate devices (HMS 4000 and HMS 5000).

The document mentions:

• "Testing was performed to demonstrate that the performance of the Stardust in its intended environment is as safe and effective as that of the legally marketed predicate devices."
• "The safety and effectiveness of Stardust were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing."
• "The Stardust was tested and found compliant with the standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993."

However, it does not provide:

• A table of specific numerical acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity values).
• Reported device performance against such criteria.
• Details about a clinical study involving a test set, ground truth establishment, sample sizes, expert qualifications, or adjudication methods for diagnostic accuracy.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
• Sample sizes or methods for establishing ground truth for training data.

The software section describes "manual scoring" and "automatic scoring" rules for identifying apneas and hypopneas based on parameters like minimum event duration and peak inspiratory value percentages. While these are rules for the algorithm's operation, they are not presented as acceptance criteria for the device's diagnostic performance against a clinical ground truth.

Therefore, requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in the provided text.

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