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The Diode Laser Hair Removal System (Model: MBT-Diode Laser) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handle. The emission laser is activated by footswitch or handle button.

The Diode Laser Hair Removal System consists of the following major components

• The main console unit that incorporates the main CPU board, power supply modules, laser power supply, laser device, cooling system and switching module
• Handpiece
• Footswitch

The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (MBT-Diode Laser). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific, quantified acceptance criteria for the new device as would be seen in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and adherence to recognized standards.

The table below summarizes the technical comparison provided, where "acceptance criteria" can be interpreted as demonstrating equivalence or justification for differences compared to the predicate/reference devices:

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical performance data. The evaluation relies on non-clinical (bench) testing and comparison to predicate devices, not human subject data.

Since no clinical study was conducted, there is no data provenance (country of origin, retrospective/prospective) for a test set.

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

Not applicable. As no clinical study was conducted and no clinical test set was used, there was no ground truth for a test set established by experts.

4. Adjudication Method for the Test Set

Not applicable. As no clinical study was conducted and no clinical test set was used, there was no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was conducted.

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

The device is a hardware product (Diode Laser Hair Removal System), not an algorithm or software-only device. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/software as a medical device (SaMD) is not applicable here. The performance is evaluated based on its physical/electrical characteristics and safety standards.

7. The Type of Ground Truth Used

For the non-clinical tests regarding electrical safety, EMC, laser safety, and biocompatibility, the "ground truth" is defined by compliance with internationally recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). The device's performance is measured against the requirements of these standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.

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

Not applicable. No training set was used.

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This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients. The device is intended for monitoring respiratory conditions such as asthma.

MSA100BT Peak Flow Meter is a hand-held pulmonary function measuring medical device that measures patient's maximum possible exhalation which is called peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision. The MSA100BT is designed for pediatric to adult patients for home use and for single user, and is intended for monitoring respiratory conditions such as asthma. The MSA100BT has an automatic memory of 250 recordings and can connect to cell phone by Bluetooth. Patients can transfer the records to phone via BLE4.0, then using app to help save and track long term. The MSA100BT is capable of measuring PEF from 50 to 900 L/min and FEV1 from 0.01 to 9.99 L. Its measuring accuracy is ± 20 L/min or ± 10% of the reading for PEF, and ± 0.050 L or ± 3% of the reading for FEV1. The MSA100BT is composed of main unit, turbine sensor, and mouth piece. After each use, the mouthpiece and turbine of the device should be cleaned by soap solution and water within 30 minutes.

The provided document is a 510(k) premarket notification for the MSA100BT Peak Flow Meter. It focuses on demonstrating substantial equivalence to a predicate device, the MSA100 Peak Flow Meter, rather than detailing a study that establishes acceptance criteria for a novel AI device and proves its performance.

Therefore, the specific information requested about acceptance criteria, a study proving device meeting criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI-powered device cannot be extracted directly from this document. This document pertains to a physical medical device (peak flow meter) and its performance validation using non-clinical testing and comparison to an existing device, not an AI algorithm.

However, I can extract the performance criteria and the testing performed to demonstrate that the device complies with certain standards, which can be interpreted as fulfilling "acceptance criteria" in the context of this device's submission.

Here's the closest information I can provide based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions about AI/ML device studies, the document does not contain this information as it is not about such a device.

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is for a physical device, not an AI algorithm evaluated on a data test set from specific provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for performance is established by reference standards for spirometry or laboratory tests for biocompatibility/electrical safety.
4. Adjudication method: Not applicable.
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, this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.
7. The type of ground truth used:
   • Performance: Reference standards specified by Standards of Spirometry (2005 Revision) and American Thoracic Society (ATS) Standard 2005 Revision.
   • Biocompatibility: Laboratory testing results against ISO 10993 standards.
   • Electrical Safety & EMC: Compliance with IEC 60601 standards.
   • Wireless: Compliance with FDA guidance.
   • Software: Software requirement specifications.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatic to adult patients. The device is intended for monitoring respiratory conditions such as asthma.

The MSA100 Peak Flow Meter is a medical device that measures patient's maximum possible exhalation which is called "peak flow" (referred to in medical terms as PEF-Peak Expiratory Flow) and "forced expiratory volume" (commonly known as FEV1) in one second. Regular monitoring of the peak flow is useful for monitoring diseases of the airways such as asthma, C.O.P.D, or chronic bronchitis, is usually used for patient home use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "The sponsor has performed bench tests to demonstrate the MSA100 Peak Flow Meter performs within specifications." This suggests the testing was laboratory-based rather than involving human subjects for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing appears to be based on engineering and laboratory standards, not clinical ground truth established by medical experts for individual cases.

4. Adjudication method for the test set:

Not applicable. The testing described involves bench tests against specified performance metrics and adherence to international standards, not subjective expert adjudication of results.

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 device is a measurement instrument (Peak Flow Meter) and does not involve AI or human "readers" interpreting data in a typical MRMC study context.

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

The device is a standalone instrument for measuring PEF and FEV1. The "algorithm only" concept doesn't directly apply as it's a physical device with embedded measurement technology (turbine transducer, photoelectric conversion). The performance described is its standalone measurement accuracy.

7. The type of ground truth used:

The ground truth used for specific performance metrics (like accuracy for PEF and FEV1) would be established by reference standards or calibrated equipment used in the bench testing. For biocompatibility and electrical safety, the ground truth is adherence to the specified ISO and IEC standards.

8. The sample size for the training set:

Not applicable. This device is a hardware measurement instrument tested against established engineering and performance standards, not a machine learning model 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 this type of device.

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