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The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via optical fibers . The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification from the FDA for the ECHOLASER X4, which is a laser surgical instrument. It details the device's indications for use, its substantial equivalence to a predicate device (K181510), and the fact that the requested change is solely a language revision of the intended use, supported by a reference predicate (K181859).

Since the submission states that no other changes have been made to the existing ECHOLASER X4 and that the technical features, design, performance, and safety are unaffected, no new non-clinical or clinical testing was performed to demonstrate performance against acceptance criteria. The submission relies on the prior clearance of the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about studies, sample sizes, ground truth, experts, or adjudication methods, as this information is not present in the provided text.

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The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

The provided text describes a medical laser system, the ECHOLASER X4, and its substantial equivalence to a predicate device for the purpose of FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical or algorithmic efficacy.

The document focuses on regulatory compliance and comparison with a predicate device (DORNIER MEDILAS D 1064 laser system) based on technical specifications and intended use.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical or algorithmic performance, which is not detailed here.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be fully provided. The document lists technical specifications of the device and compares them to a predicate device. It doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific outcome measure for a therapeutic device) or detailed "reported device performance" against such criteria. The performance shown is primarily technical parameters.

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Chito-SAM™ Active (over-the-counter use):
To control bleeding of lacerations, minor cuts and abrasions.

Chito-SAM™ 100 (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations.

The Chito-SAM" Gauze (refers to both the Chito-SAM" 100 for prescription use and Chito-SAM" Active for over-the-counter use) is made of a non-woven fabric derived from chitosan fibers. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Chito-SAM Gauze will turn into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Chito-SAM Gauze is provided in three (3) different sizes for prescription use and two (2) different sizes for over-the-counter use to accommodate a variety of treatment regions. The Chito-SAM Gauze is individually packaged in a foil pouch and is gamma-sterilized.

Please note: The provided FDA 510(k) summary for the Chito-SAM™ Active device does not explicitly state acceptance criteria or direct device performance against those criteria in a table format. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, the response below will synthesize information regarding "acceptance criteria" from the described non-clinical tests and the "reported device performance" will be derived from the general statements of a successful outcome in these tests. Information that is not present in the provided document will be explicitly stated as "Not provided in the document."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not explicitly provided. The document mentions "non-clinical testing" which includes functional testing, biocompatibility testing (per ISO 10993-1), in-vivo hemostasis testing, and shelf-life testing. The specific number of samples or animals used for each test is not detailed.
• Data provenance:
  • Country of origin: Not explicitly stated for specific tests.
  • Retrospective or prospective: The non-clinical tests described (functional testing, biocompatibility, in-vivo hemostasis, shelf-life) are generally prospective studies designed to evaluate the device.

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

• Not applicable/Not provided. For non-clinical (bench and animal) testing, "ground truth" is typically established by objective measurements, laboratory analyses, and physiological observation, rather than expert consensus on subjective data. The document does not mention the involvement of experts for "ground truth" establishment in the context of these non-clinical tests.

4. Adjudication method for the test set

• Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there is potential for disagreement in subjective assessments. The non-clinical tests described do not involve such a process.

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 hemostatic dressing, not an AI software/algorithm requiring human interpretation or assistance. Therefore, an MRMC study related to AI assistance for human readers was not performed or described.

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

• Not applicable. This device is a hemostatic dressing, not an AI algorithm. Its performance is evaluated through direct physical, chemical, and biological testing, not by an algorithm.

7. The type of ground truth used

• For non-clinical testing:
  • Functional Testing (Liquid Absorption, pH, Tensile Strength, Platelet Aggregation): Ground truth is based on established laboratory standards, specifications, and comparison against predicate devices' known performance.
  • Biocompatibility Testing (ISO 10993-1): Ground truth is determined by the specific criteria and endpoints defined in the ISO standard for cytotoxicity, irritation, sensitization, hemolysis, and systemic toxicity.
  • In-vivo Hemostasis Testing: Ground truth is established by physiological outcomes (e.g., control of bleeding, time to hemostasis) observed in the animal model, often compared to an untreated control or predicate device.
  • Shelf-life Testing: Ground truth is based on physical, chemical, and microbiological stability over time, validated through accelerated and real-time aging studies against predefined acceptance limits.

8. The sample size for the training set

• Not applicable. This is a medical device (hemostatic dressing), not an AI algorithm that requires a training set.

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

• Not applicable. As stated above, this is not an AI algorithm requiring a training set.

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Acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands.

The Xiralite fluorescence imaging system X4 detects fluorescence signals in the defined field of view using a highly sensitive camera for signal detection and light emitting diodes (LEDs) for excitation. Fluorescence signals typically result from illumination of a specific fluorophore, the fluorescence dye indocyanine green (ICG), which is administered intravenously. Fluorescence signals are recorded at different periodical time points, thus the resulting images display an image sequence. The frame rate is between half a second and a few seconds, typically one second. The duration of the entire image acquisition is dependent on the pharmacokinetics of the administered fluorophore, with ICG typically six minutes.

The provided text describes a 510(k) premarket notification for the Xiralite Fluorescence Imaging System X4. The information focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a detailed study proving the device meets those criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, and ground truth establishment is not explicitly available in the provided document.

However, based on the available information, here's a structured response.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria for the device's performance in terms of metrics like sensitivity, specificity, or accuracy. The basis for acceptance is demonstrating substantial equivalence to a predicate device, the Spy Fluorescent Imaging System (K042961, K073088). The "performance" described is largely functional and qualitative, focusing on its ability to acquire fluorescence images for visual assessment of circulation.

Study Details:

The provided document describes the basis for substantial equivalence rather than a formal, standalone clinical study with predefined acceptance criteria for AI performance. The "study" mentioned is primarily a collection of non-clinical tests and user feedback from European clinical use.

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

   • Test set sample size: Not applicable in the context of a formal performance study with a 'test set' in the AI sense.
   • Data provenance: The document references "more than 10,000 patient exams" from "more than 35 systems... in clinical use in hospitals as well as in physician offices, mainly in Germany" since 2009. This data is retrospective from real-world clinical use.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the real-world clinical observations by healthcare professionals using the device, whose qualifications are generally described as "Health care professionals." The document does not specify a panel of experts for ground truth establishment for a test set.

3. Adjudication method for the test set: Not applicable. There was no formal adjudication process for a specific test set. The conclusion of performance and safety is based on user feedback and the absence of reported adverse events.

4. 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 MRMC or human-in-the-loop study with AI assistance was described. The device itself is an imaging system, not an AI-powered diagnostic algorithm.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an imaging system, not an algorithm, so a standalone algorithm-only performance study is not relevant in this context. The non-clinical tests showed the functional performance of the device itself (e.g., linearity of signal, safety standards).

6. The type of ground truth used:

   • For safety and functional performance: Adherence to consensus standards (mechanical, electrical, thermal safety, EMC, biocompatibility) and linearity of signal with ICG concentration.
   • For effectiveness/intended use: User feedback from clinical operation and the absence of reported adverse events over 10,000+ patient exams over several years.

7. The sample size for the training set: Not applicable. This is not an AI-driven device requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.

The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality.

The acquired signals are saved in a universal data format (European Data Format - EDF). The study record, once saved on the PC, is available for analysis by Advanced Brain Monitoring's Sleep Profiler software application. The X4's downloaded study will reside on either or local PC or a cloud server, which can be a physical or virtual server. Software on the cloud server is accessed via web portal software.

The Advanced Brain Monitoring, Inc. X4 System (K130013) is a device for configurable acquisition of physiological signals, including EEG, EOG, ECG, EMG, accelerometer, acoustical, and photoplethysmographic signals. It is intended for prescription use in various environments to acquire, record, transmit, and display these signals from adult patients.

The documentation indicates that no clinical studies were performed to establish substantial equivalence for this particular submission (K130013). Instead, the determination of substantial equivalence was based on non-clinical tests, specifically focusing on risk management and software testing. The X4 System (K130013) is described as identical to a previously cleared X4 System (K120447), with the only change being the development of a Device Manager Module accessible via a web portal, which duplicates functions already present in the PC software.

Therefore, the following information is based on the provided text, and it's important to note that the acceptance criteria and performance are related to the software functionality as evaluated for this specific 510(k) submission, rather than the accuracy of physiological signal acquisition, for which no new claims are being made.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the test set. The evaluation was based on "thoroughly tested through verification of specifications and validation, including software validation." This typically implies a systematic testing process of software functions rather than a patient-based test set size.
• Data Provenance: Not applicable in the context of this software-focused non-clinical evaluation. The tests were performed on the software itself.

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 this software evaluation was the expected functional behavior of the software, as defined by its specifications. The evaluation confirmed whether the software performed these functions identically between two interfaces (desktop vs. web portal). This does not involve expert interpretation of data.

4. Adjudication method for the test set

Not applicable. As the testing focused on software functionality and identical performance, adjudication methods typically used in clinical studies (e.g., 2+1, 3+1) were not employed. The performance was assessed by direct comparison of software behavior.

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. An MRMC comparative effectiveness study was not done. The device does not involve AI for interpretation or human-in-the-loop assistance. The device is for signal acquisition and display only, and "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability."

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

Yes, in a sense, but not for diagnostic interpretation. A standalone software functionality verification and validation was done for the Device Manager module. This evaluated the module's ability to perform its specified tasks (formatting device, uploading study info, downloading data, uploading firmware) independently and identically across different interfaces (desktop vs. web portal). This is an algorithm/software-only evaluation for its operational functions, not for clinical diagnostic performance.

7. The type of ground truth used

The ground truth used was the functional specifications and expected behavior of the Device Manager software. The verification and validation activities confirmed that the software's performance matched these predefined specifications, particularly that its functions were identical between the desktop and web portal versions.

8. The sample size for the training set

Not applicable. As this submission focused on software functionality and its equivalence to a predicate, there was no machine learning component, and thus, no "training set."

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

Not applicable, as there was no training set.

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The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.

The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality.

The acquired signals are saved in a universal data format (European Data Format – EDF) that is intended to be analyzed with third party software, including Advanced Brain Monitoring's Sleep Profile Software (K120450).

The provided text describes the X4 System, a device for acquiring physiological signals. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and a limited clinical study.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the X4 System, as articulated in the clinical tests, is based on the interpretability of the acquired signals and the ease of device application.

Study Details for Acceptance Criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: While a specific number for the sample size for the clinical test is not explicitly stated, it refers to "all subjects" and "over 90% of studies recorded overnight." This suggests a prospective clinical study involving multiple subjects.
• Data provenance: Not explicitly stated, but the context of a 510(k) submission to the FDA for a US company suggests it would likely involve data from the US, potentially a prospective clinical trial.

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)

• The summary states that "signals acquired with the X4 System provide similar information as compared to the predicate device that would allow a physician to interpret the signals." and that "over 90% of studies recorded overnight with the X4 are interpretable."
• This implies that physicians are the experts who would interpret the signals to determine interpretability. However, the number of experts and their specific qualifications (e.g., board-certified sleep physicians, neurologists, years of experience) are not specified in the provided text.

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

• The text does not specify an adjudication method. It mentions that "physicians" would interpret the signals, but it does not detail how potential disagreements among interpreters would be resolved or if multiple interpreters were used for each case.

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, an MRMC comparative effectiveness study was not done.
• The X4 System is described as a device for acquiring, recording, transmitting, and displaying physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This indicates that the device itself does not perform AI-assisted analysis and therefore, a study on human reader improvement with AI assistance would not be applicable to this submission.

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

• No, a standalone (algorithm only) performance study was not done.
• The device's intended use is to acquire, record, transmit, and display physiological signals. It explicitly states "no claims are being made for analysis of the acquired signals." Thus, there is no standalone algorithm being evaluated for diagnostic or analytical performance.

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

• The ground truth for the clinical study appears to be expert interpretation (physician interpretability) of the acquired signals. The study aimed to demonstrate that the signals are "interpretable" and "behave as expected," which would rely on a physician's assessment.

8. The sample size for the training set

• Not applicable / Not provided. The X4 System is a signal acquisition and display device, not an analytical or AI-driven system. Therefore, it does not involve a "training set" in the context of machine learning algorithms.

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

• Not applicable. As a signal acquisition device without analytical claims, there is no training set or associated ground truth establishment process for algorithm training.

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The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used.

The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).

The Ti-Max X450 air-powered high-speed dental handpiece capable of reaching rotational speeds of 380,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. All models have a 45 degree back angle. Models are available to connect directly to the couplings of specific brands.

The provided text describes a 510(k) summary for a dental handpiece, the Ti-Max X450, and mentions its conformance with technical standards and internal specifications through bench testing. However, it does not include specific acceptance criteria, detailed study data, or information about AI/algorithm performance.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and AI performance cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not explicitly stated. The document mentions "bench testing" but does not provide details on sample size or data provenance. The submitter is Nakanishi, Inc. from Japan.

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 / Not explicitly stated. This device is a dental handpiece, not an AI or diagnostic device that requires expert ground truth for its performance evaluation in this context. Performance is based on physical characteristics and standards.

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

• Not applicable / Not explicitly stated. Adjudication methods are typically relevant for diagnostic or AI studies involving human interpretation. This document describes physical device performance.

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 document is for a dental handpiece, not an AI or diagnostic device. There is no mention of MRMC studies or AI assistance.

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

• No. This document is for a dental handpiece, not an algorithm.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is established by technical standards and internal specifications (e.g., ISO 1797-1, ISO 9168) and directly measured physical properties (RPM, torque, dBA).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

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The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris

The 1 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light or blue light. The spectral output peaks at wavelengths of 305nm,311nm,350nm,365nm, or 420nm depending on lamp. The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders or blue light radiation for acne vulgaris.

This 510(k) summary for the Daavlin 1 Series Phototherapy Unit is a substantial equivalence submission, not a study demonstrating the device meets performance criteria in the way a clinical trial would for an AI algorithm. Instead, it argues that the new device is safe and effective because it is essentially the same as already legally marketed devices.

Therefore, many of your requested items (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not applicable (N/A) to this type of regulatory submission and device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A. This device approval is based on substantial equivalence to existing devices, not a test set and performance metrics derived from data.

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

• N/A. Ground truth establishment for a test set is not relevant for this type of device submission.

4. Adjudication method for the test set

• N/A. 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

• N/A. This is a phototherapy unit, not an AI-powered diagnostic or assistive tool.

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

• N/A. This is not an algorithm; it's a physical medical device.

7. The type of ground truth used

• N/A. Not applicable. The "ground truth" for this submission is that the predicate devices are already legally marketed and presumed safe and effective.

8. The sample size for the training set

• N/A. This is not an AI/ML device that requires a training set.

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

• N/A. Not applicable.

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The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and to display the data as 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.

This appears to be a 510(k) premarket notification for a diagnostic ultrasound system (SONOACE X4) and its associated transducers. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo performance criteria through a clinical study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment does not apply in the context of this specific regulatory submission.

Here's why and what can be inferred:

Why the requested information doesn't apply to this document:

• Substantial Equivalence (510(k)) Process: The 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and technological characteristics as the predicate, or has different technological characteristics but does not raise different questions of safety and effectiveness.
• Focus on Comparison, Not De Novo Performance: This document primarily identifies predicate devices (K012887, K043455) and asserts that the SONOACE X4 and its transducers are substantially equivalent. It lists safety standards (UL, CSA, IEC, NEMA, ISO) that the device meets, but these are general safety and performance standards for ultrasound equipment, not specific diagnostic acceptance criteria for a particular clinical task.
• Absence of Clinical Study Data for Acceptance Criteria: There is no mention of a clinical study designed to test the diagnostic performance of the SONOACE X4 against specific acceptance criteria (e.g., sensitivity, specificity for detecting a certain condition). The "Mode of Operation" tables simply indicate what modes (B, M, PWD, etc.) are available for each clinical application, and whether they are new ("N") or previously cleared ("P") based on predicate devices.

What can be extracted/inferred from the document given the request:

Since the document doesn't contain a study proving the device meets acceptance criteria in the way you've described for a diagnostic AI model, most of your requested fields will be "Not Applicable" or "Not Provided." However, here's an attempt to address each point based on the nature of this 510(k) submission:

Acceptance Criteria and Device Performance for SONOACE X4 Diagnostic Ultrasound System

This submission is a 510(k) premarket notification for the SONOACE X4 Diagnostic Ultrasound System, which aims to demonstrate "substantial equivalence" to previously cleared predicate devices, rather than establishing de novo performance acceptance criteria through a specific clinical study for diagnostic accuracy. Therefore, the concept of a "table of acceptance criteria and reported device performance" as typically associated with a diagnostic AI model study is not applicable here.

The device's "performance" is implicitly deemed acceptable by its substantial equivalence to predicate devices which have already been cleared for marketing. The acceptance criteria met are primarily related to safety and general device performance standards for diagnostic ultrasound equipment.

1. Table of Acceptance Criteria and Reported Device Performance

¹ Note: The tables provided in the document (from {5} to {14}) list clinical applications and modes of operation for the main system and each transducer. "N" indicates a new indication (compared to the specific predicate mentioned in the footer for that table), while "P" indicates previously cleared. This is a demonstration of equivalence for intended uses, not a performance study.

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

• Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a specific test set for diagnostic accuracy. The substantial equivalence argument relies on prior clearances of predicate devices and adherence to recognized standards.
• Data Provenance: Not applicable. No patient data (retrospective or prospective) from a specific test set is discussed in the context of diagnostic performance evaluation.

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

• Number of Experts: Not applicable. No ground truth establishment for a diagnostic test set is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring ground truth adjudication is described.

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

• MRMC Study: Not applicable. This document is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

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

• Standalone Study: Not applicable. This document is for a diagnostic ultrasound system, which inherently involves human operation and interpretation.

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

• Type of Ground Truth: Not applicable. This document does not present a study requiring clinical ground truth for diagnostic accuracy.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As an ultrasound imaging system (not an AI model within the scope of this submission), there is no "training set" in the context of machine learning.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The BOVIE Model X40 Electrosurgical Generator is Indicated for Use in laparoscopic surgical procedures for the cutting and coagulation of human tissue.

The BOVIE Model X40 can be used in conjunction with the appropriate accessories and instruments for applications in:

General Surgery
Gynecology
Urology
Gastroenterology

For more than 50 years, high-frequency (HF) surgery has been used to cut and/or coagulate biological tissue using the intrinsic thermal effect of electric current. Berchtold has produced a state-of-the-art electrosurgical generator for international distribution. The BOVIE Model X40 represents one of the latest of these instruments. It is based upon Berchtold's long standing commitment to the provision of high quality surgical equipment and is produced in accordance with established international standards for such instruments.

In order to protect the patient and user from inadvertent injury from the use of this instrument it is provided with several safety features. These include:

Self checking software which performs an automatic safety check each time the instrument is turned on.

Real time, continuous monitoring of the patient contact with the neutral electrode.

Automatic detection of the use of split or single plate neutral electrode.

Automatic monitoring of HF leakage current and non-programed output.

Automatic detection and display of malfunction.

State-of-the-art control panel with audio (spoken) verification of unit function and confinmation of foot or finger switch activation.

Automatic cut-off to prevent excess tissue over-heating and electrode sticking.

Automatically adjusted output to ensure the cutting power is maintained at the minimum level required to effect the cut as tissue characteristics or electrode geometry change.

The provided text is a 510(k) premarket notification for an electrosurgical generator (BOVIE Model X40), not an AI/ML medical device. Therefore, it does not contain the specific information requested about acceptance criteria and studies related to AI/ML performance.

The document primarily focuses on:

• Device Description: High-frequency electrosurgical generator for cutting and coagulating tissue.
• Safety Features: Self-checking software, continuous patient contact monitoring, automatic detection of neutral electrode type, HF leakage monitoring, malfunction detection, audio verification, automatic cut-off for overheating, and automatically adjusted output.
• Intended Use: Laparoscopic surgical procedures (cutting and coagulation) in General Surgery, Gynecology, Urology, and Gastroenterology.
• Regulatory Information: Substantial equivalence determination by the FDA to a predicate device marketed before May 28, 1976.

Since the device is an electrosurgical generator and not an AI/ML diagnostic or prognostic tool, the concepts of "acceptance criteria for AI performance," "sample sizes for test/training sets," "ground truth establishment by experts," "adjudication methods," or "MRMC studies to compare human readers with/without AI" are not relevant to this submission.

The "safety features" listed in the summary statement act as the implicit "acceptance criteria" for this device, which are validated through general electrical safety and performance testing typically required for such devices (e.g., IEC 60601 series standards), though these specific tests are not detailed in the provided excerpt beyond a general statement that "test results obtained and included in this 510(k) Notification demonstrate that the BOVIE Model X40 is safe and effective."

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