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PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.

PodSKAN is not intended for Mammography and Fluoroscopy Applications.

PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A wall socket with 120 VAC or 240 VAC, 50/60 Hz. The technology incorporates feedback circuits to ensure highest accuracy & reproduceability of X-Ray output. It consists of

• . Tube head assembly (including collimator and goniometer)
• Base foot platform and side handle for patient support .
• External console and Hand switch .

PodSKAN HF diagnostic X-ray system can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software. Skanray recommends using 510(k) cleared flat panel detectors with AED functionality wired or wireless of size 10"x12" or 14"x17"and image acquisition systems to maintain compliance and quality

The provided document is a 510(k) summary for the PodSKAN HF Diagnostic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, the acceptance criteria and study details as requested (sample size, data provenance, ground truth establishment, MRMC study, standalone performance) are not explicitly present in the provided text. The document refers to compliance with various IEC standards and FDA performance standards (21 CFR 1020.30-1020.31) but does not present a specific study with defined acceptance criteria and reported device performance in a tabular format as requested for a diagnostic AI/medical device.

However, I can extract the relevant information regarding performance and compliance from the document and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of a diagnostic accuracy study. Instead, it discusses compliance with regulatory standards and compares technical specifications to predicate devices.

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

• The document states: "The validation testing, which includes sample clinical images, demonstrates compliance to the diagnostic quality imaging performance when used with 510k cleared detector and imaging software for the intended application."
• No specific sample size for a test set (e.g., number of images/patients) is provided.
• No data provenance (country of origin, retrospective/prospective) is mentioned.
• This device is an X-ray system (hardware), not an AI diagnostic algorithm. The "validation testing" with "sample clinical images" appears to be for general image quality assessment of the hardware, not for diagnostic accuracy of an AI.

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

• Not applicable/Not mentioned. Since this is a submission for an X-ray hardware system, not an AI diagnostic algorithm, the concept of "ground truth" for diagnostic labels established by experts is not discussed in the provided text. The performance data focuses on compliance with physical and electrical standards for X-ray generation and image quality.

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

• Not applicable/Not mentioned. This information is typically relevant for studies evaluating the diagnostic accuracy of a software algorithm, particularly when establishing a consensus ground truth. It is not discussed for this X-ray hardware system.

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 MRMC comparative effectiveness study was performed or mentioned. The device is an X-ray system, not an AI software intended to assist human readers.

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

• Not applicable. This refers to the standalone performance of an AI algorithm. The PodSKAN HF Diagnostic X-ray System is hardware.

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

• Not explicitly defined/Not applicable in the typical sense for a diagnostic algorithm. For an X-ray hardware system, "ground truth" would relate to the physical and radiation output accuracy relative to established standards (e.g., kV accuracy, mAs reproducibility, HVL), as well as the ability to produce images of "diagnostic quality," which is assessed qualitatively or against established phantom images/standards rather than disease-specific pathology or outcomes data in this context.

8. The sample size for the training set

• Not applicable. The device is hardware, not a machine learning model that undergoes a training phase.

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

• Not applicable. As above, this is hardware, not an AI/ML system requiring a training set with established ground truth.

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The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremties and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system. The system has been designed for indoor usage. It is intended for qualified medical persomel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.

SKANRAD 400 is a high frequency radiography system with 32kW generator X-Ray power. It can be used with table (recumbent position) as well as chest stand (standing position) for general radiography purpose. Electronic circuits incorporated for control, user interface, feedback circuits to ensure accuracy & reproducibility of X-Ray output. lt consists of:

1. Tube head and collimator assembly
2. Floating table assembly
3. Chest stand assembly
4. HV generator assembly
   SKANRAD 400 can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software.

The provided FDA 510(k) summary for the SKANRAD 400 describes performance testing for substantial equivalence to a predicate device, rather than explicit acceptance criteria for a new clinical indication or capability. The document focuses on demonstrating that the SKANRAD 400 X-ray system is as safe and effective as the predicate device (RADspeed Fit K173517) through non-clinical performance data and compliance with relevant standards.

Therefore, the response will interpret "acceptance criteria" as the performance aspects and standards the device must meet to demonstrate substantial equivalence, as indicated in the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for an X-ray system demonstrating substantial equivalence, the "acceptance criteria" are implied by the comparison to the predicate device and adherence to industry standards, rather than specific performance metrics for a novel clinical function. The reported device performance is primarily a statement of compliance with these standards and the successful validation of its components.

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

The document does not describe a test set or data provenance in the context of a clinical performance study using patient data. The "tests" mentioned are primarily engineering verification and validation activities against standards and functional comparisons with the predicate device.

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

Not applicable. As noted above, there was no clinical test set requiring expert ground truth establishment for a diagnostic output. The study focused on engineering performance and substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document states: "As per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices document, subject device does not have major difference when compared to the predicate device. Considering this, non-clinical data is sufficient to support the safety and performance of SKANRAD 400. Hence clinical studies are not required."

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

Not applicable. The SKANRAD 400 is an X-ray generation system, not an AI algorithm for diagnostic interpretation. Its performance is related to generating X-rays and imaging capabilities, not standalone algorithmic interpretation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic performance (e.g., pathology, outcomes data). The "ground truth" implicitly used in this 510(k) submission relates to established engineering standards for X-ray devices and the performance characteristics of the legally marketed predicate device (K173517). The performance tests would verify that the device meets its design specifications and standard requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device requiring a training set.

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SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.

SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.

SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.

The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.

SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.

SKANMOBILE consists of following sub-assemblies:

1. Tube head
2. SKANMOBILE trolley

SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:

1. Touchscreen operator console.
2. Modified brake mechanism for wheels
3. Modified cassette tray to house the cassette / flat panel detectors.

Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices.

The provided text does not contain information about specific acceptance criteria or an internal study demonstrating that the device meets those criteria. Instead, it focuses on the device's substantial equivalence to predicate devices, compliance with regulatory standards, and summarizes non-clinical performance data.

Therefore, I cannot populate the table of acceptance criteria or provide details about a study proving the device meets acceptance criteria as described in your request. The document explicitly states that "clinical studies are not required" for this submission, further indicating the absence of a study focused on proving specific performance metrics against pre-defined acceptance criteria in a clinical setting.

However, I can extract information related to the device's performance, testing, and ground truth establishment in a general sense based on the provided text, especially concerning the evaluation of the flat panel detectors which are a key component.

Here's an analysis of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, explicit acceptance criteria are not presented in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to various electrical, safety, and image quality standards (DQE, MTF).

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

• Test Set Sample Size: Not specified in terms of number of images/patients.
• Data Provenance: Not specified. It mentions testing was done "both in-house and by outsourcing to appropriate third-party vendors." The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

• The document states that "The quality of the images obtained from the subject devices were analysed by a radiographer and a radiologist and it was found the images were of good quality which were easily read by the radiologist".
• Number of experts: At least one radiographer and at least one radiologist ("a radiographer and a radiologist").
• Qualifications: "radiographer" and "radiologist." No specific years of experience are mentioned.

4. Adjudication method for the test set:

• Not specified. The text simply says "analysed by a radiographer and a radiologist." It does not describe a formal adjudication process (e.g., 2+1, 3+1).

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 MRMC comparative effectiveness study was done. The device described is a mobile X-ray system, not an AI-assisted diagnostic tool for image interpretation.

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

• Not applicable as this is an X-ray imaging system, not an algorithm for image interpretation. The "software/firmware" described primarily controls the operation of the device and integrates with image acquisition software.

7. The type of ground truth used:

• For image quality, the ground truth was "expert consensus" implicitly, as it was determined by the analysis of a radiographer and a radiologist who found the images to be of "good quality" and "easily read."
• For technical specifications (DQE, MTF, electrical safety, etc.), the "ground truth" or reference was compliance with various international standards (IEC, ISO, NEMA, ASTM, 21 CFR).

8. The sample size for the training set:

• Not applicable. The document discusses a physical X-ray device and its control software. There is no mention of a "training set" for an AI or machine learning algorithm. The software development "has been executed as per the requirements of ISO 62304" and undergone "software validation & verification," not machine learning training.

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

• Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.

In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).

Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2.

Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings.

Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details.

Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour.

Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.

The provided text describes the 510(k) premarket notification for the Skanray Technologies Pvt Ltd Star 65 patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, it is important to note that the document does not present a standalone clinical study to prove the device meets acceptance criteria. Instead, it relies on demonstrating that the subject device's performance, as measured through non-clinical (bench) testing against recognized standards, is comparable to its predicate devices, which are already legally marketed.

Here's an breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of a clinical study outcome. Instead, it details the performance specifications of the Star 65 and compares them to predicate devices. The "reported device performance" is essentially the listed specifications for the Star 65, and "acceptance criteria" can be inferred as being equivalent to or meeting the performance of the predicate devices and relevant consensus standards.

Since a strict "acceptance criteria" table from a dedicated study is not available, I will present the performance specifications of the Star 65 as its "reported performance," and the "acceptance criteria" is implied to be that these specifications are within acceptable ranges, similar to the predicate devices, and comply with the listed consensus standards.

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

The document does not specify a "test set" in the context of a patient-based study. The testing performed was non-clinical (bench testing), as stated in Section VII. "NON-CLINICAL STUDY." It refers to "Electrical, mechanical environmental safety and performance testing according to the following consensus standards" and "Performance testing- Accuracy, Environment cycling, Temperature Rise Test, wireless co-existence were performed according to Design Requirement specification and Validation plans."

Therefore, there is no patient sample size for a test set described. The data provenance is from bench testing results, not human data. The document does not specify the country of origin for the testing itself, but the device manufacturer (Skanray Technologies Pvt Ltd) is based in India.

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

This section is not applicable. Since no patient-based clinical test set was used, there was no ground truth establishment by experts in that context. The "ground truth" for the non-clinical performance validation was the specifications and performance outlined in the relevant consensus standards (e.g., IEC, ISO standards).

4. Adjudication method for the test set

This section is not applicable. No patient-based test set requiring expert adjudication was conducted.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any AI assistance in the provided document. The device is a patient monitoring system, not an AI-driven diagnostic tool that would typically involve human readers interpreting results with or without AI.

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

This section is not applicable in the sense of an "algorithm only" performance for a diagnostic task. The "standalone" performance shown is the inherent performance of the integrated hardware and software system (Star 65) measuring physiological parameters, as assessed through bench testing against standards.

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

For the non-clinical performance testing, the "ground truth" was defined by the technical specifications and accuracy requirements set forth in the international consensus standards (e.g., IEC 60601 series, ISO 80601 series) to which the device was tested for compliance. For example, for NIBP accuracy, the ground truth standard is +/-5mmHg with a standard deviation greater than 8 mmHg.

8. The sample size for the training set

This section is not applicable. The document does not describe the use of machine learning or AI models that would require a "training set." The device is a traditional multi-parameter patient monitoring system.

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

This section is not applicable, as there was no training set mentioned in the document.

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The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during Diagnostic, Surgical and Interventional procedures.

Examples of Clinical Applications may include Orthopaedic. GI Procedure like Endoscopy and Cholenography. Neurology, Urology Procedures, Vascular, Critical Care and Emergency Room Procedures.

Skan-C is not recommended for Cardiac Applications.

Skan-C Surgical C-Arm is indication in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in quiding medical intervention surgical procedures. The device can also be used for radiographic applications. The device is designed in such a way that it can be moved around and can be positioned for the required anatomical/clinical/procedural position.

SKAN-C, a Mobile Surgical C-Arm consists of two units, namely, Mobile Image Intensified C-Arm unit with generator, and a Work-Station for Image display, store and manipulation. C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, wig-wag movement and C rotation. The X-ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.

The provided document is a 510(k) premarket notification for a medical device (Skan C Mobile C-Arm X-Ray system). It outlines the device's indications for use, technological characteristics, and non-clinical/clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than providing specific acceptance criteria and detailed study results typical of a performance evaluation directly tied to an AI algorithm.

Based on the provided text, the device is an X-ray system, not an AI-powered diagnostic device. Therefore, the questions related to AI-specific metrics, ground truth establishment for AI training/testing, and multi-reader multi-case studies for AI assistance are not directly applicable to this document.

However, I can extract information related to the performance evaluation of the X-ray system itself, which serves as its "acceptance criteria" and "study" for regulatory purposes.

Here's an interpretation of the requested information based on the provided document, focusing on the device as an X-ray system:

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

The document doesn't present a direct "acceptance criteria" table in the way one might see for diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates compliance with recognized safety and performance standards and compares its technological characteristics to a predicate device. The "acceptance criteria" can be inferred as meeting these standards and showing comparable technical specifications.

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

The document does not specify a numerical sample size for "test sets" in the context of diagnostic image analysis, as it's an X-ray system, not an AI algorithm being tested for diagnostic accuracy on a dataset.

• Non-Clinical Tests: These involve testing the physical device against engineering and safety standards. There isn't a "sample size" of images or patients in the typical sense. It refers to testing the device's components and overall system functionality (e.g., radiation output measurements, EMC tests).
• Clinical Tests (Usability and Image Quality):
  • Usability: "Usability aspects of the device were tested by the users and independent participants." No specific number provided.
  • Image Quality: "Independent views of Radiologists were obtained on the imaging performances and the acquired images were of adequate quality for the indicated use." No specific number of images or patients mentioned.
• Data Provenance: Not explicitly stated for any "data." The company is based in India (Skanray Technologies Private Limited, Mysore, India). It's common for such tests to be conducted internally or by accredited labs in the manufacturer's region or contracted locations.

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)

• Number of Experts: "Independent views of Radiologists were obtained on the imaging performances." The number of radiologists is not specified, only that "Radiologists" (plural) were involved.
• Qualifications: Stated as "Radiologists." No specific experience level (e.g., "10 years of experience") or subspecialty is detailed in the document.

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

The document states "Independent views of Radiologists were obtained." This implies individual assessments. There is no mention of an adjudication method (like 2+1 or 3+1 consensus) being used for combining expert opinions or resolving discrepancies.

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

There was no MRMC comparative effectiveness study done comparing human readers with AI assistance versus without AI assistance. This device is an X-ray imaging system, not an AI diagnostic tool. Its performance evaluation focuses on the safety, technical specifications, and image quality of the X-ray system itself.

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

This question is not applicable. The device is a C-Arm X-Ray system, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report.

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

For the "clinical tests" part of the evaluation:

• Usability: The "ground truth" was user feedback and observational assessment by "users and independent participants."
• Image Quality: The "ground truth" was "Independent views of Radiologists" regarding image adequacy. This is a form of expert opinion/consensus (though the consensus method isn't detailed). There's no mention of pathology or outcomes data for this specific evaluation in the provided summary.

8. The sample size for the training set

This question is not applicable. The device is a C-Arm X-Ray system, not an AI algorithm that requires a "training set" in the machine learning sense. The X-ray system is developed and validated through engineering standards and clinical evaluations demonstrating its functionality and safety, not through machine learning training.

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

This question is not applicable, as there is no "training set" for an AI algorithm in the context of this device.

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INTRASKAN DC PLUS is High Frequency extra oral X Ray source to be used for Intra-Oral X-Ray in Dental radiography for diagnostic purpose.

INTRASKAN DC PLUS is High Frequency extra oral X Ray source to be used for Intra-Oral X-Ray in Dental radiography for diagnostic purpose. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. The Intra Oral X-ray does not have provision to connect to wireless networks or LAN.

This document is a 510(k) summary for the INTRASKAN DC PLUS, an extraoral X-ray system for dental radiography. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (INTRASKAN DC).

However, this document does not contain information about the acceptance criteria and the study that proves the device meets those acceptance criteria in the way described in the prompt.

The prompt is asking for information typically found in clinical performance studies of diagnostic devices, especially those using AI. The INTRASKAN DC PLUS is a traditional X-ray hardware device, and its approval focuses on electrical, mechanical, environmental safety, and performance as an X-ray source, not on diagnostic accuracy of an AI algorithm.

Therefore, I cannot provide the requested table and details for the following reasons:

• No acceptance criteria for diagnostic performance: The document confirms compliance with safety and performance standards relevant to X-ray hardware (e.g., UL/IEC 60601 series, FDA 21 CFR 1020.30/31). It does not list specific diagnostic performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI-powered diagnostic device.
• No diagnostic performance study: The document refers to "Performance testing performed according to FDA 21 CFR 1020.30, 21CFR1020.31 standards, Design Requirement specification, verification & validation plans." These are related to the physics and engineering performance of the X-ray tube and system (e.g., radiation output accuracy, reproducibility, image quality characteristics inherent to the X-ray source), not to the diagnostic accuracy of interpreting images or an AI's ability to locate a disease.
• No AI component: The device description clearly states: "The Intra Oral X-ray does not have provision to connect to wireless networks or LAN." This indicates it's a standalone X-ray generator, not an AI-assisted diagnostic tool.

In summary, the provided document does not contain the type of information requested about acceptance criteria and a study proving diagnostic performance, as it pertains to an X-ray hardware device and not an AI-driven diagnostic system.

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SpotSkan, a multi-parameter Spot Check Device, along with the appropriate accessories mentioned / supplied with the unit, is intended to measure a single adult or pediatric (but not neonatal) patient's vital signs at the physician's clinic. SpotSkan is not a Patient Monitor.

Vital signs measured include SpO2, Non-Invasive Blood Pressure, Pulse Rate and Temperature. A thermal recorder is provided for printing measured data. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.

SpotSkan is SKANRAY's new portable Spot Check Device, which can be used to measure SpO2, Pulse rate, Blood Pressure non-invasively and Tympanic Temperature, for adult and pediatric (but not neonatal) patients. It is a compact device which has only numeric values displayed on a 6.5" LED Backlit TFT LCD display of resolution 640*480, containing SpO2, NIBP, Pulse Rate and Temperature values. It has last 12 patients' readings saved. It does not have continuous monitoring capability of the parameters or any alarms.

Interface of a thermal recorder to take print out of real time measurements and values from patient history make the data availability through a hard copy. It has got battery backup of 2 hours, which enables it to continue measurement even during mains power OFF condition. User can enter patient ID, name, age, height, weight; and select mode and sex; these details can be recorded in the thermal print out.

The scope of application is in the medical diagnostics, where a general physician will use the monitors in clinics. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.

The provided text describes the SpotSkan device, a multi-parameter spot check device, intended to measure vital signs. The documentation focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone clinical study with detailed acceptance criteria and performance metrics of the SpotSkan device itself in a controlled study.

Therefore, much of the requested information regarding specific acceptance criteria, a standalone study, sample sizes, ground truth establishment, and MRMC studies is not explicitly available in the provided text. The document primarily references compliance with standards and the use of similar technologies from predicate devices.

However, based on the information provided, here's what can be extracted:

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

The document does not explicitly state acceptance criteria or report specific device performance metrics for the SpotSkan. Instead, it refers to compliance with various IEC and ISO standards that would implicitly define performance requirements. For example, IEC 80601-2-30 relates to the basic safety and essential performance of automatic cycling non-invasive blood pressure monitoring equipment, which would include accuracy requirements for NIBP. ANSI/SSMI SP10 also covers manual, electronic, or automated sphygmomanometers, implying performance standards for blood pressure measurement.

Implicit Acceptance Criteria (based on referenced standards):

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

The document refers to "testing" in a general sense, primarily electrical and EMC testing, and "Additional Performance Testing" referencing standards. It does not describe a clinical test set with a specific sample size, country of origin, or whether the data was retrospective or prospective for the SpotSkan device's performance results. Instead, it relies on the fact that the NIBP, SpO2, and Temperature modules use "same" technologies as already cleared predicate devices.

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. The document does not describe a clinical study that required expert-established ground truth for a test set. The performance is assessed against recognized standards and the equivalence of component technologies.

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

Not applicable. No clinical test set with an adjudication method 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

Not applicable. This device is a vital signs monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers or MRMC studies.

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

While not a "standalone algorithm" in the AI sense, the device's function as a multi-parameter spot check device implies "standalone" measurement performance. The document states, "Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices." This substantial equivalence argument is based on the device's adherence to standards and the use of technological components identical to those cleared in predicate devices, rather than a de novo clinical trial demonstrating standalone performance against a clinical reference standard. It is likely that the individual modules (NIBP, SpO2, Temp) would have internal validation data against their respective reference methods as part of their component qualification, but this is not detailed for the SpotSkan system.

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

Not explicitly stated for the SpotSkan system as a whole. For the individual measurement parameters (NIBP, SpO2, Temperature), the "ground truth" would implicitly be established by the reference measurement methods defined in the relevant consensus standards (e.g., invasive arterial pressure for NIBP, co-oximetry for SpO2, calibrated thermometer for temperature). The document focuses on compliance with these standards, not the primary establishment of such ground truth for a new clinical study.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI models that require a training set.

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

Not applicable. This device is not described as involving machine learning or AI models that require a training set.

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Star 60 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3L / 5L), SpO2, Respiration, Temperature, NIBP, IBP, IBP and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, FiCO2 readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

STAR 60 is a patient monitor with a wide range of communication options. Capacitive sensing buttons in keyboard is introduced. It fits in clearly to a new age of patient monitoring.

• ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the main board and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the main board.
• SpO2: This module is inbuilt inside the monitor on the main board. It is used to measure the partial pressure of oxygen in the human body.
• . NIBP: This module is inbuilt inside the monitor on to the chassis. It is used to non-invasively measure the systolic, diastolic & mean blood pressure.
• CO2: This module is inbuilt inside the monitor on to the chassis. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2).
• . IBP: STAR 60 can support IBP modules. For ease of understands we shall name as IBP1 & IBP 2. IBP 1/2 module is inbuilt on the main board. It is used to invasively measure the systolic and diastolic blood pressure.

Here's an analysis of the acceptance criteria and study information for the Skanray Technologies Private Limited Star 60 patient monitoring system, based only on the provided text.

It's important to note that this document is a 510(k) summary, not a full clinical study report. Therefore, detailed acceptance criteria for specific performance metrics (like accuracy ranges for ECG, SpO2, NIBP, etc.) and comprehensive study results are generally not found in this type of FDA document. Instead, it refers to compliance with recognized standards.

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for the Star 60 is implied by its adherence to various recognized medical device standards. The "reported device performance" is primarily the statement of substantial equivalence to predicate devices. This means the device is considered to perform "as well as or better than" the predicate devices and meets the safety and effectiveness requirements outlined in the standards.

Study Details (Based on available information)

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

   • The document describes "Non Clinical Testing" which includes electrical and EMC tests and compliance with various IEC/ISO/ANSI/AAMI standards. These are typically laboratory-based tests of the device itself and its components, often using test equipment, simulators, and phantoms, rather than patient data.
   • No sample size for a "test set" from patient data is mentioned for performance evaluation.
   • Data provenance is not applicable in the context of these non-clinical, lab-based engineering and performance tests.

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

   • Not applicable. The testing described is non-clinical, focused on engineering and performance standards, not diagnostic or clinical interpretation needing expert ground truth.

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

   • Not applicable. This concept typically applies to clinical studies where multiple human readers assess data, and a consensus method is used to establish ground truth or resolve discrepancies. The described tests are non-clinical hardware/software performance evaluations against known physical parameters or standard requirements.

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 study was reported. The Star 60 is a patient monitor, not an AI-assisted diagnostic tool that requires human interpretation in the same way. The document does not mention any AI components or human-in-the-loop performance studies.

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

   • Yes, in essence, a "standalone" evaluation was done through the non-clinical testing. The device's direct performance (e.g., accuracy of ECG readings, NIBP measurements, SpO2 detection, etc.) was assessed against established standards purely based on its internal functioning, without human intervention for interpretation beyond operating the test equipment. However, this is not an "algorithm only" study in the sense of a standalone AI algorithm. It's a standalone device performance test.

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

   • For the non-clinical tests, the "ground truth" would be:
     • Reference standards/equipment: Calibrated test equipment (e.g., ECG simulators, NIBP simulators, SpO2 testers, temperature probes) providing known, accurate values.
     • Established engineering specifications: Performance limits defined by the relevant IEC/ISO/ANSI/AAMI standards.

7. The sample size for the training set:

   • Not applicable / Not provided. The document does not describe a machine learning or AI algorithm that would require a "training set" for its development. The device is a traditional patient monitor.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As no training set is mentioned, this information is not relevant to the described testing.

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The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 and FiCO2 readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.

Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include:

• . ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.
• SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
• NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
• CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
• . IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
• . AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.

This document is an FDA 510(k) summary for the Skanray Technologies Pvt Ltd. "Star 90" patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics for an AI/algorithm-driven device.

Based on the provided text, the device is a cardiac monitor, and the studies mentioned are non-clinical (electrical and EMC testing, and performance testing against recognized standards). There is no information provided about AI or algorithms, human reader studies, or detailed performance metrics against specific acceptance criteria for a new AI function.

Therefore, many of the requested items cannot be extracted from this document.

For the information that can be extracted, here's a summary:

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

The document does not provide a table for acceptance criteria specific to the device's performance (e.g., accuracy, sensitivity, specificity for an AI-driven function). Instead, it lists the standards against which the device was tested for electrical safety, EMC, and basic performance of its various modules. The "reported device performance" is summarized by the statement: "Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices."

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

Not applicable. The document describes non-clinical engineering and performance testing against standards, not clinical testing with a specific test set of patient data to evaluate an algorithm.

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. There is no mention of human experts establishing ground truth for a test set in the context of an algorithm's performance.

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

Not applicable. No adjudication method is mentioned as there is no human-in-the-loop performance test 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

Not applicable. There is no mention of an MRMC study or AI assistance. The device is a patient monitoring system, not an AI-driven interpretive device in the context of this 510(k).

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

Not applicable. The document does not describe an algorithm's standalone performance study. The device is a hardware patient monitor.

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

Not applicable. For the non-clinical tests mentioned, ground truth would be defined by the technical specifications and measurement precision requirements of the standards themselves (e.g., a known, precisely generated ECG signal, or a calibrated NIBP cuff pressure).

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an AI algorithm.

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

Not applicable. This document does not describe the development or training of an AI algorithm.

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Air Techniques High Frequency Intra-Oral X-Ray is to be used as an extraoral source of X-Rays in Dental radiography.

Air Techniques High Frequency Intra-Oral X-Ray is an X-Ray System with an extraoral X-Ray source for dental diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. Air Techniques High Frequency Intra-Oral X-Ray consists of the following main components: Base Unit, Tube Housing, Beam Limiting Device-inbuilt with tube Housing, Control Console, 9.84 Ft (3 m) coiled cord, Rotating yoke for tube housing mounting, Extension arm, Scissor arm. Optional Components: Long Cone 11.8in (300mm), 9.84 Ft (3m) coiled cord with exposure switch. The Power supply is regulated to provide a selectable 50 to 70 kVp in step of 1kV at a selectable tube current of 4, 6, 7, or 8 mA. The range of exposure times is 0.04 to 4.00 seconds with 1:15 duty. Predefined exposure parameters kV, mA & exposure time values may be stored in, selected & operated via the operator control panel.

The provided text describes a pre-market notification (510(k)) submission for an X-ray device, not an AI/ML powered device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies that prove a device meets those criteria for an AI/ML product.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details as these are not relevant to the provided text.

The document discusses the following:

• Device Name: Air Techniques High Frequency Intra-Oral X-Ray
• Intended Use: As an extraoral source of X-Rays in Dental radiography.
• Safety and Effectiveness: Demonstrated through compliance with various electrical, mechanical, environmental safety, and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-1-2 EMC, FDA 21 CFR 1020.30, 21CFR1020.31).
• Predicate Devices: INTRA SKAN DC (K103579), Progeny PREVA (K043092), Dentsply Gx-770 (K935046), Gendex 765DC (K992610). The device is stated to have "Same indications for use as predicate devices."

The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to proceed to market. However, it does not detail performance acceptance criteria in the context of AI/ML metrics (like sensitivity, specificity, AUC) or the type of studies typically conducted for AI/ML devices.

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