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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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