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SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

The SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications. SPINEL 12HD is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.

The provided document is a 510(k) premarket notification for the SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System. It asserts substantial equivalence to a predicate device (KMC-950) rather than independently proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and clinical study details for the SPINEL 12HD is not explicitly stated in this document.

However, based on the information provided, I can infer some aspects and present what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results for the SPINEL 12HD itself. Instead, it argues for substantial equivalence by comparing its technical specifications and performance characteristics to a predicate device (KMC-950) and a reference device (Artis one Angiographic System for the FPD). The performance characteristics are mostly described in terms of technical specifications of components.

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

The document does not describe a clinical test set in the traditional sense (e.g., patient cases). The evaluation for this 510(k) submission primarily relies on non-clinical testing, including:

• Engineering testing
• Standards compliance testing
• Verification and Validation (V&V) activities for software (IODC and MDC functions).

Therefore, there is no patient-based test set sample size described. The data provenance would be laboratory testing environments in the Republic of Korea (where GEMSS MEDICAL SYSTEMS CO., LTD. is located). The data is generated from prospective non-clinical testing designed to verify compliance with standards and functionality.

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

Since no clinical test set with patient data was used, no experts were used to establish ground truth in the context of clinical interpretation for this submission. The "ground truth" for the non-clinical tests would have been established by engineering specifications, calibration standards, and recognized international standards (e.g., IEC, NEMA).

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

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

No MRMC study was performed or described in this 510(k) submission. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with safety standards, not on clinical comparative effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an X-ray imaging system, not an AI algorithm for image analysis. The "Intelligent Object Dose Control (IODC)" and "Metal Detected Control (MDC)" are described as software functions to optimize X-ray exposure, not to perform standalone diagnostic interpretation.

The V&V Report for IODC and MDC "contains the software quality and performance testing activities" and "The images of before and after applying each function have been compared which validates the efficacy of both IODC and MC functions." This implies some form of standalone performance evaluation for these specific software features in a technical context, showing they correctly adjust image brightness. However, it's not a diagnostic "algorithm only" study as one might see for an AI CADx device.

7. Type of Ground Truth Used

For the non-clinical testing and software V&V, the ground truth would be based on:

• Engineering specifications: Device performance parameters against designed specifications.
• Physical measurements and phantoms: For radiation output, image quality metrics (DQE, MTF), and resolution.
• Standard compliance: Adherence to recognized national and international safety and performance standards (e.g., IEC 60601 series, NEMA PS 3.1-3.20, ISO 14971, 21 CFR regulations).
• Comparison to predicate device's established performance.

8. Sample Size for the Training Set

Not applicable. This device is a medical imaging hardware system with integrated software, not a machine learning or AI model trained on a dataset of cases. Therefore, there is no "training set" in the context of AI model development.

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

Not applicable, as there is no training set.

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KMC-650 Surgical Mobile Fluoroscopic X-ray System is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional guided procedure & mammographic applications.

The KMC-650 Surgical Mobile Fluoroscopic X-rav System consists of a high voltage (HV) inverter generator. a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. Not to be used for mammography.

KMC-650 is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.

This document is a 510(k) Summary for a medical device called the KMC-650 Surgical Mobile Fluoroscopic X-ray System. It asserts substantial equivalence to a predicate device (KMC-950) rather than providing a performance study against specific acceptance criteria for a novel device. Therefore, many of the requested elements for a detailed AI/model performance description are not applicable or cannot be extracted directly from this document.

However, I can extract information related to the device's technical specifications and safety/effectiveness concerns addressed to establish substantial equivalence.

Here's an attempt to answer your questions based on the provided text, noting where the information is not present or relevant to this type of submission:

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

   This document does not present "acceptance criteria" in the typical sense of a novel device's performance targets (e.g., sensitivity, specificity for a diagnostic algorithm) and then report performance against those. Instead, it argues for "substantial equivalence" to a predicate device (KMC-950). The performance characteristics are compared to the predicate device.

   Characteristic	Predicate Device (KMC-950)	Proposed Device (KMC-650)	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Performance (KMC-650)
   X-ray Tube	Varian (RAD-99)	Toshiba (DF-151SBR)	Functionally equivalent; safe and effective	Different manufacturer and model, but no new safety/effectiveness concerns raised.
   Anode Type	Rotating	Stationary	Functionally equivalent; safe and effective	Stationary
   Heat Capacity	300,000 HU	45,000 HU	Sufficient for intended use (1 kW or less fluoro)	45,000 HU. Stated as sufficient as typical fluoroscopy mode requires 1 kW or less.
   Anode Heat Cooling	70 kHU/min	47 kHU/min	Sufficient for intended use	47 kHU/min
   Focal Size	0.3mm / 0.6mm	0.5mm / 1.5mm	Appropriately sized for imaging	0.5mm / 1.5mm
   X-ray Generator	POSKOM (HTC-120)	POSKOM (C-650)	Functionally equivalent; safe and effective	Different model, but high frequency/inverter type for both.
   Power Output	12.5 kW	2.2 kW	Sufficient for intended use (1 kW or less fluoro)	2.2 kW. Stated as sufficient as typical fluoroscopy mode requires 1 kW or less.
   Fluoro kV range	40 to 125 kV	40 to 110 kV	Within clinically acceptable range	40 to 110 kV
   Fluoro mA range	0.5 to 5 mA	0.5 to 4 mA	Within clinically acceptable range	0.5 to 4 mA
   Pulse Fluoro	Yes	Yes	Present	Yes
   ABS function	Yes	Yes	Present	Yes
   Snap Shot	8.0 mA shot available	8.0 mA shot available	Present	8.0 mA shot available
   Boost Shot	20.0 mA shot available	20.0 mA shot available	Present	20.0 mA shot available
   Image Intensifier Size	9"	9"	Same size	9"
   Magnification	9" / 6" / 4.5"	9" / 6" / 4.5"	Same options	9" / 6" / 4.5"
   Camera Type	1/2" CCD	1/2" CCD	CCD	CCD
   Active pixels	512 x 512	1,024 x 1,024	Equivalent or improved (higher resolution shown)	1,024 x 1,024
   SID	950mm	1000mm	Within acceptable range	1000mm
   Range of C-arm Rail Rotation	115° (90° / 25°)	135° (90° / 45°)	Clinically acceptable	135° (90° / 45°)
   Image Storage Capacity	Digital	Digital	Digital storage	Digital
   Image Matrix Size	5,000 images	5,000 images	Adequate storage	5,000 images
   Monitor Size	17"	19"	Adequate for display (larger shown)	19"

   Note: The "acceptance criteria" here are implicitly that the proposed device is either equivalent to the predicate or that any differences do not raise new questions of safety or effectiveness. The device "performance" is the technical specification of the KMC-650.

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

   This document describes a 510(k) submission for a fluoroscopic X-ray system, which is hardware. It does not mention any "test set" in the context of evaluation of an AI or algorithm. The "studies" referenced are non-clinical engineering and compliance tests.

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. This is not an AI/algorithm submission that requires expert-established ground truth for a test set.

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

   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

   Not applicable. This device is an X-ray system, not an AI-assisted diagnostic tool.

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

   Not applicable.

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

   Not applicable. The ground truth for this device's performance validation would be based on physical measurements of radiation output, image quality metrics (resolution, contrast, noise), electrical safety, EMC compliance, etc., according to recognized standards.

8. The sample size for the training set

   Not applicable. There is no training set for this hardware device.

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

   Not applicable.

Summary of Device Safety and Effectiveness from the Document:

The document primarily focuses on establishing Substantial Equivalence between the KMC-650 and its predicate device, KMC-950. The safety and effectiveness of the KMC-650 are asserted through:

• Comparison of technological characteristics: A detailed table comparing specifications like X-ray tube, generator, fluoroscopic modes, image intensifier, camera, and C-arm mechanics. Differences (e.g., tube's heat capacity, power output, kV/mA ranges, camera active pixels) are addressed by explaining that the proposed device's lower specifications are still sufficient for typical fluoroscopy modes (e.g., 1 kW or less) or that higher specifications (e.g., camera resolution) represent an improvement.
• Compliance with recognized standards: The device adheres to a robust set of international and FDA recognized standards, including:
  • IEC 60601-1:2005 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2007 (Electromagnetic compatibility)
  • IEC 60601-1-3:2008 (Radiation protection in diagnostic X-ray equipment)
  • IEC 60601-2-28:2010 (Medical diagnostic X-ray equipment for radiography and radioscopy)
  • IEC 60601-2-43:2010 (X-ray equipment for interventional procedures)
  • IEC 60601-2-54:2009 (X-ray equipment for radiography and radioscopy)
  • NEMA PS 3.1-3.20 (DICOM standard)
  • ISO 14971:2012 (Application of risk management for medical devices)
  • 21 CFR 1020.32 (Electronic product radiation control)
• Verification and Validation Activities: Stated that "Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."
• Instructions for Use: Labeling includes information for safe and effective operation.

The conclusion is that despite some differences in components and specifications, these differences "do not raise any new questions of safety and effectiveness."

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The TITAN 11 is a diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. This device is not intended for mammography.

TITAN 11, the high frequency inverter type of Radiographic system is operated by the built-in operation program. TITAN 11 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the SSXI detector, X-ray Generator, X-ray Collimator, PC, Detector Stand, Tube Stand, Mobile Table, PU-30(Power Supply) and viewing software. Optional devices include AEC, DAP, Hand or Foot Exposure Switch.

The provided text describes a 510(k) premarket notification for the TITAN 11 Stationary X-ray System, asserting its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-driven medical device.

The document discusses performance testing, but this is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance acceptance criteria for a novel AI/ML application. The performance testing includes non-clinical tests (e.g., electromagnetic compatibility, software validation) and a limited clinical review by a radiologist.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria, detailed study design, and quantitative performance results for an AI/ML device. The document primarily focuses on regulatory compliance and substantial equivalence for a traditional x-ray system.

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