(328 days)
The SPINEL 3G, 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 quided procedure & mammographic applications.
The Image Intensified Fluroscopic 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 for interventional quided procedure & mammographic applications.
This document is a 510(k) Summary for the Spinel 3G, a Surgical Mobile Fluoroscopic X-ray system. The purpose of this document is to demonstrate that the Spinel 3G is substantially equivalent to a legally marketed predicate device (KMC-950).
Here's an analysis of the acceptance criteria and supporting study information, based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of quantified performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. Instead, the "acceptance criteria" or rather, the basis for substantial equivalence, is rooted in demonstrating that the Spinel 3G has similar technological characteristics and intended use as the predicate device, and that it meets recognized safety and performance standards.
The reported "device performance" is primarily presented as meeting these safety and performance standards and having similar technical specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device has the same intended use. | The Spinel 3G is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This is consistent with what is typically expected of a Surgical Mobile Fluoroscopic X-ray System, which the predicate also is. Both devices are explicitly not for interventional guided procedures & mammographic applications. |
| Technological Characteristics Equivalence: Device has similar technological characteristics to the predicate. | The comparison table (page 5) details many similar technical specifications: |
- X-ray Tube: Rotating anode, 300,000 HU heat capacity, 15kHU/min anode heat cooling, 0.3mm/0.6mm focal size (choice of Varian or Toshiba for proposed, Varian for predicate).
- X-ray Generator: High frequency/inverter type, 12.0 kVA power output (same for both).
- Fluoroscopic Mode: kV range (40-120 kV for proposed vs 40-125 kV for predicate - a slight difference but considered acceptable), mA range (0.2-10 mA for proposed vs 0.5-5 mA for predicate - proposed has a wider range), Pulse Fluoro (Yes for both), ABS function (Yes for both), Snap Shot (8.0 mA for both), Boost Shot (20.0 mA for both).
- Image Intensifier: 9" size, 9"/6"/4.5" magnification (same for both, but different manufacturers for the image intensifier).
- Camera: 1/2" CCD type (same), but proposed has higher active pixels (1024x1024) compared to predicate (512x512). This is a technical improvement but not deemed to alter fundamental safety or effectiveness.
- C-arm: Similar mechanical movements and dimensions (e.g., SID, Linear FR-arm movement, Linear T-arm movement, Swing-arm rotation – though the C-arm rail rotation range is wider for the proposed device: 135° vs 115°).
- Image Processing: Both digital storage, but proposed has significantly larger storage capacity (HDD 500G, >35,000 pictures) and a larger monitor (19" vs 17").
- Collimator: Motor control/rotation, DC 24V power requirements (same). |
| Safety and Performance Standards Compliance: Device meets recognized safety, EMC, and performance standards. | Electrical, mechanical, environmental safety and performance testing according to FDA recognized standards were performed, and all test results were satisfactory.
Applied standards include: - IEC60601-1:2005 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC60601-1-2:2007 (Electromagnetic compatibility - Requirements and tests)
- IEC60601-1-3:2008 (General requirements for protection against undesirable radiation in diagnostic X-ray equipment)
- IEC60601-2-28:2010 (Requirements for the safety of X-ray source assemblies and X-ray generators for medical diagnosis)
- IEC60601-2-54:2009 (Requirements for the safety of X-ray equipment for radiography and radioscopy)
- NEMA PS 3.1-3.20 (DICOM standards for image communication)
- ISO14971:2012 (Medical devices - Application of risk management to medical devices)
- EPRC regulation (21CFR1020.32) was satisfactory.
- FDA guidance for Solid State X-ray Imaging Devices was satisfactorily considered. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in terms of patient data or images used to evaluate diagnostic performance (e.g., how accurate it is at detecting specific conditions). The "testing" mentioned is focused on engineering and regulatory compliance (safety, EMC, performance standards).
Therefore, there is no information on:
- Sample size for a clinical test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since there was no "clinical test set" described for diagnostic performance evaluation, there is no information provided regarding experts or ground truth establishment in that context. The "acceptance criteria" here are engineering and regulatory compliance, not diagnostic accuracy.
4. Adjudication method for the test set
Similarly, because there was no clinical test set for diagnostic performance, there is no adjudication method 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
No MRMC study was mentioned or conducted. This device is a standard X-ray imaging 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. This is a hardware imaging device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As noted, for the "substantial equivalence" determination, the "ground truth" refers to compliance with established engineering standards and regulations, and the technical specifications of a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device is an X-ray system, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.