(81 days)
The OTC12D Auto System is a radiographic system used in hospitals, clinics, and medical practices. The OTC12D Auto System enables radiographic exposures of the whole body including; skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The OTC12D Auto System is not meant for mammography. The OTC12D Auto System can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The OTC12D Auto System is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The OTC12D Auto System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. It is intended to produce diagnostic x-ray images of human anatomy.
The OTC12D Auto System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography.
The OTC12D Auto System typically includes a tube support, x-ray generator, x-ray tube, radiographic table, radiographic wall stand, and collimator. Systems that include the overhead tube crane provide auto-tracking of the tube crane based on the position of the radiographic table or wall stand.
The provided text is a 510(k) summary for the Del Medical, Inc. OTC12D Auto Radiographic System (K152767). It describes the device and claims substantial equivalence to a predicate device, the Siemens Multix Fusion (K121513).
However, this document does not describe a study that explicitly establishes acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting a specific condition) for the OTC12D Auto system derived from image analysis. Instead, the document focuses on demonstrating substantial equivalence in terms of safety and technical functionality compared to the predicate device.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance in terms of compliance with various consensus standards for safety and general functionality, rather than diagnostic accuracy. The "acceptance criteria" appear to be meeting these standards and demonstrating similar functionality to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to AAMI ES60601-1 (Basic Safety & Essential Performance) | Conforms (stated in Table 4) |
| Conformance to IEC 60601-1-2 (Electromagnetic Compatibility) | Conforms (stated in Table 4) |
| Conformance to IEC 60601-1-3 (Radiation Protection) | Conforms (stated in Table 4) |
| Conformance to IEC 60601-1-6 (Usability) | Conforms (stated in Table 4) |
| Conformance to IEC 60601-2-54 (X-Ray Equipment for Radiography) | Conforms (stated in Table 4) |
| Substantial equivalence in indications for use to predicate | Same (stated in Table 3) |
| Similar functionality for physical components (tube crane, wall stand, table, etc.) | Similar Functionality (stated in Table 3) |
| Safe and effective operation | Risk mitigated, instructions for use, safety features, professional operators, adheres to industry practice (Sections 7, 9) |
| Ability to produce diagnostic images | Intended to produce diagnostic x-ray images of human anatomy (Section 6) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of imaging performance data (e.g., a set of patient images to be evaluated for diagnostic accuracy). The testing performed is related to safety and technical standards compliance. Therefore, information about data provenance or sample size for an imaging test set is not available.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable/not available because no diagnostic performance study (e.g., for detecting a specific disease) is described that would require expert-established ground truth. The device is a radiographic system, and its "performance" in this submission refers to its physical and electrical safety and functional equivalence, not its diagnostic accuracy in interpreting images.
4. Adjudication Method:
Not applicable/not available for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This submission does not involve AI or algorithms assisting human readers. It describes a conventional X-ray system. Therefore, details about improved human reader performance with or without AI assistance are not applicable/not available.
6. Standalone (Algorithm Only) Performance Study:
No standalone algorithm performance study is mentioned. The device is an X-ray system, not an algorithm for image interpretation. Therefore, this information is not applicable/not available.
7. Type of Ground Truth Used:
Not applicable/not available because no diagnostic performance study is described. The "ground truth" implicitly referred to is compliance with engineering and safety standards, as verified through standard testing procedures.
8. Sample Size for the Training Set:
There is no mention of a "training set" in the context of machine learning or AI. The development and testing of this device relate to hardware and software engineering principles for an X-ray system. Therefore, this information is not applicable/not available.
9. How the Ground Truth for the Training Set was Established:
Not applicable/not available for the same reasons as point 8.
Summary of the Study Discussed in the Document:
The study presented in this 510(k) summary is primarily a technical and safety conformance study, rather than a diagnostic performance study. It aims to demonstrate that the OTC12D Auto Radiographic System is substantially equivalent to a legally marketed predicate device (Siemens Multix Fusion) by:
- Comparing Indications for Use: Showing they are identical.
- Comparing Technological Characteristics: Highlighting similarities in components (tube crane, wall stand, table, X-ray tube, collimator, X-ray generator, operator console) and noting that differences do not affect safety or effectiveness.
- Demonstrating Conformance to Consensus Standards: Providing a table of FDA-recognized consensus standards (AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54) for electromagnetic compatibility, mechanical and electrical safety, radiation protection, and usability. The document states that testing for verification and validation of the device was found acceptable to support claims of substantial equivalence.
- Risk Management: Stating that identified risks (EMC, mechanical, electrical hazards) were mitigated.
The "study" asserts that "Clinical testing is not required for a determination of substantial equivalence" for this type of device, which further clarifies why diagnostic performance parameters are not provided.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.