(71 days)
"HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.
The "HCMI X-Ray" is a radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied.
The provided document is a 510(k) summary for the "HCMI X-Ray" High Frequency Radiographic System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in efficacy studies. As such, many of the requested details about acceptance criteria, test set, ground truth, and human reader studies are not present in this regulatory document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "HCMI X-Ray" has the SAME intended use as the predicate device (Bennett X-Ray Radiographic System K952672). This implies the acceptance criterion for intended use was to match the predicate. |
| Performance Standard | Compliance with 21 CFR 1020.30. The "HCMI X-Ray" is stated to be SAME in performance standard, indicating it meets this regulation. |
| Electrical Safety | Compliance with Underwriters Laboratories Standard UL-2601(IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment. The "HCMI X-Ray" is stated to be SAME in electrical safety, indicating it meets these standards. |
| Overall Safety and Effectiveness | The device is "as safe and effective as the predicate devices." This is a qualitative statement based on "bench and user testing." |
2. Sample Size for the Test Set and Data Provenance
- The document mentions "bench and user testing" but does not specify the sample size for these tests.
- The data provenance (e.g., country of origin, retrospective/prospective) is not provided. Given the nature of a 510(k) for an X-ray system, "user testing" likely refers to operational evaluations rather than clinical trials with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- The document does not mention the involvement of experts to establish ground truth for a test set in the context of diagnostic accuracy.
- The evaluation revolved around demonstrating equivalence in function, safety standards, and electrical safety, not diagnostic performance.
4. Adjudication Method for the Test Set
- Since there's no mention of a formal test set with ground truth established by experts for diagnostic performance, an adjudication method is not applicable and not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or conducted as part of this 510(k) submission. The submission is for a basic X-ray system, where the focus is on comparing its technical specifications and safety with existing devices, not on evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No standalone algorithm performance study was mentioned or conducted. This device is an X-ray imaging system, not an AI-powered diagnostic algorithm.
7. Type of Ground Truth Used
- For the "HCMI X-Ray" system, the "ground truth" during testing was likely defined by engineering specifications, compliance with performance standards (21 CFR 1020.30), and adherence to electrical safety standards (UL-2601, IEC 60601, UL187).
- The concept of "expert consensus," "pathology," or "outcomes data" as ground truth for diagnostic accuracy is not relevant to this type of device and submission.
8. Sample Size for the Training Set
- Not applicable and not mentioned. There is no "training set" in the context of an X-ray imaging system being evaluated for substantial equivalence. This type of device does not involve machine learning or AI algorithms requiring training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable and not mentioned. As there is no training set for this device, a method for establishing its ground truth is not relevant.
§ 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.