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510(k) Data Aggregation
(64 days)
"HCMI X-Ray" High Frequency Chiropractic 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 chiropractic radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.
Acceptance Criteria and Study for "HCMI X-Ray" High Frequency Chiropractic Radiographic System
This device, the "HCMI X-Ray" High Frequency Chiropractic Radiographic System, is seeking substantial equivalence to a predicate device, the Bennett X-Ray Radiographic System (K952672). Therefore, the acceptance criteria are not in terms of specific performance metrics against a defined standard for accuracy, sensitivity, or specificity, but rather relate to demonstrating its safety and effectiveness are equivalent to the predicate device.
The study presented focuses on demonstrating this equivalence through various testing methodologies.
1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The device's intended use must be the same as the predicate device. | "SAME" - Intended for general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts, performed by a qualified doctor or technician, with the patient sitting, standing, or lying prone/supine. |
| Performance Standard Compliance: The device must meet the same applicable federal performance standards. | "SAME" - Complies with 21 CFR 1020.30. |
| Electrical Safety Compliance: The device must meet the same electrical safety standards. | "SAME, plus tested for EMC compatibility" - Complies with Underwriters Laboratories Standard UL-2601(IEC-60601) and IEC 60601, and additionally, tested for EMC compatibility. |
| Technological Characteristics Equivalence: The device must have few technological differences from the predicate device that do not raise new questions of safety or effectiveness. | The document implies equivalence through the "SAME" statements and the "few technological differences" conclusion. Specific technical details like mA, kVp, and Max KW ranges are provided and would have been compared to the predicate. |
| Overall Safety and Effectiveness Equivalence: The device must be demonstrated to be as safe and effective as the predicate device. | "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document refers to "bench and user testing" for safety and effectiveness. However, no specific sample sizes for tests (e.g., number of test images, number of test subjects) are mentioned. Similarly, there is no information provided regarding data provenance (e.g., country of origin of the data, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number of experts used for any aspect of the testing, nor does it provide any details about their qualifications. The "user testing" mentioned generally implies evaluation by end-users (qualified/trained doctors or technicians), but without further detail.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of rigorous adjudication is typically associated with studies evaluating diagnostic accuracy, which is not the primary focus of this submission, which aims for substantial equivalence based on safety and functional similarity.
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 is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. This type of study, especially one evaluating the improvement of human readers with AI assistance, is not relevant given the device is a standard X-ray system and not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not conducted, nor would it be applicable to this device, which is an X-ray imaging system, not an algorithmic diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically understood in diagnostic performance studies (e.g., expert consensus, pathology) is not explicitly mentioned or applied in this submission. The evaluation focuses on equivalence of the X-ray system itself (e.g., image quality, radiation output, electrical safety) rather than the accuracy of diagnoses made using images from the system. The "user testing" would have assessed the functional aspects and usability of the device, likely against anticipated positive outcomes of general radiographic examinations, rather than a specific disease diagnosis ground truth.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a conventional X-ray system, not a machine learning or AI-driven device that requires a training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, there is no information on how ground truth would have been established for it.
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