(35 days)
The SEDECAL X PLUS LP PLUS Universal Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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.
SEDECAL X PLUS LP PLUS Universal Radiographic Systems are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device employs new controls, including a touch screen and an infrared remote.
This K062335 510(k) summary describes a submission for a modified medical device rather than a new device with novel performance claims directly tied to specific acceptance criteria and study results. Therefore, the standard format for presenting acceptance criteria, device performance, and detailed study information for AI/algorithm performance is not fully applicable or derivable from the provided text.
Here's why and what information can be extracted:
The submission is for the SEDECAL X PLUS LP PLUS Universal Radiographic Systems, which is a stationary X-ray system. The core of this 510(k) is to demonstrate substantial equivalence to a predicate device (Sedecal URS X-Ray Units K012546), focusing on changes to the user interface (touch screen and infrared remote) and ensuring the safety and effectiveness are maintained.
When a 510(k) relies on substantial equivalence for modified devices, the "study" often involves bench testing, user testing, and adherence to performance standards to show that the modifications do not introduce new safety or effectiveness concerns, and that the device performs as well as the predicate device. It doesn't typically involve a comparative effectiveness study with AI or a standalone algorithm performance study with specific metrics like sensitivity/specificity against a ground truth.
Therefore, many sections of your requested output will be marked as "Not Applicable" or "Not Provided in Document."
Acceptance Criteria and Study Overview for K062335
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Metric (Target) | Reported Device Performance (Result) |
|---|---|---|
| Safety and Effectiveness | Device is as safe and effective as the predicate device (Sedecal URS K012546) | "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." (Source: Section 5) |
| Intended Use | Same as predicate device | "SAME" (General purpose diagnostic X-ray unit) (Source: Substantial Equivalence Chart, page 2) |
| Energy Source | Same as predicate device | "SAME" (120V, 230/240V (50/60Hz) Line or Battery Power) (Source: Substantial Equivalence Chart, page 2) |
| Maximum Output | Same as predicate device models (30kW to 64kW) | "SAME as original units." (Source: Substantial Equivalence Chart, page 2) |
| Tube Mount | Same as predicate device (Fixed with respect to receptor, arm can rotate) | "Same" (Source: Substantial Equivalence Chart, page 2) |
| Receptor Mount | Same as predicate device (Fixed on same column as tube head) | "SAME" (Source: Substantial Equivalence Chart, page 2) |
| Performance Standard Adherence | 21 CFR 1020.30 | "SAME" (Source: Substantial Equivalence Chart, page 2) |
| Electrical Safety Adherence | UL 2601, IEC 60601-1 | "SAME" (Source: Substantial Equivalence Chart, page 2) |
| Technological Differences | Few technological differences, no new indications for use that would alter safety/effectiveness | "have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices." (Source: Conclusion, page 2) |
Notes on Acceptance Criteria:
- The primary "acceptance criteria" here are demonstrating substantial equivalence, meaning the modified device performs comparably to the predicate in terms of safety and effectiveness, especially given the "new controls, including a touch screen and an infrared remote."
- "Bench, user, and standards testing" are the methods used to meet these criteria, rather than a clinical study with calculated performance metrics.
2. Sample size used for the test set and the data provenance
- Sample Size: Not provided in the document. For device modifications like this, "user testing" might involve a small number of typical users to evaluate the new interface, but specifics are not disclosed. "Bench testing" refers to engineering and quality assurance tests. "Standards testing" refers to compliance with regulatory standards.
- Data Provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. This type of information is relevant for AI algorithms interpreting medical images or data, where expert consensus often establishes ground truth. For a stationary X-ray system, experts (engineers, quality control personnel) would evaluate the device's functionality, safety, and image quality (which is assumed to be equivalent to the predicate). There is no "ground truth" in the diagnostic sense being established in this submission.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple human readers or algorithms are evaluating cases and their interpretations need to be reconciled to form a definitive "ground truth." This submission focuses on engineering and regulatory compliance, not diagnostic interpretation studies.
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, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic devices to evaluate the impact of AI on human reader performance. The device described here is a basic X-ray system, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is an X-ray machine, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the context of diagnostic performance. For this device, "ground truth" relates to functional specifications and safety standards being met, as per engineering and regulatory requirements. For example, voltage outputs measured during bench testing would be compared against engineering specifications, which themselves are the "ground truth" for those tests. Image quality being "equivalent" to the predicate would be the "ground truth," likely established through physical phantom tests and possibly expert review, but not in the detailed diagnostic sense.
8. The sample size for the training set
- Not Applicable. This is an X-ray system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm.
§ 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.