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510(k) Data Aggregation
(23 days)
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment.
The provided text describes a 510(k) premarket notification for the OXOS Medical Micro C Medical Imaging System, M01. This submission aims to expand the indications for use to include pediatric patients and surgical settings. The document heavily relies on the substantial equivalence to a previously cleared predicate device (also Micro C Medical Imaging System, M01, K203658).
However, the document does not include detailed acceptance criteria or a study that rigorously proves the device meets specific performance criteria in a way that would be typical for an AI/CADe device. The focus is on demonstrating that the expanded indications (pediatric use and surgical use) do not raise new questions of safety or effectiveness compared to the predicate device. The information provided is primarily a comparison between the subject device and its predicate, highlighting that the core technological characteristics are identical.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone AI performance are not present in the provided text, as this is a submission for an imaging device, not an AI/CADe device.
Based on the provided text, here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/CADe device (e.g., sensitivity, specificity, AUC). Instead, the "performance" discussed relates to the device's fundamental imaging capabilities and its intended use, established by its substantial equivalence to the predicate. The crucial aspect from the document is the claim that the updated indication for pediatric use and surgical use is acceptable as demonstrated by "performance data" that does not raise different questions of safety and effectiveness.
| Acceptance Criteria (Inferred from equivalence to predicate and non-clinical testing) | Reported Device Performance (from text) |
|---|---|
| Image quality for diagnostic static and serial radiographic exposures of extremities (comparable to predicate K203658) | Device is "identical" to predicate device K203658 in technological characteristics like detector, resolution, DQE, MTF. |
| Safe and effective for adult patients (established by predicate K203658) | Established as substantially equivalent. |
| Safe and effective for pediatric patients (new indication) | Supported by "performance data" related to the addition of the pediatric population, implying that the device performs adequately for this cohort without new safety/effectiveness concerns. |
| Safe and effective for use in surgery (new indication) | Supported by "usability testing for use in surgery" and "cleaning and disinfection studies." |
| Compliance with relevant guidance documents and standards | Mention of conformance with guidance for Medical X-ray Imaging Devices, Solid State X-ray Devices, Hand-held X-ray Equipment, and Pediatric Information for X-ray Imaging Device Premarket Notifications. |
2. Sample size used for the test set and the data provenance
Not provided in the document. The filing is for an X-ray imaging device, not an AI/CADe system. The "performance data" for pediatric and surgical use is not detailed with sample sizes or data provenance.
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 relates to AI/CADe studies, not the 510(k) for an X-ray imaging system.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-enabled device.
7. The type of ground truth used
Not applicable. The "performance data" for pediatric and surgical use is not specified in terms of clinical "ground truth" used for evaluation. It likely refers to technical performance evaluations and usability rather than diagnostic accuracy against a clinical gold standard for disease detection.
8. The sample size for the training set
Not applicable. This is not an AI-enabled device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-enabled device.
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