(73 days)
The 3Dscope is a mobile apparatus used for fluoroscopic examination of a patient.
The 3Dscope is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. The 3Dscope acquires, processes, displays, and stores x-ray images, for image diagnosis.
The provided text describes a 510(k) submission for the 3Dscope device, which is a mobile fluoroscopic system. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader studies for AI-powered devices.
Instead, the document focuses on:
- Substantial Equivalence: The primary argument for the 3Dscope's clearance is its substantial equivalence to a legally marketed predicate device (Digiscope RX-2). This means it claims to have the same intended use, fundamental technology, and does not reduce safety or effectiveness compared to the predicate.
- Compliance with Standards: The document lists various IEC and FDA CDRH standards that the 3Dscope conforms to. This is a form of acceptance criteria, but it relates to safety, electrical, and other engineering standards, not clinical performance or AI algorithm validation.
Therefore, most of the requested information cannot be extracted from this document. I will fill in what can be inferred and explicitly state what is missing.
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Regulatory Compliance | Compliance with IEC 60601-1 (1998) + A1(1991) + A2(1995) | Conforms | These are general safety and performance standards for medical electrical equipment. |
| Compliance with IEC 60601-1-1 (2000) | Conforms | Safety requirements for medical electrical systems. | |
| Compliance with IEC 60601-1-2 (2001) | Conforms | Electromagnetic compatibility (EMC) requirements. | |
| Compliance with IEC 60601-1-3 (1994) | Conforms | General requirements for protection against radiation in diagnostic X-ray equipment. | |
| Compliance with IEC 60601-2-7 (1998) | Conforms | Specific requirements for high-voltage generators for diagnostic X-ray generators. | |
| Compliance with IEC 60601-1-4 (2000) | Conforms | Programmable electrical medical systems. | |
| Compliance with ISO 14971 (2000) | Conforms | Medical devices - Application of risk management to medical devices. | |
| Compliance with FDA CDRH 21CFR 1020.30 | Conforms | Performance standards for X-ray equipment. | |
| Compliance with FDA CDRH 21CFR 1020.32 | Conforms | Performance standards for X-ray equipment. | |
| Clinical Performance | Not specified | Not specified | The document does not provide specific clinical performance metrics (e.g., image quality scores, diagnostic accuracy, sensitivity, specificity) for human readers or an AI algorithm. |
| Substantial Equivalence | To a legally marketed predicate device (Digiscope RX-2), with no change in intended use, fundamental technology, or reduction in safety and effectiveness. | The device meets the requirements for a special 510(k) by being a minor modification. | This is the primary "acceptance criteria" for regulatory clearance stated in the document. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document does not describe a clinical performance study with a test set of patient data to evaluate performance metrics typically associated with AI or diagnostic devices. The performance testing mentioned (
Section 6. Performance Testing) refers to compliance with engineering and safety standards. - Data Provenance: Not applicable for clinical performance data. The device is cleared based on demonstrating adherence to established technical standards and substantial equivalence to a predicate device, rather than a prospective clinical study using patient data for performance evaluation in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set and ground truth establishment are described in this document.
4. Adjudication method for the test set
- Not applicable. No clinical test set and adjudication method are described in this document.
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. This device is a fluoroscopic imaging system, not an AI-powered diagnostic assistant. No AI component is mentioned, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant for this submission type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a fluoroscopic imaging system, not an AI algorithm. Its performance is inherent in its ability to acquire, process, display, and store X-ray images, as per its design and compliance with technical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The document does not describe a performance study requiring ground truth for clinical diagnostic accuracy. The "ground truth" in this context refers to the device meeting the specified engineering and safety standards.
8. The sample size for the training set
- Not applicable. This device is a hardware imaging system, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a hardware imaging system, not an AI algorithm.
Summary of Missing Information and Context:
The provided 510(k) summary is for a traditional medical imaging device (a fluoroscopic X-ray system) seeking clearance based on substantial equivalence to a predicate device and compliance with established safety and performance standards. It does not concern an AI/ML-enabled device or a device requiring a clinical performance study with patient data to demonstrate diagnostic accuracy (e.g., sensitivity, specificity, AUC). Therefore, the specific details regarding clinical test sets, ground truth, expert readers, MRMC studies, and AI algorithm training data, which are standard for AI/ML device submissions, are not present in this document.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.