(26 days)
The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.
The ImaSight 4600 is a digital radiographic sensor which automatically collects x-ray images from an x-ray source. The ImaSight 4600 sensor collects x-rays and converts them into a computer images for display on a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor comes with an acquisition box and a computer, which holds the display and processing software.
The provided document is a 510(k) submission for the ImaSight 4600 Digital Radiography Sensor. This submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new performance criteria through a standalone study with defined acceptance criteria. Therefore, several aspects of the requested information, such as detailed acceptance criteria, specific sample sizes for test sets, expert-driven ground truth, and MRMC studies, are not explicitly provided in the document in the format typically found for a novel device performance study.
Based on the available information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit, quantitative acceptance criteria for the ImaSight 4600 as it would for a new device claiming improved performance. Instead, the basis of the submission is substantial equivalence to a predicate device, the Xplorer 1800 Digital Radiographic System (K063247).
| Acceptance Criteria (Implied) | Reported Device Performance (ImaSight 4600) |
|---|---|
| Image Quality Equivalent to Predicate Device | Produces images of similar quality to Xplorer 1800. |
| Performance Characteristics Equivalent to Predicate Device | Performance characteristics are equivalent to those of the Xplorer 1800. |
| Technical Specifications Identical/Similar to Predicate Device | Uses the same 16-megapixel CCD imaging sensor technology as Xplorer 1800. |
| Non-clinical Biocompatibility | Evaluated and found substantially equivalent to predicate device. |
| Effectiveness | Evaluated and found substantially equivalent to predicate device. |
| Thermal Safety | Evaluated and found substantially equivalent to predicate device. |
| Electrical Safety | Evaluated and found substantially equivalent to predicate device. |
| Mechanical Safety | Evaluated and found substantially equivalent to predicate device. |
| Conformance to Quality Systems | Conforms to 892.1680, ISO 9001, and ISO 13485. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for a "test set" in the context of a performance study. It states, "A set of images have been submitted along with the equivalent images from the predicate device." The exact number of images in this "set" is not provided.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the images were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As the submission relies on comparing images to a predicate device, it's possible that qualitative assessments were made, but the involvement and qualifications of experts for establishing ground truth are not detailed.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A MRMC comparative effectiveness study was not explicitly conducted or reported in this submission. The basis of the submission is substantial equivalence to the predicate device, not an evaluation of human reader improvement with or without AI (which this device does not claim to incorporate).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a digital radiography sensor, not an AI algorithm. Therefore, a "standalone algorithm performance" study as described is not applicable to this submission. The device's performance is inherently tied to its ability to capture images, which are then interpreted by humans.
7. The Type of Ground Truth Used
The concept of a "ground truth" derived from expert consensus, pathology, or outcomes data, as typically understood in AI/algorithm performance studies, is not directly applicable or specified here. The "truth" in this context is the performance and image quality of the legally marketed predicate device (Xplorer 1800). The ImaSight 4600's "truth" is its ability to produce equivalent images and performance characteristics.
8. The Sample Size for the Training Set
This information is not applicable as the ImaSight 4600 is a digital imaging sensor, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.