(88 days)
The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer's memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic images.
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Air Techniques, Inc. ScanX D5000 Series Scanner with and without Battery":
Overview:
This 510(k) summary describes a new device, the ScanX D5000 series scanner, which reads photostimulable phosphor plates. The primary claim for regulatory clearance is substantial equivalence to previously cleared predicate devices (ScanX 10/12 and Dental ScanX Scanner) and a predicate portable X-Ray system ("Any Ray" for the battery component). The document focuses on demonstrating that the D5000 series is "identical in concept, design, and function" to its predicates, with specific modifications detailed.
Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" in the format one might expect for a quantitative performance study (e.g., target sensitivity/specificity). Instead, it relies on demonstrating substantial equivalence to predicate devices through a comparison of characteristics. The "reported device performance" is implicitly that it functions identically or equivalently to the predicate devices.
Here’s a table summarizing the relevant characteristics and how they relate to demonstrating equivalence (which serves as the "acceptance criteria" here):
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (ScanX D5000 Series) |
|---|---|---|
| Intended Use | Same as predicate, plus intraoral PSP plates for dentists/veterinarians | Same as predicate (extraoral & medical imaging plates) and includes intraoral PSP plates for dentists and veterinarians (expanded). |
| Mechanical Design | Same as predicate ScanX 12 | Same as predicate (reads exposed plates with laser, ~635nm) |
| Mechanical Enclosure | Metal enclosure (predicate) | Metal and plastic enclosure |
| Electrical Design | Same as predicate ScanX 12 | Same as predicate (390nm light collected by photo multiplier tube, image displayed on PC) |
| Erasing Residual Image | Manual insertion into external plate eraser (predicate) | In-Line Erase (ILE) with red LEDs, automatically erases image |
| Viewing Image | Same as predicate | Same as predicate (displayed on computer with user software for storage, retrieval, manipulation) |
| Plate Input/Exit Heights | Accepts 10x12 inch plates and smaller (predicate) | Accepts 14x17 inch plates and smaller (improved capability) |
| Manufacturer | Air Techniques, Inc., doing business as All-Pro Imaging | Same as predicate |
| Body Size and Weight | 14"W x 14"L x 28"H, 55 lbs (predicate) | 15 ½"W x 17 ½"L x 13.75"H, 45 lbs (smaller, lighter) |
| Software | PCB and controller boards programmed with software/firmware (predicate) | New PC Boards and reconfigured firmware |
| User Interface | Licensed and trained dentist and medical technicians (predicate) | Same as predicate |
| Energy Source AC | 100 to 240VAC, 50/60 Hz, 1.5A minimum (predicate) | 100 to 240VAC, 50/60 Hz, 2.5A maximum |
| Energy Source DC (Battery) | Not Applicable (predicate ScanX 12) | Rechargeable 26.4V DC Lithium ion 8 cell battery pack |
| Battery Rating | Not Applicable (predicate ScanX 12) | 2300 mAh |
| Battery Safety & Performance Testing | Not Applicable (predicate ScanX 12) | Battery pack tested to UL 2054; Battery cells tested to UL 1642 |
| Electrical Safety Standards | UL60601-1 (safety) (predicate) | Same as predicate and UL2054 |
| EMI Safety Testing | IEC 61000 (predicate) | IEC 61000 |
| Performance Standards | IEC EMC testing /EN 60601-1-2 (predicate) | Same as predicate |
| Biocompatibility, Sterility, Shelf Life | Not applicable (no patient contact for predicate) | Not applicable (no patient contact) |
Study Details:
The provided document describes a substantial equivalence determination rather than a traditional performance study with a test set of images, ground truth, or expert readers. This is a common approach for 510(k) submissions when a device is highly similar to existing cleared devices.
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Sample size used for the test set and the data provenance:
- No explicit "test set" of images or patient data is mentioned. The study is a comparison against predicate device specifications and functionalities.
- Data provenance: Not applicable in the sense of patient data. The comparison is against the specifications and performance of existing, legally marketed devices from Air Techniques, Inc.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" for a test set of images was established by experts in this type of submission. The "ground truth" is effectively the established performance and safety of the predicate devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no test set requiring adjudication.
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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 MRMC study was done. This device is a scanner, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware/firmware device that produces images for human interpretation, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is implied to be the established safety and effectiveness of the predicate devices based on their prior clearance and market performance. The submission argues that the new device, despite some differences (like plate size, in-line erase, and battery option), maintains the same fundamental performance characteristics for image acquisition. For the battery component, the "ground truth" is the safety and performance certification (UL 2054, UL 1642) of the battery itself and its equivalence to a predicate portable X-ray system.
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The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a "training set" in the context of this 510(k) submission.
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How the ground truth for the training set was established:
- Not applicable, as there was no training set.
Conclusion from the document:
Air Techniques, Inc. concludes that the ScanX D5000 Series scanners are "safe and effective and substantially equivalent to the predicate devices as described herein," based on the detailed characteristic comparison and specific validation for new features like the battery and reconfigured firmware (mitigated through product and process validation located in Exhibit 7, though Exhibit 7 is not provided in the input). The FDA's letter concurs with the substantial equivalence finding.
§ 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.