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510(k) Data Aggregation
(99 days)
ATLAIM CORPORATION
The ATAL 9 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
The ATAL 9 is a digital radiography system, featuring an integrated flat panel digital detector (FPD). ATAL 9 is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the modified panel are the same as our previous panel with a Wi-Fi wireless feature added.
The provided document is a 510(k) summary for the ATAL 9 digital radiography system. It focuses on demonstrating substantial equivalence to a predicate device (ATAL 8, ATAL 8c, K113812), primarily due to the addition of wireless functionality. As such, the study design and acceptance criteria are geared towards proving this equivalence rather than establishing de novo performance for a new type of device or AI algorithm.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (ATAL 9 vs. ATAL 8/8c) |
|---|---|
| Technological Characteristics | |
| Pixel Pitch: Same as predicate | SAME (139 μm) |
| Limiting Resolution: Same as predicate | SAME (Over 3 lp/mm) |
| DQE (CSI) at 2 lp/mm: Comparable to predicate | 26% (Predicate: 27%) |
| MTF (CSI) at 2 lp/mm: Comparable to predicate | 42% (Predicate: 43%) |
| A/D Conversion: 14 bits or better | 16 bits (Predicate: 14 bits) |
| Active Area: Same as predicate | SAME (17 x 17 inch) |
| Pixels: Same as predicate | SAME (3,072 x 3072) |
| Software: Same functionality | SAME as K113812 |
| DICOM output: Yes | YES |
| Scintillator: Same options | UNCHANGED (Csl/GOS) |
| Interface: Gigabit Ethernet and/or wireless functionality | Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11ac, backward compatible |
| Power source: AC line and/or rechargeable battery | AC Line and/or Rechargeable Lithium Battery (10 hr run time) |
| Dimensions/Weights: Changed (due to wireless/battery) | 460(W)×461(L)×15(H)/ 2.9kg (2.4kg w/o Battery) (Predicate: 500(W)×500(L)×25(H)/ 7.8kg) |
| Safety and Effectiveness | |
| Electrical Safety: Compliance with IEC 60601-1 | Complies with IEC 60601-1 |
| EMC: Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Wireless operation: Compliance with IEEE 802.11ac and FCC | Complies with IEEE 802.11ac, Meets FCC requirements |
| Image Quality (Clinical): As good as or better than predicate | Concluded "as good as or better than" by board-certified radiologist. |
| Risk Analysis: Conducted | Conducted (as per bench testing summary) |
| Software Verification: Conducted | Conducted (as per bench testing summary) |
| Wireless connectivity: Verified | Verified |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical images were acquired and evaluated by a board certified radiologist..." However, it does not specify the number of clinical images (sample size) used for the test set.
- Sample Size: Not explicitly stated for the clinical image evaluation.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). While "clinical images were acquired," it doesn't specify if these were newly acquired for the study (prospective) or selected from an existing archive (retrospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: One.
- Qualifications of Experts: A "board certified radiologist." No further details on years of experience or sub-specialty are provided.
4. Adjudication Method for the Test Set
The document indicates that "Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." This implies a single-reader evaluation against the predicate device, not a multi-reader adjudication process. Therefore, the adjudication method was essentially none in the sense of comparing multiple experts' opinions. The single expert provided the judgment.
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
- MRMC Study: No, an MRMC study was not done.
- AI Improvement Effect Size: Not applicable. This submission is for a digital radiography panel, not an AI software/algorithm intended to assist human readers or provide automated diagnoses. The device being cleared (ATAL 9) is a hardware device for image acquisition.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, a standalone performance study as described (algorithm only without human-in-the-loop performance) was not done. The ATAL 9 is a digital X-ray panel, where the "performance" relates to image acquisition and quality, not an algorithm's diagnostic output. The clinical evaluation involved a human radiologist examining the acquired images.
7. The Type of Ground Truth Used
For the clinical evaluation, the "ground truth" was established by the expert opinion/conclusion of a single board-certified radiologist. The radiologist compared images from the new panel against those from the predicate panel. This is a form of expert consensus, albeit from a single expert, comparing image quality.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not provided. The ATAL 9 is a hardware device (digital X-ray panel). It is not an AI algorithm that undergoes a "training" phase with a large dataset. The "software" component remains the same as its predicate (K113812), implying no new algorithm training was performed for the ATAL 9.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As explained above, this device does not involve an AI algorithm with a training phase requiring a "ground truth" to be established for training data.
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(132 days)
ATLAIM
The ATAL 8 and ATAL 8c is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors that capture radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The ATAL 8 and ATAL 8C device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form. Once the system captures a radiographic image and subsequently displays and stores an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a workstation. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. The ATAL 8 and ATAL 8C differ only in the enclosure type. They have identical technological characteristics.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence or superiority to the predicate device in diagnostic quality of clinical images. | "a board certified Radiologist reviewed the images and declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality." |
| Device produces images suitable for "general radiographic images of human anatomy" and can "replace radiographic film/screen systems in all general-purpose diagnostic procedures." | The clinical evaluation concluded the device provides images of diagnostic quality, indirectly confirming suitability for its intended use. The conclusion of substantial equivalence also supports this, implying it meets the requirements for general radiography. |
| Compliance with non-clinical performance standards (MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, Lag). | "Non-clinical testing included performance tests, EMC tests, Electrical Safety and software validation tests. The performance testing was based on the requirements of the FDA Guidance Document for Solid State Imaging Devices and included tests for MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, and Lag or residual signal level from prior exposure." Results are implied to be satisfactory as per the substantial equivalence conclusion. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 30 pairs of clinical images (30 images from the ATAL 8/8C and 30 corresponding images from the predicate device).
- Data Provenance: Not explicitly stated, but based on the nature of clinical image acquisition, it would be prospective for the purposes of this equivalency study, as these images were specifically obtained for the comparison. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One
- Qualifications of Experts: "a board certified Radiologist"
4. Adjudication Method for the Test Set
- Adjudication Method: None explicitly mentioned beyond a single radiologist's review. The radiologist "declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality." This suggests a direct comparison and qualitative assessment by a single expert, without a formal adjudication process involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The study involved a single radiologist's assessment of paired images.
- Effect Size: Not applicable, as an MRMC study was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable/not explicitly stated in the context of this device. The ATAL 8 and ATAL 8C are digital X-ray detectors, not an AI algorithm. Their performance is inherently tied to producing images for human interpretation. The clinical study assessed the diagnostic quality of the images produced by the device, which are then interpreted by a human (the radiologist). Therefore, the concept of a "standalone" algorithmic performance isn't directly relevant in the same way it would be for an AI-powered diagnostic tool.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical comparison was based on expert consensus (or in this case, expert declaration by a single board-certified radiologist) that the images were of diagnostic quality and equivalent or better than those from the predicate device. This is a form of expert review for diagnostic suitability.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The document describes a medical device (digital X-ray detector), not an AI algorithm that requires a training set. The "development" of the device would involve engineering and physical testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this device does not involve an AI algorithm with a training set. The "ground truth" for non-clinical development would be established through physical and engineering specifications, validation against known standards, and performance test results (e.g., MTF, DQE).
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