(22 days)
The FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
The FS Ergo is a USB-driven sensor designed to capture intraoral digital dental x-ray images. FS Ergo can be used with any X-ray units intended for dental intraoral purposes. When connected to a computer with an appropriate image capturing software application, images are automatically acquired when the FS Ergo sensor receives a perceptible X-ray dose. The FS Ergo sensor is designed with advanced ergonomic principles. It has a bendable sensor housing together with other physical features supporting advanced erqonomics: small diameter flexible cable, 32 degrees' cable exit and sensor dimensions that fit all needs (size 1.5). Comfort is achieved in with large corner chamfers, rounded edges, and thicker sensor structure. The basic system of the FS Ergo consists of senor unit, sensor holders and hygienic covers (which are medical devices separately cleared by the FDA). A connection to a computer is required but the computer is provided by the users e.q. the computer is not part of the sensor system itself.
The provided text is a 510(k) summary for the FS Ergo dental intraoral sensor. It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria for algorithm performance, sample sizes for test sets (beyond general bench testing), or the methodologies typically associated with assessing the performance of AI/ML-driven medical devices (like MRMC studies, ground truth establishment methods for large datasets, or detailed expert adjudication processes).
The document is for an X-ray sensor device (hardware and associated image acquisition), not an AI/ML algorithm that interprets images or provides diagnostic assistance. Therefore, many of the questions asked in the prompt (related to AI acceptance criteria, training sets, test sets, ground truth, expert review for AI, etc.) are not directly applicable to this specific device submission as described.
The device's performance is primarily assessed through bench testing for image quality and other physical/electrical characteristics, and compliance with relevant safety and performance standards. The "study" proving the device meets criteria is primarily these non-clinical performance data and bench tests.
Here's an attempt to answer the questions based solely on the provided text, highlighting where the information is not present or not applicable:
Acceptance Criteria and Device Performance for FS Ergo (based on K173646)
This submission focuses on the substantial equivalence of a digital intraoral X-ray sensor (hardware) and its ability to acquire images, rather than the performance of an AI model analyzing these images. Therefore, the "acceptance criteria" discussed are largely related to image quality, electrical safety, mechanical integrity, and biocompatibility to demonstrate equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria for image quality or a direct "reported performance" against those criteria in a tabular format. Instead, it states:
- Bench Test Images: "Bench test images of skull phantoms were acquired using FS Ergo sensor, the images were reviewed by qualified external clinician to be of acceptable quality for the proposed intended use."
- Bench Testing Results: "Bench testing results indicate substantial equivalence to the predicate device Snapshot."
- Standards Compliance: The device successfully passed testing according to various IEC standards (electrical, mechanical, safety, usability, EMC). Biocompatibility was also confirmed.
Inferred "Acceptance" for Image Quality (Qualitative based on text):
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Image Quality | "acceptable quality for the proposed intended use" (based on skull phantom images reviewed by a qualified external clinician) |
| Equivalence to Predicate | "substantial equivalence to the predicate device Snapshot" (based on bench testing results) |
| Safety & Performance | Passed all tests according to IEC 60601-1:2005, IEC 60601-1-6:2013, IEC 62366:2014, IEC 62304:2006, IEC 60601-1-2:2014. Biocompatibility conforms to ISO 10993-1:2009. |
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific image quality tests. The mention of "skull phantoms" implies a limited, controlled setup rather than a large clinical test set of patient images.
- Data Provenance: Not specified. "Bench test images of skull phantoms" suggests a laboratory controlled environment, not clinical patient data from a specific country.
- Retrospective/Prospective: Not applicable in the context of bench testing phantoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "qualified external clinician" (singular, or implies a group but only states "clinician"). The number of experts is not specified if it was more than one.
- Qualifications of Experts: "qualified external clinician." No specific details on years of experience, subspecialty, or board certification are provided beyond "qualified."
- Ground Truth Establishment: For this type of device (an image acquisition sensor), the "ground truth" for image quality is typically visual assessment of clarity, contrast, resolution (e.g., ability to discern features), and absence of artifacts by a qualified radiologist or dental professional, often compared to images from established devices. The document implies a qualitative assessment rather than a quantitative ground truth for diagnostic accuracy, as this is a device for image acquisition, not diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. Given the qualitative statement about "acceptable quality" from a "qualified external clinician," a formal adjudication process for discordant reads (like 2+1 or 3+1) is not described or implied for this type of image quality assessment. It's likely a direct expert review for the purpose of validating image quality from the phantom.
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 comparative effectiveness study was not done. This type of study (often used for AI-assisted diagnostic tools) is not relevant for an X-ray sensor device whose primary function is image acquisition.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is an X-ray sensor and does not perform image interpretation or diagnosis independently; it generates images for human review. Therefore, there is no "algorithm only" performance to evaluate in the context of an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "bench test images of skull phantoms," the ground truth appears to be expert qualitative assessment of image quality (e.g., visual clarity, diagnostic utility for dental structures) compared to known characteristics of the phantom and reference images from predicate devices. It is not pathological, clinical outcome, or a broad expert consensus on patient cases.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a hardware device (X-ray sensor), not a machine learning algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set for an AI/ML algorithm.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.