(45 days)
I-View dental sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
The subject device I View is an intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
The Size 1 sensor is also known as factory code S11684-12; Size 2 sensor is known as factory code S116845-12. I View and Imagen Sensor will both have Size 1 and Size 2. Two different trade names are for marketing purposes.
The provided text is a 510(k) summary for the "I View and Imagen Sensor" dental x-ray system, which is a Class II medical device. The document states that the subject device is substantially equivalent to a predicate device, the "QuickRay HD." The primary method used to demonstrate this equivalence is by asserting that the subject device is identical in hardware and firmware to the predicate device, with only the software package being different (though its functionality is claimed to be the same).
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
Because the device is claimed to be identical to a predicate that was already cleared, the acceptance criteria are largely linked to demonstrating this identity and conformity to relevant standards rather than establishing new performance metrics.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Characteristics Comparison to Predicate | Must be identical or substantially similar to predicate (QuickRay HD). | The subject device (I View/Imagen Sensor) is claimed to be identical in hardware and firmware to the QuickRay HD and EDLENi predicate devices. | The document explicitly states: "K151926 and K150823 are identical to the subject device. The devices are exactly the same except for the trade names being different for marketing purposes." and "The subject device is identical to the predicate and reference predicate in firmware/hardware from Hamamatsu." |
| Software Functionality Comparison | Software package for subject device must provide the same functionality as the predicate device's software. | The subject device uses "DEEP-VIEW" software, which is stated to have the "same functionality as the software of the predicate device." DEEP-VIEW was previously cleared by the FDA (K160386). | This is a key point of difference but functionality is asserted to be equivalent, and prior clearance of the software is cited. |
| Clinical Performance (Diagnostic Equivalence) | Images produced must be diagnostically relevant and reliable. | Clinical images previously examined for the predicate device by Dr. Parham (a qualified practitioner) were found to be diagnostically relevant and reliable. | No new clinical study was conducted for the subject device because it's deemed identical to the predicate. |
| Biocompatibility | Device components in contact with patients must be biocompatible. | Biocompatibility testing was deemed "not warranted" because the device does not have direct or indirect patient-contacting components. It uses a single-use protective barrier. | This relies on the use of standard protective barriers. |
| Electrical Safety and EMC | Device must conform to relevant electrical safety and electromagnetic compatibility (EMC) standards. | The device conforms to IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-65 (specific for dental). | Test reports were provided in the petition. |
| Software Verification and Validation (V&V) | Firmware and driver must be verified and validated. | Firmware and driver documentation (from Hamamatsu) were included. The image management software (Deep-View) itself was previously cleared (K160386). | The V&V for the image management software relies on its previous clearance. |
| Bench Testing | Device performance must meet standards for digital x-ray imaging characteristics and IP codes. | Bench tests were performed in conformance with IEC 62220-1 (Detective Quantum Efficiency) and IEC 60529 (IP Codes). | This refers to specific technical performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new, specific "test set" in terms of patient images or cases for the subject device. Instead, it relies on:
- Clinical images from the predicate device: The text states, "Clinical images were examined by Dr. Parham... and found to be diagnostically relevant and reliable. These tests were provided for the predicate device submission..."
- The provenance of these predicate clinical images is vague, only mentioning "Dr. Parham, a qualified practitioner in Ormond Beach, FL." It does not specify the country of origin of the data nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document mentions one expert: "Dr. Parham, a qualified practitioner in Ormond Beach, FL."
- Qualifications: Described as a "qualified practitioner." No further details on specific certifications (e.g., dentist, radiologist), years of experience, or specialty are provided.
4. Adjudication Method for the Test Set
- None specified for the subject device. The reliance is on a single "qualified practitioner" for the predicate device's clinical images. There's no mention of a consensus or multi-reader adjudication process described for either the predicate's original evaluation or for the current submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission establishes substantial equivalence primarily through technical and functional identity to a predicate device, not through a comparative clinical study. Therefore, no effect size of human readers improving with or without AI assistance is reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No, a standalone study was not done as the device itself is a digital x-ray sensor for capturing images, not an AI algorithm for interpreting them without human involvement. The "Deep-View" software is an "image management software package" that assists dental professionals in diagnosing, implying human-in-the-loop performance. While the software has its own prior clearance (K160386), this document doesn't detail a standalone performance study for the interpretation aspect within this submission.
7. The Type of Ground Truth Used
- For the clinical performance validation (from the predicate device), the ground truth appears to be based on expert assessment/consensus (from Dr. Parham). The statement "found to be diagnostically relevant and reliable" implies an expert opinion as the ground truth. There is no mention of pathology, long-term outcomes data, or other objective measures for ground truth.
8. The Sample Size for the Training Set
- The document does not describe a training set in the context of machine learning or AI algorithms for image interpretation for this device. The software "Deep-View" is an image management software. If the term "training set" refers to data used to develop the core firmware/hardware for image acquisition, that information is not provided or deemed unnecessary given the equivalence claim to the predicate.
9. How the Ground Truth for the Training Set Was Established
- As no training set (in the ML/AI sense) is described, this information is not applicable and not provided in the document. The device is an image acquisition hardware, not an image interpretation AI, making the concept of a "training set" for ground truth determination irrelevant to this 510(k) submission.
§ 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.