(25 days)
The Computed Oral Radiology System is intended for intra-oral x-ray examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K072134.
The Computed Oral Radiography System is indicated for patients undergoing an intra-oral dental X-ray examination. It produces instant digital intra-oral X-ray images of a patient's mouth.
The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new scintillation material differs from the predicate in that in that it affords higher resolution and lower noise. Direct triggering via an x-ray tube continues to be supported as was cleared in K072134 and K041385. The modification offers an improvement in image quality.
The provided text describes a 510(k) premarket notification for a modification to the Schick Computed Oral Radiology System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, much of the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies, and specific ground truth methodologies for training and test sets, is not available in the provided text.
However, I can extract the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: While no explicit numerical or qualitative acceptance criteria are listed, the document states: "All validation activities have demonstrated that the predetermined acceptance criteria were met." The principal risk identified was "unintended x-ray exposure."
- Reported Device Performance:
- "A new scintillation material differs from the predicate in that that it affords higher resolution and lower noise."
- "The modification offers an improvement in image quality."
- "It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage." (This statement is about the overall system's capability, not specific performance metrics of the modification).
Since specific metrics and thresholds for "higher resolution," "lower noise," and "improvement in image quality" are not provided, a detailed table cannot be constructed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document mentions "validation studies" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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
- Not applicable and not available. This device is an imaging system (hardware modification), not an AI algorithm for interpretation. Therefore, a multi-reader multi-case study comparing human readers with AI assistance would not be relevant to this specific device modification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to an imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the validation study. The document implies that the validation focused on "imaging, software validation, and third-party safety testing" to address the risk of "unintended x-ray exposure" and demonstrate "higher resolution and lower noise." The ground truth for these types of evaluations would likely involve physical measurements (e.g., MTF, DQE for resolution/noise, dosimeter readings for x-ray exposure) rather than clinical expert consensus or pathology, as this is a hardware modification improving image capture, not diagnostic interpretation.
8. The sample size for the training set
- Not applicable and not available. This device represents a hardware modification to an X-ray imager, not an AI model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As a hardware modification, there is no "training set" in the context of machine learning.
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.