(8 days)
Toshiba Digital X-ray Sensor is an intraoral receiver of X-ray energy by the dentist to obtain instant digital images of teeth and the oral cavity of patients. Images are transmitted to a computer for display.
The Digital X-ray Sensor is an intraoral receiver of X-ray energy used by the dentist to obtain instant digital images of teeth and the oral cavity of patients. Images are transmitted to a computer for display. The Digital X-ray Sensor is composed by following components: 1) Sensor head 2) Controller 3) USB cable 4) Driver software
The provided text is a 510(k) summary for a Digital X-ray Sensor. It describes the device, its components, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical testing.
The document states that the device is "substantially equivalent to the predicate devices" and "is safe and effective when the device is used as labeled." This determination is made based on the comparison of features and specifications with already cleared devices, rather than a standalone performance study with detailed acceptance criteria.
Therefore, I cannot populate the requested table and answer many of the questions as the specific information is not present in the provided text.
Here's a breakdown of what cannot be extracted from the provided text, and why:
- Acceptance Criteria and Reported Device Performance Table: The document doesn't define specific numerical or qualitative acceptance criteria (e.g., specific image resolution, modulation transfer function values, contrast-to-noise ratio requirements) that the device must meet, nor does it report the device's measured performance against such criteria. The "Comparison Table" in Section 2 lists specifications like "Dynamic Range" (4096:1) and "Sensor size," but these are device specifications, not acceptance criteria for a performance study.
- Sample size used for the test set and the data provenance: No performance study data is presented, so no test set size or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no performance study is described.
- 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. This device is an intraoral X-ray sensor, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance study is described.
- The sample size for the training set: Not applicable, as this is hardware.
- How the ground truth for the training set was established: Not applicable, as this is hardware.
In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence based on a comparison to predicate devices, rather than through a detailed performance study with explicit acceptance criteria.
§ 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.