(63 days)
Focus is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm.
The provided text describes the 510(k) summary for the "Focus" intra-oral x-ray unit, which includes an AEC option. However, it does not contain detailed acceptance criteria, a specific study proving the device meets those criteria with performance metrics, or information about AI/algorithm performance.
The document focuses on demonstrating substantial equivalence to a predicate device (Focus K001729) and verifying the modified Focus functions as intended and provides images of equivalent diagnostic capability.
Therefore, many of the requested details cannot be extracted from this document. I will fill in the available information and explicitly state what is not present.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Functions as intended | Verification and validation testing was successfully performed to confirm that the modified Focus functions as intended. |
| Provides images of equivalent diagnostic capability to predicate device | It was also shown that modified Focus is able to provide images of equivalent diagnostic capability to that of predicate device. |
| As safe and effective as the predicate device | Modified Focus is as safe and effective as the predicate device. |
| Substantially equivalent to predicate device (Focus K001729) | The technological characteristics of Focus are essentially equivalent to the technological characteristics of predicate device; the only difference is the AEC option, which can be used with Sigma sensor. The intended uses of the devices are equivalent. |
Detailed Study Information (Based on Available Text):
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "Verification and validation testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
- 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 x-ray unit, not an AI-based diagnostic tool. The document does not mention AI assistance or MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The performance evaluation is related to the imaging capabilities of the x-ray unit itself.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document refers to "equivalent diagnostic capability to that of predicate device," implying a comparison based on image quality suitable for diagnosis. However, the specific method for establishing this "diagnostic capability" (e.g., by expert review, comparison to known clinical outcomes) is not detailed.
- The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is known:
The submission focuses on demonstrating substantial equivalence to a previously cleared device (Focus K001729) and confirming that the modifications (primarily the AEC option) do not alter the diagnostic capability, safety, or effectiveness. The term "performance data" refers to verification and validation testing, but the specifics of these tests are not provided in this 510(k) summary. The comparison is against the predicate device's established performance, implying that the new device meets similar standards.
§ 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.