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RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

The provided 510(k) summary for the J. MORITA USA Inc.'s RCM-7 Apex Locator does not contain the detailed information requested regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document focuses on establishing substantial equivalence to previously cleared predicate devices (Root ZX and DP-ZX-VL) by comparing general intended uses, principles of operation, and technological characteristics. It lists various characteristics and whether they are identical or similar to the predicate devices. However, it does not provide:

• Specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision).
• Details of a study designed to demonstrate that the RCM-7 explicitly meets such acceptance criteria.
• Information on sample sizes, data provenance, ground truth establishment, or expert involvement for any performance testing.

Therefore, most of the requested fields cannot be filled based on the provided text.

Here's an analysis of what can be inferred or what is explicitly missing:

Acceptance Criteria and Study for J. MORITA USA Inc.'s RCM-7

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not provided. The document does not describe a specific test set or study conducted for the RCM-7.
• Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not provided. The document does not mention any expert involvement for establishing ground truth for performance testing of the RCM-7.

4. Adjudication method for the test set

• Not provided. No test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. The RCM-7 is an Apex Locator, a standalone dental device for root canal length measurement, not an AI-assisted diagnostic tool that would involve human readers in an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This is an Apex Locator, which by its nature operates "standalone" in performing its measurement function. However, the document does not describe a specific "standalone performance study" with metrics and results for the RCM-7 itself. Instead, it relies on demonstrating equivalence in performance to predicate devices.

7. The type of ground truth used

• Not explicitly defined for the RCM-7. For an apex locator, ground truth for canal length would typically be established by direct measurement (e.g., manual file measurement to the apex) or highly accurate imaging, but this is not detailed for the RCM-7's submission. The document relies on the established performance of the predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. The RCM-7 is an Apex Locator, likely based on electrical impedance principles, rather than a machine learning or AI-based device that would require a "training set."

9. How the ground truth for the training set was established

• Not applicable/Not provided, as there is no mention of a training set for this type of device.

Summary of Missing Information:

The 510(k) summary for the RCM-7 primarily focuses on demonstrating substantial equivalence to its predicate devices by comparing their specifications and intended uses. It does not include specific clinical or performance study data, acceptance criteria, or details about ground truth establishment that would typically be found in submissions requiring such evidence. For devices demonstrating substantial equivalence through comparison, the detailed performance data for the predicate devices often serves as the benchmark, and new studies are usually not required unless there are significant technological differences that raise new questions of safety or effectiveness.

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