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The tomograph accessories are indicated for use in conjunction with a tomographic x-ray system to produce radiological images.

Steri-Oss has designed a series of products to be used as a complement to a tomography system. These products aid in the positioning of dental patients for radiological imaging.
A tomograph has the ability to take a cross-sectional view of dentition. In order to optimize the results obtained from tomography, patient positioning indices may be used.
The products submitted are manufactured of varying materials and are designed to assist in the use of a tomographic x-ray unit.

Here's an analysis of the provided text regarding acceptance criteria and device study, based on the requested information.

It is important to note that the provided document is a 510(k) summary for "Tomograph Accessories" from 1996. This type of document, especially from that era, typically does not include the detailed performance study information that would be expected for modern AI/ML device submissions. The "Performance Data" section explicitly states "Not applicable."

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

Acceptance Criteria and Device Performance

Explanation: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds). It is a 510(k) for accessories used with an existing tomographic system. The "Performance Data" section explicitly states "Not applicable."

Study Details (Based on available information in the document)

Given the "Performance Data: Not applicable" statement, most of these fields cannot be answered definitively for this device.

1. Sample size used for the test set and the data provenance: Not applicable. No test set or performance evaluation data is presented.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication method is described.
4. 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 accessory for patient positioning in a tomographic system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is described.
7. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context for the provided document:

The document describes "Tomograph Accessories" from Steri-Oss Inc., submitted in 1996. These are physical products designed to aid in the positioning of dental patients for radiological imaging using an existing tomographic X-ray system. The 510(k) claims substantial equivalence to the Siemens Orthophos Plus, which has built-in components for patient positioning. Steri-Oss's products are supplemental to existing radiographic units.

Crucially, the device itself is a physical accessory, not software or an AI/ML algorithm. Therefore, the types of performance studies and metrics typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, ground truth establishment for algorithms) are not relevant to this submission, especially in 1996. The "Performance Data: Not applicable" statement reflects this. The regulatory pathway relied on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than a performance study demonstrating diagnostic accuracy.

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