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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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.

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo for STERI-OSS, a Bausch & Lomb company. The logo consists of a stylized graphic to the left of the text "STERI-OSS". Below the text is the phrase "A BAUSCH & LOMB Company" in a smaller font. The text is in a bold, sans-serif font.

K 962120

Original 510(k) Tomograph Accessories

Jul 25 1996

Section 7

510(k) Summary

Manufacturer Information:

Submitter's Name:	Steri-Oss Inc.
Address:	22895 Eastpark DriveYorba Linda, CA 92687U.S.A.
Contact's Name:	Paul GasserRegulatory Affairs Specialist
Phone:	714-282-6515
Date Prepared:	June 1996

Device Names:

Common Name: Tomograph accessories

Trade Name: None

Tomographic X-ray system Classification Name:

Predicate Device:

Substantial equivalence is claimed to Siemens Orthophos Plus.

Device Description:

How device functions: 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.

Page 1 of 2

Steri-Oss Inc. - May 1996

Steri-Oss Inc. 22895 East Park Drive Yorks Linda, CA 92687 · (714) 282-6515 Fax: (714) 998-9236 · (800) 993-8100

{1}------------------------------------------------

Original 510(k) Tomograph Accessories

Device Description (cont.):

Scientific concepts: 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.

Characteristics: The products submitted are manufactured of varying materials and are designed to assist in the use of a tomographic x-ray unit.

Intended Use:

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

Comparison to Predicate:

The Siemens Orthophos Plus product is designed to take radiological images. As a built-in feature of this unit, it contains built-in components to aid in the positioning of the dental patient while the image is being taken.

Steri-Oss' products are designed to aid in the positioning of the dental patient as well; however, the products are intended to be supplemental to existing radiographic units.

Performance Data:

Not applicable.

Page 2 of 2

Regulation Number and Section

§ 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.