(107 days)
Kodak Orthodontic and OMS Imaging 8.0 software is intended for use by orthodontists, oral surgeons and their clinical staffs in storing and organizing images, including digital photographs, x-rays, electronic models, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken and make growth or surgical predictions.
Kodak OrthoImaging 8.0 software is indicated for use by orthodontists and their clinical staff in storing and organizing images, including digital photographs and x-rays. The device includes the capability to trace a digital cephalometric radiograph, analyze the measurements taken and make growth or surgical predictions.
Kodak Orthodontic and OMS Imaging 8.0 software is designed for installation on an off-the-shelf PC running Microsoft Windows in a peer-to-peer network. Identical software is to be supplied to both orthodontic (commercial name: Orthodontic Imaging 8.0) and oral surgery (commercial name: OMS Imaging 8.0) markets.
The software consists of patient management software for orthodontic, and oral surgery practices. It provides the ability to connect satellite offices and will be marketed as a base system, with additional modules offered as options. The base system will include the storage, annotation and printing of images. The optional analysis module will allow the user to trace the cephalometric x-rays using standard analyses. The optional planner module will allow the user to simulate orthodontic or surgical treatment.
When the system is used with the TrophyPan or TrophyPan C panoramic and cephalometric x-ray systems (K023346, K033690, now marketed as Kodak 8000 and 8000C) the practitioner can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data. The software does not natively control any x-ray device, but instead provides the user an interface by which he may access the control panels available with the Kodak 8000/8000C x-ray systems.
Kodak Orthodontic and OMS Imaging 8.0 software includes programming that enables the user to retrieve an electronic copy of an x-ray image from other imaging systems.
The imaging software can be integrated with Kodak practice management system software or used as a stand-alone product.
Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:
Note: The provided document is a 510(k) Summary and an FDA clearance letter for a software device. For most medical device clearances, especially software devices like this, the primary "study" proving acceptance criteria isn't a clinical trial in the traditional sense, but rather a demonstration of substantial equivalence to a legally marketed predicate device. This often involves comparing technical characteristics, intended use, and performance claims. The document focuses heavily on this equivalence rather than a detailed "performance study" with quantitative metrics against specific acceptance criteria. Therefore, some of the requested information (like sample sizes for test/training, number of experts for ground truth, MRMC study details, etc.) is not present in the provided text, as those types of studies typically aren't required for this kind of software clearance focusing on image management and basic analysis tools.
Acceptance Criteria and Device Performance Study (Based on Substantial Equivalence)
The primary "acceptance criterion" for Kodak Orthodontic Imaging 8.0 and OMS Imaging 8.0 software, as demonstrated in this 510(k) submission, is its substantial equivalence to existing, legally marketed predicate devices. This means the device performs at a similar level to approved devices, does not raise new questions of safety or effectiveness, and has the same intended use and technological characteristics.
The "study" to prove this involves a comparison showing direct parallels to the predicate devices, rather than a clinical study measuring specific performance metrics against pre-defined thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit based on Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Intended Use: Similar to predicate device(s). | "Kodak Orthodontic and OMS Imaging 8.0 software is intended for use by orthodontists, oral surgeons and their clinical staffs in storing and organizing images, including digital photographs, x-rays, electronic models, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken and make growth or surgical predictions." |
| This is explicitly stated as being for similar use to Chairside (K982422, EagleSoft) and DentalEye (K012439, Radco Data AB), "each device is indicated for use in dental or dental sub-specialty diagnostic image storage, editing, communication, manipulation and viewing." | |
| Technological Characteristics: Equivalent to predicate device(s). | "The technological characteristics and principles of operation are equivalent, as each device is software that operates on a Windows-based PC platform." |
| The software consists of patient management features, image storage/annotation/printing, optional cephalometric tracing/analysis, and treatment simulation. It integrates with specific x-ray systems (Kodak 8000/8000C) and can retrieve images from other systems. | |
| Performance (Functional Equivalence): Ability to perform key functions (image storage, organization, tracing, analysis, prediction) as expected for its class and as seen in predicate devices. | The document describes the system capabilities: "storage, annotation and printing of images," "trace the cephalometric x-rays using standard analyses," and "simulate orthodontic or surgical treatment." It implies that these functions are comparable to the predicate devices, supporting the substantial equivalence. There are no specific quantitative performance metrics (e.g., accuracy of tracing, speed of processing) reported for these functions against pre-defined thresholds within this 510(k) summary. The FDA's clearance is based on the assertion that these functionalities are similar enough not to raise new safety/effectiveness concerns. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness compared to predicate devices. | The FDA's clearance letter explicitly states: "we have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices... You may, therefore, market the device..." This determination implies that no new safety or effectiveness concerns were identified that would require more rigorous studies or different regulatory pathways. Key aspects contributing to this are the "devices are equivalent in terms of energy used or delivered, materials, biocompatibility, standards, and other applicable characteristics." (though energy/materials are less relevant for pure software). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The 510(k) summary does not detail a formal "test set" in the context of a new performance study. It relies on the equivalence to previously cleared devices.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified, as no formal "test set" or adjudication process for ground truth is described in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Was it done? No, an MRMC comparative effectiveness study is not mentioned or implied in the provided 510(k) summary. Such studies are typically not required for image management and basic analysis software cleared via substantial equivalence.
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Was it done? The document describes the software itself and its capabilities (e.g., tracing, analysis, prediction), which inherently represents its "standalone" functionality. However, it does not describe a formal "standalone performance study" with metrics specific to the algorithms (e.g., accuracy of automated cephalometric landmark detection) against a quantified ground truth in the context of proving specific acceptance criteria beyond substantial equivalence. The capabilities are outlined as features.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not specified for any specific performance validation. For the purposes of cephalometric tracing and analysis, the "ground truth" would typically refer to expert manual tracings and measurements. However, the document doesn't detail how this was established or used for the 8.0 version's clearance. The "standard analyses" referenced imply accepted methodologies.
8. The Sample Size for the Training Set
- Sample Size: Not specified. The document does not describe a machine learning model that would require a dedicated "training set" in the common sense. The software's functionality is described more as rule-based or algorithmic, rather than a learned model.
9. How the Ground Truth for the Training Set was Established
- How Established: Not applicable, as no training set is described.
§ 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.