(86 days)
The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The Planmeca ProMax 3D Max or Planmeca Maximity -x-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method. In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain preprogrammed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions in the Planmeca Romexis program (on a separate PC system). Ethernet computer networking technology is used.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Planmeca ProMax 3D Max and Planmeca Maximity devices:
The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive acceptance criteria and exhaustive study results in the manner one might find in a full clinical trial report or a performance study for novel AI/standalone devices.
Here's a breakdown of the requested information based on the provided text, with acknowledgments where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device's performance for the expanded indications (ENT region) is clinically usable and comparable to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinically usable diagnostic quality for ENT imaging | Images were reviewed by a specialist and deemed to be of a clinically usable diagnostic quality. |
| Substantial equivalence to predicate device in technical features | Imaging technology, FOV, imaging parameters, resolution, and other basic characteristics closely match the predicate device. Differences are small and have no practical effect on performance. |
| Conformance to international performance standards | Both devices conform to given international performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae" were taken, implying a collection of images, but the exact number is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical images" suggests they were acquired from human subjects, but details are lacking.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: "a specialist" (singular).
- Qualifications of Experts: Only stated as "a specialist." No further details (e.g., radiologist, years of experience, specific sub-specialty) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: "a specialist" reviewed the images. This implies a single-reader assessment rather than a consensus or adjudication process involving multiple readers (like 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported or implied. The device is an imaging system, not explicitly an AI diagnostic tool in this context, and the evaluation focused on image quality for diagnostic use.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone algorithm-only performance study was not explicitly reported. The evaluation described is of the image acquisition and reconstruction system providing images for human interpretation. The "diagnostic support" refers to the images themselves, not an automated diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by expert clinical review. The "specialist" deemed the images to be of "clinically usable diagnostic quality," indicating a subjective expert assessment of the image data for diagnostic purposes, rather than being compared to a higher standard like pathology or long-term outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not provided. The document describes a traditional imaging device, not an AI/machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/not provided, as there is no mention of an AI/machine learning training set.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.