(33 days)
The Progeny MPSe system is intended to use for acquisition of digital images of intra-oral anatomy of interest to a computer for display by Ethernet.
The X-ray MPS system is an intraoral receiver of the X-ray energy used by the dentist r ne A Tay NT & Systemler as vity. The MPSe sensor consists of 3 pieces: an X-ray to image toom an X-ray sensor driver and a power supply.
The Progeny MPSe Intraoral X-ray System consists of the following main components:
Sensor
X-Ray sensor driver
Power Supply
The provided text is a 510(k) summary for the Progeny MPSe Intraoral Dental X-ray Sensor, submitted in 2004. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the format requested.
Therefore, much of the requested information cannot be extracted directly from this document. However, I can summarize what is available:
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria for performance metrics like sensitivity, specificity, or image quality, nor does it present a formal table of reported device performance against such criteria. Instead, it relies on a comparison table of characteristics to demonstrate substantial equivalence to predicate devices.
| Characteristic | Predicate Device (Schick CDR, VisioDent RSV, Durr Vista Ray, Trophy RVG) | Progeny MPSe | Acceptance Criteria (Implied) |
|---|---|---|---|
| Product Name | CDR, RSV, Vista Ray, RVG | MPSe | (Matching general class) |
| Number of sensors | 2-3 | 2 | Comparable number |
| Sensor size [mm] | Ranges (e.g., 31x22 to 45x32) | 35x26, 41x31 | Comparable size ranges |
| Technology | CMOS, CCD | CCD | Comparable technology |
| Interface to PC | USB, EPP | Ethernet, WLAN | Functional connectivity |
| Dynamic Range | 4096:1 | 65536:1 | Comparable or better |
| Distance between Device & PC [m] | 5, 5 or 30 | Unlimited* | Functional distance |
| Sensor Cable length [m] | 2, 2.5 | 2 | Comparable length |
| Indications for Use | Intraoral receiver of X-rays in dental radiography | Intraoral receiver of X-rays in dental radiography | Equivalent indications |
| Safety and Effectiveness | Assumed safe and effective for predicates | Determined safe and effective | Equivalent safety and effectiveness |
The "Unlimited" for "Distance between Device & PC" refers to the IEEE802.3 Standard (Ethernet), implying no practical limit within a network.
2. Sample size used for the test set and the data provenance
Not applicable. This document is a 510(k) submission focused on substantial equivalence through comparison of design and indications, not a clinical study report with a test set of patient data.
3. 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 for a test set of clinical data is described.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication is described.
5. 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 document predates widespread AI integration in dental X-ray systems and does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical X-ray sensor system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established as there is no clinical data analysis in this document. The "ground truth" for the device's characteristics is based on its engineering specifications and design.
8. The sample size for the training set
Not applicable. This document describes a physical device, not a machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary from the document:
The Progeny MPSe Intraoral Dental X-ray Sensor, through its 510(k) submission, demonstrates substantial equivalence to existing predicate devices (Schick Technologies Inc. CDR, VisioDent RSV, Durr Dental Vista Ray, Trophy RVG). The argument for equivalence is based on shared indications for use, materials, design, and operational/functional features, as detailed in a comparison table. The document emphasizes that the MPSe System is determined to be safe and effective when used as labeled, similar to its predicate devices. No formal clinical study with performance acceptance criteria or a dedicated test set with human readers and ground truth is presented in this 510(k) summary.
§ 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.