(109 days)
DP-ZX-VL is a dental device, composed of a "Canal Measurement Module" and "Handpiece / LED Module".
The former can measure the length of the root canal. The latter can enlarge the root canal while monitoring the position of the file tip inside the canal, and can be used to polymerize (set) resinous and other materials by light from the Light Cure Handpiece head.
The DP-ZX-VL is a dental device, built up simply by adding the same function as VL-7 (K063529) to the DP-ZX (K031204). There are almost no new differences created in functions and structures.
The DP-ZX-VL is composed of a Canal Measurement Module and a Handpiece / LED Module.
The Canal Measurement Module can be used alone and has root canal measurement capability.
The Handpiece / LED Module can be used only when it is connected with the Canal Measurement Module. When it is connected, it has root canal measurement, canalpreparation and light cure functions.
The Canal Measurement and the Canal Preparation functions of the DP-ZX-VL are substantially equivalent to the functions of the DP-ZX (K031204). The Light Cure function of DP-ZX-VL is the additional function to the DP-ZX (K031204).
The provided text is a 510(k) summary for the J. Morita USA Inc.'s ROOT ZX II (DP-ZX-VL) device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document primarily focuses on establishing "substantial equivalence" to previously cleared devices (DP-ZX and VL-7) based on similar indications for use, principles of operation, and technological characteristics. The performance section in the comparison table only states "Similar" for the Canal Measurement Function and Light Cure Function, without providing quantitative data or thresholds.
Therefore, I cannot populate the requested table and details regarding acceptance criteria and performance study from the given text. The information required for those points is not present in this 510(k) summary.
Here's a breakdown of what is and is not in the provided text, related to your request:
What is present (or can be inferred):
- Device Name: ROOT ZX II (DP-ZX-VL)
- Intended Use:
- Canal Measurement Module: measure the length of the root canal.
- Handpiece / LED Module: enlarge the root canal while monitoring the position of the file tip inside the canal, and polymerize (set) resinous and other materials by light.
- Comparison to Predicate Devices: The device is considered "substantially equivalent" to DP-ZX (K031204) for canal measurement and preparation, and to VL-7 (K063529) for light cure function. This implies that the performance of the new device is presumed to be similar to these already cleared devices, but no new performance study data is provided to prove this for the new device.
What is NOT present in the document:
- Table of Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., accuracy, precision, error margins) or thresholds are defined as acceptance criteria, nor is there a table reporting the device's measured performance against hypothetical criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or how training ground truth was established: None of this information is available. The document refers to "Performance" as "Similar" to predicate devices, indicating that no new, independent performance study was conducted and detailed in this submission. The 510(k) pathway often relies on demonstrating equivalence rather than requiring extensive new clinical performance studies if technological characteristics and intended use are sufficiently similar to predicate devices.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.