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K Number
K101992
Device Name
3D SCANNER, MODEL 1230
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2010-10-01

(78 days)

Product Code
IYE
Regulation Number
892.5050
Type
Traditional
Panel
RA
Reference & Predicate Devices
K092019,K934303
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The 3D Scanner system, model 1230, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.

Device Description

The 3D Scanner Model 1230 is an electromechanical and software system that includes:

  1. a cylindrical tank to contain the water:
  2. a 3 axis computer controlled scanning mechanism that is mounted on the tank,
  3. a field detector mount that moves with the scan mechanism,
  4. a reference detector mount that remains stationary during a scan,
  5. electrometers with chamber polarization voltage supplies for said mounted detectors,
  6. motor controllers for the 3 axis scanning mechanism,
  7. a water level sensor that locates the water surface,
  8. computer code that controls the detector location and records the detector's dosimetry data,
  9. a user interface to the computer that enables
    a. automatic data collection at pre-programmed field detector locations,
    b. data processing and analysis that enable data transfer to the TPS system,
  10. an optional EDGE detector (diode) for waterproof Field scanning and Reference
  11. an optional leveling platform
  12. an optional lift table accessory to support the tank
AI/ML Overview

Here's an analysis of the provided text regarding the 3D Scanner Model 1230, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2010. For this type of device (a medical physics tool for radiation oncology dosimetry), the "acceptance criteria" and "device performance" are typically related to its ability to accurately measure radiation beams and provide data compatible with treatment planning systems, rather than clinical outcomes on patients. The "study" here refers to the demonstration of substantial equivalence to a predicate device. This is not a clinical trial with patient data or a typical AI/ML study.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets in the way one might see for, say, an imaging device's sensitivity or specificity. Instead, the substantial equivalence hinges on functional similarity and intended use compared to the predicate device. The "performance" is implicitly demonstrated by comparing the device's capabilities to the predicate.

The core "acceptance criteria" can be inferred from the "Similarities with Marketed Devices" section, which outlines the functional capabilities that make the new device equivalent to the predicate. The "reported device performance" is the statement that the SNC 3D Scanner Model 1230 possesses these same capabilities.

Acceptance Criteria (Inferred from Similarities)Reported Device Performance (as described for SNC 3D Scanner Model 1230)
Functional Equivalence to Predicate Device (IBA RFA-200):
1. Ability to move and position a water-resistant radiation detector in a tank containing water.Provides a field detector mount that moves with the scan mechanism. Incorporates a 3-axis computer-controlled scanning mechanism.
2. Ability to measure the response of the detector to quantify relative dose distribution.Utilizes electrometers with chamber polarization voltage supplies for mounted detectors. Measures the response of the detector to quantify the relative dose distribution resulting from therapeutic radiation beam interaction in water.
3. Ability to record position and response data systematically for TPS commissioning.Provides computer code that controls detector location and records dosimetry data. Enables automatic data collection at pre-programmed field detector locations. Enables data processing and analysis to transfer data to the TPS system.
4. Field detector mount that moves with the scan mechanism.Present.
5. One axis for profile scans (in-plane and cross-plane) keeping detector orientation to beam edge.Present. (The 3D Scanner Model 1230 provides a ring axis for rotation of the profile scan axis, which is an improvement over manual rotation, but still meets the core function of enabling profile scans).
6. Reference detector mount that remains stationary during a scan.Present.
7. Electrometers with chamber polarization voltage supplies.Present. (Specifically mentions PC Electrometer Model 1014).
8. Motor controllers for scanning mechanisms.Present.
9. Computer code controlling detector location and recording dosimetry data.Present.
10. User interface for automatic data collection, processing, analysis, and TPS data transfer.Present. (Includes features for automatic data collection, data processing/analysis, basic analysis of beam data tools (e.g., symmetry, flatness, penumbra), and export of beam data to the Treatment Planning System).
11. Intended Use: Radiotherapy dosimetry measurements for TPS commissioning and periodic QA.Present. The system "is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program." This directly matches the predicate's inferred intended use.

Study Details

This document describes a substantial equivalence submission, not a clinical study in the traditional sense, especially not for an AI/ML device. The "study" is a comparison of the new device to a legally marketed predicate device to demonstrate that it is as safe and effective.

  1. Sample size used for the test set and the data provenance:

    • There is no "test set" in the context of patient data or clinical images. The "test" consists of comparing the features and specifications of the SNC 3D Scanner Model 1230 against those of the predicate device (IBA RFA-200) and ensuring the intended use is the same.
    • Data Provenance: The comparison is based on the functional description and intended use of the predicate device, as obtained from IBA literature (manuals, datasheets, system manuals). It does not involve experimental data from the predicate device itself, nor does it specify country of origin for such data.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable in this context. "Ground truth" for this regulatory submission is established by reference to the predicate device's documented functions and specifications, and potentially by widely accepted standards for radiation dosimetry (e.g., AAPM TG-142), rather than expert adjudication of clinical cases.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable. There is no "test set" of cases requiring adjudication by experts.

  4. 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:

    • No MRMC study was done, as this is not an AI/ML diagnostic device with human readers. This device is a measurement tool.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a measurement system, not a standalone algorithm. While its "computer code" controls functions automatically, its performance is evaluated based on its functional equivalence as a dosimetry tool, not as an AI algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The "ground truth" for this submission is the functional definition and intended use of the predicate device (IBA RFA-200), as well as the generally accepted principles and guidelines for medical accelerator quality assurance (e.g., AAPM TG-142). The new device is substantially equivalent if it performs the same function in a similar manner for the same intended use.

  7. The sample size for the training set:

    • Not applicable. This is not an AI/ML device that requires a training set. The device's design and engineering are based on established physics and engineering principles for radiation dosimetry.

  8. How the ground truth for the training set was established:

    • Not applicable, as there is no training set for an AI/ML model. The "truth" for the development of such a device is rooted in physics and engineering standards for accurately measuring radiation.

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.