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510(k) Data Aggregation
(262 days)
Radiology devices Class II
CT Sim Laser Alignment System K152303 Light beam patient position indicator IWE 892.5780
The DORADOnova MR3T system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system. The position coordinates are typically chosen by the operator or provided by an external system (e.g. treatment planning system). The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla.
The LAP moving laser positioning system contains laser devices and a control system. The laser system is provided in a configuration that enables the movement of two projection planes by using an appropriate composition of motorized and fixed laser devices. The installation of the system is realized in a combined bridge solution.
This FDA 510(k) summary (K173926) describes the DORADOnova MR3T system, a medical device used for reproducible patient positioning during radiation therapy planning. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-driven device.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this specific device and document, as it is a laser positioning system, not an AI-powered diagnostic or therapeutic device.
However, based on the provided text, I can extract the relevant performance specifications and how they were tested.
Device Name: DORADOnova MR3T (LAP moving laser positioning system)
Device Type: Medical charged-particle radiation therapy system (21 CFR 892.5050, Class II) - Specifically, a laser positioning system.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical positioning device and not an AI/algorithm, "acceptance criteria" are tied to its physical specifications and safety standards, largely demonstrated through bench testing and compliance with recognized standards.
| Feature / Criterion | Acceptance Criteria (Stated or Implied) | Reported Device Performance / Characteristics |
|---|---|---|
| Intended Use | Must assist in reproducible patient positioning during radiation therapy planning and be utilized during treatment planning workflow, by projecting visual laser beams positionable at specified coordinates. Must be usable in MR environment (≤ 3 Tesla). | The DORADOnova MR3T system "assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system... The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla." (Identical to intended use). |
| Functional Principle | Must use projection of visual light/laser lines on the patient's skin surface, with reflection aiding medical staff to determine patient's position. | "Projection of a visual laser lines on the patient's skin surface. Reflection of the laser lines aide's professional medical staff to determine the patient's position." (Similar to predicate/reference devices). |
| Patient Reference Position Information | Must allow coordinates for 3 laser intersection points to be manually input or imported from a treatment planning system for reproducible patient positioning. | "The patient reference position information is the coordinates for 3 laser intersection points. They are either manually input into the device by the operator or imported from the treatment planning system." (Similar to predicate/reference devices). |
| Positioning Accuracy | Must be comparable to or better than predicate/reference devices. Reference device: +/- 0.1 mm. Predicate device: max mean: 0.27mm; max std dev: 0.65mm. | +/- 0.1 mm (Matches reference device performance, superior to predicate device in terms of stated accuracy). |
| Resolution / Line Width | Must be comparable to or better than predicate/reference devices. Reference device: |
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(28 days)
MELBOURNE FL 32940
Re: K152303
Trade/Device Name: CT Sim Laser Alignment System Regulation Number: 21 CFR 892.5780
Laser System
Establishment Registration Number:
2181970
Classification:
Regulation Number: 21 CFR 892.5780
The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.
The CT Sim Laser System allows the radiation oncologist, medical physicist and oncology technician to precisely mark a patient for radiation therapy. CT Sim provides the ability to move the lasers to particular coordinates for alignment/marking purposes on the patient. The coordinates that the lasers are to move to may be manually input through the software graphical user interface (GUI) or through a data file with a specific format (or DICOM). CT Sim is in no way integrated with the third party Radiation Therapy Treatment Planning System (RTPS) or imaging/radiological device. The primary technological characteristics of the CT Sim Laser System is usage of movable lasers, a handheld keypad, a power/control box, and a PC controller, which are operated by the CT Sim software to indicate isocenter in the CT suite.
I am sorry, but the provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in a quantitative manner.
The document is a 510(k) premarket notification summary for the "CT Sim Laser Alignment System." It states that the device has been bench tested and performs within its design specifications and equivalently to predicate devices. However, it does not provide:
- A table of specific quantitative acceptance criteria.
- Reported device performance values against those criteria.
- Information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance details, or ground truth establishment for either test or training sets.
The relevant section, "5 Performance Data and Comparison with Predicate" (page 5), only generically states: "The CT Sim Laser System has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate devices." This is a general statement of compliance, not a detailed report of a study with specific results.
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(90 days)
Regulation Name: Piston syringe Regulatory Class: II Product Code: 80 FMF Regulation Number: 21 CFR 892.5780
A single use disposable spinal needle/cannula intended for the injection of fluids into or retraction of fluids from the body. A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.
The Light Saber™ Spinal Needle consists of a needle and a collimator to which a stylet is attached. The stylet is enclosed in a cannula/hub assembly with a matching tip. The female Luer of the cannula hub, for the attachment to the syringe, is designed to comply with ISO-594 for "Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Other Medical Equipment." The Light Saber™ Spinal Needles are provided in gauges of 18, 20, 22, 23, and 25. The Light Saber™ Spinal Needle will be provided in lengths of 3.75, 6.25, 8.75, 15 and 20 cm. The tip design for these needles will provide either a Quincke, Short Bevel or Chiba point. Depth markings are standard on the cannula.
The provided text describes a 510(k) premarket notification for the MINRAD, Inc. LIGHT SABER™ SPINAL NEEDLE. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document focuses on:
- Device Identification: Name, sponsor, common/classification names.
- Predicate Devices: Lists similar devices.
- Intended Use: Specifies the purpose of the device (injection/aspiration of fluids, use with MINRAD Inc.'s Dual Radiation Targeting System™ for improved accuracy).
- Technological Characteristics: Describes the physical attributes of the needle (needle/collimator, stylet, cannula/hub assembly, Luer compliant with ISO-594, various gauges, lengths, and tip designs).
- Substantial Equivalence: Asserts the device's equivalence to predicate devices, stating minor differences in general indications for use and size/needle tip configurations raise no new safety/effectiveness issues.
- FDA Correspondence: Official FDA letter regarding the substantial equivalence determination, outlining regulatory compliance information.
- Indications for Use Form: A formal declaration of the device's intended use and indications.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as this data is absent from the provided text.
To answer your request, the input text would need to include details of specific performance metrics, benchmarks, and the results of any tests or studies conducted to demonstrate the device meets those metrics.
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(90 days)
Targeting System DRTS Drape Dated: August 21, 1997 Received: August 22, 1997 Regulatory class: II 21 CFR 892.5780
The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment.
The DRTS™ Drape is to be used in an operating room environment to cover the DRTS™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the DRTS™ device from contamination with patient fluids or tissues.
The DRTS™ Drape is a sterile plastic bag to cover the DRTS™ Dual Radiation Targeting System. The drape contains an optically flat clear window that will allow undistorted transmission of the laser beam from the DRTS™ to the patient.
I am unable to provide a comprehensive answer to your request because the provided text describes a 510(k) Pre-Market Notification for a medical device called the "MINRAD DRTS™ Drape." This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a standalone study with detailed performance metrics and acceptance criteria in the way you've outlined for an AI/algorithm-based device.
Here's why and what I can extract:
- No Acceptance Criteria or Performance Data: The 510(k) summary explicitly states: "Any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." This indicates that a detailed performance study with quantifiable acceptance criteria and reported device performance, as you'd expect for an AI algorithm, was not conducted or required for this type of submission. The focus is on demonstrating that the new device is essentially the same as a legally marketed predicate.
- Device Type: The DRTS™ Drape is a sterile plastic bag (equipment drape) designed to prevent contamination of another device (DRTS™ Dual Radiation Targeting System). It's a physical, disposable accessory, not a software algorithm or an AI-powered diagnostic tool. Therefore, the concepts of "test set," "ground truth," "MRMC study," "standalone performance," "training set," and "adjudication method" as applied to AI/algorithms do not apply to this product.
What I can provide based on the given information:
Since the request asks for specific sections, I will structure the answer by addressing each point, even if the information is not present or applicable.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance data reported, as the submission relies on substantial equivalence to predicate devices. |
Explanation: The 510(k) submission for the DRTS™ Drape focuses on demonstrating substantial equivalence to existing predicate devices (Microtek Medical, Inc. Large C-Arm Drape Product Number 4982 and Contour Fabricators Number CFI-600, equipment drape). The document explicitly states that "any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." This implies that extensive performance testing with specific acceptance criteria, as one would see for a novel diagnostic or therapeutic device, was not deemed necessary for this classification. The primary "performance" is that it functions as an equipment cover without introducing new risks.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not reported.
- Data Provenance: Not applicable.
Explanation: As this is a sterile equipment drape, not a data-driven diagnostic or AI device, there was no "test set" in the context of data analysis. The submission focuses on physical characteristics and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
Explanation: Ground truth establishment is relevant for tasks involving interpretation (e.g., image analysis, diagnoses). An equipment drape does not require "ground truth" to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
Explanation: Adjudication is used to resolve disagreements in expert interpretations for establishing ground truth. This is not relevant for an equipment drape.
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
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: MRMC studies are for evaluating interpretative performance, often of AI-assisted systems versus unassisted human readers. This concept does not apply to a sterile equipment drape.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No.
Explanation: The device is a physical drape, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable.
Explanation: Ground truth refers to the true state or outcome being predicted or interpreted. For an equipment drape, the "truth" is its ability to cover and provide a sterile barrier, which is evaluated through physical properties and sterilization validation, not expert consensus on an interpretation task.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not reported.
Explanation: This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Explanation: As there is no training set, there is no ground truth establishment for one.
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