(90 days)
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.
§ 892.5780 Light beam patient position indicator.
(a)
Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.