(40 days)
The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use.
The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use. Doppler audio sounds are heard when the transducer is positioned directly over a hemorrhoidal artery. Cessation of Doppler sounds occurs when ligation of the identified vessel has been completed successfully. Acoustic output values for this transducer are lower than the maximum pre-amendment intensities specified for "Peripheral Vessel" and "Fetal Imaging and Other" applications. There is only one transducer available with this system. The System includes disposable/single use accessories which can be used to perform the manual ligation of the hemorrhoidal arteries.
The provided text is a 510(k) summary for the MedChannel HTS System. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards rather than presenting a performance study with acceptance criteria in the way one might find for an AI/ML device.
Here's an analysis of the document regarding acceptance criteria and study information, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria for a specific performance study of the MedChannel HTS System itself, nor does it report specific device performance metrics in numerical fashion against such criteria.
Instead, the "Summary of Standards Achieved" section lists regulatory and quality standards that the device complies with, implying that meeting these standards constitutes "acceptance." These are predominantly related to safety, manufacturing quality, and general medical device characteristics.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| 21 CFR § 820 (FDA Quality Systems Regulation) | Assured through Quality System Controls |
| ISO 10993:1 (Biological evaluation of medical devices -- Part 1: Evaluation and testing) | Not explicitly detailed for the HTS System, but implied compliance. |
| AAMI 11135 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) | Not explicitly detailed, but implied compliance for accessories. |
| AAMI 11134 (Sterilization of health care products - Requirements for validation and routine control-industrial moist heat sterilization) | Not explicitly detailed, but implied compliance for accessories. |
| IEC 60601 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Compliance with general safety requirements. |
| UD 2-2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA)) | Acoustic output values are lower than maximum pre-amendment intensities for relevant applications. |
The "substantially equivalent" determination is the primary "acceptance criterion" met by this 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific performance test set with a sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data) for the MedChannel HTS System. The submission relies on demonstrating substantial equivalence to already marketed predicate devices and compliance with general safety and performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not present in the document, as there is no described performance study involving a test set and ground truth established by experts.
4. Adjudication Method for the Test Set
Since no specific test set or performance study is described, there is no information on an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study is mentioned or described in this 510(k) summary. The device, an "adjunctive audio vessel landmarking aid" using Doppler sounds, is not an AI/ML diagnostic interpretation system that would typically undergo such a study to compare human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The MedChannel HTS System is described as an "adjunctive audio vessel landmarking aid." Its function is to provide real-time audio feedback to a human surgeon during a procedure. It is inherently a "human-in-the-loop" device. Therefore, a "standalone algorithm only" performance study, as typically understood for AI devices, would not be applicable and is not mentioned. Its performance is tied to its utility in aiding a human operator.
7. The Type of Ground Truth Used
Given the nature of the device and the content of the 510(k) summary, explicit "ground truth" (like pathology or outcomes data) for a specific performance study of the HTS system itself is not discussed. The ground truth for its intended use would be the actual presence and successful ligation of hemorrhoidal arteries, which is confirmed clinically during the procedure, but this is not referred to as a "ground truth" in the context of a study within this document. The submission focuses on the device's technical specifications and safety profile, arguing its substantial equivalence to other devices, which implies its ability to contribute to successful outcomes.
8. The Sample Size for the Training Set
The document does not describe a training set or its sample size. This type of submission does not involve machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed, there is no information on how its ground truth would be established.
In summary:
This 510(k) summary for the MedChannel HTS System is a traditional submission focused on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and quality standards (e.g., ISO, AAMI, IEC, NEMA). It pre-dates the common requirements for detailed performance studies with acceptance criteria, test sets, ground truth establishment, and AI/ML specific evaluations (like MRMC or standalone performance) that are now typical for modern AI-powered medical devices. The "acceptance" of this device is based on its compliance with these foundational standards and its similarity to existing, legally marketed ultrasound devices.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.