(70 days)
The THD Slide Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD Slide proctoscope, sutures and a needle holder included in the THD Slide Kit.
The THD Slide is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.
The THD Slide consists of the THD Evolution Doppler device and the THD Slide Kit. The THD Evolution Doppler is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Kit is a sterilized surgical kit comprised of a proctoscope, a needle holder, a knot tightener and sutures.
The provided text describes a 510(k) summary for the THD Slide, a medical device. This summary primarily focuses on regulatory approval based on substantial equivalence to a predicate device and acoustic emission testing. It does not contain the detailed information typically found in a study demonstrating clinical performance or meeting specific acceptance criteria in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested sections below cannot be fully populated from the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance Study for THD Slide
The THD Slide's acceptance criteria primarily revolve around its substantial equivalence to a predicate device and meeting safety standards related to acoustic emissions, rather than specific clinical performance metrics. The study mentioned is limited to acoustic output measurements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device is substantially equivalent to legally marketed predicate devices (K07081). | The THD Slide is considered substantially equivalent to the predicate device K07081. |
| Acoustic Emissions | Acoustic emissions (MI, Ispta3, Beam Area, Wo) must be below upper limits recommended by FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 30, 1997). | Mean Values: |
| MI: 0.027 | ||
| Ispta3: 232 mW/cm² | ||
| Beam Area: 3.063 mm² | ||
| Wo: 15.633 mW |
Max Values:
MI: 0.032
Ispta3: 322 mW/cm²
Beam Area: 3.880 mm²
Wo: 18.500 mW
These reported values are stated to be below the recommended upper limits. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of clinical performance data. For acoustic emissions, the 'test set' would refer to the measurements taken on the device itself. The document does not specify how many individual measurements were taken or if multiple devices were tested; it provides mean, standard deviation, and max values, implying multiple measurements.
- Data Provenance: The acoustic emission data would have been generated internally by the manufacturer (THD S.p.A.) as part of product testing to demonstrate compliance with standards. The country of origin for the device manufacturer is Italy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as the 'ground truth' here relates to objective physical measurements (acoustic output) rather than expert interpretation of clinical data. Compliance with acoustic output limits is typically determined by specialized engineers and equipment.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images). For acoustic emissions, measurements are objective and compared against pre-defined regulatory limits.
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
- No. This is not an AI/algorithm-based device in the sense of image interpretation or diagnostic assistance. It's an ultrasonic Doppler device used for guiding a surgical procedure. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is not an algorithm that operates in a standalone manner. It is a physical medical device (Doppler probe and surgical kit) used by physicians to guide a surgical procedure.
7. The type of ground truth used
- For the acoustic emissions, the "ground truth" is adherence to established regulatory limits and standards for ultrasonic output, measured by calibrated equipment.
- For substantial equivalence, the "ground truth" is a regulatory determination made by the FDA based on comparison to an already cleared predicate device (K07081) regarding indications for use, technological characteristics, and safety/effectiveness. There is no clinical "ground truth" such as pathology or outcomes data presented in this specific 510(k) summary.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in 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.