(249 days)
The THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique.
The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits.
THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorroidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality "Light Source", to support the different THD diagnostic devices.
Identically to the predicate devices K090009, K081429 e K070815, the THD Revolution is a 8 MHz continuous wave (CW) Doppler detector with a loudspeaker and a light source.
Further, as the predicate device, the THD Revolution doppler is used with dedicated accessories (optical fiber and pneumatic foot pedal) and a dedicated kit containing a proctoscope, needle holder, knot tightener, sutures, doppler probe and Surgy proctoscope in order to allow the surgical operation through the Transanal Hemorroidal Dearterialization (THD) technique.
The provided document is a 510(k) Summary for the THD Revolution device. It describes the device, its intended use, and its equivalence to previously cleared predicate devices. It also details performance testing, but it does not contain typical "acceptance criteria" and "reported device performance" in the format of a table as might be found in a study for a new AI/software device. This is due to the nature of the device (a nonfetal ultrasonic monitor with a light source used for surgical treatment) and the type of submission (a 510(k) for substantial equivalence to existing devices, not a de novo submission for a novel device).
Therefore, I will extract the closest relevant information from the document to construct the answer, particularly from "2.8 Performance data", highlighting the differences and similarities with predicate devices which serve as the basis for substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal, quantitative acceptance criteria for the THD Revolution as a new, standalone device, nor does it present "reported device performance" against such criteria in a typical tabular format. Instead, it demonstrates substantial equivalence to predicate devices by showing that the THD Revolution's performance is either the same as or improved upon the predicate devices without raising new safety questions.
The "performance data" section focuses on:
- Compliance with recognized standards.
- Acoustic signal quality, specifically addressing the improved clarity due to DSP technology.
- Light source efficacy and photobiological safety.
- Clinical effectiveness in treating hemorrhoidal disease, extending to Grade IV.
Here's an attempt to synthesize the information into a table format, focusing on the comparisons made:
| Feature/Parameter | Acceptance Criteria (Implied by Predicate Equivalence or Standards) | Reported Device Performance (THD Revolution) |
|---|---|---|
| Acoustic Output Levels | Equivalent to predicate device K090009: Max Ispta3 = 347 mW/cm², Max Isppa3 = 0.347 W/cm², Max MI = 0.032 | Max Ispta3 = 347 mW/cm², Max Isppa3 = 0.347 W/cm², Max MI = 0.032. (Identical to predicate) |
| Acoustic Signal Quality | Equivalent to predicate devices (K07815, K081429, K090009) in audibility. | At least as good as predicate devices; clearer thanks to DSP technology which sharply reduces background noise, confirming substantial equivalence. |
| Light Source (Wattage) | Equivalent to predicate devices (50W). | 50W LED (Predicate uses 50W tungsten halogen lamp). |
| Luminous Efficacy | Sufficient illumination for surgical area, equivalent to or better than predicate. | 10300 lux (Significantly higher than predicate's 1580 lux halogen lamp), demonstrating improved illumination. |
| Photobiological Safety | Compliance with IEC 62471. | Classified as "Risk group: Exempt" according to IEC 62471, demonstrating compliance. |
| Surgical Efficacy (Hemorrhoid Grades) | Effective for Grade II and III hemorrhoids (like predicate devices). | Effective for Grade II, III, and IV hemorrhoids (additional efficacy for Grade IV demonstrated in clinical studies). Resulted in low incidence of complications and high patient satisfaction. |
| Compliance with Standards | IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. | Manufactured in accordance with these standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on two clinical studies for surgical efficacy:
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Study 1: Giorndano P, et al. Colorectal Dis. 2014 May;16(5):373-6.
- Sample Size: 31 patients.
- Data Provenance: Not explicitly stated, but authors' names and journal suggest potential European origin. The abstract mentions "Colorectal Dis." which is a UK-based journal.
- Retrospective/Prospective: Not explicitly stated, but typical for such intervention studies, it would likely be prospective observation or a clinical trial. The text says "were operated," which could imply retrospective data collection on outcomes, but the context of proving effectiveness for Grade IV hemorrhoids often means dedicated follow-up.
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Study 2: Morrett R.S. Crujano General. Vol 34 Num 2; 2012.
- Sample Size: 250 patients (including 21 patients with Grade IV hemorrhoids).
- Data Provenance: "Crujano General" is likely "Cirujano General," a Spanish-language journal for general surgeons, suggesting data from a Spanish-speaking country (e.g., Mexico, Spain, Latin America).
- Retrospective/Prospective: Not explicitly stated. Similar to Study 1, "were operated" suggests observation of outcomes post-procedure.
For technical performance (acoustic output, signal quality, luminous efficacy), the "tests were conducted" using the THD Revolution and predicate devices. No sample size of devices or specific data provenance is mentioned beyond "a THD Revolution prototype representative of the standard THD SpA production."
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)
This section is not applicable in the context of this device and submission. The performance of the THD Revolution is evaluated based on its physical/electrical characteristics and clinical outcomes (e.g., recurrence, pain, satisfaction) as reported in surgical studies, rather than by human expert interpretation of output (like in imaging AI). The "ground truth" for surgical efficacy is the patient's clinical outcome after the procedure, as assessed by the operating physician and patient reporting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The clinical studies cited concern surgical outcomes, not diagnostic interpretations requiring adjudication.
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
This is not applicable. The THD Revolution is a surgical device, not an AI software intended to assist human readers in interpretation. There are no "readers" involved in this use case, and thus no MRMC study or AI assistance effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The THD Revolution is a hardware device (an ultrasonic monitor with a light source) used by a surgeon. It does not operate as a standalone algorithm in the sense of AI or software. Its operation is always "human-in-the-loop" as it requires a specialist physician to use it for diagnosis and surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical effectiveness data:
- Outcomes data: The primary ground truth for clinical efficacy is the patient's clinical outcome (e.g., resolution of hemorrhoids, absence of intra-operative complications, recurrence rates, post-operative pain levels, patient satisfaction). This is determined by the treating physicians' assessments and patient self-reports.
For the technical performance data (acoustic output, luminous efficacy, safety):
- Objective measurements and international standards: Ground truth is established by objective measurements using calibrated equipment (e.g., illuminance meter) and compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62471).
8. The sample size for the training set
This is not applicable. The THD Revolution is a hardware device. It does not use Machine Learning or AI models that require a "training set" of data.
9. How the ground truth for the training set was established
This is 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.