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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:

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:

• 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.

• 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.

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The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.

The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle. The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes). The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscopes and Surgical Proctoscopes. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle. The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light.

The manufacturer, THD S.p.A., submitted a 510(k) premarket notification for a "Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope". This submission is for device modifications to an already approved product family (K103647). The modifications include the availability of THD Light-scope devices in sterile condition and changes to the handle materials (ABS Terluran and ABS Novodur replacing ABS Lustran).

The document does not describe a study involving AI, human readers, or a test set in the traditional sense of diagnostic or clinical performance studies. Instead, the provided text details design verification tests to ensure the updated device's safety and effectiveness due to manufacturing material and sterilization changes.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" (design verification tests) that proves the device meets them, as much as possible given the context of a medical device modification submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not detail specific sample sizes for these design verification tests. The tests are related to material changes and sterilization processes, so "test set" here refers to the samples of the modified devices subjected to validation. The data provenance is internal to THD S.p.A., an Italian company, performing design verification tests for a 510(k) submission to the FDA. These would be prospective tests performed on the modified devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For these types of engineering and sterilization validation tests, "experts" typically refers to qualified engineers, microbiologists, and materials scientists involved in the testing and evaluation process. The document does not specify the number or qualifications of these experts. The "ground truth" for these tests is established by industry standards, regulatory requirements, and validated test methodologies for sterilization efficacy and material biocompatibility/durability.

4. Adjudication Method for the Test Set

Not applicable in the context of these design verification tests. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or image interpretation by multiple readers. Here, the outcome of the tests (e.g., successful sterilization, material integrity) is determined by objective measurements against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for device modifications concerning materials and sterilization, not a diagnostic AI device requiring clinical performance or human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (anoscope, proctoscope, rectoscope, light-scope), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these design verification tests is based on:

• Sterilization Validation Standards: Demonstrating that the sterilization process achieves a specified sterility assurance level (SAL), typically accepted industry standards (e.g., ANSI/AAMI/ISO 11135 for ethylene oxide, or similar for other methods).
• Material Safety Standards: Demonstrating the biocompatibility and physical properties of the new handle materials meet safety and performance requirements, often referencing ISO standards (e.g., ISO 10993 for biocompatibility) and relevant engineering specifications.
• Packaging Integrity Tests: Ensuring the packaging maintains sterility and product integrity over the claimed shelf life, according to ISO and ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set in that context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the device's technical validation (as described above in point 7) is established through adherence to recognized international and national standards for medical device manufacturing, sterilization, and materials.

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The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination. The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctocope and Rectoscope and Surgical Proctoscopes. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD pen light.

Here's an analysis of the provided text regarding the acceptance criteria and study for the THD disposable anoscopes, proctoscopes, rectoscopes, and light-scope:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests performed are described as "Design verification and effectiveness test," "Safety and electromagnetic tests," and "Design verification." These descriptions typically refer to internal engineering and functional testing rather than clinical studies with human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention using experts to establish ground truth for a test set. The tests appear to be related to the device's physical and functional properties, as opposed to diagnostic performance requiring expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of method is typically used in clinical trials where multiple readers interpret results to establish a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned in the provided text. The submission is for device modifications to an already cleared predicate device, focusing on functional and safety aspects of the changes rather than clinical effectiveness comparisons.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a medical device (anescope, proctoscope, rectoscope) for direct observation and intervention, not an imaging or algorithmic diagnostic device. Therefore, a standalone (algorithm only) study is not applicable and was not performed.

7. Type of Ground Truth Used

The ground truth for the "tests performed" appears to be based on engineering specifications, safety standards, and functional requirements to ensure the device's "safety and effectiveness." It is not based on expert consensus, pathology, or outcomes data in the clinical sense for these verification tests.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device's verification and validation process described. Training sets are typically used for machine learning algorithms, which are not involved here.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set in the context of this device and its studies, the method for establishing its ground truth is not applicable.

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