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The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.

The i-Cut is a single use laparoscopic power morcellator. It is provided sterile.

The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue.

The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device.

The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.

This 510(k) clearance letter pertains to the i-Cut, a single-use laparoscopic power morcellator. The provided text details regulatory information, device description, indications for use, and non-clinical performance testing. However, it does not include information about clinical studies with human participants, acceptance criteria tables, sample sizes for test sets (in the context of clinical performance), expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document primarily focuses on non-clinical bench testing to demonstrate substantial equivalence to a predicate device (LiNA eXcise, K101458). Therefore, I cannot address most of the requested points related to clinical study acceptance criteria and performance as this information is not present in the provided text.

Here's an analysis of what can be extracted from the provided text, and where gaps exist:

Preamble:

The provided 510(k) clearance letter for the i-Cut device focuses on demonstrating substantial equivalence through non-clinical performance testing (bench testing) rather than clinical trials with human participants. Therefore, many of the requested details pertaining to clinical study design, human reader performance, and expert consensus for ground truth are not present in this document. The "acceptance criteria" and "device performance" discussed here apply to the bench testing conducted, not clinical outcomes in human subjects.

1. A table of acceptance criteria and the reported device performance

Based on the provided non-clinical performance testing section, we can infer some "acceptance criteria" as implied by the successful completion of each test. The "reported device performance" is generally stated as "passed" or "met requirements." No numerical data for specific criteria are provided beyond the stated specifications (e.g., cutting rate, speed).

2. Sample sizes used for the test set and the data provenance

• Sample Size: The document does not specify the sample sizes (e.g., number of devices, number of tests) for each of the non-clinical performance tests. It only states that the tests were performed and passed.
• Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, A.M.I. Agency for Medical Innovations GmbH. The country of origin of the manufacturer is Austria. This data is inherently prospective as it involves new testing for the device's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical bench testing study. "Ground truth" in this context pertains to engineering specifications and performance metrics rather than clinical diagnoses established by medical experts. Usability testing involved "surgeons of different experience with laparoscopic morcellators," but it was to assess device compatibility and integrity, not to establish a clinical ground truth for a diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was a non-clinical bench testing study. Adjudication methods are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth.

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

Not applicable. No MRMC comparative effectiveness study was performed or described. The clearance is based on substantial equivalence demonstrated through non-clinical bench testing. The device is a physical surgical tool, not an AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical tool and does not employ a standalone algorithm for diagnostic or interpretative purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For non-clinical bench testing, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO, ASTM, IEC), and predefined pass/fail criteria for device performance (e.g., measuring force, checking for wear, verifying electrical safety compliance). There is no "expert consensus" or "pathology" in the medical sense for these tests.

8. The sample size for the training set

Not applicable. This device is a mechanical/electrical surgical tool, not an AI/ML algorithm that requires 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.

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More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.

When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.

The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:

• A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).

• B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.

The A.M.I. EasyInstruments device is a modular instrument system for use in laparoscopic highfrequency (HF) surgery and is designed for monopolar application. The Easylnstruments system comprises three-part detachable instruments, which include 1) different functional handles (EasyHandle), 2) instrument shafts of various diameters and lengths (EasyShaft), and 3) a wide range of different, application-specific attachments (EasyTips). It is intended during laparoscopic procedures to mobilize, manipulate, grasp, hold, fix, retract, dissect, cut, and coagulate tissue.

This FDA 510(k) summary describes a medical device, the EasyInstruments, which are electrosurgical cutting and coagulation devices and accessories. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria in a clinical study for a new AI/software component. Therefore, much of the requested information (like number of experts, adjudication methods, MRMC studies, ground truth for test/training sets, effect size of AI improvement) is not applicable or cannot be extracted from this document because it pertains to the evaluation of AI/software in a clinical context, which is not the subject of this 510(k) for electrosurgical instruments.

However, I can extract information related to the performance testing that was conducted to demonstrate safety and efficacy compared to predicate devices for these hardware instruments.

Here's an attempt to answer the questions based on the provided text, noting where the requested information is not present or applicable:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in precise numerical terms or detailed performance metrics in a table. It lists numerous tests performed to demonstrate safety and performance relative to predicate devices. The "reported device performance" is summarized as "The results of these tests indicate that the EasyInstruments are substantially equivalent to the predicate devices" and "it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices."

Below is a summary of the types of tests performed and the general outcome:

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 explicitly specified for each test. For "Thermal effects on tissue," it mentions "ex vivo animal tissues (liver, kidney, and muscle)," implying a sample of tissue, but the quantity is not detailed. For bench performance, it refers to "disposable tips," "reusable tips," "EasyHandle," and "EasyShaft," suggesting multiple units were tested, but precise numbers are not provided.
• Data provenance: Not specified. The manufacturer is based in Austria, but the location where the tests were specifically conducted or the origin of the animal tissues is not stated. The tests are non-clinical (bench, ex vivo).

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)

Not applicable. This document pertains to the 510(k) clearance of electrosurgical instruments (hardware), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here related to performance testing (e.g., measurements of thermal damage, visual inspection criteria, electrical readings), not clinical diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, for the same reasons as #3. Adjudication methods are typically used in clinical studies involving interpretation of medical data, where there might be disagreement among experts.

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

Not applicable. This is not an AI/software device, so no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance and thermal effects testing, the "ground truth" would be established by:

• Engineering specifications and standards (e.g., for electrical safety, dimensions, opening angles, grasping strength, continuity checks).
• Histological assessment for thermal damage (directly observing tissue changes).
• Standardized methods for cleaning/sterilization efficacy.
• Biocompatibility test results against established safety limits.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as #8.

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The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.

FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following:

• Probe: Component made of stainless steel that passes through the fistula tract.
• Guide: Component made of stainless steel that compresses tissue within the fistula tract.
• Base Plate: Component made of stainless steel that acts as a stop for the Circular Cutter.
• Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.

The provided text describes a medical device called FiXcision, a manual cutting instrument for use during anal fistula surgery. However, the text does not contain information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria.

The document discusses:

• Indications for Use: The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access to internal structures and for manipulating soft tissue (cutting) for the treatment of simple anal fistulae.
• Device Description: It's an EO-sterilized, single-use, multi-part, manual cutting instrument consisting of a Probe, Guide, Base Plate, and Circular Cutter.
• Predicate Device: K760715, Flexible Cutting Scissors / V. Mueller O.V. Baxter Healthcare Corp.
• Summary of Non-Clinical Testing:
  • Sterilization and shelf life validation
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993-5 and 10993-10)
  • Performance testing (bench):
    • Design validation: Wear of the cutting edge, Tensile force of the Circular Cutter, Bending test for the Probe, Strength of screwed end of the Guide.
    • Usability per IEC 62366-1

The text explicitly states: "No FDA performance standards have been established for FiXcision." Therefore, there are no acceptance criteria, and consequently, no study described to prove the device meets them, in the typical sense of clinical performance metrics like sensitivity, specificity, or accuracy.

The non-clinical testing performed is to demonstrate equivalence to the predicate device and ensure safety and basic functionality, not to establish performance against specific acceptance criteria for diagnostic or treatment effectiveness.

Therefore, I cannot populate the requested table or answer the specific questions regarding acceptance criteria and performance studies because that information is not present in the provided document. The document focuses on regulatory clearance based on substantial equivalence to a predicate device through non-clinical testing.

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The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.

The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.

The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (

This document is a 510(k) premarket notification for the Wi-3 HAL-RAR System and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner requested. The document outlines non-clinical testing performed, but does not provide specific acceptance criteria or performance results in a quantifiable way for clinical efficacy.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance cannot be extracted from this document.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states that "non-clinical testing" was performed, but does not specify acceptance criteria or quantitative performance results for clinical efficacy. The types of non-clinical tests mentioned are:

• Biocompatibility: Compliant to ISO 10993-1.
• Software Verification: Compliant to IEC 60601-1 and IEC 60601-1-4.
• Electromagnetic Compatibility and Electrical Safety: Compliant to IEC 60601-1-2 and IEC 60601-2-37.

For these non-clinical tests, the "reported device performance" is simply that the device was found to be "in compliance" or "tested in compliance" with the stated standards. No specific performance metrics or quantitative results are given.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document discusses non-clinical testing of the device itself (biocompatibility, software, electrical safety) rather than clinical performance data from a test set of patient data.

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)

Not applicable. This document does not describe a study involving expert review for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document does not describe a study involving adjudication of a test set.

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

Not applicable. The device described, the Wi-3 HAL-RAR System, is a surgical tool for detecting and ligating hemorrhoidal arteries. It is not an AI-based diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device or document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Wi-3 HAL-RAR System is a physical medical device (ultrasound system for surgery) used by a human operator, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As noted, the testing described is non-clinical and related to device safety and compliance with standards, not diagnostic or therapeutic efficacy requiring ground truth from clinical data.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an algorithm using a training set.

9. How the ground truth for the training set was established

Not applicable. This document does not describe the development or training of an algorithm using a training set.

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