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The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication.

The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage.

The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device.

The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.

The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag.

The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as:

• AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
• Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt)
• Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt)

The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.

The provided text describes a 510(k) premarket notification for the "AMT Low-Profile Suprapubic Catheter & Drainage Set." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. The document primarily describes the types of testing performed and concludes that the device met acceptance criteria, but generally does not specify these criteria or report quantitative performance results against them.

Here's an attempt to answer the questions based on the available information:

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

The document states that the device "met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices." However, specific numerical acceptance criteria and precise performance data are not detailed in this summary. The performance is generally stated as meeting standards.

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:
  • Bench Testing: Not specified. The document lists the types of tests but not numbers of samples.
  • Clinical Performance (Literature Review): Clinical experience was reported on 34 adults and 188 pediatric patients across 22 published articles.
• Data Provenance: The clinical data is from a systematic literature review (retrospective). The countries of origin are not specified, only that the literature from "independent organizations" was reviewed.

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 was a systematic literature review, not a study where experts established ground truth for newly collected patient data. The "ground truth" for the clinical performance was derived from the findings reported in the published literature.

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

Not applicable. The clinical evidence was gathered through a systematic literature review. The "reporting of this systematic review was guided by the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute." This describes the methodology for reviewing existing literature, not an adjudication process for a new 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. This device is a suprapubic catheter, not an AI-assisted diagnostic or therapeutic device. The submission does not mention any AI components or MRMC studies.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For the clinical performance aspects, the "ground truth" was derived from "clinical experience... reported on 34 adults and 188 pediatric patients" across published literature, guidelines from organizations like the Pediatric Urologists of Canada and the Canadian Urological Association, operative textbooks, and information from the International Continence Society (ICS). This can be broadly categorized as published clinical outcomes data and expert-derived guidelines/clinical experience.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device.

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The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.

This document is an FDA 510(k) clearance letter for a medical device called the "AMT Suture Passer." It outlines the regulatory review process and the basis for the FDA's determination of substantial equivalence to previously cleared devices.

The request asks for details on acceptance criteria and a study proving the device meets these criteria. However, the provided document does not describe a study involving an AI/Machine Learning algorithm, human readers, or a test set with ground truth established by experts.

Instead, the document details the performance data for a physical medical device (AMT Suture Passer) through bench testing, biocompatibility testing, sterilization validation, and shelf-life testing. It explicitly states:

• "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."
• "E. Animal Study: Animal testing was NOT performed."
• "F. Clinical Study: Clinical testing was NOT performed."

Therefore, I cannot provide the requested information regarding an AI study, test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details from this document. The information requested aligns with studies typically performed for AI/ML-driven medical devices, which the AMT Suture Passer is not.

However, I can extract the acceptance criteria and performance data for the physical device as presented in the document:

Acceptance Criteria and Device Performance (Based on the Provided Document for a Physical Device)

The "AMT Suture Passer" is a physical medical device, not an AI/ML diagnostic tool. Therefore, the acceptance criteria and performance data relate to its physical properties, sterility, biocompatibility, and functionality as a surgical instrument. There is no mention of AI performance metrics like sensitivity, specificity, AUC, or reader improvement.

Here's a summary of the performance data and acceptance criteria as described:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a physical instrument without AI components, the following points as requested in the prompt are not applicable or detailed in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable for a physical device's bench/biocompatibility testing in this context. These tests are typically performed on a statistically relevant sample size of manufactured devices/materials, but specific numbers are not provided. Data provenance would be from manufacturing and testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by direct measurement and compliance with engineering/material standards, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 AI component).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (no AI algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, the "ground truth" for acceptance is determined by adherence to established material specifications, manufacturing tolerances, mechanical performance criteria, and sterility/biocompatibility standards as measured through laboratory testing.
8. The sample size for the training set: Not applicable (no AI component).
9. How the ground truth for the training set was established: Not applicable (no AI component).

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The AMT G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.

The Applied Medical Technology, Inc. G-Tube Balloon Gastrostomy Feeding Device (AMT G-Tube) is made of silicone elastomer and is designed for enteral feeding in a gastrostomy tract. The device can be used as a replacement device through a mature stoma tract or for initial placement in a supported stoma tract. The device is offered in several French (FR) sizes ranging from 12 FR to 24 FR. On the shaft near the end is located a balloon which, when properly inflated acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The external bolster (preassembled on the AMT G-Tube) acts as a stabilizer to prevent inward migration. The device is sold as sterile and can be placed in an outpatient or home setting by a health care professional or care giver.

Here's a breakdown of the acceptance criteria and study information for the AMT G-Tube Balloon Gastrostomy Feeding Device, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, therefore, sections 2-6 and 8-9 do not apply.

Acceptance Criteria and Reported Device Performance

Device Name: AMT G-Tube Balloon Gastrostomy Feeding Device

Study Information

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided document does not specify the sample sizes for the individual bench tests or the country of origin/provenance for the data. The studies performed were bench testing, meaning they were conducted in a laboratory setting rather than with human subjects, therefore, provenance like "country of origin" is less relevant than for clinical data. The tests are prospective in nature, as they are specifically designed to evaluate the performance of the manufactured device.

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 as the studies described are bench tests (biocompatibility, sterilization, shelf life, and various physical performance tests) and do not involve expert review or establishment of ground truth in the context of diagnostic interpretation. The "ground truth" for these tests is the objective measurement against established engineering, material, and safety standards (e.g., a specific tensile strength, absence of pyrogens, a confirmed SAL).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among human readers/experts, typically in diagnostic studies. The studies performed were bench tests against pre-defined engineering and safety standards.

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 section is not applicable. The device is a physical medical device (gastrostomy feeding tube), not an AI/ML powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical medical device and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the various performance tests (biocompatibility, sterilization, shelf life, and bench tests) is based on established industry standards, design specifications, and objective laboratory measurements. For instance, a confirmed Sterility Assurance Level ($10^{-6}$) is an objective measurement against a standard, not an expert consensus or pathology report. Similarly, meeting specific tensile strength, flow rate, or leak test criteria are objective measurements against defined engineering specifications.

8. The sample size for the training set:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set.

9. How the ground truth for the training set was established:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set and its associated ground truth establishment.

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Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The device consists of a flexible specimen bag and an introducer tube which can be redeployed for multiple uses within a single procedure. The product will be available in two models, a 10 mm model with a 265 ml specimen bag and a 15 mm model with a 1600 ml specimen bag size. The device is provided sterile and is constructed of a Ripstop nylon specimen bag, various polymers and stainless steel. The major differences between the predicate and the subject device include the subject device featuring a stronger Ripstop nylon specimen bag and the ability to be redeployed multiple times within a single surgical procedure.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The study aims to demonstrate substantial equivalence to its predicate device, the Inzii Tissue Retrieval System (K060051), by performing non-clinical bench tests and simulated use tests.

Acceptance Criteria and Reported Device Performance:

Study Information:

1. Sample sizes used for the test set and data provenance:

   • The document does not explicitly state the exact sample sizes for each specific performance test (e.g., number of devices tested for leak, strength, etc.). It refers to "sample size" generally in the context of the performance data summary.
   • The data provenance is from non-clinical bench tests and simulated use tests conducted by Applied Medical Resources Corporation. There is no indication of country of origin for data or whether it's retrospective or prospective, as these are bench tests.

2. Number of experts used to establish the ground truth for the test set and qualifications:

   • This information is not applicable as the document describes performance testing of a physical medical device (specimen retrieval system), not an AI/software device that requires expert-established ground truth. The 'ground truth' here is the objective outcome of the physical/mechanical and biological tests.

3. Adjudication method for the test set:

   • This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations, not for bench testing of physical device performance.

4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human readers' performance is augmented by AI. The Inzii Ripstop Redeployable Retrieval System is a physical surgical tool.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • No, a standalone study was not done. This concept is specific to AI algorithms. The device described functions with human interaction during surgery.

6. Type of ground truth used:

   • For the performance testing, the "ground truth" used was based on objective measurements and observations from the non-clinical bench tests and simulated use tests. This includes parameters like liquid tightness, resistance to tearing/puncture, and mechanical functionality, as well as established ISO standards for biocompatibility.

7. Sample size for the training set:

   • This information is not applicable as the document describes performance testing of a physical medical device, not an AI/machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • This information is not applicable as there is no training set for a physical medical device.

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The Voyant Maryland Fusion Device with Single-Step Activation is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device with Single Step is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

The medical device in question is the Voyant® Maryland Fusion Device with Single-Step Activation. It is an electrosurgical device intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissue bundles up to 7mm in diameter.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that the devices "met all acceptance criteria" or that results were "sufficient to represent the subject device is safe and effective."

Note: The document generally indicates that the device "met all acceptance criteria" without specifying the exact numerical thresholds for many of these criteria. This type of summary is common in 510(k) submissions where the focus is on demonstrating substantial equivalence rather than presenting a detailed performance report.

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

The document does not explicitly state the exact sample sizes for all test sets. However, it provides some information:

• Burst pressure testing: "vessels representative of the devices' indications" were used. (No specific number mentioned).
• Thermal spread testing: (No specific number mentioned).
• Simulated repeated-use testing: (No specific number mentioned for activations or devices).
• Animal testing: "large porcine animal models" were used. The number of animals or vessels tested is not specified.

Data Provenance:

• Country of Origin: Not explicitly stated, but typically these studies are conducted by the manufacturer or contract research organizations, often in the country where the manufacturer is based (USA, in this case).
• Retrospective or Prospective: The testing described (simulated repeated-use, system testing, animal testing, software verification) are all prospective studies, designed and executed to evaluate the new or modified device. The reference to the predicate device's data suggests that previously collected prospective data from the predicate was leveraged.

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the described performance tests. For electrosurgical devices, "ground truth" often refers to objective measurements (e.g., burst pressure, thermal spread measurements, histopathological analysis in animal studies) rather than subjective expert interpretations like in imaging studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given that most of the described tests are objective measurements (e.g., electrical parameters, burst pressure, thermal spread, software testing), an adjudication method as typically understood in studies involving human interpretation (like imaging reads) would not be applicable. For animal studies, evaluation of hemostasis and hematoma would typically follow pre-defined histological or gross pathology criteria.

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

No, an MRMC comparative effectiveness study was not done. The device is a direct-use surgical instrument, not an AI-based diagnostic tool requiring human interpretation/reading. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

While the term "standalone" typically refers to AI algorithms, in the context of this electrosurgical device, the device itself is a "standalone" instrument. The performance tests (electrical, mechanical, system, animal) described are evaluating the performance of the device only (or the device in combination with its specified generator), without a human-in-the-loop actively assisting in output. The software verification tests are also standalone evaluations of the algorithm's performance within the device's control systems.

7. The Type of Ground Truth Used

The ground truth used for various tests includes:

• Objective Measurements: For burst pressure (quantifiable pressure values), thermal spread (measurable tissue damage), and electrical safety/EMC (compliance with quantifiable standards).
• Biological/Pathological Outcomes: For animal studies, this would involve macroscopic and potentially microscopic examination of sealed vessels and surrounding tissues to assess hemostasis, presence of hematoma, and tissue damage, serving as the "ground truth" for seal quality and safety.
• Software Design Specifications: For software verification, the "ground truth" is adherence to predefined design requirements and functional specifications.

8. The Sample Size for the Training Set

The document describes performance testing for an electrosurgical device, not an AI/ML product. Therefore, the concept of a "training set" (used for training machine learning models) is not applicable to this submission.

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

As the concept of a "training set" is not applicable, the question of how its ground truth was established is also not applicable.

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The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.

The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

This document is a 510(k) summary for the GelPOINT® V-Path Vaginal Access System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document describes functional testing but doesn't explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. Instead, it describes general successful outcomes.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document mentions "bench testing" and "Functional bench testing" but does not provide specific sample sizes (e.g., number of devices tested, number of trials).
• Data Provenance: The studies were internal company studies ("A protocol was developed by Applied Medical"). There is no mention of country of origin of data, and these are laboratory bench tests, not patient data, so the retrospective/prospective distinction is not applicable in the usual sense for clinical data.

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

This information is not provided in the document. The studies are described as functional bench tests, suggesting engineering or quality assurance personnel would evaluate the performance rather than clinical experts establishing a ground truth in the context of diagnostic accuracy.

4. Adjudication method for the test set:

This information is not provided. Given the nature of bench testing, it's unlikely an adjudication method like 2+1 or 3+1 (typically used for clinical imaging assessments) would be applied.

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:

• MRMC Study: No.
• AI Assistance: The document describes a medical device for surgical access, not an AI-powered diagnostic or assistive tool. Therefore, a study on human readers improving with AI assistance is not applicable and was not conducted.

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

No. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not applicable.

7. The type of ground truth used:

For the functional tests, the "ground truth" would be the successful demonstration of the device's intended functions (e.g., maintaining an open pathway, retaining its position, maintaining insufflation). For biocompatibility, the ground truth is established by meeting the pass/fail criteria outlined in the referenced ISO standards and USP . For shelf-life, the ground truth is the device maintaining specifications after accelerated aging.

8. The sample size for the training set:

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

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

Not applicable. As above, this is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating the substantial equivalence of a physical surgical access device through functional bench testing, biocompatibility testing, and shelf-life studies. It does not involve clinical studies with patient data, expert review of images, or artificial intelligence algorithms. Therefore, many of your requested points related to AI performance, reader studies, and large-scale data sets are not relevant to this type of device submission.

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The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.

The Alexis® Contained Extraction System is a sterile, single use tissue bag with a guard system component. The polyurethane tissue bag consists of a flexible ring, tabs, strap with a snap fastener, and an attached tether It is available in two models GTB14 and GTB17 with the following dimensions and volumes:

The tissue bag is used to contain and isolate specimens for surgical removal and/or manual morcellation. The strap with snap fastener maintains the folded bag and flexible ring in a collapsed state during insertion. After the device is fully inserted and deployed into the abdominal or pelvic cavity, the opening of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether, tabs, and strap are used to maneuver the ring to the surface of the extraction site.

If the specimen requires manual morcellation. the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site.

The guard system consists of a guard and a self-retaining retractor. The guard is composed of a coiled polyethylene material that conforms to the extraction site. The self-retaining retractor consists of two polyurethane rings connected by a polyurethane sheath and a tether attached to the inner ring. It helps anchor the guard at the extraction site. The guard system provides a robust barrier between the bag and sharp instruments.

The Alexis® Contained Extraction System can be inserted and retrieved either through an abdominal incision or through the vaginal canal and colpotomy. In both cases, manual morcellation is performed extracorporeally at the extraction site.

The provided text describes a 510(k) summary for the Alexis® Contained Extraction System. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific performance metrics and acceptance criteria for a new AI/software device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size for test sets (including provenance, expert qualifications, and adjudication methods), MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from the provided text.

The document details engineering tests related to the physical device's characteristics (biocompatibility, sterilization, shelf life, and functional performance) to support its substantial equivalence to an existing device, as opposed to clinical performance data against defined metrics for a diagnostic or AI-driven system.

The "Discussion of Performance Data" section refers to:

• Biocompatibility: Evaluation in accordance with ISO 10993-1 and FDA guidance.
• Sterilization/Shelf Life: Validation performed in accordance with ISO 11135-2.
• Functional Performance: Design Verification testing for various physical attributes (e.g., integrity of tissue bag, tether, guard system, resistance to penetration, ability to maintain a closed system, specimen capture). This also included "simulated use testing with the subject device in both an abdominal bench model and a vaginal bench model."

However, these are engineering and safety tests typical for a physical medical device, not performance studies as would be conducted for a diagnostic algorithm or AI system.

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The Voyant Fine Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures, including head and neck procedures, where the ligation and division of vessels and tissue bundles is desired.

The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Fine Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

Here's a breakdown of the acceptance criteria and study information for the Voyant Fine Fusion Device (EB230), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• System Testing (Burst Pressure): Not explicitly stated, but "vessels representative of the devices' indications" were used.
• System Testing (Thermal Spread): Not explicitly stated.
• Acute Animal Study: "Large porcine animal models" were used. The number of animals is not specified.
• Chronic Survival Study: "Large porcine animal models" were used. The number of animals is not specified.
• Data Provenance: The animal studies were conducted using porcine models, indicating prospective animal study data. The location of these studies is not specified, but the submission is to the U.S. FDA.

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

• Acute Animal Study: "Functional staining techniques" were used, and "Samples were sent to a qualified histopathology laboratory for evaluation." The number and specific qualifications of the histopathologists are not provided.
• Chronic Survival Study: "Vessels representative of the devices' indications were sealed and evaluated by a qualified histopathologist for hemostasis and signs of hematoma." The number and specific qualifications of the histopathologists are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for conflicting expert opinions. The evaluations were performed by "qualified histopathologists," implying a certain level of expertise, but no mention of multiple reviewers or a consensus process.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The studies focus on device performance characteristics rather than human reader improvement with AI assistance. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device.

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

This is not applicable as the Voyant Fine Fusion device is an electrosurgical instrument for direct surgical use, not an AI algorithm. The software mentioned is for the device's internal control, not for diagnostic or analytical tasks that would typically involve standalone algorithm performance evaluation in the context of AI.

7. Type of Ground Truth Used

• System Testing (Burst Pressure & Thermal Spread): Objective measurements (burst pressure values, thermal spread measurements) of physical properties served as the ground truth.
• Animal Studies (Acute & Chronic): Histopathological evaluation of tissue (cellular viability, hemostasis, signs of hematoma) by qualified histopathologists served as the ground truth for biological effects.

8. Sample Size for the Training Set

No training set is mentioned in the context of this device. The software verification refers to the internal software script of the device, not an AI model that undergoes training.

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

Not applicable, as no training set for an AI model is mentioned for this electrosurgical device.

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Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel.
The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.

The Python Embolectomy Catheter & Over-the-Wire Latis Graft Cleaning Catheters are sterile, single use vascular balloon catheters intended for use in the removal of thromboemboli, occlusion of vessels, and the infusion of fluids. The devices are intended for use in arterial vessels and artificial vascular grafts respectively. The body of the catheters utilize a dual lumen design with one inflation lumen used to inflate the balloon, and one through lumen allowing for insertion over a guide wire or infusion of fluids. The outer diameter of the body is designed to accommodate use with a standard percutaneous access sheath. The Over-the-wire Latis Graft Cleaning Catheter includes a braided mesh which surrounds the balloon and is designed to increase engagement with wall of artificial vascular graft.

The provided text describes a medical device's 510(k) submission to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the physical and material characteristics of the catheters and the bench testing performed. However, it does not contain information pertinent to the typical acceptance criteria or study design for AI/ML-based medical devices, such as a test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I am unable to provide the requested information based on the input text.

The document discusses the following:

• Device Name: Python Catheter and Over-the-Wire Latis Graft Cleaning Catheter
• Intended Use: Removal of thromboemboli from the peripheral arterial system/vascular grafts, and for occlusion and infusion of fluids into a vessel/graft.
• Testing Performed:
  • Engineering/Bench Testing: Balloon Pull Force, Inflation & Guidewire Hub Pull Force, Catheter Body Tensile Strength, Catheter Balloon Cycling Test, Balloon Burst Pressure Test, Inflated Balloon Diameter Inspection, Guidewire & Inflation Hub Leak Test, Simulated Use Bend Test, Torsion Test, Kink Test.
  • Biocompatibility Testing: Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Hemolysis, Materials Mediated Pyrogenicity, Platelet and Leukocyte Counts, Partial Thromboplastin Time, Complement Activation, Thrombogenicity.
• Standards Referenced: ISO 10555-1:ed2:2017 and EN 13868.

This information relates to the physical and biological safety and performance of the catheter itself, not to the performance of an AI/ML component.

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The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

The Applied Medical Anoscope consists of a one-piece polycarbonate half round channel with a tapered closed tip. The device retracts the anal sphincter and provides access to the anorectal anatomy during transanal procedures.

The provided document is an FDA 510(k) clearance letter for the Applied Medical Anoscope. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond general biocompatibility and functional performance tests.

The 510(k) summary (page 4) states: "The anoscope is a simple one-piece device that provides a passage into the anal canal. There are no recognized performance standards for access devices of this kind. Therefore, Applied Medical devised criteria by which to assess safety and efficacy, including a computer-aided simulation and a compression test."

This indicates that while some criteria and tests were performed, their details (specific quantitative acceptance criteria, the results of these tests, sample sizes, ground truth establishment, expert involvement, etc.) are not included in this publicly available 510(k) clearance document.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: Not detailed in the document.
2. Sample sizes used for the test set and the data provenance: Not detailed for the described "computer-aided simulation and a compression test."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing described is physical, not interpretive, and not detailed in the document.
4. Adjudication method for the test set: Not applicable based on the described tests.
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 device is a physical anoscope, not an AI or imaging device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical anoscope.
7. The type of ground truth used: Not applicable for the described physical tests.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of technological characteristics (page 4), noting minor differences like the pre-existence of a dedicated light source channel in the predicate vs. the subject's larger lumen and use of external light sources.
• Biocompatibility testing (page 4) against ISO 10993-1 endpoints (cytotoxicity, intracutaneous irritation, sensitization), which the device passed.
• Functional performance testing (page 4), which involved a "computer-aided simulation and a compression test." The details of these tests and their results are not provided.

In summary, this document is a regulatory clearance letter, not a detailed scientific study report. It states that the manufacturer "devised criteria" and conducted "computer-aided simulation and a compression test" to assess safety and efficacy, but it does not provide the specific quantitative acceptance criteria or the results of those tests.

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