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The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

Electrosurgical Instruments

The provided document is a 510(k) summary for the Gyrus Medical Inc. Open Forceps, which is a regulatory submission to the FDA. It does not contain a study that proves the device meets specific acceptance criteria in the way one would expect for a diagnostic or AI-driven device.

This document is for an electrosurgical device and focuses on establishing substantial equivalence to a predicate device based on its intended use and general performance characteristics. It outlines the device's function (electrosurgical coagulation, mechanical grasping, dissection, and vessel sealing) and compares it to a previously cleared device (K024286).

Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving those criteria were met, as that information is not present in the provided text.

Here is what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the document. For an electrosurgical device like the Gyrus Medical Inc. Open Forceps, acceptance criteria would typically involve engineering specifications, safety standards (e.g., electrical safety, biocompatibility), and performance benchmarks (e.g., sealing strength, reliable coagulation). However, the 510(k) summary provided does not detail these specific criteria or report performance against them. It relies on the concept of "substantial equivalence" to a predicate device (K024286).

2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe specific clinical or technical studies with test sets in the context of accuracy, sensitivity, or specificity that would involve sample sizes or data provenance for a diagnostic device. Substantial equivalence for this type of device usually relies on design comparisons, bench testing, and potentially animal studies, but details of these are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment for a test set is relevant for diagnostic devices that classify or measure a condition, requiring expert adjudication. This device is an electrosurgical instrument.

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. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable.

8. The sample size for the training set:
Not applicable. This device does not have a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
Not applicable.

Summary of what the document does provide:

• Device Name: Gyrus Medical Inc. Open Forceps
• Intended Uses: Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during open general surgical procedures.
• Predicate Device: Gyrus Medical Open Forceps (K024286)
• Regulatory Class: Class II (Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400)
• Regulatory Mechanism: 510(k) Premarket Notification based on "substantial equivalence" to a legally marketed predicate device.

The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering comparisons and general performance characteristics rather than detailed clinical outcome studies with predefined acceptance criteria as would be seen for a new diagnostic or AI-powered medical device.

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The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.

The ACMI® DUR-HL Laser Systems are pulsed solid-state Holmium YAG Lasers with a wavelength of approximately 2080 nm (2.1um). This wavelength is absorbed primarily by water, whereby an average penetration depth of approx. 400 um (0.4 mm). The lasers are Class IV lasers pursuant to 21CFR 1040 and designed to comply with the requirements outlined in 21 CFR 1040. The ACMI® DUR-HL Laser Systems are comprised of the following components:

• Laser Unit, which includes Laser console, control and display panel .
• . Fiber port for delivery systems
• System microprocessor control electronics .
• Covered footswitch .
• . Operating software
• (For use with) a variety of fiber optic delivery devices/accessories. .

Acceptance criteria and device performance information is not present in the provided text. The text describes a 510(k) submission for a laser surgical instrument, focusing on its intended use, technological characteristics, and substantial equivalence to predicate devices, but lacks details on specific performance metrics or clinical study results.

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The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.

The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

The provided text describes the ACMI® DUR-Digital Ureteroscope and Choledochoscope System. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes, expert qualifications, or quantitative performance metrics typically found in a clinical study or even a rigorous design verification and validation report for a complex medical device.

The information primarily focuses on demonstrating substantial equivalence to predicate devices for 510(k) clearance, rather than a standalone performance study with defined acceptance criteria and statistical proof.

Here's an analysis based on the provided text, highlighting what is and is not available:

Acceptance Criteria and Device Performance (Based on Provided Text)

The document states that the new device met performance requirements by demonstrating comparable performance to predicate devices. It does not define explicit, quantitative acceptance criteria in this summary.

Study Details and Missing Information:

Here's a breakdown of the requested information, indicating what is present and what is absent from the summary:

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

   • Availability: Partially available (implied criteria, general statement of performance). No specific quantitative criteria are provided.
   • Details: The "acceptance criteria" are implied to be "performance characteristics comparable to predicate devices." The "reported device performance" is a general statement that these characteristics were met or exhibited.

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

   • Availability: Not available.
   • Details: The document refers to "design verification" and "testing" but does not specify the sample size of devices tested or the data provenance. It's likely these were internal engineering tests rather than a clinical study.

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)

   • Availability: Not available.
   • Details: No information is provided about experts, ground truth establishment, or any form of expert review for testing. This type of submission focuses on technical equivalence rather than clinical performance evaluated by experts.

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

   • Availability: Not available.
   • Details: No adjudication method is mentioned, as there's no reported expert-based evaluation.

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

   • Availability: Not available.
   • Details: No MRMC study was mentioned. This device is an endoscope system (a direct visualization tool), not an AI-powered diagnostic or assistive tool, so such a study would not be applicable or expected for this type of 510(k) submission.

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

   • Availability: Not applicable/Not available.
   • Details: This device is a manual medical imaging instrument (endoscope) used by a medical professional, not an algorithm, so a standalone algorithm performance study is irrelevant. The comparison focused on the technical performance of the device itself (e.g., image quality, physical dimensions) against predicate devices.

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

   • Availability: Not available.
   • Details: Since the "testing" focused on comparing physical and visualization characteristics against predicate devices, the "ground truth" would likely be the established performance specifications or measured characteristics of those predicate devices, rather than clinical ground truth (like pathology or outcomes) for this type of submission. The summary does not elaborate on how this was established.

8. The sample size for the training set

   • Availability: Not applicable/Not available.
   • Details: This device is a hardware system, not a machine learning algorithm. Therefore, there is no "training set" in the AI sense.

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

   • Availability: Not applicable/Not available.
   • Details: As there is no training set, this question is not relevant.

Summary of the Study:

The "study" described is a design verification and validation process conducted internally by the manufacturer (ACMI Corporation). Its purpose was to demonstrate substantial equivalence to already legally marketed predicate devices, the ACMI® DUR®-8E (for flexible endoscope technology, physical characteristics, and indications for use) and the ACMI® Invisio™ ICN System (for basic video imaging technology).

The core of the study involved:

• Comparing the physical performance characteristics of the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) against the predicate DUR®-8E.
• Comparing the digital visualization characteristics of the DUR®-D against the predicate Invisio™ ICN.

The conclusion was that the new device met its performance requirements and exhibited comparable performance characteristics to both predicate devices, thus presenting "no new questions of safety or efficacy." This type of demonstration is standard for a Traditional 510(k) submission, where the focus is on showing similarity to existing products rather than proving novel clinical effectiveness through large-scale trials.

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Intended to be a conduit for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.

The UroPass Access Sheath is a single use, sterile (EtO sterilized) disposable product. The sheath is made of layers of polyurethane and PTFE with a stainless steel coil sandwiched in between (the coil provides kink resistance). The sheath has a funnel at the proximal end to ease the insertion of an LDPE dilator. The dilator is equipped with a polypropylene luer connector for injection of irrigation or contrast. The dilator is removable from the sheath by means of a clip fixed to the luer connector. The outside of the sheath has a lubricious coating for ease of insertion into the ureter. For ease of visualization, the dilator and sheath are radiopaque. Two holes (suture loops) are incorporated into the funnel to facilitate attachment to surgical drapes for stabilization of the sheath during surgery.

The provided text describes the UroPass® Ureteral Access Sheath, its intended use, and its substantial equivalence to predicate devices for 510(k) clearance. However, it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific study types based on the provided input. This type of information is typically found in detailed design verification and validation reports, which are not part of the 510(k) summary provided.

The document states: "The fundamental technology of the modified device has not changed. The UroPass Ureteral Access Sheath remains a ureteral access sheath that permits direct passage of catheters, endoscopes and other devices through the urinary tract. The UroPass Ureteral Access Sheath is substantially equivalent in design, materials and intended use to previously cleared devices." This indicates that the clearance was based on similarity to already approved devices, not necessarily a new clinical study with specific acceptance criteria.

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The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the examination/operation of the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Like the predicate ACMI® MR-Series Ureteroscopes, the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are semi-rigid endoscopes with two working channels. Flexible accessories such as stone baskets, retrievers, forceps, electrohydraulic lithotripter probes and laser fibers may be used through either working channel. The main component parts of each device include: The metal shaft, Two working channels, An eyepiece, Optical imaging fibers, Light guide connector post, A distal lens, Light carrier fibers. This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals.

The provided text describes a Special 510(k) Notification for the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes, focusing on modifications to an existing predicate device. This submission primarily addresses changes in sterilization method and material, not performance studies as typically seen with AI/ML devices. Therefore, a direct response to many of your questions regarding acceptance criteria and performance studies in the context of AI/ML evaluation cannot be fully provided by the given text.

However, I can extract information related to the device and the nature of this 510(k) submission, and explain why certain aspects of your request are not applicable based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document is a 510(k) Summary of Safety and Effectiveness for modifications to an existing device, not a new device requiring extensive performance studies with specific acceptance criteria in the way an AI/ML diagnostic device would. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device despite the proposed changes.

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

This information is not provided in the document. The submission focuses on modifications to an existing device (sterilization method and material change), rather than clinical performance testing in a "test set" as would be done for a diagnostic or prognostic AI/ML device. The "data provenance" would likely refer to engineering and biocompatibility testing, but specific details are not outlined here.

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

This information is not applicable and not provided in the document. There is no mention of a "ground truth" derived from expert consensus for clinical image interpretation, as this is a physical medical device modification.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above.

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 information is not applicable and not provided as this is a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided as this is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" in this context would implicitly be engineering specifications, material science data, and sterilization validation results demonstrating that the modified device meets design requirements and remains safe and effective for its intended use, comparable to the predicate device. This is not explicitly detailed in the provided 510(k) summary, as the summary focuses on the conclusion of substantial equivalence rather than the raw data.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train AI/ML models, which is not relevant to this type of device modification submission.

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

This information is not applicable and not provided for the same reasons as #8.

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The dual lumen ureteral catheter is designed for percutaneous and THC uddi lamon aretoral os indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, including, but not limited tial/anesthetic agents and guidewire placement.

Like the predicate Flexible Tip (open or closed) Ureteral Catheter, the Dual Lumen Catheter is a ureteral catheter with a flexible tip used for guidewire placement and for contrast injection. The Dual Lumen Catheter incorporates the same technological characteristics as the predicate device. The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness. Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns. The method of manufacture (extrusion) is the same for both the predicate and the proposed device. The new material used in the Dual Lumen Catheter has been used in other legally marketed devices within the same classification regulation for the same intended use and has had an established history of successful clinical application in Urology. Like the predicate device, the Dual Lumen Catheter features a hollow plastic tube placed inside the ureter, which, as in the predicate device, allows for the passage of guidewires and for the injection of fluid. Both catheters are fitted with female luer lock Tuohy-Borst adaptors, and feature soft tips to ensure protection of tissue during passage. This Special 510(k) proposes an addition of the second lumen to the catheter, a modification of the material characteristics, shortening of the working length and a change of color of the device. The indications for use, principles of operation, and diameter of the Dual Lumen Catheter remain the same as in the predicate device.

The provided document is a 510(k) Summary of Safety and Effectiveness for the ACMI Corporation's Dual Lumen Catheter. This type of document is for a medical device seeking premarket clearance through the FDA's 510(k) pathway, which establishes substantial equivalence to a predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, statistical studies, ground truth establishment, sample sizes, or expert involvement that would be present for a new, high-risk device requiring a PMA or a comparative effectiveness study for AI/software.

Based on the document, here's what can be extracted and what cannot:

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

This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than defining new performance acceptance criteria. It states that the proposed modifications "are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device."

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

This information is not available. The document does not describe a "test set" in the context of a clinical performance study. The evaluation likely involved engineering testing and a review of existing clinical data for the modified materials. The mention of "Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns" suggests some testing, but details on sample size, design, or provenance are absent.

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 information is not available. There is no "ground truth" establishment described in the context of a clinical performance study with expert review, as this is not a diagnostic device or a study involving interpretation.

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

This information is not available. No adjudication method is mentioned, as no multi-reader or expert consensus study is described.

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 information is not available. This is a physical medical device (catheter), not an AI-assisted diagnostic or decision support tool. Therefore, an MRMC study with AI assistance is not relevant or described.

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

This information is not available. As explained above, this is a physical medical device, not an algorithm.

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

This information is not available. There is no ground truth described as this device did not involve diagnostic or interpretive tasks. The "ground truth" for a device like this would be its physical properties and functionality meeting manufacturing specifications, and its biocompatibility, which is briefly mentioned as having been tested.

8. The sample size for the training set

This information is not available. There is no "training set" as this is not a machine learning or AI device.

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

This information is not available. No training set or associated ground truth establishment is mentioned.

Summary of what the document does convey regarding acceptance criteria (implicitly) and safety/effectiveness:

The primary "acceptance criterion" for this 510(k) notification is substantial equivalence to the predicate device (K930483, Ureteral Catheter, "The Flexible Tip (open or closed) Ureteral Catheter").

The study that "proves" the device meets this acceptance criterion is the 510(k) submission itself, which argues and presents evidence for substantial equivalence. This is demonstrated by:

• Similarity in Intended Uses: The Dual Lumen Catheter has the same indications for use as the predicate (ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safe wire/guidewire placement).
• Similarity in Technological Characteristics: Both are ureteral catheters with flexible tips for guidewire and contrast injection, hollow plastic tubes for fluid/guidewire passage, and fitted with female luer lock Tuohy-Borst adaptors and soft tips.
• Evaluation of Modifications:
  • Addition of a second lumen: The document implies this does not fundamentally alter the device's mechanism or safety profile in a way that would raise new questions of safety or effectiveness.
  • Modification of material characteristics (polyurethane to polyethylene): Biocompatibility testing was performed to confirm no new safety concerns. The new material has a "history of successful clinical application in Urology" in other legally marketed devices.
  • Shortening of working length and change of color: These are considered minor aesthetic or dimensional changes that do not impact safety or efficacy.
• Manufacturing Method: The method (extrusion) remains the same.

In conclusion, for this type of medical device 510(k) submission, the "study" is the comparison to a legally marketed predicate device, and the "acceptance criterion" is proving that the new device is substantially equivalent, meaning it is as safe and effective as the predicate. The document states, "The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness," and "The proposed modification in design specifications, performance specifications, and dimensional specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." The FDA's clearance letter confirms their agreement with this assessment.

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The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.

The Invisio IRL Digital Rigid Laparoscope is a standard USA Series Laparoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image replacing the rod lens system typically used in the rigid laparoscope The Invisio IRL Digital Rigid Laparoscope can be inserted into the abdomen or chest through small skin cuts allowing the surgeon to explore the whole cavity without the need of making large standard openings dividing skin and muscle.

I am sorry, but without a clear description of acceptance criteria or a study within the provided text, I cannot complete your request. The provided text primarily describes a device for a 510(k) submission, including its name, predicate devices, and intended use. It does not contain information on acceptance criteria, device performance results, study methodologies (like sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or training/test set details.

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The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

Like the predicate ACMI® Electronic Video CystoNephroscope (ECN) System, the ACMI® INVISIO ICN (ICN) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. The ICN can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.

The ICN incorporates the same basic video imaging technology located in the endoscope as the predicate device. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.

Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

This Special 510(k) proposes modifications in the proximal handle design, a reduction in flexible shaft outer diameter, elimination of the secondary active deflection mechanism, and a minor software algorithm modification for the ACMI® INVISIO ICN. The indications for use, principles of operation, working channel length and diameter of the ACMI® INVISIO ICN remain the same as in the predicate device.

The provided document is a 510(k) Summary of Safety and Effectiveness for a medical device (ACMI® INVISIO ICN). It states that the device is substantially equivalent to a predicate device and outlines its intended use and modifications. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

This type of submission (Special 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "summary of safety and effectiveness" here is an assertion that the modifications do not significantly affect safety or efficacy, based on the principle of substantial equivalence to the predicate.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used, ground truth establishment, or details about MRMC or standalone studies because this information is not present in the provided text.

The document states: "The proposed modifications for the ACMI® INVISIO ICN, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, dimensional specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This suggests that the primary "proof" relies on the established safety and effectiveness of the predicate device and the minor nature of the changes to the new device.

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ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.

ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems.
ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.

The provided text is a 510(k) summary for the ACMI® M4™ Telescope. It indicates that the device is substantially equivalent to a predicate device (ACMI Resectoscope System and accessories, K890328/B) and does not describe a study involving acceptance criteria in the way one might for a novel AI/software-as-a-medical-device.

Therefore, the requested information elements related to such a study (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment) are not applicable to this submission.

Here's an interpretation based on the provided document:

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

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

• Not applicable. This 510(k) relies on substantial equivalence to a predicate device rather than performance data from a specific test set.

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.

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. This is not an AI/software device.

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 concensus, pathology, outcomes data, etc)

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Explanation:

The K031758 submission is a 510(k) Pre-market Notification for a medical device (telescopes for endoscopy) that establishes substantial equivalence to existing predicate devices. This regulatory pathway primarily focuses on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate, and that any differences do not raise new questions of safety or effectiveness.

It explicitly states: "The M4 Series designs utilize similar telescope technology (design, materials, and performance specifications) as in the predicate devices and, therefore, are substantially equivalent to the ACMI M2 and M3 series telescopes." and "The proposed modification in materials, design, and processing are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

Therefore, the submission does not detail a clinical study with specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, nor does it refer to data from test sets, expert consensus, or training sets as would be common for AI/ML-based devices. The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence according to FDA regulations.

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The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures

The ECN Video Cystonephroscope is a flexible endoscope that incorporates video sensor technology to capture the endoscopic image, replacing the fiber optic image bundle typically used in most endoscopes. The ECN Video Cystonephroscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney

This 510(k) premarket notification for the ACMI ECN Video Cystonephroscope does not contain the detailed information required to answer the questions about acceptance criteria and a study that proves the device meets those criteria.

The document is a submission to the FDA for substantial equivalence to legally marketed predicate devices, not a report on a clinical or performance study with defined acceptance criteria. It primarily focuses on comparing the new device's technological characteristics and intended use to existing devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's why the information is missing:

• 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, primarily through comparison of technological characteristics and intended use. It often does not require new clinical trials or performance studies with specific statistical endpoints like those requested in your prompt, unless there are significant differences from the predicate that raise new questions of safety or effectiveness.
• Focus on Substantial Equivalence: The document explicitly states its purpose is to show "Technological Characteristics and Substantial Equivalence." It lists predicate devices and highlights how the ECN Flexible Video Cystonephroscope utilizes existing flexible endoscope technology, video sensor technology (CMOS), and video processing technology found in those predicates.
• Lack of Performance Data: The provided text does not include any performance metrics, success criteria, or results from a study designed to quantify the device's accuracy, sensitivity, specificity, or inter-reader agreement.

In summary, the provided document is a regulatory filing for market clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

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