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The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).

The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)

The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.

However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document does mention:

• Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
• Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).

Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.

Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.

If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.

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The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • o Footswitch
• Veloxion Resecting Device Kit: ●
  • o Veloxion Resecting Device
  • o Sheath
  • 0 Continuous Flow Optical Obturator
• Veloxion Fluid Control Set ●
• Veloxion Saline Pole ●

The Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.

The provided text is a 510(k) premarket notification from the FDA, and it describes a medical device called the "Veloxion System" for endoscopically controlled tissue chip resection and coagulation, specifically for prostate adenomas.

However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, number of experts, ground truth, or MRMC studies) related to the clinical performance or efficacy of the device.

The "Performance Data" section (VII) lists various types of engineering and safety tests (e.g., Sterility, Biocompatibility, Software, EMC, Mechanical Integrity, Functional Testing, Dimensional Testing, Simulated Use, Thermal effect, Usability). These are primarily focused on the device's technical specifications, safety, and manufacturing quality, rather than its clinical efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document does not contain this type of information.

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The Schoelly Cystoscopes Hysteroscopes and Accessories are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

The proposed Schoelly Cystoscopes/Hysteroscopes and Accessories comprise several models of rigid endoscopes as well as endoscopic sheaths, obturators, instrument bridges and grasping forceps. The devices are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Endoscopes (Cystoscopes/Hysteroscopes):
The endoscopes described in this submission are rigid reusable endoscopes for visualization of the operating site during cvstoscopic and hysteroscopic minimally invasive procedures in conjunction with a commercially available light source, video camera, monitor, and printer.

Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.

Technical parameters of the Schoelly Cystoscopes/Hysteroscopes that characterize the optical view are the Direction of View (0°-70°) and the Field of View (70°-85°). The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. Models of the Schoelly Cystoscopes/Hysteroscopes differ in diameter and length of the insertion tube (2.9mm; 4mm / 300mm - 365mm). None of the endoscope models have a working channel.

Like other currently marketed rigid cystoscopes and hysteroscopes, all endoscope models have outer surfaces mainly made from metal (Phynox cobalt-nickelchromium stainless steel alloy, 304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.

Some Schoelly endoscope models have already been cleared for marketing by FDA (K060899) for the same general intended use but with a different material of the insertion tube and a different bonding material used for the fixation of the plan glass at the endoscope's distal end. Accessories do not have a prior 510(k) clearance.

Sheath:
The endoscopic sheaths included in this submission are rigid reusable instruments with an inner lumen and mainly made from stainless steel; the sheath serves as the most outer part of the whole device setup in cystoscopic or hysteroscopic procedures. The proximal end of the endoscopic sheath has two irrigation ports with integral stopcocks for the introduction and the egress of irrigation media. The distal end of the sheath is cut away in a fenestration to permit the use of working instruments and endoscopes with a Direction of View of more than 0°. Opposite to the fenestration, the sheath is bevelled to facilitate its introduction into natural body orifices (transurethral/transvaginal). The outer diameter of the sheaths in this submission ranges from 17Fr - 25Fr, which are standard sizes used in cystoscopic or hysteroscopic procedures in adults. The sheaths can be used with all endoscopes models, obturators and bridges that are included in this submission.

Obturator:
The obturators included in this submission are rigid reusable instruments with (visual obturators) or without (blind obturators) an inner lumen and mainly made from stainless steel. During application, the obturator can be attached to the endoscopic sheath; it fills the space inside the sheath to provide a smooth surface. The visual obturator has an inner channel that accommodates the endoscope and allows the sheath to be introduced under direct vision. The overall length of the obturator used in conjunction with the sheath complies with the working length of the endoscope.

Bridges:
This submission includes standard endoscope bridges, which are rigid reusable instruments with an inner lumen and mainly made from stainless steel. The evaluation bridges without any accessory port allow the connection of the endoscope to the endoscopic sheath; the single horn bridges include an accessory port with stopcock to allow the insertion of instruments through the inner lumen of the sheath. Both types of bridges are available in a range of lengths for use with the full range of endoscope working lengths.

Grasping forceps:
As with standard endoscopic grasping forceps, the one described in this submission is a flexible forceps solely made from stainless steel and designed for grasping tissue and/or retrieving foreign bodies under endoscopic visualization. It consists of a flexible shaft and a manual proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws. The outer diameter and the working length of the grasping forceps comprised in this submission are 7Fr and 400 mm, respectively. The grasping forceps can be introduced into the instrument bridge and moved forward through the inner lumen of the sheath towards the tip.

The Schoelly Cystoscopes/Hysteroscopes and Accessories are delivered in a nonsterile condition and will have CE mark.

The provided document describes Schoelly Cystoscopes/Hysteroscopes and Accessories, which are medical devices intended for endoscopic diagnostic and therapeutic surgical procedures. The document focuses on establishing substantial equivalence to legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "Performance data demonstrated that the Schoelly Cystoscopes/Hysteroscopes and Accessories have met pre-determined acceptance criteria and are substantially equivalent to predicate devices. The devices are as safe, as effective, and perform as well as or better than the predicate devices."

The specific acceptance criteria are not explicitly detailed in a pass/fail format within the provided text. Instead, the document lists various performance tests and implies that meeting the standards referenced is the acceptance criteria. The reported device performance is that it met these criteria.

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

The document does not specify a "test set" in terms of patient data or images. The testing described is non-clinical performance testing on the device itself.

• Sample Size for Test Set: Not applicable in the context of patient data. The number of physical devices or components subjected to each non-clinical test is not specified, but it's implied that sufficient samples were used to meet the requirements of the listed standards.
• Data Provenance: Not applicable in the context of patient data. All testing is non-clinical, likely conducted in a laboratory setting. The manufacturer, Schoelly Fiberoptic GmbH, is based in Germany.

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

This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.

4. Adjudication Method for the Test Set:

This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of the device's physical and optical characteristics, sterilization, and biocompatibility, not its effectiveness in a clinical diagnostic setting with human readers.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable. The device is a rigid endoscope and accessories, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used:

This information is not applicable as the described testing is non-clinical performance (e.g., optical properties, reprocessing efficacy, material biocompatibility), which uses established engineering and biological standards as the "ground truth" for performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm that requires a training set.

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

This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm.

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The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.

The Epix Irrigation Pump (model C7000) is reusable and operates outside of the sterile field. The Epix Suction Irrigation Tubing Set (model C7100) is a sterile, single use device, used in conjunction with the Epix Irrigation Pump and the house vacuum to deliver sterile irrigation fluids and to evacuate blood, tissue debris, and smoke from the surgical site.

Here's a breakdown of the acceptance criteria and study information for the Epix® Suction Irrigation System, based on the provided 510(k) summary:

This device is a suction irrigator, not an AI/ML powered device. As such, many of the typical categories for AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for a diagnostic algorithm) are not applicable. The study predominantly focuses on benchtop performance testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state quantitative acceptance criteria with numerical targets for each test. Instead, the "acceptance criteria" are implied to be that the subject device performs comparably to the predicate device in the specified functional tests, demonstrating substantial equivalence. The reported device performance is that these tests confirmed substantial equivalence.

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

The summary describes "bench top tests" where "the devices were tested side-by-side." It does not specify a numerical sample size (e.g., number of devices tested, number of trials). The data provenance is a laboratory setting from Applied Medical Resources Corporation. This is a prospective test, as the protocol was created specifically to confirm substantial equivalence.

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

Not applicable. This is a functional performance test for a physical device, not an AI/ML diagnostic device requiring expert ground truth for classification or interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a functional performance test for a physical device.

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/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device. The "standalone" test refers to the device's functional performance in a laboratory setting, as described in the benchtop tests.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is the expected physical and functional performance according to engineering and safety standards (e.g., IEC 60601-1, ISO 10993, ISO 10079-3) and by comparison to the established performance of the predicate device.

8. The Sample Size for the Training Set

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

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

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

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The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.

The Disposable Suction And Irrigation System is composed of a stainless steel Suction / Irrigation Probe which is connected to a handle having two trumpet type valves. Using the fingers, the action of depressing one valve will control the irrigation fluid from the Poly Venyl Chloride (PVC) tubing through the irrigation probe and be delivered onto the site of surgery. By depressing the other valve would enable the action of suction to remove blood and tissue debris from the site of surgery through the suction probe and these will be transported through the PVC tubing and be deposited into a waste container. The handle is joined to two PVC tubes. One divides itself into two branches to conduct irrigation fluids from a saline bag. The clamp is used to hold the two tubes in a vertical position. This irrigation fluid passes down the tubes, then through the Suction / Irrigation Probe and is deposited onto the surgical site. The other tube will conduct waste tissue debris or blood or smoke. A vacuum pump will be connected to the Suction end to draw the tissue debris or blood or smoke from the site of surgery, through the stainless steel Suction / Irrigation Probe and these are transported through this PVC tubing until they are deposited into a waste container. This device is for single use only.

The provided document describes a 510(k) Premarket Notification for a medical device called the "Disposable Suction And Irrigation System." This type of submission to the FDA focuses on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through a standalone study.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) is not present and not applicable to this type of regulatory submission.

Here's why and what information can be extracted:

• Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is "as safe, as effective, and performs very much the same way as" a legally marketed predicate device. This is done by comparing technological characteristics, intended use, and indications for use.
• No "Acceptance Criteria Study" in the sense of a clinical trial: The document does not describe a study designed to prove the device meets specific performance metrics against pre-defined acceptance criteria. Instead, it relies on a comparison to the predicate device.
• No AI Component: The device described is a physical medical instrument for suction and irrigation, not an AI/ML powered device. Therefore, questions regarding AI performance metrics, training sets, and ground truth for AI algorithms are not relevant.

Information Extracted from the Document:

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

   • Not applicable. This document demonstrates substantial equivalence, not performance against specific acceptance criteria. The "performance" assessment is comparative to the predicate device.

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. No test set or clinical study data is described. The comparison is based on device characteristics.

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. No ground truth establishment for a test set is described.

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

   • Not applicable. No test set or adjudication method 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:

   • Not applicable. This is not an AI device, and no MRMC study is described.

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

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

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

   • Not applicable. No ground truth is established for device performance in the context of a clinical study. Substantial equivalence relies on comparing the device's design, materials, and intended use to those of a predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

   • Not applicable. No training set is described.

Information Related to Substantial Equivalence (as found in the document):

• Predicate Device: Applied SI Suction Irrigator
• Basis for Equivalence: "The technological characteristics of The Disposable Suction System as compared to the predicate device - Applied SI Suction Irrigator, are found to be very similar. This device has the same technological characteristics in terms of design, structure, material composition, indication for use, intended use are similar as the predicate device."
• Conclusion: "It is demonstrated that the device Disposable Suction And Irrigation System is as safe, as effective, and performs very much the same way as the predicate device, Applied SI Suction Irrigator. It also has the same design, performance and structure as predicate device. Hence it is substantially equivalent to the predicate device."

In summary, this document is a regulatory submission for substantial equivalence for a physical medical device, not a performance study for an AI algorithm or a clinical trial against specified acceptance criteria.

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The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors

The 24 Fr GDD Cystourethroscope is designed with a continuous flow outer sheath, a separate inner sheath/bridge, and an obturator. The outer sheath has the inflow and outflow Stopcocks attached to it. The inner sheath/bridge has one integral accessory port and can accommodate one accessory up to 9 Fr in size. The obturator is designed to allow atromatic introduction of the outer sheath in a natural orfice. The true continuous flow design washes away blood and small tissue particles to ensure a clear operative field. The working length is 23.2 cm to allow access to the entire lower urinary tract. The dedicated operative channel stabilizes accessories including laser fibers. The Continuous Flow Laser Cystourethroscope is designed to be used with low viscosity fluids, including normal saline, Glycine, Sorbitol, or Ringer's Lactate, and standard surgical accessories.

The provided document is a 510(k) summary for the Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories. It explicitly states in section "K. Clinical Data" that "No clinical tests were performed." This means that the submission for this device did not include any studies proving the device meets specific acceptance criteria based on clinical performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document.

The manufacturer, Laserscope, based their rationale for substantial equivalence and safety on the device sharing "the same Indications For Use, similar design, materials, component features, and functional features" with the predicate device, the Stryker Urology and Gynecology Hardware System. They concluded that "There are no new issues raised regarding the safety or effectiveness of the device."

In summary, the document does not contain the information needed to answer your questions because no clinical studies were conducted for this 510(k) submission.

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The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.

The Resection Pump 2228 is used in combination with a large diameter resectoscope to suction off tissue chips by a short pulse vacuum after the removal with a high-frequency electrode. The complete procedure is done under endoscopic view and continuous flow conditions. The airflow of the control tube is interrupted when the grip of the working element is in the end position and the tissue is cut. This results in a change in pressure which triggers the resection pump to open the tube clamp valve for a short period of time. This generates a brief vacuum pressure via the secretion trap and the tissue chip is sucked off and collected in the chip fluid trap. The resection pump 2228 is software controlled. Key functions and components are automatically monitored to ensure safe operation. If there is a fault, a message is shown on the LCD display in conjunction with an acoustic signal.

The provided documents describe the Resection Pump 2228, a medical device for tissue chip resection and removal. However, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is limited from the perspective of an AI-based device's performance metrics and clinical studies.

Based on the provided text, the device's performance is primarily established through design to standards and lack of clinical tests. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to establish efficacy unique to this device.

Here's an analysis based on your requested categories, acknowledging the limitations of the provided text:

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

Study Proving Acceptance Criteria:

The document explicitly states: "No clinical tests performed."

The "study" proving the device meets its acceptance criteria is primarily based on technical design, adherence to recognized safety standards, and a demonstration of substantial equivalence to already legally marketed predicate devices. This is typical for a 510(k) premarket notification. The FDA's acceptance is based on the review of the submitted documentation, including product specifications, design principles, and comparison to predicates, rather than new clinical trials.

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

• Sample size: Not applicable, as no clinical tests or specific "test sets" for performance evaluation (in the AI/clinical study sense) were performed.
• Data provenance: Not applicable.

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

• Not applicable, as no clinical tests were performed, and thus no "ground truth" was established through expert review for a test set.

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 device is not an AI-assisted diagnostic or interpretive tool, but a mechanical pump.

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

• Not applicable. This device is not an algorithm; it's a physical pump that operates with human interaction (endoscopic view, high-frequency electrode).

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

• Not applicable in the context of clinical performance data for this submission. The "ground truth" for the 510(k) submission is the functional and safety specifications of the device, proven by engineering design, internal testing (not detailed), and compliance with standards, establishing substantial equivalence to predicates.

8. The sample size for the training set:

• Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model.

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

• Not applicable for this type of device.

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The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:

Dilation of the urethra, and cold-slitting of urethral strictures

Trans-urethral incision and resection of the prostate

Trans-urethral removal of bladder tumors

Trans-cervical resection and ablation of the endometrium

Trans-cervical resection of fibroids

The Stryker Urology and Gynecology Hardware System is composed of endoscopes, sheaths, accessories, and applied parts which provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that comprehensively proves the device's performance against such criteria. The document is a 510(k) summary for a medical device (Stryker Urology and Gynecology Hardware System) seeking substantial equivalence to existing devices.

Here's what the document does include and why it doesn't meet the request:

• Device Description and Intended Use: It describes the device, its components, and its intended uses in diagnostic and therapeutic surgical procedures.
• Predicate Devices: It identifies predicate devices to which the Stryker system claims substantial equivalence.
• Performance Standards: It lists several IEC and ISO performance standards (e.g., IEC 60601-1, ISO 10993) to which the device conforms for safety and biological evaluation. However, these are general compliance standards, not specific acceptance criteria for a performance study.
• Substantial Equivalence Claim: The core of a 510(k) submission is the claim of substantial equivalence to a legally marketed predicate device, rather than a detailed performance study proving specific acceptance criteria in the way you've requested.
• FDA Clearance Letter: The letter indicates that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This decision is based on the information provided in the 510(k) summary, which in this case emphasizes equivalence rather than a separate, detailed performance study with outlined acceptance criteria.

Therefore, I cannot provide the requested table and study details because the input document does not contain:

1. A table of specific acceptance criteria.
2. Reported device performance against such criteria.
3. Details about sample sizes for test sets, data provenance.
4. Information on experts, adjudication methods for ground truth.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone algorithm performance study.
7. Details about the type of ground truth used in a performance study.
8. Sample size for a training set or how its ground truth was established, as this device does not appear to be an AI/ML type device requiring such training.

The document focuses on regulatory clearance through substantial equivalence, which primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through design comparison, material biocompatibility, and adherence to general safety standards, rather than new, extensive head-to-head performance studies with detailed acceptance criteria and expert-adjudicated ground truth.

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GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.

Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.

Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.

Here's what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
• Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "The results of design validation raise no new issues of safety and effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.

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 as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.

4. Adjudication method for the test set

• Not applicable/not provided, as no expert-adjudicated test set 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 is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.

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

• This is not applicable as the device is a physical instrument, not a standalone algorithm.

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

• Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."

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

• Not applicable for the same reason as above.

Summary based on the provided text:

The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:

• The devices have the same intended use.
• They are made of the same materials.
• They are produced to the same international and FDA-recognized standards.
• "All materials used... were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices."
• "All results were in conformance with the cited harmonized device standards."
• "The results of design validation raise no new issues of safety and effectiveness."

However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.

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The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery.

The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. The SIGF is validated per AAMI HF18 for electrocautery application. The tips may be sterile packaged and disposable (single-use only) or non-sterile packaged for reusable purposes. The SIGF is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of 10to is 1.66 Mrads.

This document is a 510(k) summary for a medical device and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive efficacy submission.

Therefore, I cannot extract the requested information. The provided text is a regulatory summary focused on substantial equivalence to predicate devices, material safety, and sterilization validation, rather than a performance study with detailed acceptance criteria and results.

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