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The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.

The AED Sinuscope is a reusable rod lens sinuscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem.

AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).

The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use.

The provided document describes the AED Sinuscope, a reusable rigid rod lens sinuscope, and its substantial equivalence to a predicate device (Schoelly Sinuscope) for 510(k) clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance testing for the device itself (temperature, optical parameters, reprocessing). It does not mention a "test set" in the context of patient data, imaging data, or human interpretation. Therefore, phrases like "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable to the type of device and testing described. The tests were performed on the device prototypes/production samples in a lab environment.

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

This information is not applicable as the document describes physical and reprocessing performance testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth from medical images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as points 2 and 3. The testing involves objective measurements against established technical standards, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document describes the testing of a physical medical device (sinuscope), not an AI algorithm intended to assist human readers. Therefore, there is no mention of "human readers" or "AI assistance" in this context.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described are the specified technical standards and internal specifications. For example:

• Temperature Testing: Ground truth is defined by the limits and requirements of IEC 60601-2-18.
• Optical Parameter Testing: Ground truth is defined by the minimum requirements in ISO 8600-3:1997 and Amendment 1:2003, and internal specifications.
• Reprocessing: Ground truth for cleaning efficacy and sterilization assurance is defined by the requirements and methodologies outlined in the various AAMI and ISO standards (e.g., AAMI TIR12, AAMI TIR30, ISO 14937, ANSI/AAMI/ISO 17665-1).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical instrument, not an AI or machine learning model that requires a "training set."

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

This information is not applicable for the same reasons as point 8.

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AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The AED Hysteroscope and Accessories is a reusable surgical device that incorporate operative and examination sheaths. The AED Hysteroscope is a reusable rod lens Hysteroscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem. Examination Sheaths are designed to be used with a hysteroscope alone. An operative sheath is an examination sheath with one or more instrument channels. The operative and examination sheaths are composed of surgical grade stainless steel with the exception of a Fixing Ring (where applicable) which is composed of Nylon. There are two designs for Continuous Flow Sheaths. One design consists of a single sheath with two interior channels (18-2307 and 18-2308) for the inflow and outflow of media to be used with the hysteroscope alone. Alternatively, an inner and outer sheath may be used to perform the same function (18-2304 and 18-2309). The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.

The provided document is a 510(k) Premarket Notification summary for the AED Hysteroscope and Accessories. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing the kind of detailed performance study data typically associated with a medical AI/software device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a specific performance study where a device's performance metrics are reported against predefined targets. Specifically, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information on expert ground truth establishment for test or training sets.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes for human readers.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).

Instead, the document primarily focuses on demonstrating that the AED Hysteroscope and Accessories are substantially equivalent to predicate devices (Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope K935716) in terms of:

• Intended Use: "to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." (Pages 2, 5)
• Technological Characteristics: They share the same operating principle, basic mechanical design, and are manufactured using the same materials. The main difference noted is the predicate's adjustable ocular lens versus the AED Hysteroscope's fixed non-adjustable one. (Page 5)

Performance Testing:

The document briefly mentions "Performance Testing" on page 6, stating:

• "Testing was performed according to IEC 60601-2-18. Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate devices. The AED Hysteroscope and Accessories met all specified design and performance requirements."
• "The device conforms to ISO 8600-4:2014, 8600-1:2013, 8600-3:1997 Amendment 1 2003, 8600-5:2005, 8600-6:2005 and IEC 60601-2-18 (1996) and IEC 60601-2-18 Edition 3.0 2009-08."

This indicates that the device underwent bench testing to meet established industry performance standards for hysteroscopes, focusing on hardware safety and functionality (e.g., thermal performance, simulated use). However, it does not provide specific performance metrics (like sensitivity, specificity, accuracy) that would be relevant for an AI/software device. The "acceptance criteria" here are implied to be adherence to the safety and performance requirements of the cited IEC and ISO standards.

Conclusion:

This document is a regulatory submission for a physical medical device (hysteroscope), not an AI/software medical device. Therefore, it does not contain the specific information requested about acceptance criteria and performance studies in the context of AI development and validation. The "study" referenced is compliance testing against established international standards for hysteroscopes to demonstrate substantial equivalence, not a clinical performance study with human readers or standalone algorithm performance.

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Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.

Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:

• · Endoscope
• · Resectoscope sheaths with obturators
• · Working Element
• · Electrodes
  The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
  The body contact materials are 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.

The provided text is a 510(k) summary for the AED Resectoscope, and it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. This document focuses on demonstrating substantial equivalence to predicate devices, rather than independent performance studies with specific acceptance criteria and detailed statistical analysis.

Therefore, many of the requested fields cannot be filled from the given text.

Here's a breakdown of what can and cannot be answered:

1. A 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 provided. The document describes a "design analysis and comparison" rather than a clinical or performance test set involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth establishment is typically for diagnostic devices or those requiring expert interpretation. This device is a surgical instrument. The evaluation here is against engineering standards and comparison to predicate devices, not against a "ground truth" established by experts in a clinical scenario.

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

• Not applicable / Not provided. This relates to clinical studies with expert reviewers, which is not the type of evaluation 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 device is a resectoscope, a surgical instrument, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

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

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

• Not applicable. For this type of device, the "truth" is typically adherence to engineering specifications, safety standards, and functional equivalence to legally marketed predicate devices, not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable. This relates to machine learning models, which are not involved here.

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

• Not applicable. (See point 8).

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AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.

AED Bipolar Forceps consist of
• Standard insulated bipolar handles
• Outer shaft with insulated tip
• Jaw inserts (forceps, scissors)

The device is reusable and provided non-sterile. The device must be cleaned and sterilized before use. All forceps are of the same basic design with differences in tip configurations.

This document is a 510(k) summary for the AED Bipolar Forceps, which is a medical device. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed performance study directly comparing the device against specific acceptance criteria for a new and innovative technology. Therefore, many of the typical questions for AI/algorithm performance studies are not directly applicable or available in this specific document.

However, I will extract the relevant information and indicate where details are not provided due to the nature of this type of regulatory submission.

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

For a medical device like the AED Bipolar Forceps, the "acceptance criteria" and "reported device performance" are framed in terms of meeting recognized safety and performance standards, and demonstrating substantial equivalence to legally marketed predicate devices. The document does not provide a table of numerical performance metrics for the device itself as one would expect for an AI algorithm. Instead, it refers to compliance with established electro-medical and sterilization standards.

Study that proves the device meets the acceptance criteria:

The document describes a "Design analysis and comparison" that confirms the basic functional characteristics are substantially equivalent to the predicate devices (Richard Wolf Medical Instruments, K023813; Stryker Endoscopic Instruments and Accessories, Stryker Endoscopy, K935237). This comparison is the primary "study" or evidence provided to the FDA for substantial equivalence. It is not a clinical trial or an AI performance study with a test set, experts, and ground truth in the typical sense for an AI/CADe device.

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

This information is not applicable/provided in this 510(k) summary. For a traditional medical device demonstrating substantial equivalence, a "test set" in the context of an AI algorithm is not used. The evaluation relies on engineering design, material specifications, and comparison to existing devices.

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 applicable/provided. The ground truth concept, as it applies to expert consensus or pathology for an AI algorithm's test set, is not relevant to this type of device submission. The "ground truth" here is the established safety and performance of the predicate devices and the compliance with international standards.

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

This information is not applicable/provided 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/provided. MRMC studies are used for evaluating the impact of AI/CADe systems on human reader performance, which is not the scope of this 510(k) for a physical surgical instrument.

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

This information is not applicable/provided. There is no algorithm or AI component in the AED Bipolar Forceps to evaluate in standalone mode.

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

The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices and general medical device standards. This is not based on expert consensus, pathology, or outcomes data in the way it would be for an AI algorithm. Instead, it's based on engineering specifications, material science, and regulatory compliance frameworks for electrosurgical devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as the device is a physical instrument, not an AI algorithm.

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

This information is not applicable/provided. As there is no training set, there is no ground truth established for one.

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AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

AED Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated Shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.

The provided text describes AED Monopolar Lap Accessories, focusing on their substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.

Therefore, for many of your requested points, the information is not directly available in the provided text. The device is a physical surgical accessory, and the "study" referred to is a comparison to predicate devices and adherence to performance standards, not a clinical trial or performance evaluation with human readers or AI.

Here's the information based on the provided text, with notes where information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable or not provided as this is not an AI/software device that uses a "test set" in the traditional sense of data or images. The evaluation is based on design analysis and comparison to predicate physical devices, and adherence to established performance standards.

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

This information is not applicable as there is no "test set" of data requiring expert ground truth establishment for this physical device. The evaluation relies on engineering and regulatory assessment.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" or diagnostic assessment requiring adjudication.

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

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that analyze medical images or data interpreted by human readers, often with AI assistance. The AED Monopolar Lap Accessories are physical surgical tools.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

No. A standalone performance study of an algorithm was not done. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established engineering standards (IEC 60601-2-2, ISO 14937:2000) and the demonstrated safety and effectiveness of legally marketed predicate devices (Dan Monopolar Lap Accessories, Gyrus Open Forceps). The evaluation confirms that the new device's design and functional characteristics are substantially equivalent, meaning it performs similarly to what is already accepted as safe and effective.

8. Sample Size for the Training Set

This information is not applicable as this is not an AI/software device that uses a "training set."

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

This information is not applicable as there is no "training set" for this physical device.

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This device is used to provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure.

The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in:

• Diagnostic cystoscopy procedures.

AED Cystoscope

This document is a 510(k) clearance letter from the FDA for a medical device called the "AED Cystoscope." It states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

This document is a regulatory clearance letter, not a technical report or a summary of a performance study. It confirms that the device has met the FDA's requirements for substantial equivalence to a predicate device, which allows it to be marketed. However, it does not detail the specific performance metrics (acceptance criteria) that were tested or the methodologies of any studies conducted to demonstrate those metrics.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details from the provided text.

Based on the document, I can infer:

• Device Name: AED Cystoscope
• Intended Use: To provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure. Specifically, for diagnostic cystoscopy procedures, providing illumination and visualization.
• Regulatory Class: II (21 CFR §876.1500/Procode: 78 FAJ)
• Type of Clearance: 510(k) substantial equivalence. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and performance data (which are not detailed in this specific clearance letter).

To obtain the information you're asking for, you would need to access the original 510(k) submission document (K993689) itself, which would contain the technical details and study summaries.

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This device is used to provide visual information about the condition of the interior of the pelvic cavity, and visualization of the interior of the abdominal cavity or areas subject to general or plastic surgery for diagnostic and surgical procedures. This device provides information for diagnosis and/or surgical access with only a small incision.

The AED line of rigid Laparoscopes is indicated to provide illumination and visualization in:

• Diagnostic and operative laparoscopic procedures.

AED Laparoscope

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (AED Laparoscope). It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain any information regarding:

• Acceptance criteria: The letter doesn't specify any performance metrics or thresholds the device needed to meet.
• Study details: There is no mention of any clinical or performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This type of information is typically found in the 510(k) submission itself or a separate performance study report, which is not included here.

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The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscope procedures.

Not Found

This document is an FDA 510(k) clearance letter for the AED Arthroscope. It does not contain information about acceptance criteria, study details, or performance data for the device. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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