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The Viction Disposable Irrigation and Suction system is intended to provide irrigation and suction functions during general surgery and laparoscopic surgery.It is designed to deliver irrigation fluids to surgical sites and to remove fluid waste and tissue debris.

The Viction disposable Irrigation and suction system are constitutes with Irrigation & suction device and a double tubes(optional accessories).The Irrigation & suction device including an inner/outer stainless steel tubes,On-off Control Button,Conical connectors and Hand-piece. Double tubes constitutes with Irrigation tube、suction tube, and it connects with Yankee joint、Insert needle and Robert Clip.The Viction Disposable Suction Irrigation system is used to deliver sterile irrigation fluids to surgical sites during laparoscopic and endoscopic procedures.

The Irrigation & suction device including an inner/outer stainless steel tubes,On-off Control Button,Conical connectors and Hand-piece. On-off control button on handle-piece can control fluid circuit on and off. It is designed to deliver-sterile irrigation fluids to surgical sites during surgery procedures.

Double tubes constitutes with Irrigation tube,suction tube, and it connects with Yankee joint,Insert needle and Robert Clip.The suction tube is connected to the negative pressure device of the hospital through the Yankee joint, The waste liquid is discharged through a suction tube under the negative pressure environment.Which to improve the surgeon's visibility.

There are 12 models of the product, models VC-FLA0514;VC-FLA0523;VC-FLA0532;VC-FLB0514;VC-FLB0523;VC-FLB0532;VC-FLC0514;VC-FLC0523;VC-FLC0532;VC-FLD0514;VC-FLD0523;VC-FLD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction System" addresses acceptance criteria and the studies performed to meet them. However, it focuses heavily on non-clinical bench testing and comparisons to a predicate device, as is common for medical devices of this classification. It does not present information related to clinical performance metrics involving human readers or AI algorithms, as the device is a physical surgical tool and not an AI-powered diagnostic or assistive system. Therefore, sections related to multi-reader multi-case studies, standalone algorithm performance, and training set details for AI are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance characteristics and implies that the device met these criteria through bench testing. The specific acceptance criteria values are directly stated for some tests.

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

The document describes non-clinical bench testing. Therefore, the concept of a "test set" and "data provenance" in the context of human or patient data does not apply. The tests described were performed on physical units of the Viction Disposable Irrigation and Suction System. The origin of the device manufacturer is China.

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

Not applicable. The ground truth for the bench tests was established by objective measurements against predefined engineering and safety standards, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set:

Not applicable, as no expert adjudication was involved in the non-clinical bench testing.

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

No. This is a physical device, not an AI-powered diagnostic or assistive 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. The device is a physical surgical instrument and does not involve any algorithms.

7. The Type of Ground Truth Used:

For the performance tests (flow rates, pressure, sterility, coating adhesion, etc.), the ground truth was based on objective engineering specifications and recognized international standards (e.g., ISO 11135 for sterilization, ASTM D3359-23 for coating adhesion). For biocompatibility, the ground truth was established by adherence to FDA Blue Book Memorandum #G95-1 and ISO10993-1, which define acceptable biological responses.

8. The Sample Size for the Training Set:

Not applicable. The Viction Disposable Irrigation and Suction System is a physical medical device. It does not utilize a training set in the context of machine learning or AI.

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

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

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The Viction Disposable Irrigation and Suction Catheter is indicated for use in conjunction with the handpiece , dual tubing, and probes to provide controlled powered irrigation during Laparoscopic surgery.

The Viction Disposable Irrigation and suction Catheter is constitutes with Suction/irrigation handpiece , dual tubing, Irrigation device that is a battery-powered mechanical pumping system connect with dual tubing(suction tubing and irrigation tubing) to deliver sterile fluids to surgical sites. Control of the irrigation flow is generated by depressing the on-off Control Button on the handpiece. The mechanical pumping system is powered with nine(9) standard AAlkaline Battery.
Hand piece equipped with pistol style attach to Suction irrigation probes and suction tubing . And it should be used with negative pressure device of the hospital.
There are 8 models of the product, models VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532,VC-IRC0523,VC-IRD0532, VC-IRD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction Catheter" (K250124) concerns a medical device, specifically an endoscope accessory. It does not involve an AI/ML component for diagnosis or analysis, but rather outlines the substantial equivalence of a physical medical device to a predicate device.

Therefore, many of the requested elements typically relevant to AI/ML software (such as ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The "acceptance criteria" for this device are demonstrated through bench testing, electrical safety, electromagnetic compatibility, biocompatibility, and sterilization performance against predefined criteria and relevant industry standards, establishing substantial equivalence to a legally marketed predicate device.

Here's the information that can be extracted and presented based on the provided document:

Device Acceptance Criteria and Performance (Based on provided 510(k) Summary)

The device, "Viction Disposable Irrigation and Suction Catheter," demonstrates substantial equivalence to its predicate device, CORE E3 Suction/Irrigator (K202303), primarily through non-clinical performance data and design comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical "sample size" for the performance tests (e.g., number of devices tested for flow rate, pressure, etc.). It states "All the test results meets the predefined acceptance criteria..." implying that a sufficient number were tested to demonstrate compliance.
• Data Provenance: Not explicitly stated (e.g., in terms of country of origin of testing facilities), but implies internal testing performed by the manufacturer or a contracted lab. The studies were non-clinical bench and lab tests, not human subject data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is a physical medical device, not an AI/ML diagnostic tool. "Ground truth" in this context refers to established technical standards (e.g., IEC, ISO) and comparison to a predicate device's established performance specifications. There were no human expert readers establishing "ground truth" labels from medical images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human "adjudication" of test results in the sense of resolving disagreements among experts for a diagnostic task. Performance was measured against technical specifications and standards.

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

• Not Applicable. No MRMC study was conducted or is relevant for this device type. This device is a tool for surgery, not an imaging analysis or diagnostic aid requiring human reader performance evaluation.

6. Standalone (Algorithm Only) Performance

• Not Applicable. There is no standalone algorithm. This is a physical device.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (IEC, ISO), and the performance characteristics of the legally marketed predicate device. For example, the "truth" for biocompatibility is conformance to ISO 10993, and the "truth" for electrical safety is conformance to IEC 60601-1.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

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

• Not Applicable. There is no training set for this device.

Summary of the Study Proving Device Acceptance:

The "study" proving the device meets acceptance criteria is a comprehensive set of non-clinical performance tests and analyses. These include:

• Electrical Safety & EMC Testing: Following IEC 60601-1 and IEC 60601-1-2 standards to ensure the device is electrically safe and compatible within its intended electromagnetic environment.
• Biocompatibility Testing: Following ISO 10993-1 guidelines, including tests for acute systemic toxicity, skin sensitization, intracutaneous reactivity, pyrogenicity, and in vitro cytotoxicity. This demonstrates the materials used are safe for patient contact.
• Bench Testing: Evaluation of critical functional parameters such as fluid flow rate of the irrigation tube, negative pressure resistance of the suction, and sealing integrity of the irrigation tube. These tests confirm the device performs its intended functions effectively.
• Sterilization Validation: Performance qualification for ethylene oxide sterilization to ensure the device achieves a required Sterility Assurance Level (SAL) of 10⁻⁶, rendering it safe for single use in surgical environments.
• Comparative Analysis: A detailed comparison of technological characteristics (intended use, design, materials, specifications) against the predicate device (CORE E3 Suction/Irrigator, K202303) demonstrated substantial equivalence.

The document states, "All the test results meets the predefined acceptance criteria and complied with the design specification of the subject device throughout the use life. The results of the non-clinical testing demonstrate that the viction disposable irrigation and suction catheter is as safe and effective as the predicate device." This statement serves as the conclusion that the device successfully met its acceptance criteria through these documented non-clinical studies. No clinical testing was deemed applicable or necessary for this submission.

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The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.

The SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. The SPY Laparoscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near-infrared spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

The provided FDA 510(k) clearance letter for the SPY Laparoscope primarily details bench testing and compliance with various recognized standards to demonstrate substantial equivalence to a predicate device. It explicitly states that "The subject device does not require clinical studies to support the determination of substantial equivalence."

Therefore, the information you've requested regarding acceptance criteria and study proving performance, particularly related to human-in-the-loop performance, multi-reader multi-case studies, and the specifics of clinical ground truth establishment, is not available in this document. The clearance is based on a demonstration of equivalent technical performance and safety through non-clinical testing.

Here's how we can address your request based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

Since no clinical study data is presented, the "acceptance criteria" here refers to meeting the performance specifications and standards compared to the predicate device, primarily through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Information Not Available (Due to Reliance on Non-Clinical Testing)

The following points cannot be addressed from the provided document because the 510(k) clearance was based on non-clinical testing for substantial equivalence, not on clinical performance studies involving human subjects or AI:

2. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data. The "test set" here refers to the physical units of the SPY Laparoscope and reference devices used in the various bench tests. Data provenance is internal lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is derived from metrology and engineering standards.
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 an endoscope, not an AI-driven image analysis tool. The document explicitly states "The subject device does not require clinical studies to support the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; no AI algorithm is mentioned or evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and optical standards, and measurements. For example, FOV measurements are compared against an acceptable range, not a clinical diagnosis.
8. The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary: The FDA clearance for the SPY Laparoscope, as described in this 510(k) summary, is based entirely on a demonstration of non-clinical substantial equivalence to a predicate device. This includes demonstrating equivalent optical performance, electrical safety, biocompatibility, reprocessing efficacy, and overall risk management. Clinical studies or studies involving human-in-the-loop performance, AI, or advanced diagnostic accuracy metrics were not part of this clearance process.

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The Disposable Trocars have applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments in abdominal area.

Disposable Trocars are medical devices that penetrate the abdominal wall during laparoscopic surgery. They provide a passageway for the surgical device insertion and removal and maintain pneumoperitoneum during surgical procedures.

The model numbers of Disposable Trocars include AVTB 5-70, AVTB 5-100, AVTB 10-70, AVTB 10-100, AVTB 12-70, AVTB 12-100, AVTC 5-70, AVTC 5-100, AVTC 10-70, AVTC 10-100, AVTC 12-70, AVTC 12-100, AVTC 15-70, and AVTC 15-100.

The AVTB Disposable Trocars comprise an upper sealing component, a casing component, and a puncture rod component.
The upper sealing component is composed of a seal lid, an upper retaining ring, a wave seal ring, a conical sealing ring, a lower retaining ring, and a retaining cover for locking. The casing component is composed of choke valve, self-commissioning sealing cap, casing seat, seal ring, trocar sleeve, gas injection valve, and gas injection switch. The puncture rod component is composed of an upper fixing cover, a locking buckle, a puncture rod, and a lower fixing cover.

AVTC Disposable Trocars comprise casing component, puncture rod component, upper sealing component, and converter component (only applicable to AVTC 15 specification).
The casing component is composed of choke valve, self-commissioning sealing cap, casing seat, sealing ring, trocar sleeve, gas injection valve, and gas injection switch. The puncture rod component is composed of an upper fixing cover and a puncture rod. The upper sealing component (5/10/12 specification) is composed of seal lid, an upper retaining ring, a wave seal ring, a conical sealing ring, a lower retaining ring, and a retaining cover for locking. The upper sealing component (15 specifications) is composed of a seal lid, an elastic seal ring, and a retaining cover for locking. The converter component (15 specifications) is composed of converter, converter cover, sealing cap of upper converter cover, and upper converter cover.

Disposable Trocars are divided into B and C according to different shapes. According to the inner diameter of the trocar, it is divided into four sizes: 5, 10, 12, and 15. According to the length of the trocar, it is divided into two sizes: 70 and 100.

The provided FDA 510(k) clearance letter and summary for Sinolinks Medical Innovation, Inc.'s Disposable Trocars (K250820) do not contain information about acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML-enabled device evaluation.

The document pertains to a traditional medical device (Disposable Trocars) and its non-clinical performance testing (bench, ex vivo, biocompatibility, sterility, packaging, shelf-life, transport, etc.) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot extract the information required to answer your prompt, which is tailored for AI/ML device evaluations. The document explicitly states: "No clinical study is included in this submission." and the "Summary of non-clinical testing" section details a range of physical, mechanical, and biological tests relevant to a non-AI/ML medical device.

To answer your prompt for a device that is not an AI/ML device, the following would be the most relevant information:

Acceptance Criteria and Device Performance for Disposable Trocars (K250820)

The acceptance criteria for the Disposable Trocars are demonstrated through a series of non-clinical tests which show the device meets its design specifications and performs comparably to the predicate device. The "performance" in this context refers to the successful completion and passing of these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device, the "acceptance criteria" are embodied in the successful completion of the various non-clinical tests to predefined standards. The "reported device performance" is that the device met these standards.

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

The document does not explicitly state the numerical sample size for each bench or ex vivo test. It mentions "porcine tissue" for ex vivo studies. It does not provide explicit data provenance in terms of country of origin for the datasets used in these non-clinical tests, though the manufacturer is based in China. The data would be considered prospective for the purposes of these clearance tests, as they were conducted specifically for this submission.

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

This concept is not applicable to the non-clinical testing of a traditional medical device like a trocar. "Ground truth" established by experts is a concept primarily relevant to diagnostic AI/ML models where human interpretation serves as the reference standard. For a trocar, the "ground truth" is determined by established engineering standards, material science principles, and biological safety evaluations.

4. Adjudication method for the test set:

Not applicable for non-clinical performance testing of a traditional device. Adjudication methods (e.g., 2+1 reader consensus) are used in human-in-the-loop or standalone AI/ML studies to resolve discrepancies in expert labeling or diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is specifically for evaluating the impact of AI/ML assistance on human reader performance, which is irrelevant for a disposable trocar.

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

No. This is an AI/ML specific evaluation. The "device" itself performs its function (e.g., creating an entry path) without an "algorithm" in the diagnostic sense.

7. The type of ground truth used:

For this traditional medical device, the "ground truth" is effectively:

• Established engineering specifications and performance standards for mechanical and physical properties (e.g., dimensions, strength, air-tightness).
• Industry consensus standards for biocompatibility (e.g., ISO 10993 series), sterility (e.g., ISO 11135), and packaging (e.g., ASTM standards).
• Biological responses (e.g., no cytotoxicity demonstrated on cell cultures, no irritation in animal models for biocompatibility).

8. The sample size for the training set:

Not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. This device does not use AI/ML.

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

Not applicable, as there is no AI/ML training set.

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The cannulas, obturators, seals, and related accessories are intended to establish a port of entry for instruments, endoscopes, or accessories. They are intended to be used only in a medical facility by trained medical professionals in accordance with its associated user manual.

The subject device 8 mm and 12 mm Assist Cannulas are used as part of a trocar system to establish a port of entry into the surgical site. The 8 mm and 12 mm Assist Cannulas are intended to be used laparoscopically (independently of the da Vinci Systems), but may be used in conjunction with da Vinci systems to assist robotic procedures.
The cannula is a stainless steel hollow tube that serves as a port of entry for endoscopic instruments. A seal is attached to a cannula and an obturator is placed through the seal. The seal attaches to the top of the cannula to create an air-tight system that allows an insufflated body cavity to be maintained. The seal has an insufflation port with a universal luer fitting and stopcock which connects to the da Vinci Insufflator Tube Set with Smoke Evacuation.

This FDA 510(k) clearance letter pertains to medical devices (8 mm and 12 mm Assist Cannulas), not AI/ML software. Therefore, the information typically found for AI/ML device studies (such as acceptance criteria for algorithm performance, sample sizes for test sets, expert consensus, MRMC studies, or training set details) is not present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing relevant to surgical cannulas, such as dimensional measurements, mechanical and functional verification, biocompatibility, and sterilization.

Here's a breakdown of the available information related to performance and testing, framed to align with your request where applicable, but noting the absence of AI/ML-specific details:

Device: 8 mm Assist Cannula; 12 mm Assist Cannula

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated numerically. The performance data section vaguely mentions "bench and animal" testing. The human factors evaluation refers to "post-market data and the MAUDE database" and "formative usability evaluations." Specific numbers for test units or subjects are not provided.
• Data Provenance:
  • Bench and Animal Testing: Implied to be conducted internally or by a testing facility, but no specific country of origin is mentioned. These are typically prospective tests.
  • Human Factors Evaluation: "Post-market data and the MAUDE database" is retrospective data from device adverse event reporting. Formative usability evaluations are prospective. No country of origin is specified for these studies.

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

This information is not applicable and not provided in the document as this is a traditional medical device (surgical cannula) clearance, not an AI/ML device that requires expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically relevant to the establishment of ground truth in AI/ML diagnostic studies through expert review.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating human reader performance with and without AI assistance for diagnostic tasks, which is not relevant for a surgical cannula.

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

No, this is not applicable. The device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

For the physical device, "ground truth" would correspond to engineering specifications and safe/effective performance. This was established through:

• Design Input Requirements: The pre-defined criteria for the device's function and performance.
• Bench Testing: Direct physical measurements and functional tests against specifications.
• Animal and Cadaver Models: Simulated use to confirm performance in a biological context.
• Biocompatibility Standards: Adherence to ISO 10993-1.
• Sterilization Standards: Confirmation of steam sterilization methods.
• Human Factors Analysis: Identification and mitigation of use-related risks through analysis of historical data and usability assessments.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train AI/ML algorithms. This device does not use an AI/ML algorithm.

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

Not applicable, as there is no AI/ML training set for this device.

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The Boehringer Laboratories Liver Retractor is indicated for use in laparoscopic surgical procedures to elevate the liver, improve access to surgical sites, and provide visualization of target anatomy.

The Boehringer Laboratories Liver Retractor is comprised of three components: a Suction Delivery Assembly, a Positioning Clip, and an Integral Suction Regulator. The suction delivery assembly is composed of a Flexible Tube with a proximal Suction Cup and a distal Grasping Suture.

The suction delivery assembly is introduced into the abdomen via a standard laparoscopic trocar. A standard suture passer is then used to grip the grasping suture and pull the upper portion of the flexible tube percutaneously through the abdominal wall. The now externalized tip of the flexible tube is cut off and the open end is connected to the integral suction regulator. The conformable suction cup can then be applied laparoscopically to the liver and the external portion of the flexible tube manipulated to adjust liver position. Once at the desired height, the positioning clip is placed around the external portion of the flexible tube and against the skin to lock the device in place. The suction cup can be efficiently repositioned via laparoscopic technique to accommodate the evolving requirements of a procedure. The device is inserted, manipulated, and removed by or under the direct supervision of a surgeon.

The provided FDA 510(k) clearance letter and summary for the Boehringer Laboratories Liver Retractor (K243399) does not describe an AI device. It's a physical medical device (a liver retractor) and the clearance is based on substantial equivalence to a predicate device, supported by non-clinical testing (bench testing, animal studies, biocompatibility, sterilization, packaging, shelf-life).

Therefore, the information requested in your prompt (AI-specific acceptance criteria, test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this specific medical device clearance. The document does not contain any reference to AI, machine learning, or software performance studies that would require the details you've asked for.

To reiterate:

• No AI device: This is a physical liver retractor.
• No AI acceptance criteria: The device's performance is demonstrated through physical properties and functionality (retraction times, regulator functionality, integrity) and safety (biocompatibility, animal safety).
• No test sets, ground truth, or MRMC studies for AI: These concepts are relevant for AI/ML-driven medical devices, which this device is not.

If you have a document for an AI/ML-driven medical device, I would be happy to analyze it against your criteria.

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This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.

32HS710S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDMI, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.

The provided FDA 510(k) clearance letter and summary for the Medical Monitor (32HS710S) do not contain information about acceptance criteria or specific studies that prove the device meets such criteria in terms of clinical performance or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K241402) by confirming:

• Same Indications for Use: The new device is intended for the same purpose as the predicate.
• Technological Comparison: Differences in specifications (resolution, connectors, power, physical size) are acknowledged but deemed not to affect safety and effectiveness.
• Non-Clinical Bench Tests: Compliance with electrical safety and electromagnetic compatibility standards (IEC60601-1 Ed 3.2, IEC60601-1-2 Ed 4.1, IEC TR 60601-4-2) is confirmed.
• Software Validation: The software belongs to "Basic Documentation Level" and was developed and verified/validated according to IEC 62304 and FDA guidance for device software functions.

Therefore, I cannot extract the requested information (points 1-9) as it pertains to clinical performance, device accuracy, or studies with human readers and ground truth data from this document. This type of information is typically required for devices that perform a diagnostic or analytical function where accuracy metrics like sensitivity, specificity, or reader agreement are critical.

The Medical Monitor (32HS710S) is a display device. Its "performance" in this context refers to its ability to accurately and safely display images from other medical equipment, not its ability to interpret or diagnose medical conditions. For such a device, the acceptance criteria would focus on technical display characteristics (e.g., color accuracy, resolution, brightness, refresh rate) and safety standards, rather than diagnostic accuracy metrics.

Here's what can be inferred or stated based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria related to diagnostic accuracy or clinical performance (e.g., sensitivity, specificity, AUC) and corresponding reported device performance values are NOT available.

The document refers to compliance with electrical safety and electromagnetic compatibility standards and software validation standards. These are the "acceptance criteria" for this type of device, which is primarily a display unit.

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 / Not provided. The tests described are bench tests for electrical safety and EMC, and software validation. These do not typically involve "test sets" of patient data in the way a diagnostic AI algorithm would.

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 is not established in this context as the device is a monitor, not an interpretive diagnostic tool.

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

Not applicable / Not provided.

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

No. This type of study is not relevant for a medical display monitor.

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

No. The device is a display monitor; it does not perform an algorithm-only function that would yield diagnostic output without human interpretation.

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

Not applicable / Not provided. The concept of "ground truth" for diagnostic accuracy is not relevant for a display monitor. The "ground truth" for this device would be its ability to accurately display the incoming video signal according to technical specifications.

8. The sample size for the training set

Not applicable / Not provided. This information is relevant for AI/ML algorithms that are trained on data, which is not the case for this medical monitor.

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

Not applicable / Not provided.

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The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

The Arthrex Synergy Vision Endoscopic Imaging System includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.

The Arthrex Synergy Vision Endoscopic Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the laparoscope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.

The provided FDA 510(k) clearance letter and summary for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) describes the device and its indications for use, but does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a study that proves the device meets those criteria.

Specifically, the document states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This implies that performance data demonstrating device capabilities against specific acceptance criteria (beyond general functional testing and compliance with standards) were not generated through clinical studies or animal studies for this submission.

However, based on the information provided, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance (Inferred/Missing)

Since no human or animal clinical studies were performed, there appears to be no specific clinical performance acceptance criteria listed in this document. The "Performance Data" section primarily focuses on engineering and regulatory compliance testing.

Study Details (Based on Provided Document and Inferences)

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

   • Test set sample size: Not applicable for clinical performance as the document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."
   • Data provenance: Not applicable for clinical performance. The data provenance for engineering tests (e.g., EMT, EMC, software) would be internal Arthrex testing labs.

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

   • Not applicable as no human clinical studies establishing ground truth for clinical performance were conducted for this submission. Ground truth for engineering tests is established through technical specifications and industry standards.

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

   • Not applicable for clinical performance.

4. 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:

   • No MRMC study was done. The device description does not indicate AI assistance features. The system is described as an endoscopic video camera and imaging system, not an AI-powered diagnostic aide.

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

   • Not applicable. The device is hardware (imaging system) with associated software, not a standalone algorithm.

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

   • For the engineering and regulatory compliance tests: Ground truth was established by adherence to design specifications, industry standards (e.g., for biocompatibility, sterility, EMT, EMC), and internal product requirements.
   • For clinical performance (e.g., diagnostic accuracy for a specific disease): No such ground truth was established or presented as no clinical studies were performed.

7. The sample size for the training set:

   • Not applicable, as this device does not appear to utilize machine learning for clinical interpretation or outcome prediction in a way that requires a "training set" in the context of AI/ML models. "Software testing" refers to verification against technical requirements, not AI model training.

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

   • Not applicable for the same reasons as #7.

Summary of Key Takeaways from the Document:

The 510(k) clearance for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) is based on substantial equivalence to existing predicate devices (K241361 and K243008). The justification for this clearance relies heavily on:

• Similar intended use and indications for use.
• Similar technological characteristics (e.g., components, imaging modes, specifications).
• Successful completion of engineering and regulatory compliance testing (e.g., functional testing, biocompatibility, sterility, EMT, EMC, software).

Crucially, the document explicitly states that no animal testing or human clinical studies were required or performed to demonstrate the device meets acceptance criteria related to clinical performance. This means the clearance is not based on a study proving diagnostic accuracy or clinical effectiveness in patients, but rather on the device's technological similarity and safety/performance in a non-clinical, engineering test environment compared to previously cleared devices.

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The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.

The provided document is a 510(k) summary for the LAGIS Suction Irrigation System, which is a medical device, not an AI/ML algorithm. Therefore, the information requested regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device is not applicable to this document.

This document details:

• Device Name: LAGIS Suction Irrigation System
• Intended Use: To provide suction and irrigation functions in laparoscopic procedures to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
• Regulatory Class: Class II (Product Code GCJ - Laparoscope, General & Plastic Surgery)
• Predicate Device: Taiwan Surgical Disposable Suction Irrigation (K150253)
• Performance Tests: The summary lists performance bench tests conducted to verify design characteristics and ensure the device can be used as intended. These include:
  • Biocompatibility testing (following ISO 10993-1)
  • Sterilization validation (according to ISO 11135)
  • Functional and performance characteristics (airtightness, kinking resistance, flattening resistance, bending resistance, and pressing force performances).
• Conclusion: The tests met the predefined acceptance criteria, and no new questions of safety and effectiveness were identified. The device was deemed substantially equivalent to the predicate device.

Since the device is a physical medical instrument (suction irrigation system) and not a software/AI product, the detailed questions about AI model training, test sets, expert ground truth, adjudication methods, and MRMC studies are irrelevant to this submission.

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The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.

The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.

The provided FDA 510(k) clearance letter for the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) does not contain information related to software, artificial intelligence (AI), diagnostic performance, or studies involving human readers or ground truth for diagnostic accuracy.

The document describes a medical device, a specimen retrieval system, and its non-clinical testing to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not applicable to a submission for a physical surgical device like this.

Therefore, I cannot populate the requested table or answer the specific questions related to AI-driven diagnostic studies based on the provided text.

Here's a summary of what is available regarding acceptance criteria and studies, framed according to the nature of this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" and "device performance" are primarily related to its physical characteristics, functionality, and safety as compared to a predicate device, rather than diagnostic accuracy.

Given that this is a 510(k) for a physical medical device (a specimen retrieval system) and not an AI/software-as-medical-device, the following points are not applicable as they pertain to AI/diagnostic studies:

2. Sample sizes for test set and data provenance: Not applicable. No test set of diagnostic data was used.
3. Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for diagnostic accuracy was established.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers were evaluated for improvement with AI assistance.
6. Standalone (algorithm only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

The "studies" conducted for this device were non-clinical performance and biocompatibility tests to demonstrate the device's physical and material safety and functionality, and its substantial equivalence to a legally marketed predicate device.

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