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Endoscope EN-580T: This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine and rectum. Never use this product for any other purposes.

Over-tube TS-1314B: This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Balloon BS-4: This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Tube Kit TY-500D: This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.

The endoscope EN-580T is inserted both perorally and transanally into the gastrointestinal tract during clinical use. The insertion of the device has a mechanism which bends the tip from right to left and up and down, and a flexible tube consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.

The over-tube TS-1314B is introduced in the patient's anatomy with the pairing endoscope. TS-1314B is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1314B is provided sterile and single-patient use only.

The balloon BS-4 is attached to the balloon-compatible endoscope. The balloon air feed outlet should be contained inside BS-4. The accompanying fixing rubber is used to affix the scope balloon in place. The fixing rubbers are made specifically for BS-4 but should not be mixed with the fixing rubber of other scope balloons. BS-4 is provided sterile and single-patient use only.

The tube kit TY-500D consists of a set of two tubes connects the over-tube to the balloon controller by its air inlet. The other tube connects the same balloon controller to the endoscope by its balloon air feed inlet. TY-500D is only compatible with PB-30, cleared K153483. TY-500D is provided non-sterile. The tubes are not patient-contacting and reusable, but each filter is single-patient use only.

This document does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically seen for AI/ML-driven devices. Instead, it describes a 510(k) premarket notification for updated medical devices (Endoscope and accessories) that aim to demonstrate substantial equivalence to previously cleared predicate devices.

The "acceptance criteria" here are inherent to the regulatory process of demonstrating substantial equivalence for traditional medical devices, focusing on safety and effectiveness compared to existing devices rather than a performance benchmark against a clinical gold standard using a specific test set.

Here's an breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a table with specific numerical performance metrics (like sensitivity, specificity, AUC), the "acceptance criteria" are compliance with relevant safety and performance standards for medical devices, and the "reported device performance" is the successful completion of testing to demonstrate this compliance and substantial equivalence to predicate devices.

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

This document does not describe a "test set" in the context of AI/ML evaluation (e.g., a set of medical images or patient cases). The performance data cited refers to standard engineering and biological testing (sterility, biocompatibility, endoscope-specific tests). Therefore, information on sample size or data provenance for such a "test set" is not applicable or provided here.

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

Not applicable. Ground truth, in this context, would imply expert annotations or diagnoses on patient data. This document describes the substantial equivalence of physical medical devices and their components, not an AI/ML algorithm's diagnostic performance. Therefore, no experts were used to establish ground truth for a test set in this manner.

4. Adjudication Method for the Test Set

Not applicable, as there is no diagnostic "test set" to adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

No. This document does not pertain to AI or an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

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

No. This document does not pertain to an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is compliance with established international and FDA standards for medical device safety and performance. This is confirmed through laboratory testing for sterility, biocompatibility, and functional performance, rather than clinical outcomes or pathology data.

8. The Sample Size for the Training Set

Not applicable, as there is no AI/ML algorithm involved, and thus no "training set."

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

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

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Endoscope Model EG-580UT

FUJIFILM Endoscope Model EG-580UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.

Endoscope Model EG-580UR

FUJIFILM Endoscope Model EG-580UR is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.

Endoscope Models EG-580UT and EG-580UR are comprised of three general sections; a control portion. an insertion portion, and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains class fiber bundles, several channels, and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The qlass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors or diagnostic ultrasound systems, and peripheral devices such as monitor, printer, foot switch, and cart.

Based on the provided text, the document is a 510(k) summary for FUJIFILM Endoscope Models EG-580UT and EG-580UR. It describes the devices and compares them to a predicate device (K183433). The primary purpose of this document is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria for AI assistance in image analysis.

The document discusses acceptance criteria for two endoscopic specifications: "Resolution" of the endoscope's camera, not an AI-driven image analysis technology. Therefore, many of the requested details regarding AI-specific studies (e.g., sample size for test/training sets, expert adjudication, MRMC studies, ground truth for AI) are not applicable here as this document does not describe the validation of an AI/ML medical device.

However, I can extract the information related to the device's optical performance criteria as presented.

Here's the breakdown of the information that is available in the document:

1. Table of acceptance criteria and the reported device performance (for Endoscopic Resolution, not AI performance):

Important Note: The document presents these "Acceptance Criteria" under the "Resolution" characteristic of the proposed device, directly implying that the device meets these specifications, as it's part of the substantial equivalence claim. There isn't a separate section detailing the "reported performance" against these, beyond stating them as the device's characteristic.

Study Type and Details (Based on available information in the document):

• Type of Device: This document describes Endoscope Models EG-580UT and EG-580UR, which are physical medical devices (endoscopes) used for ultrasonic imaging of the upper GI tract. It is not an AI/ML-driven diagnostic or assistive device.

• Study Purpose: The studies mentioned are primarily for demonstrating the safety and effectiveness of the endoscopes by showing substantial equivalence to a predicate device, focusing on reprocessing, biocompatibility, EMC, ultrasonic safety, and acoustic output. The document explicitly states: "The proposed devices share the same intended use, physical characteristics, and principle of operation as the predicate device. The differences have been evaluated for the EMC, ultrasound endoscopic safety, and acoustic output. There remains no new concern regarding the safety and effectiveness of the proposed device."

• AI/ML Application: There is no mention of an AI/ML component in these endoscopes or in their validation. Therefore, questions related to AI-specific study designs (test/training sets, experts, MRMC, standalone performance, ground truth for AI) are not applicable to the information provided in this document.

Here are the answers to the other questions based only on the provided text, noting their applicability:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not applicable for AI/ML performance testing. The document describes performance testing for the endoscope's physical specifications (e.g., resolution, bending capability, acoustic output). It does not specify sample sizes for these tests in terms of patient data or clinical images. Data provenance is also not mentioned for these engineering/performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable for AI/ML performance testing. Ground truth, in the context of diagnostic performance (especially for AI), would typically involve expert interpretations or pathological findings. The "ground truth" for the device's resolution (e.g., 0.08mm line pair readable) is an objective engineering specification, not established by human experts in the way clinical ground truth is.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable for AI/ML performance testing. Adjudication methods are relevant for resolving discrepancies in expert opinions, typically in diagnostic studies involving human readers or AI. This document does not describe such a study.

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. Not applicable as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. Not applicable as this is not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* For the endoscopic resolution, the ground truth is based on physical measurement against a standardized test chart (square wave chart). For other performance tests like reprocessing, biocompatibility, EMC, and acoustic output, the ground truth is established by adherence to specific international standards (ISO, IEC) and FDA guidance documents.

8. The sample size for the training set:
* Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established:
* Not applicable. There is no mention of a training set.

In summary, this FDA 510(k) summary focuses on demonstrating that new endoscope models are substantially equivalent to a previously cleared device based on their physical and operational characteristics, and compliance with various engineering and safety standards. It does not pertain to the validation of an AI-driven image analysis device.

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FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.

FUJIFILM Endoscope Model El-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

This document is an FDA 510(k) summary for a medical device, specifically an endoscope (FUJIFILM Endoscope Model EI-740D/S). It is not a study proving the device meets specific performance criteria related to the type of AI/ML evaluation detailed in your request.

The provided text describes a substantial equivalence determination for a traditional medical device (an endoscope) to a predicate device. This process primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing, biocompatibility, electrical safety, software validation, and adherence to relevant standards. It does not involve clinical effectiveness studies or AI/ML performance evaluations such as those measured by sensitivity, specificity, or AUC, as these would be required for AI/ML-driven diagnostic devices.

Therefore, I cannot directly extract the specific information you requested in bullet points 1-9 from this document, as it outlines a different type of device clearance process.

Here's why each point cannot be addressed from the given text:

1. Table of acceptance criteria and reported device performance: The document mentions "Additional performance specifications were evaluated against pre-defined acceptance criteria" but does not provide a table with specific criteria or values. The performance data section focuses on compliance with various safety and compatibility standards rather than diagnostic performance metrics (e.g., sensitivity, specificity).
2. Sample size and data provenance: This information is not relevant or included for a traditional device's 510(k) submission focused on substantial equivalence to a predicate, as there are no "test sets" in the context of AI/ML validation here.
3. Number of experts and qualifications for ground truth: Not applicable. There is no AI/ML component requiring ground truth establishment by experts for diagnostic performance.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is for AI-assisted human reading, which is not what this endoscope's submission is about.
6. Standalone (algorithm only) performance: Not applicable. This is not an AI/ML diagnostic algorithm.
7. Type of ground truth used: Not applicable. No diagnostic ground truth as required for AI/ML validation is discussed.
8. Sample size for training set: Not applicable. No AI/ML model training is described.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document is for a traditional endoscope's 510(k) clearance, not for an AI/ML-enabled diagnostic device. Therefore, the detailed AI/ML-specific performance metrics and study design elements you asked for are not present.

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The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.

The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories.

The OER-Elite originally featured an "extra disinfection process" which can provide an extra three-minute process for delivering fluid to both the forceps elevator area and elevator wire channel when reprocessing endoscopes with a forceps elevator.

The software of the OER-Elite was changed to apply the "extra disinfection process" to the ultrasound endoscope with balloon channel in addition to the endoscopes with a forceps elevator.

The proposed OER-Elite differs from the predicate OER-Elite in the following minor modifications:

Add "Extra disinfection process" to ultrasound endoscope with balloon channel.
Optimize the threshold values of existing error codes.
Replace the electronic cooling fan due to discontinuing of the product.
Change the material used for fluid pathways.

The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak testing, cleaning, disinfection, rinsing, and an alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories.

The OER-Elite utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Elite's cleaning cycle includes ultrasonic cleaning. which helps remove debris and dirt from endoscope surfaces.

The OER-Elite is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, fluid flow, and the operating states of the components within the OER-Elite.

The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer, displayed on a touch screen, or exported to a portable memory.

The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.

The provided text describes the 510(k) premarket notification for the Olympus OER-Elite Endoscope Reprocessor. This document focuses on demonstrating substantial equivalence to a predicate device for a medical device (endoscope reprocessor), not an AI / Machine Learning (ML) enabled medical device. Therefore, the information requested in points 1-9 (acceptance criteria, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document, as these are typically requirements for AI/ML device submissions, particularly for those involving image analysis or diagnostic support.

The OER-Elite is a physical device that cleans and disinfects endoscopes. The changes in this submission are minor modifications to its software (applying an "extra disinfection process" to an ultrasound endoscope with a balloon channel and optimizing error code thresholds), a hardware component change (cooling fan), and a material change for fluid pathways. The "performance testing" described is for the device's physical and operational parameters, not for an AI's analytical performance on data.

Therefore, since this document is not about an AI/ML device, I cannot extract the information requested in questions 1-9.

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The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector:

• Is composed on non-porous plastic material that allows for air flow
• Has minimal contact points with the endoscope or medical/surgical instruments
• Fits a wide variety of devices: 4.9mm -15mm outer diameter
• Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage.
  The Endoscope Tip Protector is available both non-sterile and sterile.

Based on the provided text, the Acceptance Criteria and Device Performance for the Endoscope Tip Protector are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each test (e.g., number of endoscope tip protectors tested, number of cycles for transport or attachment/detachment). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. It summarily states "Proposed Endoscope Tip Protector" and "PASS" for each criterion.

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

The document does not mention the use of experts to establish ground truth for this device's testing. The tests appear to be physical and biological performance tests rather than subjective evaluations requiring expert consensus.

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

There is no mention of an adjudication method, as the tests outlined are objective performance metrics (e.g., force, time, compliance with standards) rather than interpretations.

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 a physical endoscope tip protector, not an AI-assisted diagnostic tool or system that would involve human readers or comparative effectiveness studies of AI assistance.

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

This is not applicable. As noted above, the device is a physical product, not an algorithm.

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

The "ground truth" for the tests appears to be defined by industry standards (ISO 10993-10, ISO 10993-5, ASTM standards) and defined physical/mechanical performance requirements (e.g., "minimal force," "reduce impact force," "remain on the endoscope for at least 7 days"). These are objective, measurable criteria rather than subjective interpretations requiring expert consensus or clinical outcomes data in the traditional sense.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

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

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The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.

The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories.

The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories. The OER-Elite utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Elite's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces.

The OER-Elite is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, fluid flow, and the operating states of the components within the OER-Elite.

The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer, displayed on a touch screen, or exported to a portable memory.

The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.

The provided text describes an Endoscope Reprocessor, not an AI/ML powered device. As such, it does not contain information related to AI/ML specific acceptance criteria or studies. The document describes the device's intended use, technical characteristics, and non-clinical testing performed to establish its safety and effectiveness for cleaning and high-level disinfection of endoscopes.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove the device meets those criteria for an AI/ML powered device, as the provided content does not pertain to such a device.

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The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles:

• · STERRAD 100NX sterilization system using the Express and DUO cycles
• · STERRAD 100S sterilization system using the Standard cycle
• · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · Steris V-PRO 1 using the V-PRO/Lumen cycle
  The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 12.2 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is a stainless steel tray with silicone inserts and a stainless steel lid. The tray and lid have a grid pattern to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S and Steris V-PRO maX V-PRO 1 Plus and V-PRO 1 sterilization systems.

The provided text describes the regulatory clearance (K183139) for an "Endoscope Sterilization Tray" by Intuitive Surgical, Inc. It is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to demonstrate substantial equivalence, rather than proving safety and effectiveness de novo. Therefore, the study described is a non-clinical performance study to demonstrate substantial equivalence to the predicate device K180964, not a clinical study to establish new efficacy or safety claims.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial (e.g., a specific sensitivity or specificity threshold). Instead, it lists various tests performed to demonstrate that the device meets its functional requirements and is substantially equivalent to the predicate device. The "reported device performance" refers to the outcome of these tests.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test. Phrases like "The subject Endoscope Sterilization Tray underwent..." or "Each tray was inspected..." suggest that multiple devices were tested for durability and reuse, but precise numbers are not given. For biocompatibility, it references "established biocompatibility results of the predicate device," implying no new animal or human testing for the subject device for biocompatibility.
• Data Provenance: The studies are described as "non-clinical testing" conducted by Intuitive Surgical, Inc. (the manufacturer). This is retrospective in the sense that it relies on existing knowledge for biocompatibility and laboratory/bench testing for performance. The location of the testing is not specified, but it's internal to the company or contracted out for specific tasks like sterilization validation.

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

Not applicable. This is not a study involving human interpretation or subjective data requiring expert consensus or ground truth establishment by human experts. It is a performance study of a physical medical device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective data. The tests are objective performance measurements against engineering specifications and industry standards.

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

No. An MRMC study is relevant for diagnostic imaging or similar applications where multiple human readers interpret cases. This document describes non-clinical performance testing of a sterilization tray.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ANSI/AAMI ST77, ISO 10993-1, ASTM D4169-09), and validated test protocols designed to assess its functional requirements, biocompatibility, and ability to withstand sterilization and handling. For sterilization efficacy, the "ground truth" is typically defined by microbial reduction levels (e.g., sterility assurance level) achieved in validated sterilization cycles.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles:

• STERRAD 100NX sterilization system using the Express cycle .
• . STERRAD 100S sterilization system using the Standard cycle
• Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles ●
• Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles .
• Steris V-PRO 1 using the V-PRO/Lumen cycle

The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated. FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray (P/N: 400490) is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes (Model #'s 470026, 470027) during the transport and sterilization process.

The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight; it is the same tray as no changes were made to these parameters.

This document is a 510(k) premarket notification for an Endoscope Sterilization Tray (K180964). It asserts substantial equivalence to a previously cleared predicate device (K170640). The core argument is that the subject device is identical to the predicate device in design, materials, and manufacturing processes, with only a minor change to the reprocessing instructions related to where specific endoscope model numbers are referenced.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria is largely absent because the submission relies on a claim of identity to a previously cleared device, not new performance data.

Here's an attempt to fill in the requested information based on the provided text, with many fields indicating "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The provided document does not describe a new study to demonstrate that the subject device (K180964) meets specific acceptance criteria. Instead, it relies entirely on the assertion of substantial equivalence to a previously cleared predicate device (K170640). The fundamental premise is that because the device itself is identical to the predicate (same design, materials, weight, manufacturing processes), and the only change is in the documentation (where specific model numbers are referenced), no new performance testing (cleaning, biocompatibility, sterilization validation, bench testing) was deemed necessary.

Therefore, the "study" is effectively the original substantial equivalence determination for the predicate device (K170640), which would have included such testing. This current submission leverages that prior clearance.

Additional Requested Information (based on provided text):

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

• Sample Size: Not Applicable / Not Provided (no new testing performed for this submission)
• Data Provenance: Not Applicable / Not Provided (no new testing performed)

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

• Number of Experts: Not Applicable / Not Provided (no new testing performed and no ground truth establishment relevant to this specific submission)
• Qualifications of Experts: Not Applicable / Not Provided

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

• Not Applicable / Not Provided (no new testing performed)

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 / Not Provided. This device is a physical sterilization tray, not an AI or diagnostic device.

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

• Not Applicable / Not Provided. This device is a physical sterilization tray, not an algorithm.

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

• Not Applicable / Not Provided. For the predicate device, the ground truth would have been established through validated sterilization efficacy, cleaning efficacy, and biocompatibility testing according to relevant standards.

8. The sample size for the training set:

• Not Applicable / Not Provided. This is not an AI/machine learning device.

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

• Not Applicable / Not Provided. This is not an AI/machine learning device.

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The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:

• · STERRAD 100NX sterilization system using the Express cycle
• · STERRAD 100S sterilization system using the Standard cycle
• · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · Steris V-PRO 1 using the V-PRO/Lumen cycle
  The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi Endoscopes during the sterilization process. It is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and the lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope.

This document is a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K170640) and does not contain detailed information about acceptance criteria and the comprehensive study that proves the device meets them in the context of the requested questions. This type of FDA filing primarily establishes substantial equivalence to a predicate device, rather than providing granular performance data or detailed study methodology as would be included in a clinical trial report.

However, based on the provided text, I can extract the following information relevant to device performance and testing:

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

The document mentions that "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements."
The testing mentioned is:

• Cleaning Validation
• Human Factors Validation

No specific quantitative acceptance criteria or reported device performance metrics are provided in this document. The overall "performance" is stated as being "substantially equivalent" to the predicate.

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

This information is not provided in the document.

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 provided in the document. The device is a sterilization tray, not a diagnostic or AI device that would typically involve expert ground truth generation.

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

This information is not provided in the document. As addressed above, this type of adjudication is typically for diagnostic interpretation, not for validating a sterilization tray.

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 type of study is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI-assisted diagnostic tool.

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

This is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI algorithm.

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

For "Cleaning Validation," the ground truth would likely be established through standardized laboratory testing methods to detect residual soil or microbial load, adhering to relevant industry standards (e.g., AAMI, ISO).
For "Human Factors Validation," the ground truth would typically be observations of user interactions and assessment against usability criteria, often involving user tasks and satisfaction surveys.
Specific details are not provided in the document.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/ML device.

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

This information is not provided and is not applicable as this is not an AI/ML device.

In summary: The provided FDA 510(k) document focuses on establishing substantial equivalence for a physical medical device (sterilization tray) and, as such, does not contain the detailed performance study information typically requested for AI/ML or diagnostic devices. The performance data mentioned relates to cleaning and human factors validation, but specific results, sample sizes, and detailed methodologies are not included in this summary.

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The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:
• STERRAD 100NX sterilization system using the Express cycle
• STERRAD 100S sterilization system using the Standard cycle
• Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• Steris V-PRO 1 using the V-PRO/Lumen Cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 8.9 lbs.
The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle) and the following Steris low temperature hydrogen peroxide gas sterilization systems:

• o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• Steris V-PRO 1 using the V-PRO/Lumen Cycle o
  The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.

This document describes a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K151450) from Intuitive Surgical, Inc. The purpose of this submission is to update the Indications for Use for an existing, legally marketed predicate device (K142937) to accommodate a heavier endoscope.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative manner as one might expect for a diagnostic or AI-driven device. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its ability to accommodate a heavier endoscope and maintain sterilization efficacy.

The key performance aspect being validated is the ability of the tray to facilitate sterilization with the specified sterilizers, even with an increased maximum weight. The "acceptance criteria" can be inferred from the "Performance Data" section.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "sterilization validation and bench testing." It generally refers to "testing conducted."
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a US-based company (Intuitive Surgical, Inc., Sunnyvale, CA 94086), the testing would typically be conducted according to US regulatory standards and likely in a controlled laboratory environment. It is a retrospective evaluation against a predicate device.

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

• This information is not provided in the document. The nature of the device (sterilization tray) doesn't typically involve expert interpretation of medical images or conditions for establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical ability to hold the endoscope and allow for effective sterilization, which is assessed through laboratory testing and engineering specifications.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. For this device, the "acceptance" is based on meeting technical specifications and demonstrating equivalency through validation tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This device is an endoscope sterilization tray, which is a physical medical device, not a diagnostic or AI-assisted system that involves human readers or interpretation of cases. Therefore, the concept of "human readers improving with AI" is not relevant here.

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

• Not applicable/Not done. This device is a physical product, not an algorithm. The concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on engineering and performance specifications related to the physical dimensions of the tray, its material properties, and its ability to withstand and facilitate sterilization processes.
  • Weight Capacity: The actual measured weight of the endoscope and tray against the specified maximum.
  • Sterilization Efficacy: Demonstrated through validation tests that confirm the sterilizer cycles achieve the required sterility assurance level (SAL) when the endoscope is contained within the tray. This would involve standard microbiology tests, not expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable/Not provided. As there is no training set for an AI/ML algorithm, there is no ground truth established for a training set. The relevant "ground truth" for this medical device's function (sterilization and protection) is established through established scientific and engineering principles and validated testing protocols.

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