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The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector.

The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.

The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.

The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve.

These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The provided FDA 510(k) summary (K232067) describes the acceptance criteria and the study that proves the device meets those criteria for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, and Endogator Fujifilm 500/600 Single Use Connector.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide explicit numerical acceptance criteria for each test. Instead, it states that "non-clinical performance testing was performed on the subject device to support the substantial equivalence determination" and concludes that the device "has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the performance of the new devices was within acceptable ranges compared to the predicate devices or met internal engineering specifications for each test.

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

The document does not specify the exact sample sizes used for each non-clinical performance test. It only mentions that "non-clinical performance testing was performed."

The data provenance is from non-clinical performance testing. There is no indication of human data, so country of origin and retrospective/prospective classification are not applicable in this context. These are laboratory/engineering tests performed by the manufacturer.

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

This information is not applicable. The performance tests are engineering and materials science tests, not clinical evaluations requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against established technical specifications or predicate device performance.

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

This information is not applicable as the studies were non-clinical performance tests, not clinical evaluations requiring adjudication of subjective assessments. The results would be objective measurements.

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, an MRMC comparative effectiveness study was not done. This device is a single-use valve/connector for endoscopes, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a mechanical accessory, not an algorithm.

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

The "ground truth" for these non-clinical performance tests would be objective measurements against established technical specifications or the performance of the legally marketed predicate devices. For example, a flow rate test would have a specified minimum/maximum flow, or a leak test would have a maximum allowable leak rate. Biocompatibility utilized ISO 10993 standards.

8. The sample size for the training set

This information is not applicable. This is a medical device accessory undergoing non-clinical performance testing, not a machine learning model requiring a training set.

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

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

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The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.

The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.

The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.

The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The provided text describes a 510(k) premarket notification for a set of single-use endoscopy valves. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with acceptance criteria for device performance. Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria, such as clinical effectiveness or diagnostic accuracy.

The document discusses non-clinical performance testing to support substantial equivalence, but these tests are not presented as meeting specific clinical acceptance criteria or performed as a comparative effectiveness study with human readers or standalone algorithm performance.

Here's an attempt to answer your questions based on the available information, noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not use the term "acceptance criteria" for clinical performance. Instead, it describes non-clinical performance testing conducted to demonstrate the safety and effectiveness of the device as substantially equivalent to predicate devices. The "reported device performance" are the results of these non-clinical tests.

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

The document does not specify the sample size for individual non-clinical tests (e.g., how many valves were tested for flow rate or mechanical properties). It refers to "testing" as being performed on "the subject device."

The data provenance is from non-clinical performance testing conducted by the manufacturer, Medivators (A Subsidiary of STERIS Corporation), located in Conroe, TX 77303, USA. These are laboratory-based tests, not clinical data from patients.

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

This information is not applicable to this 510(k) submission. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human expert assessment is needed. This submission relies on engineering and laboratory testing for functional performance and safety.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to establish a definitive diagnosis or outcome, often from multiple expert opinions. The testing mentioned here is non-clinical and lab-based.

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

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices, often involving AI. The devices described here are single-use endoscopic valves, which are mechanical accessories, not diagnostic imaging devices or AI tools.

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

This information is not applicable. Standalone algorithm performance is relevant for AI-based devices. The devices described here are mechanical endoscopic accessories.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document speaks of "non-clinical performance testing" and "biocompatibility assessment" to demonstrate substantial equivalence to predicate devices. The "ground truth," in this context, would be the established functional performance characteristics and safety profiles of the predicate devices, along with relevant engineering standards and regulatory requirements. It is based on engineering benchmarks, physical measurements, and internationally recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11607/ASTM 4169 for packaging).

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train machine learning algorithms. The devices described are mechanical accessories and do not involve AI or machine learning.

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

This information is not applicable for the reasons stated in point 8.

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The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.

The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.

The provided text describes the acceptance criteria and the study conducted for Medivators' Defendo Fujifilm 700 Single-Use Valves Set, which includes several types of valves and a cleaning adapter. It's important to note that this submission is for accessories to endoscopes, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI/SaMD (like ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of device clearance.

The study focuses on demonstrating the substantial equivalence of these new single-use accessories to existing predicate devices, primarily through engineering and performance testing, and biocompatibility.

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 present a table of "acceptance criteria" with numerically reported device performance against those criteria in a summary format. Instead, it describes various "Non-Clinical Performance Testing" conducted for each component (Air/Water Valve, Suction Valve, Biopsy Valve, Auxiliary Waterjet Valve (Connector), Cleaning Adapter). The conclusion states that the "subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use," implying that all tests performed achieved their respective pass/fail criteria.

However, we can infer the types of acceptance criteria from the performed tests:

• Water flow rate testing: Likely to ensure sufficient water flow for lens washing.
• Backflow prevention testing: To prevent backflow of contents.
• Mechanical testing:
  • Depression Force
  • Valve Application Force
  • Valve Removal Force
  • Force to Disassemble via Axial Pull
    (Ensures proper function, insertion, removal, and integrity).
• Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
  | Suction Valve | - Suction Bypass: To ensure proper suction path.
• Suction Rate (water and soil): To demonstrate adequate aspiration capability.
• Mechanical testing:
  • Depression Force
  • Valve Application Force
  • Valve Removal Force
  • Force to Disassemble via Axial Pull
    (Ensures proper function, insertion, removal, and integrity).
• Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
  | Biopsy Valve | - Workability / Instrument Access Testing: To ensure smooth passage and exchange of endoscopic instruments.
• Slit Length / Dimensional Stability: To maintain proper sealing and instrument passage.
• Confirmatory testing: To ensure continued performance as intended, especially given the change in sterility status compared to a prior predicate. | Met criteria (Substantially Equivalent) |
  | Auxiliary Waterjet Valve (Connector) | - Flow Rate / Durability Testing: To ensure adequate irrigation flow and sustained performance.
• Backflow Prevention Test: To prevent backflow. | Met criteria (Substantially Equivalent) |
  | Cleaning Adapter | - Gas Flow Rate: To ensure proper air channel cleaning.
• Water Flow Rate: To ensure proper water channel cleaning.
• Mechanical Testing:
  • Depression Force
  • Adapter Application Force
  • Adapter Removal Force
    (Ensures proper function, insertion, and removal).
• Button Cycling / Durability Testing: To ensure repeated functional use for pre-cleaning. | Met criteria (Substantially Equivalent) |
  | Packaging | - ISO 11607/ASTM 4169 testing: To ensure sterile barrier maintenance after shipping/transit. | Met criteria (Sterile Barrier Maintained) |
  | Biocompatibility | - ISO 10993-1 assessment: "Biocompatibility testing conducted on the patient-contacting portions... in accordance with the ISO 10993 standard." "The test result shows that the subject devices are biocompatible." | Met criteria (Biocompatible) |

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

The document does not specify the exact sample sizes (N) for each of the performance tests. It states that "Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination."

Data provenance: The testing was performed by Medivators (A Subsidiary of STERIS Corporation) in Conroe, Texas, USA. It's engineering performance test data, not patient data, so "country of origin of the data" in the sense of patient demographics is not applicable. The data is retrospective based on the tests performed for this submission.

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

This is not applicable as this is a 510(k) submission for physical medical device accessories (valves, connectors, adapters), not an AI/software device that requires human expert review for "ground truth" establishment from medical images or clinical data. The "ground truth" for these performance tests is based on engineering specifications, physical measurements, and functional requirements.

4. Adjudication method for the test set

Not applicable, as this is related to expert consensus for AI/SaMD ground truth, which is not relevant for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/SaMD.

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

Not applicable. This is not an AI/SaMD.

7. The type of ground truth used

The "ground truth" for the performance of these physical accessories is defined by established engineering and functional specifications, industry standards (e.g., ISO 11607 for packaging, ISO 10993 for biocompatibility), and the performance of the legally marketed predicate devices. The tests verify that the subject devices meet these specifications for safe and effective use.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD, so there is no "training set."

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

Not applicable.

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The single-use BioShield biopsy valve is used to cover the biopsy/suction channel of gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

The BioShield Irrigator – extension tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator.

The BioShield Irrigating Adaptor is intended to be used with the biopsy valve to provide access for irrigation.

The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suction channel of endoscopes during endoscopic procedures and other procedures. It provides access to the endoscope's working channel, minimizes leakage of biomaterial and other fluids during insufflation and instrument exchange and allows for irrigation. The device consists of a valve body and a cap. The device is made from thermoplastic elastomer. There are a total of 10 versions of the BioShield biopsy valve. All 10 versions of the BioShield Biopsy valve are subject to the major change of removing the skirt that aided in maintaining insufflation in the predicate device and two of these 10 versions have had an irrigation line added. Seven versions of the biopsy valve that are compatible with Olympus and Fujinon endoscopes and three versions of the valve that are compatible with Pentax endoscopes. Also, of these 10 versions, there are two versions that have an irrigation line to provide another irrigation option for the user. All valves, with the exception of one version, are supplied non-sterile.

There are two irrigation devices provided with the BioShield biopsy valve. These devices were not previously cleared under the 510(k) process. Their product code is OCX. They are the BioShield Irrigator and the BioShield Irrigator Extension Tubing. The BioShield Irrigating Adaptor consists of a luer connection attached to a stainlesssteel tip. The Bioshield Irrigating Adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe directly through the BioShield biopsy valve. The BioShield Irrigator Extension Tubing is a 180 cm long piece of irrigation tubing that has connectors on both ends. The tubing can be connected to a BioShield Irrigator biopsy valve on one end and to an irrigation system (irrigation tubing connected to an irrigation source used with an auxiliary water pump) on the other end in order to provide hands-free foot pedal irrigation control. Both of these irrigation devices are provided non-sterile.

This document describes the premarket notification (510(k)) for the BioShield Biopsy Valve, Irrigator, and Irrigating Adaptor. The focus of the provided text is primarily on the regulatory submission and does not detail a study proving device performance against acceptance criteria in the typical sense of a clinical or non-clinical performance study with detailed methodologies, sample sizes, or ground truth establishment.

Instead, the document states: "Based on the intended use, technological characteristics and non-clinical performance data, the subject device is shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the 'study' to prove the device meets acceptance criteria is primarily a non-clinical performance testing suite designed to demonstrate equivalence to a predicate device and compliance with material and functional safety standards.

Here's the information extracted and inferred:

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

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

The document does not explicitly state the sample sizes used for the leakage or biocompatibility testing. The data provenance is non-clinical, meaning it's likely conducted in a laboratory setting. There is no information regarding country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable and not provided in the document. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on medical images or pathology reports) is not relevant for non-clinical performance tests like leakage or biocompatibility. These tests rely on predefined technical standards and measurements.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert disagreement on ground truth might occur. For non-clinical performance tests, results are usually objective measurements against established criteria.

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 document describes a medical device (biopsy valve, irrigator, adaptor), not an AI/software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.

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

No. This document describes a medical device, not an algorithm or AI.

7. The type of ground truth used

For the non-clinical performance testing:

• Leakage Testing: The ground truth is the absence of spraying or geyser-type leaks, which would be objectively observed during the test.
• Biocompatibility Testing: The ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993 series), which involve laboratory assays and tests to determine cytotoxicity, sensitization, irritation, and pyrogenicity. The 'Pass' result indicates compliance with these established biological safety criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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 single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.

The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

The provided text is a 510(k) Summary for medical device clearance, specifically concerning the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve. It outlines the safety and effectiveness information for these devices and compares them to a predicate device.

However, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for details like:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established.

The provided document describes physical medical devices (valves for bronchoscopes), not an AI/algorithm. Therefore, concepts like "AI assistance," "human readers," "effect size of human readers improve with AI," "standalone algorithm performance," and "training/test sets for an algorithm" are not applicable to the information given.

The document does mention "Performance Test" in Section 9, stating:
"The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications."

While this section indicates that performance tests were done and met specifications, it does not provide the acceptance criteria or the specific performance results in a quantitative manner. It also does not involve human readers, AI, or traditional "ground truth" as it would apply to a diagnostic algorithm.

Conclusion based on the provided text:

The provided document is for physical medical devices (valves), not an AI/algorithm. Therefore, most of the requested information (related to AI performance, human reader studies, training/test sets for AI, ground truth establishment for AI) is not present and not applicable to this submission.

The document states that bench testing was performed and the devices met established specifications. However, the specific quantitative acceptance criteria and the reported performance values are not detailed in this summary.

To answer your request based only on the provided text:

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

   • Acceptance Criteria: Not explicitly detailed in quantitative terms within the summary, but implied that each test (endoscope compatibility, suction flow, vacuum leak, water leak, pressing force, fatigue, squeegee leak) had "established specifications."
   • Reported Device Performance: The document summarily states: "The performance data demonstrated that the subject devices met established specifications." No specific quantitative results are provided.

2. Sample sized used for the test set and the data provenance: Not applicable to this type of device testing as described. The testing is bench testing on physical units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for these physical devices would be their ability to perform their mechanical functions according to engineering specifications.

8. The sample size for the training set: Not applicable (not an AI/ML algorithm).

9. How the ground truth for the training set was established: Not applicable (not an AI/ML algorithm).

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The single-use BioShield biopsy valve is used to cover the biopsy/suction channel of gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

The BioShield Irrigator - extension tubing is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator.

The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.

The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suction channel of endoscopes during endoscopic procedures and other procedures. It provides access to the endoscope's working channel, minimizes leakage of biomaterial and other fluids during insufflation and instrument exchange and allows for irrigation. The device consists of a valve body and a cap. The device is made from thermoplastic elastomer. There are a total of 10 versions of the BioShield biopsy valve. All 10 versions of the BioShield Biopsy valve are subject to the major change of removing the skirt that aided in maintaining insufflation in the predicate device and two of these 10 versions have had an irrigation line added. Seven versions of the biopsy valve that are compatible with Olympus and Fujinon endoscopes and three versions of the valve that are compatible with Pentax endoscopes. Also, of these 10 versions, there are two versions that have an irrigation line to provide another option to the user to irrigate. All valves, with the exception of one version, are supplied non-sterile.

There are two accessories provided with the BioShield biopsy valve. These devices were not previously cleared under the 510(k) process. Their product code is OCX. They are the BioShield Irrigator and the BioShield Irrigator Extension Tubing. The BioShield Irrigator consists of a luer connection attached to a stainless-steel tip. The Bioshield Irrigator is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe directly through the BioShield biopsy valve. The BioShield Irrigator Extension Tubing is a 180 cm long piece of irrigation tubing that has connectors on both ends. The tubing can be connected to a BioShield Irrigator biopsy valve on one end and to an irrigation system (irrigation tubing connected to an irrigation source used with an auxiliary water pump) on the other end in order to provide hands-free foot pedal irrigation control. Both of these irrigation accessories are provided non-sterile.

Here's an analysis of the provided text, extracting the acceptance criteria and study details as requested. It's important to note that this document is a 510(k) summary for a medical device and therefore focuses on non-clinical performance testing (bench and simulated use), not clinical studies involving human patients or complex AI algorithms requiring ground truth establishment through expert consensus.

The document discusses devices related to gastrointestinal endoscopes (BioShield Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor). The testing described is primarily focused on the mechanical and fluid dynamic performance of these physical devices, not on diagnostic performance or interpretation of medical images.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided text)

Given that this is a 510(k) summary for physical medical devices and not an AI/software device, many of the requested categories related to AI performance, human readers, and image interpretation are not applicable (N/A) to this document. The testing described is "Non-clinical performance testing" which "consisted of ... bench and simulated use testing."

1. Sample sized used for the test set and the data provenance:
* Sample Size: Not explicitly stated for each test, but the nature of bench and simulated use testing implies a sample size sufficient to demonstrate consistent performance across different models/versions of the device and against the predicate.
* Data Provenance: The document does not specify country of origin for the test data for these non-clinical tests. The tests are "bench and simulated use testing," implying laboratory-based evaluations rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Ground truth in the context of expert review for diagnostic/AI performance is not applicable here. The "ground truth" for these mechanical tests is based on measurable physical properties (e.g., force, flow rate, or visual observation of leakage/spraying) and comparison to a predicate device's established performance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Adjudication methods are typically used in clinical studies or AI performance evaluations involving subjective human assessment. For these mechanical/fluid dynamic tests, results are objective (Pass/Fail based on quantitative and qualitative criteria).

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:
* N/A. This applies to AI-assisted diagnostic tools, not to physical endoscope accessories.

5. Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* N/A. This applies to AI algorithms. The device itself is a physical accessory.

6. Type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Bench and Simulated Use Data / Objective Measurements / Predicate Device Performance. The ground truth for evaluating these devices is their ability to meet defined physical and functional criteria, often compared directly to a legally marketed predicate device's known performance characteristics (e.g., retention force = 3.2 lbs).

7. The sample size for the training set:
* N/A. No "training set" in the context of machine learning is applicable. Device development would involve iterative design and testing, but not a formally defined AI training set.

8. How the ground truth for the training set was established:
* N/A. As no AI training set is involved, this question is not applicable.

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The single use BioShield® biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

The BioShield® biopsy valve EUS - Linear is an accessory to a linear echoendoscope. The EUS biopsy valve allows the end user to cover the accessory port of a linear echoendoscope. The BioShield® biopsy valve EUS - Linear consists of tether and cap. The biopsy valves' cap can be removed from the accessory port while being held on the echoendoscope via the tether to the cap. The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.

Here's a breakdown of the acceptance criteria and study information for the BioShield® biopsy valve EUS - Linear, based on the provided document:

This document is a 510(k) summary for a medical device called the "BioShield® biopsy valve EUS - Linear." It describes the device's technical characteristics, indications for use, and a summary of performance testing conducted to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Retention Force Testing:
  • 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
  • 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
• Leakage Testing:
  • 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
  • 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
• Device Exchange Testing:
  • 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
  • 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).

Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, this testing would typically be prospective bench testing conducted by the manufacturer (Steris Corporation, located in Mentor, OH, USA).

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

This information is not applicable to this type of device and study. The testing described is bench testing of physical device performance (e.g., retention force, leakage, device passage), not a clinical study involving experts establishing ground truth for diagnostic or interpretative tasks.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. There wasn't a subjective assessment by experts that required adjudication.

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

No, a MRMC comparative effectiveness study was not done. This document describes bench testing of a physical accessory, not a diagnostic or interpretative AI-powered device that would involve human readers.

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

Not applicable. This device is a physical biopsy valve, not an algorithm or software. The "performance" being evaluated is the mechanical functionality of the valve itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on measurable physical properties and functional criteria as defined by the acceptance criteria. For example:

• Retention Force: Measured force in pounds.
• Leakage: Visual observation of spraying or geyser-type leaks.
• Device Exchange: Observation of successful passage and non-detachment during instrument usage.
• Biocompatibility/Sterilization: Adherence to established ISO/AAMI standards.

8. The Sample Size for the Training Set

Not applicable. This 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

Not applicable. As mentioned above, there is no training set for this device.

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The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.

The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.

The provided text is a 510(k) Premarket Notification for the Andorate Biopsy Valve and Andorate Biopsy Irrigator, seeking substantial equivalence to existing predicate devices. It describes the devices, their intended use, technological characteristics, and performance data. However, this document does not describe a study involving a medical device that uses AI or machine learning algorithms, nor does it contain information about expert ground truth establishment, reader studies, or training/test sets for such algorithms.

The document details the acceptance criteria and study proving the devices meet these criteria for mechanical and material performance of traditional medical devices. Therefore, I will extract information relevant to those types of devices based on the provided text.

Here's the information parsed from the document for the Andorate Biopsy Valve and Andorate Biopsy Irrigator:

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

The document outlines performance tests conducted for each device. The reported performance is that the tests were conducted and the results imply that the subject devices provide and maintain a sterile barrier and their intended performance before the expiration date, and that they support safety and efficacy, and substantial equivalence to predicate devices. Specific quantitative acceptance criteria values are not provided in this summary, but rather the types of tests performed.

Andorate® Disposable Biopsy Valve:

Andorate® Disposable Biopsy Irrigator:

General Performance Criteria (Both Devices):

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The Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.

The Seal™ Single-Use Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Seal™ Single Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.

The valve is designed with a hollow body with a distal end that attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.

The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding study design elements such as sample sizes, expert involvement, or ground truth establishment.

The text is a 510(k) summary for the Boston Scientific Seal Single Use Biopsy Valve, outlining its intended use, technological characteristics, and a statement that bench testing was performed.

Here's what can be extracted:

• Device Name: Seal Single Use Biopsy Valve
• Intended Use: To provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
• Performance Data Mentioned:
  • Bench testing for air and water leak testing, device insertion and removal, and scope compatibility.
  • Biocompatibility testing (cytotoxicity, sensitization, and irritation testing).
• Result of Performance Data: The device "passed all Bench testing" and "passed all Biocompatibility testing."

However, none of the specific details requested in your prompt regarding acceptance criteria values, performance metrics, study design specifics (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment, training set details) are present in the provided document.

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The Disposable Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Disposable Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Disposable Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free. The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve. The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

The provided document is a 510(k) premarket notification for a medical device: the Disposable Biopsy Valve. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain any information regarding the acceptance criteria for a study proving the device meets those criteria, nor details of such a study.

Specifically, the document states under "7. Non-Clinical Testing":
"The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The Single Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed."

And under "Performance testing" in the comparison table (pages 7 and 8):
"Design verification Pressure test with valve closed - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test with instrument inserted - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test: Following removal of instrument the device holds pressure for 1 Min at 10 PSI"

While these are performance tests, they are described as "Design verification" and do not provide:

1. A table of acceptance criteria and reported device performance. The document lists the tests performed (pressure tests) and states the device "holds pressure for 1 Min at 10 PSI", but it doesn't explicitly state quantitative acceptance criteria (e.g., "must hold pressure for minimum of X minutes at Y PSI") against which a reported performance would be quantitatively compared.
2. Sample size used for the test set and data provenance: Not specified.
3. Number of experts used to establish ground truth and their qualifications: Not applicable for these types of physical performance and biocompatibility bench tests.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: No such study described. The device is a physical component (biopsy valve), not an AI/imaging device that would typically involve human reader studies.
6. Standalone (algorithm only) performance: Not applicable as this is a physical device, not an algorithm.
7. Type of ground truth used: For these bench tests, ground truth would be the physical measurements and observations of the device's performance under test conditions.
8. Sample size for the training set: Not applicable; this is a physical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

In summary, the document refers to "bench testing of performance" and "design verification pressure tests" but does not provide the detailed study information requested, such as specific acceptance criteria tables, sample sizes, or details typically associated with clinical or AI/imaging performance studies.

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