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The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.

Erbe's Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The ERBEFLO CleverCap® devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation; whereas, the ERBEFLO AeroRinse® devices provide a conduit for water for endoscopic lens cleaning as well as air for insufflation. There are four (4) and three (3) variants of Erbe's Tubing/Cap Sets for each group respectively (i.e., ERBEFLO CleverCap® and ERBEFLO AeroRinse®). All of the Sets respectively interface with a specified brand of scope (i.e., Pentax®, Olympus®, Fujifilm®, and Fujinon® Gastrointestinal Video Endoscopes). The Sets consist of tubing segment(s) and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, an irrigation tubing line (segment) of a Set (as applicable- only for the ERBEFLO CleverCap® Sets) interfaces with a designated peristaltic pump and via an ERBEFLO connector accessory attaches to the specified endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified endoscope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube in which the endoscope is used to pressurize the water bottle for functionality (air and water to the endoscope)]. Also, for the Pentax Set there is an additional air inlet tube that directs air from the endoscope's processor. For each Set, the irrigation tubing segment (as applicable) as well as the air/water tubing segment has a back flow check valve. The irrigation (as applicable) and air/water segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's Tubing/Cap Sets are provided sterile and are disposable.

The provided text describes the 510(k) premarket notification for Erbe's Tubing/Cap Sets. This submission is for a Class II medical device (Product Code OCX) which is tubing and cap sets for endoscopes. The submission demonstrates substantial equivalence to legally marketed predicate devices, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance (such as sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance, and expert adjudication) is not applicable to this document.

However, based on the provided text, the acceptance criteria and supporting studies for the Erbe's Tubing/Cap Sets can be summarized as follows:

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

The following information is not applicable as the device is not an AI/ML powered device.

2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The ERBEFLO 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

In general; the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector will be manufactured with materials or agents that can be used in the medical device industry such as plastics, silicone, solvent, etc. The device adjoins an irrigation line of an of an ERBEFLO Tubing/Cap Set designated for a Pentax Scope to a Pentax Gastrointestinal Video Endoscope with a forward water jet channel for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated ERBEFLO Tubing/Cap Set for Pentax Scopes, back flow (check) valve, and housing (a scope specific connector for a Pentax Scope). The Port Connector is provided sterile, is single patient use, and is disposable.

The provided text describes a 510(k) premarket notification for the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector, which is an accessory to an endoscopic irrigation system. This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving de novo clinical effectiveness or diagnostic accuracy of an AI/ML device. Therefore, the questions related to AI/ML comparative effectiveness studies, standalone algorithm performance, and ground truth establishment for complex medical imaging interpretations are not applicable to this submission.

However, I can extract the relevant information from the document regarding the acceptance criteria and the studies performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Detailed Information as per Request:

1. A table of acceptance criteria and the reported device performance:
   (See table above)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify exact sample sizes for the functional and sterilization tests, nor does it refer to "test sets" in the context of clinical data/images. The evaluations focus on the physical device itself and its materials. There is no mention of data provenance (e.g., country of origin) as this is a device clearance based on engineering and biological testing, 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 (e.g. radiologist with 10 years of experience):
   Not applicable. This submission is for an accessory device based on engineering and materials testing, not for an AI/ML diagnostic or imaging device requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. No clinical test set or adjudication process is mentioned 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-assisted device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This is not an AI-driven algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable in the context of clinical ground truth. The "ground truth" for this device's performance would be established through industry standards for biocompatibility (e.g., ISO 10993), sterilization (e.g., ISO 11135), and functional testing (e.g., ISO 594 for luer connections).

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

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI/ML model.

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The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.

The ERBEFLO® 2 Disposable Tubing System, as described in K190469, is intended to provide a sterile water source through an irrigation pump and an endoscope for endoscopic procedures. The information provided outlines several evaluation and testing types that address different aspects of the device's performance, safety, and efficacy. However, it does not present a formal table of acceptance criteria with corresponding reported performance for each criterion. It rather lists the types of tests performed and general conclusions about meeting performance specifications or demonstrating adequacy.

Here's an attempt to structure the information based on the provided text, while acknowledging that a direct "acceptance criteria" table is not explicitly given:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any of the described tests (e.g., number of tubing systems, connectors, or test cycles). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The tests described are primarily engineering and performance evaluations, not diagnostic accuracy studies involving expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (functional, mechanical, sterility), an adjudication method in the context of expert consensus is not applicable.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on the safety and efficacy of the device itself through various engineering and sterilization tests, not on its impact on human readers' performance with or without AI assistance.

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

This question is not applicable as the ERBEFLO® 2 Disposable Tubing System is a physical medical device (tubing system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Established performance specifications (for visual inspection, flow, pressure, tensile strength, durability, connections).
• Recognized standards (for biocompatibility, sterilization, packaging, ethylene oxide residuals).
• Demonstrated functional properties (sufficient back flow protection, 24-hour multi-patient use, usability according to instructions).

8. The Sample Size for the Training Set

This information is not applicable as the product is a 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

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

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The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.

In general; the ERBEFLO® Olympus® Scope Port Connector will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, adhesive, etc. The device adjoins an irrigation line of an of an ERBEFLO 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated Olympus ERBEFLO Tubing/Cap Set, check (backflow) valve, and housing (a scope specific connector for an Olympus Scope). The Port Connector is provided sterile, is single patient use and is disposable.

The provided text describes the ERBEFLO® Olympus® Scope Port Connector and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain the specific information requested about acceptance criteria for device performance, the study that proves it meets those criteria, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.

The document focuses on the regulatory clearance process for a physical medical device (a port connector), not a device involving an algorithm or AI. Therefore, most of the requested fields are not applicable or cannot be extracted from this text.

I can, however, extract the information that is present:

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

The following requested information is not present in the provided text as the document pertains to a physical medical device and not an AI/algorithmic device:

• 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 a physical connector.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The evaluations are for material biocompatibility, functional performance, packaging, and sterility of a physical device.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

In general; Erbe's CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, nitrile rubber, acrylic, nylon, ink, solvent, adhesive, etc. The ERBEFLO CleverCap® CO2 devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation; whereas, the ERBEFLO AeroRinse® CO2 devices provide a conduit for water for endoscopic lens cleaning as well as air or CO2 for insufflation. There are three (3) types of Erbe's CO2 Tubing/Cap Sets for each group (i.e., ERBEFLO CleverCap® CO2and ERBEFLO AeroRinse® CO-) which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olymous, and Fujinon Gastrointestinal video Endoscopes). There are two subsets of Sets for the Olympus scope in aech group; one that attaches to standard CO2 sources and the other which specifically attaches to an Olympus CO2 Unit Model UCR. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set (as applicable- only for the ERBEFLO CleverCap® CO2 Sets) interfaces with a designated pump and via ERBEFLO 2 single use connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CQ2 Source through the Set's CO2 segment.]. The third and final segment for both the Olympus and Fujinon Sets is for connecting to a CO2 Source for CO2 insufflation. For each Set, both the irrigation (as applicable) as well as the air/water tubing segments has a backflow valve. The CO2 segment of the Sets have a standard female luer connector for access a CO₂ Source or in the case of specified Olympus Sets there is a connector on the CO2 segment designed to accessing the Olympus CO3 Unit Model UCR. All of the CO2 segments have a hydrophobic air/gas filter which filters particulates from the CO, Source and keeps fluid from flowing into the CO2 Source. The irrigation (as applicable), air/water, and CO2 segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's CO2 Tubing/Cap Sets are provided sterile and are disposable.

This document is a 510(k) premarket notification for a medical device (Erbe's CO2 Tubing/Cap Sets), and as such, it does not describe a study involving an AI/Machine Learning device or a diagnostic accuracy study with expert readers and ground truth establishment. Instead, it demonstrates substantial equivalence to a predicate device through a series of engineering tests and evaluations.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves an AI device meets them (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth types for AI models, training set details) are not applicable to this type of regulatory submission.

The document discusses performance testing for a physical medical device (tubing and cap sets) rather than an AI algorithm.

However, I can extract information related to the device's performance evaluation and acceptance criteria as presented in this 510(k) summary, interpreting "acceptance criteria" as meeting performance specifications for substantial equivalence.

Here's a breakdown of the device performance evaluation based on the provided document, addressing the relevant points from your request:

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

The document doesn't provide a quantitative table of specific acceptance criteria values and measured performance results in the way one would for an AI model's accuracy. Instead, it lists the types of tests performed and states that the proposed products "met established performance specifications" or "demonstrated safety and efficacy."

• Package integrity testing
• Visual inspection
• Flow testing
• Back flow pressure testing
• Pressure decay testing
• Tensile strength testing
• Durability testing (ensuring no leaks and connectability upon stressing Sets)
• Clamp testing |
  | Packaging Evaluation | Demonstrated adequacy and integrity of the packaging. |
  | Sterilization Evaluation | Demonstrated product sterility and met ethylene oxide residual requirements per recognized standards. |

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

• Sample Size: Not specified in the document. The document refers to "evaluations and tests" but does not give the number of units tested for each evaluation.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for this type of device testing. These are engineering and sterilization validation tests performed on manufactured units.

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

• Not Applicable. This document is for a physical medical device (tubing/cap sets), not an AI/ML diagnostic device that requires expert-established ground truth. Performance is evaluated against engineering specifications and recognized standards.

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

• Not Applicable. See point 3.

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 diagnostic device.

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

• Not Applicable. This is not an AI diagnostic device.

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

• Not Applicable. The "ground truth" for this device's performance is adherence to established engineering specifications, material biocompatibility standards, and sterility assurance levels, as verified through various physical and chemical tests (e.g., pressure measurements, flow rates, sterility tests, material compatibility tests).

8. The sample size for the training set

• Not Applicable. There is no "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 "training set" or its associated ground truth.

Summary of the Study (Device Performance Evaluation):

The "study" described in the 510(k) summary is a series of engineering and biological evaluations performed on the Erbe's CO2 Tubing/Cap Sets to demonstrate their safety and efficacy and establish substantial equivalence to a legally marketed predicate device (ERBEFLO CleverCap* Hybrid CO₂ Tubing/Cap Sets and Connector Tube, K132340).

The evaluations focused on:

• Biocompatibility: Ensuring materials used are safe for patient contact.
• Sterilization Validation: Proving the device can be consistently sterilized and that residuals are within limits.
• Packaging Integrity: Verifying the packaging maintains sterility and protects the device.
• Functional Performance: Testing various physical attributes like flow, pressure, tensile strength, durability, and leak prevention to ensure the device performs its intended function (providing sterile water, CO2/air to an endoscope) reliably.

The approach taken is purely for a traditional-hardware medical device and does not involve AI or machine learning components, human reader studies, or diagnostic performance metrics common in AI/ML submissions.

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ERBEJET® 2 System - The ERBEJET 2 is intended for lifting mucosal lesions by injection into the submucosa as well as the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) in open as well as endoscopic surgery.

HybridAPC Probe - The HybridAPC probe is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope and for HF ablation of the mucosal lesions by Argon Plasma Coagulation (APC).

The HybridAPC Probe is used with the ERBE Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator (APC) Model APC 2/ElectroSurgical Unit (ESU) VIO Model System. The Water Jet delivers pressurized sterile normal saline through the Probe to provide a saline cushion beneath mucosal lesions. The induction of the saline into the submucosa is a routine practice and acts as a cushion which can reduce/limit unwanted tissue damage (penetration depth) when applying argon plasma coagulation. The APC/ESU System with the Probe supplies ionized (electrically charged) argon gas to create the HF argon plasma for the ablation of the lifted lesions. The HybridAPC Probe consists of tubing to the Water Jet, a cable with a filter integrated connector for the APC, and dual lumen tubing. The inside lumen delivers the pressurized sterile normal saline and the outer lumen delivers the electrically charged argon gas for the HF argon plasma. Clinicians would attach the Probe to the Water Jet and APC/ESU System. Then the Probe is positioned at the operative site under direct visualization endoscopically. If an operative endoscope is utilized, the working channel must be greater than 2.5 mm. Upon the setup of the Water Jet and APC/ESU System, the Probe is ready for use. The pedal of the ERBEJET 2 footswitch activates its water-jet capabilities. The tip of the Probe is placed against a lesion and the saline accumulates within the submucosal layer which cushions the lesion. Then the tip of the Probe is placed in close proximity of the raised lesion (not touching/non-contact modality). Finally, the footswitch for the APC/ESU System is depressed which delivers the ionized argon gas to create the HF argon plasma for the ablation of the lesion. The HybridAPC Probe's dimensional working parameters (tubing/tip interfacing with scope as applicable/tissue) are 2.3 mm Outer Diameter, 1.9 m Length. The device is manufactured with typical materials or agents used in the medical device industry such as tungsten, stainless steel, plastics, silicone, etc. The HybridAPC Probe is provided sterile and is single use.

The document describes a 510(k) premarket notification for the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe. The focus is on demonstrating substantial equivalence to predicate devices, particularly regarding the new HybridAPC Probe and the added functionality of lifting mucosal lesions to the ERBEJET 2 System.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: The study used three (3) different ex-vivo tissue types (esophagus, stomach, and rectum) from pigs.
  • For coagulation/ablation testing, each tissue type was tested with and without submucosa lifting, and then with coagulation. Testing was done with minimum, default, and maximum intensity settings in triplicate (3X) for both the proposed and predicate devices.
  • For submucosa lift testing, the ERBE WaterJet System settings were Effect 40, 70, and 80 to deliver 2 ml, 3 ml, and 5 ml of 0.9% NaCl at an application angle of 90° into each specified tissue type in triplicate (3X) for both the proposed and predicate devices.
• Data Provenance: The data was generated from ex-vivo animal (pig) tissue. This indicates a lab-based, pre-clinical study. The data is prospective in the sense that the experiments were conducted specifically for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is ERBE USA, Inc. with the parent company ERBE Elektromedizin GmbH, suggesting European or US-based research.

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

This information is not provided in the document. The study involves macroscopic and histological examination, which implies expert assessment, but the number and qualifications of the individuals performing these assessments are not specified.

4. Adjudication method for the test set:

This information is not provided. Given the nature of macroscopic and histological examination, an adjudication method (such as independent expert review or consensus) would typically be employed, but it is not described.

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

This was not an MRMC comparative effectiveness study, nor does it involve AI. The study is a bench and ex-vivo animal study comparing a new medical device to predicate devices for its physical and functional performance, not human diagnostic performance.

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

This is not applicable. The device is an electrosurgical cutting and coagulation device with a waterjet and APC probe, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. The type of ground truth used:

• For the coagulation/ablation and thermal damage assessment: Macroscopic and histological examination of the ex-vivo pig tissues. This is a form of expert assessment of tissue damage and morphology.
• For the lifting/cushioning assessment: Macroscopic measurements for height and area of the created lift/cushion. This is an objective measurement based on the observed physical effect on the tissue.
• For the non-perforation test: Observation of the absence of detrimental damage (perforation) to the tissue.

8. The sample size for the training set:

This is not applicable/not provided. This study describes a pre-market submission for a physical medical device, not an AI/ML algorithm that would typically have a training set. The term "training set" is generally used in the context of machine learning model development.

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

This is not applicable/not provided for the same reasons as #8.

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The ERBECRYO 2 Cryosurgical Unit and Accessories are intended for (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion.

Clinical Indications for Cryosurgery:

| Gynecology: | Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative),
Neoplasia |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Dermatology: | Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor (palliative), Warts, Naephus |
| Ophthalmology: | Ablatio Retinae, Glaucoma, Lid Tumor |
| ENT: | Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma, Angioma, Haemangioma |
| Thoracic Surgery: | Post-Operative |
| Urology: | Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative) |
| Phlebology: | Varicose Veins of the Lower Limbs (Cryo Stripping) |
| Proctology: | Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor (palliative), Rectal Tumor
(palliative), Acute Anal Fissures |
| Pulmonology: | Tumors, Granulomatous Tissue, Malignant Lesions (palliative) |
| Pneumology: | Tracheobronchial Stenoses (Cryo re-canalization) |

The ERBECRYO 2 Cryosurgical Unit and Accessories consists of a cryosurgical unit, probes with a cryosurgical tip, a connecting hose to be connected to a CO2 (Carbon Dioxide) gas bottle and a footswitch for activation. The system is mounted on a cart, which also carries up to two CO2 gas bottles.

The ERBECRYO 2 Cryosurgical Unit and Accessories is used to apply extreme cold to tissue during surgical procedures. The system uses the Joule-Thomson principle where pressurized gas expands through a fine orifice inside the tip of the cryosurgical probe producing a rapid drop in temperature and freezing the probe tip and the surrounding tissue.

The unit and accessories are provided non sterile. The cryoprobes are reusable and directions for cleaning and sterilizing the cryosurgical probes are provided in the Notes on Use.

Design and materials of the ERBECRYO 2 Cryosurgical probes are very similar to the predicate probes.

I am sorry, but based on the provided text, there is no information about a study that describes acceptance criteria and proves the device meets those criteria. The document is a 510(k) premarket notification for a medical device (ERBE ERBECRYO 2 Cryosurgical Unit and Accessories), which focuses on demonstrating substantial equivalence to a predicate device.

The document mentions "Physical and Performance Testing" and states that "The system conforms with the following standards" and lists several international standards (e.g., EN ISO 14971, ANSI/AAMI ES60601-1). It also notes that "The intended use was validated in comparative tissue studies against the predicate system. The performance was similar for both systems." However, it does not provide:

• A table of specific acceptance criteria.
• Reported device performance against such criteria.
• Details about sample sizes for test sets, data provenance, or ground truth establishment.
• Information on expert involvement or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them from the given text.

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The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The Endo QuickConnect Scope Port Connectors will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, solvent, etc. The devices respectively adjoin an irrigation line of an ERBEFLO tubing/cap set to a designated gastrointestinal video endoscope. This line is a conduit for water to irrigate in endoscopic procedures. Each Port Connector has a standard female luer lock connection that attaches to an ERBEFLO tubing/cap set, backflow valve, and a scope specific connector (for an Olympus® or Pentax® Scope). The Port Connectors are provided sterile and are disposable.

The provided text describes the regulatory clearance of a medical device, the ERBEFLO® 2 Endo QuickConnect Scope Port Connectors, and outlines the testing conducted to demonstrate its safety and efficacy. However, it does not contain the level of detail requested for acceptance criteria and a structured study demonstrating performance against those criteria.

Specifically, it does not include:

• A table of acceptance criteria with specific performance metrics and reported values.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance, as these are typically relevant for AI/software devices. This device is a hardware accessory.
• Details on the training set or its ground truth establishment, again, not relevant for this type of hardware device.

Instead, the document focuses on comparative testing against a legally marketed predicate device (ERBEFLO® 2 Disposable Tubing System, K103235) to establish substantial equivalence for regulatory approval.

Here's a summary of the available information and an explanation of why many of your specific requests cannot be fully addressed from this document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes evaluations and testing without providing specific numeric acceptance criteria or detailed quantitative results in a table format. The reported performance is qualitative and comparative.

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

• Test Set Sample Size: Not explicitly stated. The "Performance Feasibility Testing" and "2X Sterilization Functional Testing" imply that a sample of the new connectors was tested, but the exact number isn't provided.
• Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective) for a hardware accessory. The testing was likely conducted in a controlled lab environment by the manufacturer (ERBE USA, Inc.).

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

• Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant for the performance testing of a sterile scope port connector. The "ground truth" for this device's performance would be engineering specifications and established test protocols (e.g., measuring flow rate, pressure resistance, sterility).

4. Adjudication method for the test set:

• Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used for interpreting results from human observations or AI outputs in areas like radiology. The testing described here involves objective physical and biological measurements.

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

• No, this type of study was not done. MRMC studies are usually for evaluating diagnostic imaging software/AI's impact on human readers, which is not applicable to a physical medical device like a scope port connector.

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

• Not applicable. This device is a passive hardware accessory, not an algorithm or software. Its "performance" is inherent in its physical properties and function, not an algorithmic output.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on engineering specifications, material science standards (biocompatibility), and established test methodologies for fluid dynamics (flow, pressure, leaks), sterility, and packaging integrity. It's not based on expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing are based on established engineering principles and prior device experience (predicate device).

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

• Not applicable, as there is no training set for this hardware device.

In conclusion: The provided document is a regulatory approval letter and 510(k) summary for a physical medical device. It successfully demonstrates "substantial equivalence" to a predicate device through various engineering and material tests. However, the nature of this device (a connector, not an AI, diagnostic, or therapeutic system) means that many of the detailed questions regarding acceptance criteria, ground truth, and study methodologies (especially those related to AI/software performance) are not directly applicable or documented in the format you've requested. The regulatory submission focused on proving that the new device is as safe and effective as the existing, legally marketed device through direct comparison of features and performance characteristics.

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The ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

In general; the Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tubes will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, nickel plated brass, nitrile rubber, acrylic, nylon, ink. solvent, adhesive, etc. The devices provide as a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation.

There are three (3) types of ERBEFLO CleverCap Hybrid CO>Tubing/Cap Sets for which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olympus, and Fujinon) along with one (1) CO2 Connector Tube to attach to a CO2 source. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CO2 Source through a CO2 Connector Tube and a Pentax CO2 Adaptor (Pentax part #OF-G11).]. The third and final seqment for both the Olympus and Fujinon Sets is for connecting to the CO2 Connector Tube for CO2 insufflation. For each Set, both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to close the tubing while not in use. Additionally, each Set is designed for use with designated irrigation pumps and has an air/water connector(s) for its specified The Hybrid CO2Tubing/Cap Sets are provided sterile and are endoscope. disposable.

The CO₂ Connector Tube has a standard female luer connector for accessing a CO₂ Source. The other end of the Tube has a hydrophobic air/gas filter which filters particulates from the CO2 Source and keeps fluid from flowing into the CQ2 Source. The filtered end of the CO2 Connector Tube attaches to the CO2 segments of the Sets or in the case of the Pentax Set, the Pentax CO2 Adaptor that adjoins the Set to the Endoscope. The CO2 Connector Tube is provided non-sterile and is disposable.

The provided text describes a medical device, the ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube, and its review process for 510(k) clearance. However, it does not contain information related to software algorithms, AI, or diagnostic performance metrics typically associated with AI/ML device studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or answer most of the specific questions you've asked, as it appears this is a submission for a physical medical device (tubing and caps) and not a software-driven diagnostic tool.

The document focuses on demonstrating substantial equivalence to predicate devices through various non-AI related evaluations and tests, such as:

• Biological Evaluation: To ensure biocompatibility of materials.
• Performance Feasibility Testing: Comparing flow performance to predicate devices.
• Flow Rate Testing: Measuring irrigation and lens cleaning flow rates.
• Pressure Testing: Ensuring the device can withstand maximum internal pressures.
• Durability Testing: Confirming suitability for 24-hour use.
• 2X Sterilization Functional Testing: Verifying performance after double sterilization.
• Packaging Evaluation: Assessing adequacy and integrity of packaging.
• Sterilization Evaluation: Demonstrating product sterility.

These tests are designed to show that the new device is as safe and effective as existing legally marketed devices, rather than to prove diagnostic accuracy from an AI algorithm.

Summary of what can be extracted from the provided text regarding "acceptance criteria" and "study":

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

   • Acceptance Criteria (Implied): The device must perform comparably to or better than predicate devices in terms of flow performance, flow rates (irrigation and lens cleaning), withstand maximum internal pressures, be durable for 24-hour use, retain functionality after 2X sterilization, and be biocompatible. Packaging must be adequate, and sterility must be demonstrated according to recognized standards.
   • Reported Device Performance:
     • Biological Evaluation: "demonstrated that there were no biocompatibility issues."
     • Performance Feasibility Testing: "showed that the flow performance... was as good or better than the predicate devices."
     • Flow Rate Testing: "were found to be comparable to or better than the predicate devices and/or commercially available products."
     • Pressure Testing: "demonstrated that the proposed devices would withstand maximum internal pressures."
     • Durability Testing: "proved durable for 24 hour use."
     • 2X Sterilization Functional Testing: "met established performance specifications."
     • Packaging Evaluation: "demonstrated the adequacy and integrity."
     • Sterilization Evaluation: "demonstrate product sterility."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described in the provided text. The document refers to "evaluations and tests" but does not detail sample sizes for these tests, nor does it mention data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or described. The "ground truth" here is based on engineering specifications and performance benchmarks, not expert diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" or reference standard for this device's performance evaluation would be defined engineering specifications, established scientific methods (e.g., for flow rates, pressure resistance, sterility), and comparison to the performance of the predicate device.

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

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications. The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible. Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables.

The provided document describes a Special 510(k) for an updated electrosurgical unit (ESU), the ERBE ESU Model VIO dV with Accessories. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics for an AI algorithm.

Therefore, many of the requested elements regarding acceptance criteria for device performance, sample sizes for test and training sets, expert involvement, and ground truth establishment are not applicable to this type of device submission. The focus here is on design control, verification, and validation against recognized consensus standards, and demonstrating that the modifications do not raise new questions of safety or effectiveness.

Here's a breakdown of the available information:

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

• Not applicable in the context of a 510(k) for an ESU based on substantial equivalence. The submission focuses on demonstrating that the modified device's performance, as verified through design controls and testing to recognized consensus standards, is equivalent to the predicate device. Specific numerical "acceptance criteria" and "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, F1-score for AI) are not provided nor typically required for this type of medical device.
• The document states: "The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards"." This implies adherence to established engineering and safety standards relevant to ESUs, which serve as the "acceptance criteria" for the device's technical functionality and safety.

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. This information is relevant for studies involving data-driven algorithms (like AI/ML) where test sets are used to evaluate model performance on unseen data. This document describes a hardware device (electrosurgical unit), not a data-driven algorithm requiring a test set in that sense. Testing would involve engineering verification and validation on physical units to ensure compliance with standards.

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

• Not applicable. "Ground truth" in the context of expert consensus is typically used for AI/ML performance evaluation. For an ESU, the "truth" is its ability to safely and effectively cut and coagulate tissue as specified by engineering standards, verified through testing, not through expert-labeled data.

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

• Not applicable. Adjudication methods are used in studies where multiple human readers or algorithms produce outputs that need to be resolved to establish a definitive ground truth. This is not relevant to the verification and validation of an ESU's hardware and software against engineering standards.

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. MRMC studies are used to evaluate the impact of AI assistance on human reader performance, typically in diagnostic imaging. This device is an electrosurgical unit, not an AI diagnostic tool.

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

• Not applicable. This question pertains to the performance of an AI algorithm independently. The device described is a medical instrument (ESU) that operates under human control, not an autonomous AI algorithm.

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

• Not applicable in the AI/ML context. For this device, the "ground truth" for verification and validation would be adherence to recognized consensus standards for electrical safety, electromagnetic compatibility, performance characteristics (e.g., power output, voltage curves for different modes), and functional specifications. This is established through objective measurements and compliance with regulatory standards.

8. The sample size for the training set

• Not applicable. This information is relevant for machine learning algorithms. The ESU is a hardware device with programmed functionalities, not a system that is "trained" on a dataset in the AI sense.

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

• Not applicable. As above, the concept of a "training set" and "ground truth" for it is not relevant to this ESU's design and approval process.

Summary of Device Acceptance / Study Information from the Document:

• Acceptance Criteria Basis: The primary "acceptance criteria" for this Special 510(k) submission are based on demonstrating substantial equivalence to the predicate device (ERBE ESU Model VIO 300 D) and compliance with FDA's "Recognized Consensus Standards."
• Study Proving Acceptance: The study conducted was a design control process involving:
  • Design and development planning: (Page 3)
  • Design input: (Page 3)
  • Design review: (Page 3)
  • Design verification/design output: (Page 3)
  • Design validation: (Page 3)
  • Design transfer: (Page 3)
  • Design change control: (Page 3)
• Specific evidence of meeting acceptance criteria:
  • "The ERBE ESU Model VIO dV with Accessories has been verified or validated in design control." (Page 3)
  • "The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards"." (Page 3)
  • The conclusion explicitly states: "The ERBE ESU Model VIO dV with Accessories has the same intended use, principles of operation and technological characteristics as the predicate device... The subject device has been verified or validated in design control. In conclusion, there are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices." (Page 3)
• Nature of Testing: The document indicates that animal or clinical performance testing was not considered necessary (Page 3), reinforcing that the acceptance was based on engineering verification, validation, and standard compliance, demonstrating equivalence to a lawfully marketed predicate device.

In essence, the "study" for this device was its robust design and development process, including verification and validation activities conducted according to established procedures and adherence to recognized consensus standards, which collectively demonstrated its safety and effectiveness as being substantially equivalent to the predicate device.

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