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Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.

Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments.

The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized.

The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier.

The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations:

• Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
• Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
• Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) .

The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).

This document is a 510(k) Summary for a medical device (Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not to present a comparative effectiveness study or a detailed algorithm performance study for an AI/ML enabled device.

Therefore, the provided text does not contain the information required to populate most of the fields in your request, such as a formal acceptance criteria table with reported performance specific to an AI device, sample sizes for test/training sets of AI models, details about expert ground truth establishment, or MRMC study results. The non-clinical performance testing described focuses on standard medical device validation (e.g., sterilization, biocompatibility, physical properties) rather than AI model performance.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance Study (Non-AI Device)

This document is a 510(k) submission for a non-AI medical device (Hydrophilic Intermittent Catheter). The "acceptance criteria" here refer to testing to ensure the device meets established standards and performs comparably to predicate devices, rather than a statistical performance threshold for an AI algorithm. The "study" refers to non-clinical bench testing, packaging tests, aging tests, and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical medical device (catheter) and not an AI device, "acceptance criteria" and "reported device performance" are described in terms of compliance with relevant international standards and successful bench testing, rather than metrics like sensitivity, specificity, or AUC for an AI model. Therefore, a table structured for AI performance metrics is not directly applicable. However, we can reframe the "acceptance criteria" as the types of tests performed and the "reported device performance" as compliance with those tests and standards.

2. Sample Size for Test Set and Data Provenance

This document describes a medical device (catheter) validation, not an AI/ML model study. Therefore, the concept of a "test set" in the AI/ML sense (a dataset used to evaluate a trained model) does not apply. The validation involves various physical, chemical, and biological tests on samples of the manufactured device. The document does not specify the exact number of units or samples used for each bench test, but it indicates the tests were performed to demonstrate compliance with relevant standards.

• Date Provenance: The manufacturing entity is Well Lead Medical Co., Ltd. in Guangzhou, China. The testing would have been conducted on devices manufactured within their facility or by contracted laboratories. The origin of the data (i.e., test results) is from these non-clinical, controlled tests. It is not "retrospective" or "prospective" in the clinical study sense for data collection.

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

Not applicable. For a physical medical device like a catheter, "ground truth" is established by adherence to engineering specifications, material properties, sterility, and biocompatibility. This is determined through objective testing against widely accepted standards (e.g., ISO, ASTM), rather than by expert consensus on clinical data similar to an AI diagnostic device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies or AI algorithm validation where expert disagreement on ground truth labels needs to be resolved. For standard device testing, compliance to a defined physical, chemical, or biological specification is measured objectively.

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

Not applicable. An MRMC study assesses the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). This device is a physical catheter, not an AI-enabled diagnostic tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's validation is based on:

• Compliance with international standards (e.g., ISO, ASTM for sterility, biocompatibility, physical properties).
• Objective measurements from bench testing (e.g., pH, osmolarity, strength, seal integrity).
• Established material science and biological compatibility criteria.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is not an AI/ML algorithm.

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The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the urethra for emptying the bladder.

The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments. The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet. The catheter is intended to be used for less than 24 hours based on the biocompatibility information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).

This document is a 510(k) Premarket Notification for a medical device (Wellead® PVC Hydrophilic Urethral Catheter), not a study report for an AI/ML-driven device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, training set details, or effect size of AI assistance on human readers.

The document discusses the substantial equivalence of the subject device to predicate devices based on bench testing and biocompatibility testing, rather than clinical performance studies involving AI or human interpretation of results.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria for AI/ML Performance: The acceptance criteria listed in the document (ASTM, ISO standards for physical properties, biocompatibility) are for a physical medical device (catheter), not a software or AI/ML device that requires performance metrics like sensitivity, specificity, or AUC.
• Study Design for AI/ML Performance: The "Test Summary" section outlines laboratory bench tests and biological evaluations for the catheter, not diagnostic performance studies like those typically conducted for AI/ML algorithms.
• AI/ML Specifics (Sample Size, Ground Truth, Experts, MRMC): These concepts are entirely absent because the device is a physical catheter, not an AI/ML algorithm. There are no "test sets" of data for an AI to analyze, no "ground truth" to establish for an AI, and no "human readers" whose performance is assisted by AI.

In summary, this document is for a traditional medical device clearance, not an AI/ML device, and thus does not contain the type of information you've requested.

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The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).

Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.

The document describes a 510(k) premarket notification for a medical device, the Wellead® Ureteral Catheter (K220036). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. While it includes "Test Summary" and "Comparison to predicate device and conclusion" sections, it does not present acceptance criteria or a study design in the way typically expected for assessing AI/ML-based device performance.

This document focuses on the physical and material properties of a non-AI/ML medical device (a ureteral catheter) and its equivalence to a predicate device. Therefore, many of the requested items related to AI/ML device performance (like expert adjudication, MRMC studies, standalone performance, training sets) are not applicable.

Here's an interpretation of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail performance metric for the device's intended use. Instead, it relies on demonstrating that the subject device's various characteristics are equivalent to a predicate device and meet relevant industry standards.

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

The document refers to various "lab bench testing" (e.g., for ASTM, ISO standards) but does not provide specific sample sizes for these tests. It indicates that the tests were performed on the "Ureteral Catheter," implying testing was done on samples of the subject device. The provenance of these test results is from the manufacturer, Well Lead Medical Co., Ltd. in China.

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

This information is not applicable as the device is a physical medical instrument, not an AI/ML system that requires expert interpretation for a "ground truth" test set. The "ground truth" here is the physical and biological performance as measured by objective engineering and biocompatibility tests against established standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as above. Testing involved objective measurements against standards, not subjective interpretation requiring adjudication.

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

This is not applicable as the device is not an AI-assisted diagnostic or imaging device. There is no human-in-the-loop component for which an MRMC study would be performed.

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

This is not applicable as the device is a physical ureteral catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is based on:

• Compliance with international and national standards (e.g., ISO 10993, ASTM F1929, EN 1618).
• Objective physical and chemical measurements (e.g., tensile strength, leakage, radiopacity, cytotoxicity, sensitization, irritation).
• Demonstrated equivalence to a predicate device (Cook Incorporated's Ureteral Catheters, K171662) which itself was previously cleared based on similar principles.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a "training set."

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

This is not applicable for the same reasons as above. There is no training set for this type of device.

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WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.

Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.

The provided text pertains to a 510(k) Premarket Notification for the "Wei Nasal Jet Tube" and describes non-clinical performance testing. It does not describe a study that proves the device meets acceptance criteria for an AI/ML powered medical device. Therefore, I cannot extract the information required to answer your query regarding AI/ML device acceptance criteria and study details.

The document focuses on:

• Substantial Equivalence (SE) determination: Comparing the proposed device to a predicate device (Boussignac/Vygon Endotracheal Tube).
• Non-clinical performance testing: This includes physical dimension tests (length, diameter, curvature, bevel angle, kink resistance), connector strength tests, and biocompatibility tests, sterilization validation, and shelf-life studies.
• No clinical study: The document explicitly states, "No clinical study is included in this submission." ([Page 11])

The provided text does not contain any information about:

• An AI/ML powered medical device.
• Acceptance criteria for an AI/ML device (e.g., sensitivity, specificity, accuracy).
• A test set, training set, or ground truth establishment for an AI/ML model.
• Expert involvement (number, qualifications, adjudication methods) for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided input.

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Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope.

The Endoscopic Seal is mounted to the proximal port of the endoscope working channel and intended to resist the backflow of distention fluid when the channel is not being used or when instruments are passed through the working channel.

The Endoscopic Seal consists of a silicone seal, an introducer, and an adapter with sealing ring (optional). The Introducer is used to enable improved access during endoscopic procedures. The Adapter and Sealing Ringare optional for Endoscopic Seal. They are used with the non-standard Luer endoscopes.

The silicone seal combined with introducer can be used with all endoscopes with the proximal port of the working channel between 6 mm to 9 mm in its largest outside diameter. Mount the silicone seal onto the working channel of the Endoscope. Make sure the connection is tight. Insert the introducer into the silicone seal.If using the WOLF endoscope, mount the adapter with sealing ring onto the endoscope working channel port first and then place the silicone seal and introducer onto the adapter.

The provided text is a 510(k) Summary for the Endoscopic Seal. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and comparisons, rather than providing details of a clinical study with acceptance criteria and device performance metrics in the way you've outlined for a typical AI/software device.

Therefore, for aspects related to clinical performance, ground truth, expert involvement, and AI-specific studies (MRMC, standalone), the information is not applicable as this device is a physical medical device (an endoscopic seal), not an AI/software as a medical device (SaMD).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various bench tests conducted to demonstrate the safety and performance of the Endoscopic Seal. It does not explicitly state "acceptance criteria" in a quantitative format for most tests, but rather implies that the device "meets the requirements" or is "identical to the predicated device."

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

• Test Set Sample Size: Not explicitly stated. The tests are bench tests on the device hardware itself, not clinical data.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting.

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

• Not Applicable. This is a physical device, and the "ground truth" is established by adhering to established engineering and biocompatibility standards.

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

• Not Applicable. This is a physical device.

5. If a multi-reader multicase (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 is a physical device, not an AI/software.

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

• No. This is a physical device, not a standalone algorithm.

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

• For the physical and biocompatibility testing, the "ground truth" is defined by the acceptance criteria and methodologies specified in the cited ASTM and ISO international standards. Successful completion of these tests according to the standards serves as the evidence of compliance.

8. The sample size for the training set:

• Not Applicable. This device does not involve a training set for an algorithm.

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

• Not Applicable. This device does not involve a training set for an algorithm.

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All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals.

The All Silicone Foley Catheter with Temperature Sensor is made from medical grade silicone, consists of temperature sensor for monitoring core body temperature and Foley catheter including a shaft, drainage funnel, inflation funnel, balloon, valve, and X-ray opaque line. The device is provided sterile by ethylene oxide and is for single use only. It is provided in a variety of sizes and color-coded by size.

The provided text is a 510(k) summary for a medical device called "All Silicone Foley Catheter with Temperature Sensor." It discusses the device's intended use, description, and comparison to a predicate device, focusing on its MR compatibility. However, the document does not contain information regarding acceptance criteria and a study proving that the device meets these criteria in the context of AI/ML performance.

The document is a regulatory submission for a physical medical device (catheter) and the "testing" mentioned refers to bench-top non-clinical testing for MR compatibility of the physical device, not performance benchmarks for an AI/ML algorithm.

Therefore, I cannot extract the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance (for an AI/ML system).
2. Sample size used for an AI/ML test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for AI/ML.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during endoscopic procedures.

The ClearPetra Suction-Evacuation Sheath consists of a straight distal tube and a proximal bifurcated tube. The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance. One segment of the proximal bifurcated tube is straight and is contiguous with the distal tube. The other is constructed in an oblique angle with a longitudinal pressure control vent. An obturator is included for the insertion of the sheath. The obturator can be locked to the proximal end of the straight tube using a luer lock mechanism. A rubber cap with central aperture is included as an accessory. It is to be placed at the proximal end of the straight tube after the removal of the obturator. The oblique tube is to be connected directly to a negative pressure aspirator with a clear tube or alternatively, connected to a specimen collector (packed separately) then onto a negative pressure aspirator.

The provided document is a 510(k) Summary for a medical device called the "ClearPetra Suction-Evacuation Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device (K161110 - ClearPetra Suction-Evacuation Sheath) rather than presenting a performance study against specific acceptance criteria for a new AI/software device.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth are not applicable in this context, as this submission is for a modified hardware device, not an AI software.

Here's an analysis based on the information provided in the document:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, etc.) for a diagnostic or AI device. Instead, it relies on comparison to a predicate device and bench testing to demonstrate that the modifications do not negatively impact safety and effectiveness.

The "acceptance criteria" can be inferred from the "Verdict" column in the comparison table and the subsequent non-clinical testing. These broadly aim to demonstrate that the modified device performs as well as or similarly to the predicate device, or within acceptable safety parameters for the new specifications.

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

This information is not provided in the document. The studies mentioned are primarily "Non-Clinical Testing" and "Bench Testing" rather than clinical studies with human participants. Therefore, concepts like "test set," "data provenance," and "retrospective/prospective" as they relate to clinical data are not applicable here. The testing would have likely involved physical samples of the device components.

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

This information is not applicable as the document describes a hardware device modification and bench testing, not a study requiring expert-established ground truth for diagnostic accuracy (e.g., for an AI system evaluating medical images).

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

This information is not applicable for the same reasons as above. No clinical expert adjudication is mentioned or implied for the non-clinical testing performed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. This type of study is relevant for AI-powered diagnostic aids, not for the modification of a physical medical device like a suction-evacuation sheath.

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

A standalone performance study of an algorithm is not applicable as this submission is for a physical medical device, not an algorithm or AI software.

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

The concept of "ground truth" (in the context of expert consensus, pathology, or outcomes data) is not applicable here. The ground for determination of "acceptance" or "substantial equivalence" relies on:

• Physical/material specifications comparison.
• Biocompatibility testing against ISO standards.
• Performance bench testing results demonstrating functional equivalence and intended performance.
• Sterilization validation.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm or software being trained.

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

This information is not applicable as there is no AI algorithm or software being trained.

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The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.

The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Endotracheal Tube with Evacuation Lumen." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria in the way AI/ML devices might.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document.

This FDA clearance is based on the device being substantially equivalent to a predicate device (K110269-Well Lead Endotracheal Tube with Evacuation Lumen), primarily by demonstrating that material modifications (changing PVC containing DEHP to DEHP-free PVC and PU) did not alter the intended use, fundamental scientific technology, or raise new safety and effectiveness issues.

Here's a breakdown of why your specific questions aren't addressed:

• Clinical Performance vs. Substantial Equivalence: This submission is about comparing a modified device to an existing one, not about establishing novel clinical performance metrics with an AI/ML algorithm.
• No AI/ML Component: The device is a physical medical device (an endotracheal tube), not an AI/ML software device. Therefore, there are no "algorithms," "training sets," "test sets," "expert readers," or "ground truth" to evaluate in the context of an AI's diagnostic or predictive performance.
• Focus on Bench Testing and Biocompatibility: The "study" mentioned for this device is non-clinical performance testing (bench testing) and biocompatibility testing to ensure the new materials and design maintain the same safety and performance characteristics as the predicate device.

However, I can extract information relevant to the device's validation and the comparison made for substantial equivalence:

Device Name: Endotracheal Tube with Evacuation Lumen

Predicate Device: K110269-Well Lead Endotracheal Tube with Evacuation Lumen

Reason for New Submission: The only modification made is to the materials of the cuff, main tube, inflation tube, suction line, and pilot balloon, changing from PVC containing DEHP to DEHP-free PVC and PU.

1. Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing):

The acceptance criteria here are implicitly that the modified device performs as well as the predicate device and meets established safety/performance standards for endotracheal tubes. The study involved a series of bench tests and biocompatibility tests.

• Suction Line O.D. & Length
• Tensile Force Test (Inflating tube and tracheal tube)
• Tensile Force Test (Suction tube and the connector of suction tube)
• Negative Pressure Resistance of Suction Line
  Conclusion: "Bench-top testing was conducted to assure conformance to... standards" and "The test results demonstrated that the device meets the performance requirements for its intended use." (Implies meeting or being equivalent to predicate device performance). |
  | Biocompatibility | Performed in accordance with ISO 10993-1.
  Specific tests:
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous reactivity
• Acute systemic toxicity
• Subchronic systemic toxicity
• Genotoxicity
• Material-mediate pyrogenicity
• Implantation
  Conclusion: "Biocompatibility testing provided in this submission demonstrate that the modified Endotracheal Tube with Evacuation Lumen is as safe and effective and performs as well as the predicate device." |
  | Sterilization | Validation of Ethylene Oxide sterilization.
  Conclusion: "Sterilization by ethylene oxide has been validated for Endotracheal Tube with Evacuation Lumen." |
  | Risk Analysis | Performed according to ISO 14971 - Medical Devices Application of risk management to medical devices, using "Failure Mode and Effect Analysis" technique.
  Conclusion: "No new issues of safety and effectiveness were identified during this process." |

The following information is not applicable to this 510(k) submission for a physical medical device. These questions are typically asked for AI/ML-driven diagnostic devices.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis for AI.
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. No "ground truth" in this AI/ML sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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 Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.

The Stomach Tube is a sterile, single-use tube manufactured in various sizes from medical grade PVC. The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The tube is inserted into a patient's stomach through the patient's nose or mouth.

The Stomach Tube is supplied in French size ranging from 6 to 22, consists of main tube and connector. The stomach tube connector connects to suction device for suctioning, The tube is available in open tip and closed tip form. It is composed of biologically safe materials and supplied sterile and intended for single use only.

The Stomach Tube device, K162340, is a non-AI device. The provided text does not contain information about acceptance criteria and performances related to AI/ML technology. Therefore, the questions related to AI/ML technology (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, how ground truth for training set was established) are not applicable.

Here's the information regarding the device's acceptance criteria and the study proving it meets them:

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

The provided text states that "The Stomach Tube meets all the pre-determined testing and acceptance criteria" but does not explicitly list the specific acceptance criteria and detailed performance results for each test. Instead, it broadly lists the types of tests conducted.

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

Not applicable as this is not an AI/ML device. The performance testing refers to physical product testing. The document does not specify the sample size used for each physical test or the origin of the test data (e.g., specific country for collecting samples).

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

Not applicable as this is a non-AI/ML device. Ground truth is not established by human experts in this context; performance is determined by established engineering and biological testing methods.

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

Not applicable as this is a non-AI/ML device. Adjudication methods are typically relevant for human expert review in diagnostic studies, not for physical performance testing of a medical device like a stomach tube.

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 a non-AI/ML device.

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

Not applicable as this is a non-AI/ML device.

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

For the non-clinical performance testing, the "ground truth" is based on established engineering standards and biological testing protocols. For instance:

• General performance testing (Dimensions, Leakage, Flow Rate, Tensile, Suction Tubing Collapse): The ground truth is determined by the specifications and tolerances defined in relevant engineering standards or internal company specifications for the device's physical properties and functional performance. It is measured objectively using instruments and procedures.
• Biocompatibility testing (Cytotoxicity, Irritation, Sensitization): The ground truth is established by the results of biological assays performed according to ISO 10993 standards, which assess the material's interaction with biological systems. The "truth" is whether the material elicits an adverse biological response according to the defined criteria of these standards.

8. The sample size for the training set

Not applicable as this is a non-AI/ML device.

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

Not applicable as this is a non-AI/ML device.

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The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

The Well Lead Extraction Bag is used for removal of tissue specimens during a suitable laparoscopic surgery.The device consists of a cylindrical sheath, a pusher and a polyurethane bag that minimizes spillage and intraoperative contamination by isolating and containing specimens. The bag is made of biocompatible high strength PU material, it is transparent and soft. which makes a qood visuality.

The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. It's easy to enter, open, close and exit, higher efficiency, and different type and size available. It is offerd in 4 types: Type B, Type C, Type D and range in bag volume from 200ml for different surgery needs. The well thought-out rang of types and sizes are suitable for all laparoscopic procedures. The main differences between all types are the deployment system and operation method.

The provided text describes a 510(k) submission for the "Well Lead Extraction Bag" and focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not explicitly present in the provided document, as they are not typically required for a 510(k) for this type of device.

However, I can extract information related to non-clinical performance testing and what constitutes the acceptance criteria as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Testing datas and results are included in this submission" but does not specify the sample size for the non-clinical performance tests (e.g., how many bags were tested for leakage, tensile strength, etc.).
The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, likely conducted in China where the manufacturer (WELL LEAD MEDICAL CO., LTD.) is located. The tests are non-clinical, so terms like "retrospective or prospective" do not directly apply in the same way they would to human subject studies.

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

Not applicable/Not provided. For non-clinical performance testing of a medical device like an extraction bag, ground truth is established through standardized engineering and laboratory testing protocols, not by expert human graders. The "experts" involved would be technicians or engineers conducting the tests and interpreting the results according to the specified standards (e.g., ISO standards for biocompatibility).

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

Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment where there might be disagreements in interpretation. For objective, non-clinical performance tests, results are typically quantitative and assessed against a pre-defined pass/fail threshold, not through an adjudication process.

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 device is an extraction bag, a physical surgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is entirely irrelevant and was not conducted.

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

No. This question applies to AI algorithms. As mentioned above, the device is a physical surgical tool, not an AI algorithm.

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

For the non-clinical performance tests:

• Engineering specifications and recognized standards (e.g., criteria for what constitutes a "leak," a specified "rated volume," or a minimum "tensile strength").
• Biocompatibility standards (ISO 10993 series) define the ground truth for assessing non-toxic, non-irritating, and non-sensitizing properties of materials.

8. The sample size for the training set

Not applicable/Not provided. This question pertains to machine learning models. The Well Lead Extraction Bag is a physical device, so there is no "training set" in this context.

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

Not applicable/Not provided. As there is no training set for this device, this question is irrelevant.

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