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The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

The Ready-to-Use Hydrophilic Catheter is a single use, disposable polyurethane catheter. It is coated and placed in the water, packed and sealed in a foil bag and sterilized. The catheter is prelubricated with a coating containing polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film. The Ready-to-Use Hydrophilic Catheter is available for men, women and children, in three different tip configurations of Nelaton (straight and rounded), Tapered (curved and tapered) and Olive (curved and olive), in single or combination with an insertion aid (a sleeve) which provides an easy grip, allowing for insertion without touching. There are two polished drainage eyelets on the catheter in various configurations and types. The Tiemann catheter has a bended tip along with a guide stripe (in the shaft) and/or aligned with a raised ridge (on the funnel), which will help ensure the catheter tip is still correctly oriented when approaching the bladder.

The provided text describes a 510(k) premarket notification for a "Ready-to-Use Hydrophilic Catheter." The acceptance criteria and the study that proves the device meets them are outlined in the "Summary of Non-Clinical Testing" section (page 6).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests met the pre-determined acceptance criteria." It does not provide specific numerical acceptance criteria or detailed numerical performance results for each test. Instead, it lists the properties tested and the standards used.

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

The document does not explicitly state the sample sizes used for the non-clinical bench testing. It also does not discuss data provenance in terms of country of origin or whether studies were retrospective or prospective, as these are non-clinical bench tests, not clinical studies involving human subjects.

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

This information is not applicable. The tests conducted were non-clinical bench tests (e.g., strength, flow rate, biocompatibility) based on international and internal standards, which do not involve expert consensus for ground truth determination in the same way clinical studies with human subjects or image analysis algorithms would. The "ground truth" for these tests is defined by the objective pass/fail criteria established within the cited standards.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews where there's a need to resolve discrepancies among multiple human readers or observers.

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

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating 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 device is a physical medical catheter, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to report.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is based on objective measurements and established pass/fail criteria defined by the relevant international standards (e.g., ISO 20696, ASTM D 1894, ISO 10993-1, AAMI/ANSI/ISO 11137, ASTM F1980) and the manufacturer's internal methods for coating adhesion.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical catheter and does not involve a "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

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The BEVER™ Reinforced Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during anesthesia. The product may be used where the patient's neck is likely to be moved or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

BEVER™ Reinforced Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm10.0 mm in 0.5 mm increments
BEVER™ Reinforced Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm7.0 mm in 0.5 mm increments
BEVER " Reinforced Endotracheal tube is an Endotracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen.
The BEVER™ Reinforced Endotracheal tube is sterile, single use device supplied with a standard 15 mm connector. It is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, cuff, inflating system (including inflating tube, valve and pilot balloon) and 15 mm connector. The uncuffed tube is composed of main tube and 15 mm connector. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.

The provided document is a 510(k) summary for the BEVER™ Reinforced Endotracheal Tube. It primarily demonstrates substantial equivalence to predicate devices based on design, materials, and compliance with various international standards for medical devices, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or AI-driven device.

Therefore, the requested information, particularly regarding sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/diagnostic studies, is not applicable to this type of submission. This document describes a traditional medical device (an endotracheal tube), not a software or AI/ML-based device that would typically involve such studies.

However, I can extract the "acceptance criteria" and "reported device performance" in the context of compliance with relevant standards and the conclusions drawn for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For the remaining points, as explained, the context of this 510(k) summary for a reinforced endotracheal tube does not involve the type of diagnostic or AI performance studies implied by these questions. This is a traditional device submission focused on material conformity, biocompatibility, and sterilization validation.

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 submission focuses on compliance with physical, chemical, and biological standards for a manufactured medical device, not on data analysis from a "test set" of patients or images.

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 establishment by experts is not relevant for this type of device.

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

• Not applicable. No test set requiring expert adjudication was 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. No MRMC or AI-assisted study was conducted or mentioned.

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

• Not applicable. This device is not an algorithm and does not have a "standalone" performance in that sense.

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

• Not applicable. The "ground truth" for this device's safety and effectiveness relies on compliance with established ISO and AAMI standards for physical properties, materials, biocompatibility, and sterility.

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. No training set was used.

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The BEVER™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during mechanical ventilation and anesthesia.

BEVER Evaller Endotracheal Tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the contaminated mucous and subglottic secretion that accumulate above the cuff by continuous or intermittent suctioning.

BEVER™ Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm ~10.0 mm in 0.5 mm increments

BEVER™ Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm~9.0 mm in 0.5 mm increments

BEVER™ Endotracheal Tube with cuff (Oral preformed) is available in sizes 4.0mm~10.0mm in 0.5 mm increments

BEVER™ Endotracheal Tube without cuff (Oral preformed) is available in sizes 3.0mm ~9.0mm in 0.5 mm increments

BEVER™ Endotracheal Tube with cuff (Nasal preformed) is available in sizes 5.0mm ~10.0mm in 0.5 mm increments

BEVER™ Endotracheal Tube without cuff (Nasal preformed) is available in sizes 4.0 mm~9.0mm in 0.5 mm increments

BEVER Eva™ Endotracheal tube (Oral) is available in sizes 6.0mm~9.0mm in 0.5mm increments

The BEVER™ Endotracheal Tube made of polyvinyl chloride is sterile, single use device supplied with a standard 15 mm connector. The Endotracheal Tube is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, high volume/low pressure cuff, inflating system (including inflating tube, valve and pilot balloon) and 15mm connector. The uncuffed tube is composed of main tube and 15mm connector. The main tube incorporates a Magill curve, a beveled/hooded tip with Murphy eye and a tip-to-tip radiopaque line to assist in radiographic visualization.

The design of BEVER Evalls Endotracheal tube is based upon the cuffed Endotracheal Tube (Oral/Nasal) with the addition of a third (integral) lumen within the tube. The lumen terminates above the cuff via a 'notch' (evacuation port) which enables the entrance (via suction) of secretions which have pooled above the cuff into the third (suction) lumen. Approximately half way along the tube length the suction lumen is joined to a suction tube which is external to the main tube. The suction tube is joined to the suction lumen in a similar manner to that of the joint between the inflating tube and the inflating lumen. The distal end of the suction tube terminates in a capped Luer connector which can be connected to either suction tubing or a syringe. The Eva™ Endotracheal tube is available in cuffed and for oral use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BEVER™ Endotracheal Tube and BEVER Eva™ Endotracheal Tube. It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailed performance studies for an entirely novel device.

Acceptance Criteria and Study for BEVER™ Endotracheal Tube and BEVER Eva™ Endotracheal Tube

The manufacturer, Hangzhou Bever Medical Devices Co., Ltd., demonstrated device performance by confirming compliance with existing international standards, particularly ISO 5361:1999(E) for the physical characteristics of endotracheal tubes and various ISO 10993 standards for biological safety. No custom, performance-based acceptance criteria (e.g., minimum sensitivity/specificity for a diagnostic device) are explicitly stated beyond these standard compliances.

1. Table of Acceptance Criteria and Reported Device Performance

• Sensitization (compliance with AAMI/ANSI/ISO 10993-10:2002/Amd. 1:2006(E))
• Irritation (compliance with AAMI/ANSI/ISO 10993-10:2002/Amd. 1:2006(E))
• Genotoxicity (compliance with AAMI/ANSI/ISO 10993-3:2009)
• Implantation (compliance with AAMI/ANSI/ISO 10993-6:2007) | The subject device passed all listed biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation) and is compliant with the respective AAMI/ANSI/ISO 10993 standards. |
  | Sterilization | - Ethylene Oxide sterilization process validation (compliance with AAMI/ANSI/ISO ISO11135-1:2007)
• Ethylene Oxide Sterilization Residuals (compliance with AAMI/ANSI/ISO 10993-7:2008) | The sterilization process has been validated to be compliant with AAMI/ANSI/ISO ISO11135-1:2007 and AAMI/ANSI/ISO 10993-7:2008. |
  | Shelf Life | - Device compliance with specification requirements after 183 days accelerated aging.
• Validation of 4-year shelf life through real-time stability study. | After 183 days of accelerated aging, BEVER™ Endotracheal Tubes and BEVER Eva™ Endotracheal Tubes remained compliant with device specification requirements. A 4-year shelf life has been validated through a real-time stability study. |

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

The document does not specify a "test set" in the context of clinical performance or a dataset of patient images. The testing described focuses on in-vitro (biocompatibility, sterilization, accelerated aging) and conformity to standards, not a clinical trial or performance evaluation on a patient cohort for diagnostic accuracy.

• Sample Size: Not applicable in the context of clinical test set. For biocompatibility, sterilization, and shelf-life, standard laboratory sample sizes would have been used as per the relevant ISO standards, but these are not explicitly detailed in the summary.
• Data Provenance: Not applicable for a "test set" from patients. The data provenance mentioned refers to laboratory testing.

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

Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment for patient outcomes or diagnostic interpretations. The document describes laboratory testing and compliance with engineering and biological standards.

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

Not applicable. There is no clinical test set requiring expert adjudication.

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

Not applicable. This device is an endotracheal tube, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its approval.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the device's performance is compliance with established international standards (ISO 5361, ISO 10993, ISO 11135) and internal device specifications for physical properties, sterility, biocompatibility, and shelf life. This is determined through objective laboratory testing.

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model.

Summary of Approach in the 510(k):

This 510(k) summary demonstrates substantial equivalence by showing that the new device shares the same intended use, technological characteristics, and materials as the predicate devices. The "device performance" section primarily focuses on showing compliance with recognized voluntary standards for safety and efficacy relevant to endotracheal tubes. This approach is typical for devices seeking 510(k) clearance, where the goal is to prove the new device is "as safe and effective" as a legally marketed predicate device, rather than to prove absolute safety and effectiveness through extensive novel clinical trials.

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The BEVER™ intermittent catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for men, women and children, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip. The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water packet, it becomes slippery and thus reduces friction against the urethra.

The provided text describes the regulatory submission for the BEVER™ Intermittent Catheter, primarily focusing on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria related to clinical performance. The "Device Performance" section refers to compliance with EN standards, and then details a series of biocompatibility tests.

Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not provided in this regulatory submission document.

However, I can extract the information relevant to the acceptance criteria and performance as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are based on compliance with established standards (EN and ISO) and the qualitative outcomes of the conducted tests (e.g., no cytotoxicity, non-irritant, no sensitization, no tearing). There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy mentioned as this is a medical device (catheter) and not an AI/diagnostic device.

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

• Cytotoxicity Test: L-929 mouse fibroblast cells were used. The specific number of replicates or wells is not explicitly stated but implied by the use of "a 96-well microplate." Data provenance is laboratory testing.
• Irritation Test: Test articles were contacted with vaginal tissue (animal model implied). The number of test subjects (animals) is not specified. Data provenance is laboratory testing.
• Sensitization Test: Ten test guinea pigs (per extract) for the test group and five control guinea pigs (per vehicle) for the control group were used. Data provenance is laboratory testing (animal study).
• Packaging Shipment Testing: 2 pieces of packaged-products were submitted for testing. Data provenance is laboratory testing.
• Shelf Life Testing: The sample size for accelerated and real-time aging studies is not specified in the provided text. Data provenance is laboratory testing.

The country of origin for the data (tests) is not explicitly stated, but the submitter is based in Hangzhou, China, suggesting the testing was likely conducted there or overseen by the Chinese manufacturer. All studies appear to be prospective studies conducted for regulatory submission.

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

• Not applicable. The tests performed are laboratory-based assays (e.g., cell viability, tissue examination, animal skin reaction, physical integrity) whose "ground truth" is determined by the experimental results and established biological/physical standards, rather than expert consensus on complex diagnostic images or clinical scenarios. No human expert interpretation to establish a ground truth is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the tests are laboratory-based with objective measurements (e.g., cell viability assays, macroscopic/microscopic tissue examination, visual inspection for tearing). There is no mention of a subjective "test set" requiring adjudication in the context of clinical or diagnostic performance.

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 document describes a medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or human reader improvement with AI are not relevant.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Ground truth was established based on the results of standardized biological assays interpreted against pre-defined criteria in ISO 10993 standards and the control groups. For example, cell viability percentage for cytotoxicity, macroscopic and microscopic evaluation for irritation, and skin reaction scoring for sensitization.
• Physical/Material/Packaging/Sterility/Shelf Life: Ground truth was established by demonstrating compliance with specific EN and ISO standards and by meeting the device specifications after various tests (e.g., physical inspection, sterility indicator, stability testing).

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The manufacturing processes and material selection might be informed by historical data or R&D, but not a formally defined "training set" for an algorithm.

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

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

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