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Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.

Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, a total of 3 types, and each type is divided into different specifications according to different inner diameter and the diameter of attaching endoscopic distal end. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10⁻⁶ and placed in a sterility maintenance package to ensure a shelf life of one year.

The provided FDA 510(k) clearance letter and summary for the "Disposable Distal Cap" does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, AI-specific ground truth, and training set information is not applicable and cannot be extracted from the given document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K984358) based on intended use, technological characteristics, and various performance and biocompatibility tests typical for a physical medical accessory. These tests ensure the device's physical and biological safety and performance, not the performance of an AI algorithm.

Below is a breakdown of what can be extracted or inferred from the provided text, but it will not fulfill the requirements for an AI device as those details are absent.

Acceptance Criteria and Device Performance (Non-AI Device)

Since this is not an AI device, there are no AI-specific performance metrics like sensitivity, specificity, AUC, etc. The acceptance criteria revolve around physical and biological attributes. The document states that the proposed device, "Disposable Distal Cap," is substantially equivalent to the predicate device, "Disposable Distal Attachment (K984358)". This substantial equivalence forms the primary "acceptance criterion" for clearance.

Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Performance Data provided for a Non-AI Device):

Information NOT Applicable/Present for an AI Device:

1. Sample size used for the test set and the data provenance: Not an AI device, so no "test set" in the context of AI algorithm evaluation. The testing involved physical device samples.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device. No ground truth established by experts for algorithmic performance.
3. Adjudication method: Not an AI device. No adjudication method for algorithmic output.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not an AI device. This type of study is irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI device.
6. The type of ground truth used: Not an AI device. "Ground truth" for this device refers to meeting established engineering and biological safety standards (e.g., passing a cytotoxicity test, maintaining a certain connection force).
7. The sample size for the training set: Not an AI device. No training set.
8. How the ground truth for the training set was established: Not an AI device. No training set.

In summary, the provided document details the regulatory clearance for a physical medical accessory, not an AI medical device. Therefore, the questions specifically related to AI device performance and study design cannot be answered from this text.

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This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.

The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope.

The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.

The provided text is a 510(k) summary for a medical device called "Extraction Basket". It describes the device, its intended use, and comparison to a predicate device, along with performance data. However, this document does not describe acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic or AI-driven performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, which involves:

• Biocompatibility testing: To ensure the materials are safe for use in the human body.
• Performance testing: To confirm the mechanical functionality and intended operation of the physical device.
• Shelf-life and packaging integrity testing: To ensure the device remains sterile and functional over time.
• Sterilization validation: To confirm the sterilization process is effective.

Therefore, the information required to answer your request (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document.

The "Performance Data" section lists various types of tests conducted, such as "Dimension Testing," "Connection Force Testing," "Simulated-Use Testing," and "Stone Capture and Durability Testing," but it does not provide specific acceptance criteria or quantitative results of these tests.

The document explicitly states:

• No animal study is included in this submission.
• No clinical study is included in this submission.

The question you've posed is typically relevant for AI/ML-driven diagnostic devices or devices where performance is measured against a clinical outcome or diagnostic accuracy. This document describes a physical medical tool (an extraction basket) for removing stones/foreign bodies, and its clearance is based on demonstrating mechanical and material safety and effectiveness, not diagnostic performance.

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The Biliary Plastic Stent is used to drain obstructed biliary ducts.

The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement.

The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement.

The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts.

The Biliary Plastic Stent Set short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.

The proposed device Biliary Plastic Stent Set is a sterile, single-use endoscopic device, the device is used to drain obstructed biliary ducts. Biliary Plastic Stent Set includes Biliary Plastic Stent (hereafter referred as Category 1), Biliary Plastic Stent Introducer (hereafter referred as Category 2), Biliary Plastic Stent Set (hereafter referred as Category 3), Biliary Plastic Stent Introducer/ short-wire compatible (hereafter referred as Category 4) and Biliary Plastic Stent Set/ short-wire compatible (hereafter referred as Category 5). Category 3 is commonly used in traditional ERCP (short for endoscopic retrograde cholangiopancreatography) surgery with a long guidewire (4.5m) while Category 4 and Category 5 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 4 and Category 5, the main feature of the short wire design is the guide wire exit port on the inner tube of the introducer which is used to separate guidewire from the proposed device (For Biliary Plastic Stent Introducer (Normal), the guide wire exit on the inner tube; for Biliary Plastic Stent Introducer (Pusher), the guide wire exit on the outer tube). The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.

There are 66 specifications of Category 1 which mainly differ in plastic stent shape (side bend, center bend, double pigtails), plastic stent diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and plastic stent working length (3cm-18cm).

There are 4 specifications of Category 2 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and can be divided into two types including Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher) depending on whether with or without inner tube assembly. There are 66 specifications of Category 3, each specification contains both plastic stent and introducer. The plastic stent in Category 3 is the same as that in Category 1, which mainly differ in plastic stent shape, plastic stent diameter and plastic stent working length, the introducer in Category 3 is the same as that in Category 2, which includes Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 3 corresponds to Biliary Plastic Stent Introducer (Pusher), and the rest correspond to Biliary Plastic Stent Introducer (Normal).

There are 3 specifications of Category 4 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr) and can be divided into two types including Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher) depending on whether with or without inner tube assembly.

There are 54 specifications of Category 5, each specification contains both plastic stent and introducer/ short-wire compatible. The plastic stent included in Category 5 is the same as that (except 11.5Fr diameter) in Category 1, the introducer short-wire compatible in Category 5 is the same as that in Category 4, which includes Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 5 corresponds to Biliary Plastic Stent Introducer/ short-wire compatible (Normal), and the rest correspond to Biliary Plastic Stent Infroducer/ short-wire compatible (Pusher).

The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional. They have an indicated indwell of up to 3 months

The provided text is a 510(k) summary for a medical device (Biliary Plastic Stent, etc.) and does not contain information about an AI/ML-driven device, a comparative effectiveness study, or details about establishing ground truths with experts.

Therefore, I cannot extract the information required to populate the fields related to AI/ML device performance, expert consensus, ground truth establishment, or MRMC studies. The document describes a traditional medical device (a stent and its introducer), and the "performance data" refers to biocompatibility testing, physical property testing (e.g., dimension, flow rate, strength), and shelf-life studies, not the performance of an algorithm.

The document's statement "No clinical study is included in this submission" further confirms the absence of the type of study you are asking about (which would typically involve human readers/AI evaluation).

I am unable to fulfill your request as the provided text does not contain the necessary information regarding acceptance criteria and study details for an AI/ML device.

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The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.

The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.

The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Pancreaticobiliary Video System consists of:

Single-Use Video Pancreaticobiliary Scope:

• CDS11001
• CDS11002
• CDS11003
• CDS11004
• CDS11005
• CDS22001 ●
• CDS22002
• CDS22003
• CDS22004
• CDS22005

PB Digital Controller:

• BS-W-100

The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.

The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Insertion port
• Suction port
• Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope

The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.

CMOS and optical components are identical for all specifications of products.

• Working channel port
• Lever which can lock the control

The Single-Use Video Pancreaticobiliary Scope have different size as follows:

• Maximum insertion portion width
• Effective working length
• Minimum accessories channel width

The PB Digital Controller has the following physical and performance characteristics:

• Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
• Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
• Can connect to an external monitor
• Reusable device

The provided text describes a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd.'s Single-use Video Pancreaticobiliary Scope and PB Digital Controller. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study proving an AI device meets acceptance criteria.

The document discusses bench testing to demonstrate the performance of the proposed device against a predicate, but it does not involve an AI device or a study structured to prove an AI's performance against specific acceptance criteria, including human expert evaluation.

Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for an AI device, sample sizes for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details.

The relevant sections of the document explicitly state:

• "No animal study is included in this submission."
• "No clinical study is included in this submission."

This indicates that clinical (human) performance data, which would be crucial for evaluating an AI device's effectiveness, was not part of this submission for market clearance. The "Performance Data" section (page 10-11) lists a series of bench tests for physical and electrical characteristics of the scope and controller, not for an AI algorithm.

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The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.

The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device.

The Elastic Traction Device is a single use tissue traction device. It is consisting of clip assembly, silicone band and delivery system. The silicone band is consisting of three rings. Ring A is preloaded with the clip.

The Clipping Device is a single use device, and its purpose is to use it as a second clip. The second clip is used to engage the silicone band of the previously anchored clip of Elastic Traction Device.

The provided text describes the Micro-Tech (Nanjing) Co., Ltd. Elastic Traction System, an endoscopic traction device. The information details the device's characteristics, its comparison to a predicate device, and the non-clinical performance data used to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria appear to be framed around demonstrating substantial equivalence to the predicate device, ProdiGI Traction Wire (DEN220006), across various performance aspects that confirm safety and effectiveness for its intended use. While explicit numerical acceptance criteria values are not given in this summary, the document states that tests were performed to demonstrate that the device performs as intended under anticipated conditions of use and is considered safe and effective for its intended use.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual bench test. It mentions that "bench tests below were tested and evaluated." For the animal study, it states an "animal test" was conducted, implying one study, but the number of animals or procedures is not specified.
• Data Provenance: The data provenance is from non-clinical studies (bench tests, animal study, usability assessment, shelf-life, sterilization, biocompatibility testing) conducted by Micro-Tech (Nanjing) Co., Ltd. The animal study was conducted according to 21 CFR §58 (GLP Regulations), suggesting it was a prospective study. The bench tests are laboratory-based.

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

• This information is not provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering specifications, validated test methods, and regulatory standards rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as the performance data is derived from objective, replicable tests (bench, animal, etc.) rather than subjective assessments requiring adjudication.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission."

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

• This information is not applicable. The device is a physical medical device (an endoscopic traction system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data presented refers to the device's physical and functional characteristics.

7. Type of Ground Truth Used

• For the non-clinical performance tests (bench tests), the ground truth is based on engineering specifications, established test methods, and compliance with relevant international standards (e.g., ASTM F1980, ISO 11135, ISO 10993-1).
• For the animal study, the ground truth for safety and effectiveness would be established through direct observation of the device's performance in vivo and histological examination or other relevant biological assessments, evaluated against pre-defined success criteria.

8. Sample Size for the Training Set

• This information is not applicable. The device is a physical medical device, not an AI algorithm 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 a physical medical device.

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The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue.

The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound.

The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided text describes the Micro-Tech (Nanjing) Co., Ltd. Endobronchial Ultrasound Aspiration Needle (AreusTM and TridentTM) and its equivalence to a predicate device. However, the document does not contain specific acceptance criteria nor detailed study results with performance metrics that would allow for the construction of a table comparing acceptance criteria to reported device performance.

Instead, the document broadly states that the device "met the predetermined acceptance criteria" without listing those criteria or the precise performance values attained for each. It focuses on demonstrating substantial equivalence through various non-clinical tests.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract the information that is present in the document.

Missing Information:

• Specific acceptance criteria values: The document states that criteria were met but doesn't define them.
• Reported device performance values: Similarly, specific performance numbers are not provided, only a general statement that they "met" the criteria.
• Details on the "study" itself: No specific study names or designs are outlined, beyond mentioning various bench tests and validation activities.
• Sample size used for the test set: Not specified.
• Data provenance for the test set: Not specified (e.g., country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth: Not applicable, as the tests were non-clinical/bench tests, not involving human interpretation of medical images or data.
• Adjudication method for the test set: Not applicable for non-clinical tests.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not done/not applicable, as it's a device, not an AI diagnostic tool.
• Standalone (algorithm only) performance: Not applicable, as it's a physical medical device.
• Type of ground truth used (for test set, if applicable): Not applicable for non-clinical/bench tests.
• Sample size for the training set: Not applicable, as it's a physical medical device, not an AI algorithm requiring a training set.
• How ground truth for the training set was established: Not applicable.

Here's a summary of the information that is available in the document regarding the device's testing and compliance:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific numerical acceptance criteria and reported device performance values are not provided in this document. The document states:

"The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Vizishot 2 Flex."

The following types of tests were performed:

• Dimension
• Sheath and Needle Insertion and Withdrawal force
• Stylet Insertion and Withdrawal Force
• Puncture Force
• Ultrasound Visibility
• Locking Force of Handle Portion
• Adjustment Length
• Attach and Detach Adaptor to Scope
• Tensile Strength
• Durability
• Aspiration Capability
• Transmission Force
• Needle Deformation Angle

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

• Sample size for the test set: Not specified in the document.
• Data provenance: Not applicable. These were non-clinical bench tests performed on the device itself.

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

• Not applicable. The ground truth for these non-clinical, physical performance tests would be based on engineering specifications and measurement standards, not medical expert consensus.

4. Adjudication method for the test set

• Not applicable. This is for non-clinical, physical performance tests.

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 is a physical medical device (Endobronchial Ultrasound Aspiration Needle), not an AI-powered diagnostic tool, so an MRMC study is not applicable.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the non-clinical bench tests, the "ground truth" would be the engineering specifications and established test methods/standards (e.g., measurements against dimensional tolerances, force thresholds, durability cycles). For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's compliance with ISO 11135. For shelf-life/packaging, it's compliance with ASTM F1980-16, ISO 11607-1, and ISO 11607-2.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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The Through the Scope Tracheal Stent System is in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Through the Scope Tracheal Stent System consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is fully covered with silicone membrane and a polymer coating. The Parylene N is added on the surface of silicone membrane to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. The stent has different dimension with the diameters of 10mm, 12mm, 16mm, 18mm, with the lengths of 20mm, 30mm, 40mm, 50mm, 60mm, 80mm.

The stent is deployed through the endoscopy working channel and under direct vision of endoscopy. The delivery system allows for desheathing to deploy and reposition the stent during the placement procedure. The delivery system consists of two coaxial sheaths and one inner core. The outer sheath serves to constrain the stent until being retracted during the stent deployment. The middle sheath serves to support the delivery system. The round tip acts as a guide when the delivery system enters the body. The front handle is used for deploying the stent. The seal ring, locking ring, and safe lock work to lock the device and prevent the stent from being exposed. The decoration nut connects with the back handle.

The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The provided text does not describe a study that uses AI or machine learning. It pertains to a medical device (Tracheal Stent System) and its premarket notification (510(k)) to the FDA. The tests conducted are non-clinical performance tests of the physical device, its materials, and its delivery system, ensuring its safety and effectiveness.

Therefore, many of the requested points related to AI/ML model evaluation (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this document.

However, I can still extract the acceptance criteria and performance related to the physical device based on the information provided.

Device: Through the Scope Tracheal Stent System
Product Code: JCT
Regulation Name: Tracheal Prosthesis

Since the document does not contain information about an AI/ML model's performance, I will interpret the request in the context of the physical medical device's performance given the available information.

Acceptance Criteria and Reported Device Performance

The document states that "The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device Tracheal Stent System (OTW) cleared under K202204."

While the specific numerical acceptance criteria are not detailed in the provided text (e.g., what percentage drop in expansion force is acceptable), the document lists the types of tests conducted and affirms that the device met these criteria, thus demonstrating substantial equivalence.

Here's a table based on the information provided:

Non-Applicable Information (for AI/ML studies)

As this document describes a traditional medical device (a tracheal stent), the following points are not applicable and no information is provided for them:

2. Sample size used for the test set and the data provenance: Not an AI/ML study. Performance tests are typically done on a defined number of physical samples, but this is not a data test set in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study involving human reader ground truth.
4. Adjudication method for the test set: Not an AI/ML study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not an AI/ML study. Measurements and physical properties constitute the "ground truth" for this device.
8. The sample size for the training set: Not an AI/ML study. There is no "training set."
9. How the ground truth for the training set was established: Not an AI/ML study.

In summary, the provided document describes the non-clinical performance testing of a physical medical device (a tracheal stent) to demonstrate its substantial equivalence to a predicate device, rather than the evaluation of an AI/ML-driven medical device.

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The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of:
a .Endoscopic Marking
b. Hemostasis for:

• Mucosal/Submucosal defects

The Disposable Hemostatic Closure Clip Device is a sterile, single-use endoscopic clipping device, intended for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The device is indicated for clip placement within the GI tract for the purpose of.
a. endoscopic marking
b. hemostasis for:

• mucosal/submucosal defects

The provided text describes the acceptance criteria and the studies performed to demonstrate the substantial equivalence of the "Disposable Hemostatic Closure Clip Device" (Proposed Device) to the "OTSC™ (Over-The-Scope-Clip) System Set" (Predicate Device).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a separate section with pass/fail results for each criterion. Instead, it states that various performance tests were conducted, and the results demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device.

The table below summarizes the technical characteristics compared, which implicitly serve as acceptance criteria for similarity to the predicate device. The "Remark" column indicates if the characteristic is "Same" or "Similar" to the predicate, implying acceptance if it falls within these categories or if differences do not affect substantial equivalence.

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The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

The proposed device Retrieval Balloon Catheter includes Sterile Biliary Stone Retrieval Balloon Catheter (hereafter referred as Category 1) and Retrieval Balloon / short-wire compatible (hereafter referred as Category 2). Category 1 is commonly used in traditional ERCP surgery with a long guidewire (4.5m) while Category 2 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 2, the main feature of the short wire design is the C-shaped groove on the sidewall of catheter which is used to separate guidewire from the proposed device. The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.

The proposed device Retrieval Balloon Catheter is sterile, single-use endoscopic device, and is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

The proposed Retrieval Balloon Catheter is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.

Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire and the guidewire is able to be loaded either from the front or the back. Another separate lumen is designed for contrast medium. There are for injection-distal or injection-proximal options offered to support physician preference and facilitate procedural needs.

The balloon can be inflated to 9 mm, 12 mm, 15 mm, 18 mm diameters using the pre-measured syringes and a single balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.

There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

This document describes the performance testing and acceptance criteria for the "Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible" (Device Name: Retrieval Balloon Catheter), submitted under 510(k) K211021.

It is important to note that this submission does not involve Artificial Intelligence (AI) or machine learning. Therefore, information concerning human reader improvement with AI, standalone algorithm performance, or training set details are not applicable to this medical device submission. The device is a physical medical instrument, not a diagnostic AI tool.

1. Acceptance Criteria and Reported Device Performance

The submission states that "Performance testing was conducted to demonstrate the performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device."

While specific numerical acceptance criteria and precise performance values are not detailed in this public summary, the document indicates that the following tests were conducted and the proposed device met the acceptance criteria and supported substantial equivalence to the predicate device.

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

• Sample Size: The document does not specify the exact sample sizes for each of the bench tests, shelf-life tests, or biocompatibility tests. It states that "Performance testing was conducted" and "results of the tests below were evaluated as substantially equivalent."
• Data Provenance: The tests are described as bench tests and laboratory evaluations conducted by the manufacturer, Micro-Tech (Nanjing) Co., Ltd., which is located in Nanjing, Jiangsu Province, China. The data is retrospective in the sense that it was collected prior to the submission for regulatory review. It is not patient or clinical data.

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

This is not applicable as the described tests are laboratory-based performance and safety evaluations of a physical medical device, not a diagnostic AI tool requiring expert image interpretation or clinical consensus for ground truth. The "ground truth" for these tests relates to engineering specifications, material properties, and biological safety standards. These are established by validated test methods and established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This is not applicable for the same reason as above. Adjudication methods like "2+1" or "3+1" are relevant for establishing ground truth in clinical data (e.g., for diagnostic accuracy studies involving human readers or AI), not for bench testing of a physical device.

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

This is not applicable. This submission is for a physical medical device (Retrieval Balloon Catheter) and does not involve AI or machine learning. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

This is not applicable. As stated, this device is a physical medical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations of this device is based on:

• Engineering Specifications: Meeting predefined dimensional tolerances, force requirements, fluid flow rates, and fatigue limits.
• International Standards: Compliance with recognized standards such as ISO 11607 (packaging), ISO 11135 (sterilization), and ISO 10993 (biocompatibility).
• Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is demonstrating substantial equivalence to a legally marketed predicate device (Extractor™ Pro Retrieval Balloon Catheter cleared under K102082) in terms of technology, safety, and performance.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" to establish ground truth for.

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