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The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract). The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. ClearTip is offered in various needle gauges for insertion and aspiration. The available needle gauge sizes of 19, 22, and 25 gauge. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the length of the coil sheath and the needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human gastrointestinal tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

This FDA 510(k) clearance letter pertains to a medical device, and as such, it does not detail acceptance criteria or a study that would demonstrate the device meets those criteria in the way typically seen for AI/software-as-medical-device (SaMD) products. This document describes a traditional medical device (a biopsy instrument), not an AI system.

The "acceptance criteria" and "device performance" mentioned in your request are usually quantifiable metrics (e.g., sensitivity, specificity, AUC) for SaMD products, often against a ground truth for diagnostic accuracy. For a physical device like the ClearTip FNA and FNB Types, acceptance criteria typically relate to physical properties, functionality, safety, and compatibility, which are assessed through non-clinical (engineering, bench) tests rather than clinical performance studies against a diagnostic "ground truth."

Therefore, I will extract the information provided based on the context of a physical medical device submission, focusing on the nearest equivalents to your requested categories.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the performance standards for the non-clinical tests conducted. The reported "device performance" is typically that the device met these standards. The document does not provide specific numerical acceptance criteria or performance metrics for each test, but rather lists the types of tests performed.

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

This document does not describe a "test set" in the context of clinical data for diagnostic performance. The "tests" mentioned are non-clinical (bench/engineering) tests conducted on the physical device itself. Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided given the nature of the device and the submission.

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

Not applicable. This is not an AI/SaMD product requiring expert-established ground truth for diagnostic accuracy. The "ground truth" for a physical device's performance often relates to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication in a clinical context is described.

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

No. An MRMC study is typically for evaluating diagnostic performance of imaging or AI systems with human readers. This clearance is for a physical biopsy instrument.

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

No. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and regulatory requirements (e.g., for sterility, biocompatibility, mechanical strength). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning system.

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

Not applicable. There is no training set for this device.

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ClearHemograsper has been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

ClearHemograsper is a monopolar endoscopic instrument intended to coagulate or to perform hemostasis using high-frequency current within the digestive tract. It can assist in endoscopic surgical procedures such as ESD (Endoscopic Submucosal Dissection). ClearHemograsper consists a Slider for opening or closing the Jaw, a Catheter Tube which is a part passing through the working channel of endoscope, a pair of Jaw for catching the bleeding site and for delivering high-frequency current, a plug for connecting with high frequency transmission equipment, and an irrigation port for removing foreign substances by injecting distilled water or saline solution. It is available in various working lengths.

The provided FDA 510(k) clearance letter for ClearHemograsper is for an endoscopic electrosurgical unit and accessories, which is a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information on acceptance criteria, test sets, ground truth establishment, or clinical studies typically associated with the evaluation of AI models.

The information requested in the prompt (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is specific to the validation of AI/SaMD, particularly for diagnostic or prognostic purposes where ground truth and human reader performance are critical.

Since the ClearHemograsper is a physical device used for cauterizing and coagulation, its performance is evaluated through bench testing (e.g., dimension, rotatable performance, pushability, actuation, tensile strength, output value, hemostatic performance, short circuit, catheter tube temperature tests), biocompatibility studies, sterilization validation, shelf-life studies, and electrical safety/EMC testing. Clinical studies were not considered for this submission (as stated on Page 10, Section 13).

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/SaMD metrics.
• Sample sizes, data provenance, expert numbers, adjudication, MRMC studies, standalone performance, or ground truth establishment methods for an AI test set.

The document describes the device's technical specifications and comparisons to a predicate device, focusing on physical and electrical performance, and safety standards for a mechanical/electrical medical device.

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The ClearCap Distal Attachment has been designed to the distal end of the endoscope to facilitate endoscopic therapy.

The ClearCap Distal Attachment is intended for the following:

• · Gastrointestinal mucosal resection (endoscopic mucosal resection)
• · Keeping the suitable depth of the endoscope's view field

The ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures.

The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter.

Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 are for upper GI tract.

It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.

This document does not contain the information requested for acceptance criteria and the study proving the device meets them.

The provided text is a 510(k) summary for a medical device called "ClearCap Distal Attachment." While it discusses the device's design, intended use, and comparison to a predicate device to establish substantial equivalence, it specifically states that non-clinical tests were performed, and it does not mention any clinical study or human subject data.

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

• No Acceptance Criteria or Performance Data for a "Study": The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and non-clinical performance (e.g., direct comparison testing for gap, endoscope compatibility, viewing, and suction function). It does not present acceptance criteria in the context of a clinical study or report device performance against such criteria.
• No Clinical Study Details: There is no mention of a clinical study, test set, training set, human readers, ground truth established by experts, or MRMC analysis. The device is evaluated through "non-clinical tests."

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study that proves the device meets those criteria, as such a study (in the sense of human performance or clinical outcomes) is not described in this document.

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The Clear Tip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract) and tracheobronchial tree. The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. This device passes through a working channel of an endoscope, and the average contact time with the submucosal or external lesions of a gastrointestinal tract or a tracheobronchial tree is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.

The provided document does not contain information regarding the acceptance criteria of a study that proves the device meets specific performance metrics. It's a 510(k) summary for a medical device (ClearTip) seeking substantial equivalence to predicate devices, not a study report demonstrating specific performance against acceptance criteria.

The document discusses substantial equivalence based on:

• Indications for Use: The ClearTip is intended for Ultrasonically Guided Fine Needle Aspiration (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.
• Comparison to Predicate Devices: The document provides a detailed comparison table between the subject device (ClearTip) and two predicate devices (SonoTip Pro and Pro Flex EBUS-TBNA Needle System, and Clear-Tip EUS-FNA) regarding various characteristics like device name, classification, product code, regulation number, indications for use, needle gauge, material, length, sheath material, accessory channel diameter, endoscope compatibility, use with syringe/stopcock, principle of operation, shelf life, sterility, and single use.
• Non-clinical Tests: The following tests were performed on the subject device to support substantial equivalence: Sterilization Validation Test, Shelf-Life Test, Appearance, Dimensions, Operability, Elasticity, Bending Strength, Pull-out, Tensile Force, and Biocompatibility Tests. The document states that the test results support the device's substantial equivalence but does not provide specific acceptance criteria or reported performance values for these tests.

Therefore, the requested information for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, adjudication methods, or MRMC/standalone study results cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing primary performance metrics through a clinical or non-clinical study with defined acceptance criteria.

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The ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy. The ClearCap Distal Attachment is intended for the following: Gastrointestinal mucosal resection (endoscopic mucosal resection) Keeping the suitable depth of the endoscope's view field

ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures. The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter. Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-EC0001, FM-EC0005, FM-EC0006 and FM-EC0007 are for lower GI Tract, and FM-EC0002, EC0003 and EC0004 are for upper GI tract. It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a medical device called the "ClearCap Distal Attachment." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, the device is not an AI/Software as a Medical Device (SaMD). It is a physical accessory designed to be attached to the distal end of an endoscope. Therefore, the questions related to AI/SaMD acceptance criteria, test sets, ground truth establishment, expert consensus, MRMC studies, and training sets are not applicable to this document.

The document focuses on demonstrating the physical device's safety and effectiveness through non-clinical testing, primarily biocompatibility and performance testing, to show its substantial equivalence to already marketed predicate devices.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

   The document does not present a formal table of "acceptance criteria" in the way one might see for an AI model (e.g., specific thresholds for sensitivity, specificity, or F1-score). Instead, substantial equivalence for this physical device is demonstrated through:

   • Indications for Use (IFU) comparability: The ClearCap Distal Attachment has the same IFU as its primary predicate device (US Endoscopy Distal Attachment Cap).
   • Technological Characteristics Comparability: A table compares the subject device to its primary predicate and a reference device across various characteristics like company, device name, classification, product code, regulation number, IFU, appearance, materials, outer diameter, maximum diameter of attaching endoscope, total length, inner diameter of distal end, size and number of the drain, sterility, and reuse.
   • Non-Clinical Testing Results: The device underwent specific tests to ensure it met relevant standards and performed comparably to expectations for such devices. The "performance" is reported as meeting these standards, rather than numerical metrics for AI performance.

   Table of Non-Clinical Testing and Outcome (interpreted as meeting "acceptance"):

   Acceptance Criterion (Testing Standard)	Reported Device Performance (Outcome)
   Biocompatibility (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017)	Completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, and Pyrogen Test (Demonstrated biocompatibility and substantial equivalence)
   Performance Testing (Finemedix's design control system)	Appearance, Dimension, Extractable Substance, Endoscope Compatibility, and Suction testing (Performed as per system)
   EO Sterilization Residuals (ISO 10993-7:2008)	Tested (No specific pass/fail values given, but implies acceptance)
   Shelf Life Testing (ASTM F1980)	Tested (No specific duration or pass/fail values given, but implies acceptance)
   EO Sterilization Validation (ISO 11737-1:2006, ISO 11737-2:2009)	Tested (Leveraged from K180363, implies acceptance)

   The conclusion explicitly states: "The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device."

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

   • Not applicable (N/A) for AI/SaMD test set. This document describes a physical medical device.
   • For the non-clinical tests (biocompatibility, performance, sterilization, shelf-life), specific sample sizes for tests on the physical device are not detailed in the provided summary, but standard practices for these types of tests would have been followed. The provenance would be the manufacturing site where the device prototypes were produced for testing.

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

   • N/A for AI/SaMD. Ground truth as understood in AI (e.g., image annotations by radiologists) is not relevant for this physical device. The "ground truth" for this device's performance would be the physical properties and material characteristics verified by laboratory testing professionals.

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

   • N/A for AI/SaMD. Adjudication methods are typically used for establishing consensus ground truth for complex interpretations (like medical images), which is not relevant here.

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:

   • N/A for AI/SaMD. This device is an accessory for an endoscopy procedure, not an AI system. No human reader studies (MRMC) would be relevant.

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

   • N/A for AI/SaMD. This is a physical device, not an algorithm.

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

   • For this physical device, the "ground truth" is established through objective laboratory measurements and tests against established international standards (e.g., ISO, ASTM) for biocompatibility, sterility, dimensions, material properties, and functional performance. It's not based on expert consensus on diagnostic interpretations or patient outcomes data in an AI sense.

8. The sample size for the training set:

   • N/A for AI/SaMD. There is no training set for a physical medical device.

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

   • N/A for AI/SaMD.

In summary, the provided document pertains to the FDA 510(k) clearance of a physical medical device accessory, not an AI or software product. Therefore, most of the requested information regarding AI model validation and performance is not present or applicable. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through comparability of indications for use, technological characteristics, and successful completion of standard non-clinical safety (biocompatibility, sterility) and performance tests.

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ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for

• (1) Endoscopic marking
• (2) Hemostasis for
  • (a) Mucosal/sub-mucosal defects

ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is preloaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.

ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.

The provided text describes Finemedix Co., Ltd.'s ClearEndoclip, a medical device for endoscopic clipping. However, it does not contain information about software or AI, nor does it discuss acceptance criteria and study results related to AI device performance. The document is a 510(k) summary for a physical medical device, focusing on its substantial equivalence to a predicate device, functional descriptions, indications for use, and performance data related to its MR (Magnetic Resonance) compatibility.

Therefore, I cannot fulfill your request as the necessary information regarding AI device performance, study types (MRMC, standalone), ground truth establishment, training set details, and expert involvement is not present in the provided text.

The "Performance Data" section specifically details tests for MR compatibility (e.g., magnetically induced displacement force, torque, image artifact, RF induced heating, and MR pull-off test), all of which relate to the physical properties of the clip in an MRI environment, not the performance of an AI algorithm.

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ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for

• (1) Endoscopic marking
• (2) Hemostasis for
• (a) Mucosal/sub-mucosal defects

ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is pre-loaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.

ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative performance metrics like sensitivity, specificity, accuracy, or a pass/fail percentage for a diagnostic or AI-driven device.

Instead, the performance data section focuses on demonstrating conformance to established standards and comparing the device's characteristics to a predicate device. The general acceptance criterion seems to be "demonstrates equivalent safety and performance profile as the predicate device" and "conformance to the appropriate recognized standards of FDA, ISO 10993-1 (2009)."

Here's a summary of the performance claims:

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The ClearGrasp Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

ClearGrasp Snare is a monopolar electrosurgical instrument intended for EMR which is Endoscopic Mucosal Resection by applying high-frequency current during endoscopic electrosurgical procedures. It is used for grasping and resecting the targeted lesion within the digestive tract by opening and closing the loop. Users can choose an oval or a crescent type based on their preference and the characteristic of the lesion. The loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. There is a stiff type distinguished by the strength of loop. The device consists of a flexible Rope Wire and various size of loop, which can be extended and rotated from the flexible Catheter Tube using two handle control knobs such as Handle and Slider. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. This device passes through the working channel of endoscope, and the average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

The provided text describes the 510(k) premarket notification for the "ClearGrasp Snare" device. It outlines the device's indications for use, its technical characteristics, and the non-clinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for performance, a study proving the device meets specific performance criteria with reported device performance metrics, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in studies for AI/software devices.

The document focuses on demonstrating substantial equivalence primarily through technical specifications, biocompatibility, and electrical safety testing, as is common for electrosurgical accessories. It does not present a study with specific performance metrics against defined acceptance criteria that would be relevant for an AI/software device.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer based on the available information, with clear indications where information is not present.

Acceptance Criteria and Study for ClearGrasp Snare

The provided 510(k) submission for the ClearGrasp Snare does not present a study with specific performance acceptance criteria and reported device performance metrics in the way a study for a diagnostic or AI device would. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical safety testing rather than a performance study against predefined numerical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that these tests were performed and implies successful completion ("demonstrate that the subject device is substantially equivalent"). It does not provide specific numerical results or quantitative acceptance criteria (e.g., "tensile strength > X N") for most of these tests in the publicly accessible summary.

Regarding AI/Software specific details (Items 2-9):

The ClearGrasp Snare is described as a monopolar electrosurgical instrument intended for Endoscopic Mucosal Resection (EMR). It is a physical medical device (snare) and not an AI or software device. Therefore, the following requested information is not applicable to this submission, as it relates to the evaluation of AI/software performance, which is not the subject of this 510(k).

2. Sample size used for the test set and the data provenance: Not applicable; this is a physical device, not an AI/software being tested on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (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; this is a physical device, not an AI/software with a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Clear-Jet Injection Catheter consists of a stainless-steel needle attached to inner tube, an Injector Head attached to Catheter tube, and Slider where a standard syringe can be attached for injection of solutions through the lumen of the needle into tissue. It is available in various sizes and working lengths. The needle sizes are 21 gauge (outer diameter 0.8mm) and 23 gauge (outer diameter 0.6mm), and the needle lengths are 4.0mm and 6.0mm. The needle wall thicknesses are 0.1mm, 0.05mm, and the Catheter Tube length (=Working length) includes 1,800mm, 2,300mm.

There are two types of Clear-Jet Injection Catheter such as Head type and Non-head type has the Injector Head made of stainless steel alloys attached to the Catheter Tube, Non -head type does not have the Injector Head made of stainless steel alloys.

This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

This is a 510(k) premarket notification for a medical device (Clear-Jet Injection Catheter), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving a specific device performance against pre-defined acceptance criteria using clinical studies.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a diagnostic AI product is not directly applicable to this document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract information related to the non-clinical testing that was performed to support the substantial equivalence claim.

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance:
   This document does not provide a table of acceptance criteria and performance metrics in the way you might see for a diagnostic AI product (e.g., sensitivity, specificity thresholds). Instead, it states that the device was tested to evaluate its substantial equivalence according to various standards for medical devices. The "performance" reported is that the device met these standards and demonstrated substantial equivalence.

   Acceptance Criterion/Standard	Reported Device Performance
   Biocompatibility ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006	Cytotoxicity, Sensitization, Intracutaneous reactivity and Acute Systemic Toxicity tests were completed and met.
   Performance testing (appearance and dimension)	Performed as per Finemedix's design control system, results met.
   Physical and Chemical Safety Testing (color and transparent, pH, KMnO4 Consumption, Non-Volatile residue, ultraviolet absorption, heavy metal as lead, EO Sterilization residuals test, and sterility test)	Performed as per Finemedix's design control system, results met.
   EO Sterilization Testing ISO 11737-1:2006 and ISO 11737-2:2009	Met the standards.
   Shelf Life Testing ASTM F1980	Met the standard.

2. Sample sized used for the test set and the data provenance:
   The document does not detail specific sample sizes for each non-clinical test. These tests typically involve material samples and/or device units rather than patient data. There is no information on data provenance in terms of country of origin or retrospective/prospective data as this is non-clinical testing.

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-clinical device clearance process, not a diagnostic study requiring expert ground truth for classification.

4. Adjudication method for the test set:
   Not applicable (see #3).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This is not an AI/diagnostic product that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The Clear-Jet Injection Catheter is a medical device (catheter), not an algorithm or AI product.

7. The type of ground truth used:
   For the non-clinical tests, the "ground truth" or reference is the established performance specifications and regulatory standards (e.g., ISO standards for biocompatibility, sterility, etc.). Tests are designed to confirm the device meets these pre-defined objectives.

8. The sample size for the training set:
   Not applicable. This is not a machine learning model; therefore, there is no "training set."

9. How the ground truth for the training set was established:
   Not applicable (see #8).

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The Clear-Tip EUS-FNA is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Clear-Tip EUS-FNA is used in conjunction with an ultrasound endoscope. It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port. The insertion is composed of the Catheter Tube, Needle, and Stylet. A Syringe is attached to the aspiration port on the handle section to aspirate that was punctured with the Needle. Syringe and Stopcock are accessories to provide and control the vacuum suction to aspirate the tissue specimen. They also can be used to expel the samples after the procedure. Clear-Tip EUS-FNA is offered in various needle gauges for insertion. The available needle gauge sizes of 19, 22 and 25 gauges. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the Catheter Tube and Needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a Stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized. This device is for Rx used only.

The provided text describes the 510(k) premarket notification for the "Clear-Tip EUS-FNA" device, focusing on its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on comparing the new device's characteristics and performance to an already legally marketed device, rather than extensive clinical studies or acceptance criteria defined for a specific performance metric.

Therefore, the document does not contain information on acceptance criteria for a specific device performance metric (e.g., sensitivity, specificity for an AI algorithm) or a study proving the device meets such criteria.

The "acceptance criteria" mentioned in the document relate to non-clinical testing standards to demonstrate substantial equivalence, not to performance metrics like those for an AI algorithm. The study described is a non-clinical testing program to show that the device is as safe and effective as the predicate.

Here's a breakdown of the available information from the document with respect to your requested points:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a physical medical device (biopsy needle) and not an AI/ML diagnostic tool, the "acceptance criteria" are not in the format of performance metrics like accuracy, sensitivity, or specificity. Instead, they are related to established international and FDA standards for medical device safety and functionality.

Study Details (Non-Clinical Testing for Substantial Equivalence)

The document describes a series of non-clinical tests to demonstrate substantial equivalence to the predicate device, not a study focused on a specific performance metric.

2. Sample size used for the test set and the data provenance: Not applicable in the context of an "AI test set." The "test set" here refers to physical samples of the Clear-Tip EUS-FNA device that underwent various laboratory tests (biocompatibility, mechanical properties, sterilization, etc.). The document does not specify the number of samples used for each test. The provenance is the manufacturer, FINEMEDIX CO., LTD., located in Republic of Korea. The testing is assumed to be prospective, laboratory-based testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these non-clinical tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and the results obtained from standardized laboratory procedures, not by expert consensus on clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 are typically used for clinical study endpoints, particularly when human readers are involved in disagreement resolution. These are laboratory tests against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical biopsy needle, not an AI-assisted diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" is adherence to the specified parameters and ranges defined by the international standards (e.g., ISO 10993 for biocompatibility, ASTM F1980 for shelf life, specific values for tensile strength, etc.).

8. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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