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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. Also indicated for sphincterotome-aided, wire-quided selective cannulation of the biliary ducts.

Tesla BiCord Active Cord:

This device is used to connect the Teslatome Bipolar Sphincterotome to compatible electrosurgical generators.

ln a sphincterotomy, access to the biliary tract is gained by passing a sphincterotome through a duodenoscope and positioning the distal tip adjacent to the major papilla is cannulated using the tip of the sphincterotome. The papilla is then incised using an electrosurgical current applied to the cutting wire by an electrosurgical generator that is connected to the sphincterotome by an active cord.

The Teslatome consists of a three-ring handle, tri-lumen catheter, and cutting wire with a connection to an electrosurgical generator via the Tesla BiCord active cord. The connection delivers a current to the cutting wire that is exposed at the device. A multilumen catheter allows for the injection of contrast and/or the passage over a prepositioned wire guide using the proximal end of the device.

The provided text is a 510(k) summary for the Teslatome Bipolar Sphincterotome and Tesla BiCord Active Cord. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets these criteria, or any clinical study details.

The document explicitly states: "The non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability demonstrate adherence to the quality design and risk management systems of the manufacturer. The Teslatome and BiCord active cord are substantially equivalent to the currently cleared predicate devices."

This indicates that while non-clinical tests were performed, the 510(k) relies on the substantial equivalence to a predicate device (K192339) rather than a de novo clinical study with specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, along with the reasons why other information cannot be provided based on the input:

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

• Cannot be provided. The document broadly mentions "non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability." However, it does not list specific quantitative acceptance criteria for these tests or the reported performance values against those criteria. It only states that the tests "demonstrate adherence to the quality design and risk management systems of the manufacturer" and that the devices are "substantially equivalent."

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

• Cannot be provided. The document does not detail sample sizes for the non-clinical tests. It also does not discuss any test set in the context of clinical data or data provenance (country of origin, retrospective/prospective), as it relies on non-clinical testing and substantial equivalence.

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

• Cannot be provided. This information is relevant for studies involving human interpretation or clinical data with ground truth establishment. The provided text only discusses non-clinical device testing for substantial equivalence, not studies requiring expert ground truth.

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

• Cannot be provided. This is relevant for clinical studies involving multiple readers and ground truth adjudication. Not applicable to the non-clinical testing mentioned.

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

• Cannot be provided. The device described (Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord) is an endoscopic electrosurgical unit and accessories, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and not mentioned.

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

• Cannot be provided. As noted above, this is not an AI algorithm. The device is a physical medical instrument.

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

• Cannot be provided. For the non-clinical tests mentioned, the "ground truth" would be established engineering specifications, performance standards, or comparison to the predicate device's known characteristics, not clinical ground truths like pathology or expert consensus. Specific details are not included.

8. The sample size for the training set

• Cannot be provided. This information is related to machine learning models. The device discussed is a physical medical instrument, not an AI model requiring a training set.

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

• Cannot be provided. This information is related to machine learning models. Not applicable for this device.

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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking. - 2. Hemostasis for - · Mucosal/submucosal defects less than 3 cm, - · Bleeding ulcers, - · Arteries less than 2 mm. - · Polyps less than 1.5 cm in diameter, - · Diverticula in the colon, and - · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, - 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively. 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment. The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with three-year shelf life.

The provided text describes a 510(k) premarket notification for the "Instinct Plus Endoscopic Clipping Device." This is a regulatory submission for a medical device, where the manufacturer demonstrates that their new device is substantially equivalent to a legally marketed predicate device. The information presented is primarily focused on demonstrating this equivalence rather than a full clinical study report on diagnostic accuracy or comparative effectiveness of an AI product.

Therefore, many of the requested items (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study results, standalone performance of an AI algorithm, etc.) are not applicable to this type of document, as it concerns a physical medical device (an endoscopic clipping device) and not an AI-based diagnostic tool. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications of the physical device and bench testing results, not a clinical study to establish diagnostic performance.

However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to a predicate device (K192697) by tightening dimensional specifications and performing non-clinical bench testing. The "acceptance criteria" here relate to the device's functional performance during these tests.

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

• Test set sample size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to devices used in bench testing.
• Data provenance: The testing was "non-clinical bench testing" and "validation testing" performed by the manufacturer, Cook Medical Inc. This is not clinical data (e.g., country of origin, retrospective/prospective) in the context of human subjects.

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

• Not applicable. This pertains to an AI/diagnostic product that requires expert-annotated ground truth. This document describes a physical medical device and its engineering performance.

4. Adjudication method for the test set

• Not applicable. This pertains to expert review and consensus for AI/diagnostic product ground truth.

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 a physical medical device, not an AI product or a diagnostic tool. No MRMC study was performed.

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 AI algorithm.

7. The type of ground truth used

• Engineering specifications and functional performance criteria. The "ground truth" for this device's performance is whether it meets its design requirements and functional specifications (e.g., consistent clip deployment, strength of components). This is established through engineering and quality control procedures, not expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device and its engineering performance, not an AI model requiring a training set.

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

• Not applicable. This document describes a physical medical device and its engineering performance.

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This device is used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.

The provided text describes a 510(k) premarket notification for a medical device called the "Tri-Ex Extraction Balloon with Multiple Sizing." This device is used for endoscopic removal of biliary stones and for contrast injection. The submission seeks to demonstrate substantial equivalence to a predicate device (Tri-Ex Extraction Balloon K170292).

However, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI device performance. It is a regulatory submission for a physical medical device, not an AI-powered one. Therefore, I cannotExtract the requested information about AI device acceptance criteria and study details from this document.

The document only states the following regarding performance:

• Performance Data: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended."
• Summary of non-clinical testing:
  • Functional Testing/ Design Verification Testing
  • Biocompatibility Assessment
  • Fluoroscopic Visibility

This information indicates that bench testing was performed to demonstrate that the device meets its intended performance, but no specifics on "acceptance criteria" or detailed study results are provided, nor is there any mention of AI elements.

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This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.

The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.

The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.

This document describes the Cook Medical ERCP Catheters (ERCP, GT, FS-GT, HRC, and SUC) and their substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information relevant to the acceptance criteria of such a device can be extracted.

No information available for the requested sections:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.

The Captura® Disposable Bronchoscope Biopsy Forceps (subject device) represents modifications made to the Disposable Bronchoscope Biopsy Forceps (predicate device) currently cleared to market via 510K K923847 by Wilson-Cook Medical, Inc. The Captura® Disposable Bronchoscope Biopsy Forceps consist of a spool handle, coated coilspring catheter, drive cable, forceps cups and forceps housing.

The bronchoscope biopsy forceps is used by passing the device through a prepositioned endoscope to the targeted location. The forceps cups are attached on one end of the coilspring sheath with the spool handle attached to the opposite end. The handle is actuated by moving the spool forward to open the forceps cups and backward to close. The Captura® Bronchoscope Biopsy Forceps have a surgical rim edge around the circumference of the cups and the cups are fenestrated. The cups are opened and pressed against the biopsy site. When the cups are closed, they are pulled away from the biopsy site, pinching off the top surface, obtaining a tissue biopsy.

This document is a 510(k) premarket notification for the Captura® Bronchoscope Biopsy Forceps, a medical device. It does not describe a study involving machine learning, AI, or software, but rather a traditional medical device equivalency assessment. Therefore, most of the questions about acceptance criteria, AI performance, ground truth, and training sets are not applicable.

Here's the information that can be extracted from the provided text, aligning with the spirit of your request where possible:

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

Since this is a submission for a physical medical device, there isn't a direct "performance metric" like accuracy or precision as would be found in an AI/ML study. Instead, the "performance" relates to demonstrating the device functions comparably to a predicate device and adheres to safety and functional standards.

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

The document does not specify general "sample sizes" in terms of patient data or clinical images, as this is not an AI/ML study. Instead, testing involves physical exemplars of the device. The text states:

• Sample Size: Not specified for individual tests. Testing would typically involve multiple units of the device for each test (e.g., several devices for flex and fracture, multiple packaged units for burst/dye leak tests).
• Data Provenance: The testing was conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. This is a medical device manufacturer based in Winston-Salem, North Carolina, USA. The data is from in-house design verification and validation testing, which is prospective for the purpose of demonstrating substantial equivalence.

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

Not applicable. This is a submission for a physical medical device. "Ground truth" in this context refers to engineering specifications, validated test methods, and compliance with standards, not expert medical opinion on diagnostic images or data.

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

Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 are typically used for interpreting ambiguous cases or establishing ground truth in clinical or imaging studies involving human readers, 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

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML-driven diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. There is no algorithm or AI component to this physical biopsy forceps device.

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

The "ground truth" for this medical device's performance is established by:

• Engineering Specifications: The design and manufacturing specifications of the device.
• Validated Test Methods: Adherence to established scientific and engineering principles for testing functionality, durability, and safety.
• Regulatory Standards: Compliance with FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility).
• Predicate Device Performance: The cleared performance of the previously marketed predicate device (Disposable Bronchoscope Biopsy Forceps, K923847) serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

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

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This device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The target population is adult use only.

The ECHO-3-22: Echotip Ultra and the EUSN-1, EUSN-3: Echotip Ultrasound Needles are sterile, single use devices. The Ultrasound Needles consist of an adjustable luer slip handle, an outer and an inner catheter with a needle, extension locks (ECHO-3-22) or spacers (EUSN-1, EUSN-3), a stylet, and a syringe with a stopcock. All devices are compatible with ultrasound endoscopes with a minimum accessory channel of 2.8 mm. The catheter is made of polyether ether ketone, PEEK (ECHO-3-22), or polytetrafluoroethylene, PTFE (EUSN-1, EUSN-3), while the needle of all devices is stainless steel, and the stylet is nitinol. The tips of the needles are dimpled for echogenicity.

This document describes a 510(k) premarket notification for a medical device and is a regulatory submission, not a study report. Therefore, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance as typically expected for an AI/ML medical device.

The document states that "Performance testing consisting of non-clinical bench testing demonstrates that the Ultrasound Needles meet the performance requirements to fulfill the intended use of the device." and lists the types of non-clinical testing conducted. However, it does not provide:

• Specific acceptance criteria values or the reported device performance against those criteria.
• Any information about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because these are concepts typically associated with diagnostic or AI/ML device performance evaluations, not for a biopsy needle.
• Any training set information as this device is a physical medical instrument, not an AI/ML algorithm.

Therefore, I cannot populate the table or provide the requested details from the provided document. The document confirms that non-clinical bench testing was performed to demonstrate performance, but the specifics of that performance or the criteria used are not included in this summary.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:
* Cannot be provided. The document states that "Performance testing ... demonstrates that the Ultrasound Needles meet the performance requirements" but does not define these requirements (acceptance criteria) or report specific performance metrics or values.

2. Sample size used for the test set and the data provenance:
* Cannot be provided. This document describes non-clinical bench testing of a physical device (a needle), not a diagnostic algorithm with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic device performance evaluation using patient data, not for the physical performance testing of a biopsy needle itself.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No. This is a physical medical device (biopsy needle), not an AI/ML diagnostic system. Therefore, an MRMC study is not relevant here.

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 (expert consensus, pathology, outcomes data, etc.):
* Not applicable. Ground truth is not relevant in the context of the physical performance testing of a biopsy needle against engineering specifications.

8. The sample size for the training set:
* Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable. See point 8.

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Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

The modified EchoTip® Ultra Fiducial Needle is generally identical to the cleared predicate device. The modified device is also composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures. The Intended Use and Indications for Use are identical in the modified device as is the fundamental operating principle. Modifications to this iteration of the device include minor dimensional, geometric and tolerance adjustments.

The provided text is a 510(k) summary for a medical device (EchoTip Ultra Fiducial Needle) and a clearance letter from the FDA. This type of submission is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study proving performance against explicit acceptance criteria for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/human-in-the-loop system. The device described is a physical medical instrument, not an AI or software device that would typically have acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's why the requested information is not present:

1. Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific performance acceptance criteria for a novel technology. The "Discussion of Tests and Test Results" section states that "Cook conducted verification and validation testing specific to the risks identified to ensure that risks were mitigated and the device continued to perform as intended," but it does not list specific numerical performance criteria or results.
2. Sample Size and Data Provenance (for a test set): Not applicable, as there's no diagnostic AI algorithm being tested on a "test set" of data. The "tests" mentioned are likely engineering and bench tests for the physical device.
3. Number and Qualifications of Experts for Ground Truth: Not applicable for a physical device. Ground truth is usually relevant for diagnostic software where human experts label images or data.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study investigates the impact of AI assistance on human reader performance, which isn't relevant for a physical fiducial needle.
6. Standalone (Algorithm-Only) Performance: Not applicable. This device is a physical instrument, not an algorithm.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for the Training Set: Not applicable. This device is not an AI model that requires a training set.
9. How Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided submission describes a physical medical device and its regulatory clearance process through substantial equivalence, not the performance evaluation of a software or AI device against acceptance criteria in a clinical study.

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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

The Instinct Endoscopic Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Instinct Endoscopic Hemoclip is 230 cm long. The deployed clip portion of the Instinct Endoscopic Hemoclip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.

The provided text describes a 510(k) summary for the Instinct Endoscopic Hemoclip. This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not directly available in this document.

However, I can extract information related to the device's performance assessment as presented in the submission.

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

Based on the provided text, specific numerical acceptance criteria are not detailed. The performance assessment focused on demonstrating that the device met "performance requirements" through non-clinical bench testing.

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

The document mentions "non-clinical bench testing." This typically refers to laboratory-based evaluations.

• Sample Size: Not specified.
• Data Provenance: Non-clinical bench testing data. Country of origin not specified (implied to be within the company's testing facilities, likely in the USA where the company is based). The data is generated prospectively during the device development and testing phase.

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

This information is not applicable to non-clinical bench testing. Ground truth for mechanical performance tests is typically established by engineering specifications and objective measurements, not by expert consensus.

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

This information is not applicable to non-clinical bench testing. Mechanical test results are objective and measured against predefined specifications.

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

An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic imaging devices with human interpretation, not for mechanical devices like a hemostasis clip.

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

This concept is not applicable to a mechanical medical device like a hemoclip. There is no "algorithm only" performance for such a device; its function is mechanical and directly applied by a clinician.

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

The "ground truth" for the non-clinical bench testing would be the pre-defined engineering specifications and measurable performance standards for visual verification and tensile strength.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical bench testing for a device like this. Machine learning algorithms, which require training sets, are not mentioned.

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

Not applicable, as there is no training set mentioned.

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This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP

The proposed Endoscopic Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cook Medical, Inc. The Endoscopic Wire Guide is .025" in diameter and is compatible with a full range of Wilson-Cook accessories.

The provided 510(k) summary (K122816) does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML powered medical device.

This document describes an "Endoscopic Wire Guide," which is a physical medical device (a wire guide for ERCP procedures). The performance data section states: "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Processes. We believe the proposed device to be substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested and biocompatibility."

This suggests that the performance evaluation was likely based on traditional engineering tests, biocompatibility assessments, and comparison to a predicate device's established performance, rather than a clinical study with acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or human reader improvement, which would be typical for an AI/ML-powered device.

Therefore, I cannot provide the requested information for acceptance criteria and related study details for an AI/ML device from this submission.

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This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

The proposed Cook Device is assembled by the end user from three component pieces: a handle with a threaded piston and directional arrow, a sterile needle cannula with an attached pressure gauge to track pressure in the event of needle kinks/bends in the tortuous GI anatomy and a sterile 10 cc syringe filled with a mixture of sterile water and sodium CMC. Blue colorant may or may not be added to enhance endoscopic visibility. After creation of a starter bleb below affected tissue, the gel is then injected into the starter bleb. The bleb will then stay elevated from the muscle layer to allow for endoscopic dissection or resection with a separately supplied endoscopic electrosurgical device. After excision and retrieval of affected tissue, the bleb will dissolve and pass out of the body naturally.

The prompt describes a medical device called the "Cook GI Endoscopic Injection Gel Kit," which is intended for submucosal lift of polyps or other gastrointestinal mucosal lesions prior to excision. The provided text is a 510(k) summary for this device, outlining its intended use, description, comparison to predicate devices, and performance data.

However, the provided text does not contain the information requested in the prompt regarding acceptance criteria and a detailed study proving the device meets those criteria. Specifically, the prompt asks for:

1. A table of acceptance criteria and reported device performance: This is not present. The document states "Pre-clinical testing verified the biological safety of the injection media and validated the performance capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing." This is a general statement, not a table of specific criteria and results.
2. Sample size for the test set and data provenance: No specific sample sizes for tests are given, nor is the data provenance detailed beyond "bench and animal testing."
3. Number of experts and qualifications for ground truth: No information on expert involvement or ground truth establishment is provided for testing.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This is typically for AI/imaging devices, which this is not.
6. Standalone performance study (algorithm only): Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not specified, beyond the general "bench and animal testing."
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document discusses the "PERFORMANCE DATA" in a very high-level manner, stating that "Pre-clinical testing verified the biological safety of the injection media and validated the performance capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing." It also highlights a key characteristic: "The viscosity of the subject gel overcomes the limitation of injection of saline and other low viscosity materials with respect to time the bleb remains elevated from the muscularis and other mechanical mucosal separation techniques that may result in muscle layer involvement." This implies a performance benefit related to longer bleb elevation, but specific metrics and acceptance criteria for this are not detailed.

In conclusion, based only on the provided text, it is not possible to answer the detailed questions about acceptance criteria and specific study methodologies because that information is not present in the 510(k) summary. The summary focuses on regulatory substantial equivalence rather than a detailed report of all performance testing and its corresponding acceptance criteria.

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