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The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument intended for single-patient use only.

This document is a 510(k) premarket notification for the EasyPass Guidewire. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and statistically proven.

Therefore, the requested information cannot be fully provided in the typical format for a study proving device meets acceptance criteria. However, I can extract the relevant information regarding the performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, "acceptance criteria" are not explicitly stated in a quantitative manner with pass/fail thresholds for specific performance metrics in the way one might expect for a de novo or PMA submission. Instead, the performance is demonstrated by comparing the device to a predicate and showing it meets "the same performance requirements." The "acceptance criteria" are therefore implicitly that the device performs equivalently to the predicate device in the specified tests.

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

The document does not specify the exact sample sizes (N) used for each non-clinical performance test. It only states that these tests were conducted. The data provenance is "non-clinical performance data" generated from bench testing and biocompatibility assessments of the proposed EasyPass Guidewire. There is no information regarding the country of origin or whether it's retrospective/prospective as these are not clinical tests.

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

Not applicable. This document describes non-clinical testing (bench and biocompatibility), not studies involving expert evaluation of clinical data or images.

4. Adjudication method for the test set

Not applicable. No expert adjudication was described for these non-clinical 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

Not applicable. This device is a medical guidewire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

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

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be established by the standardized methods and specifications relevant to each test (e.g., ISO 10993 for biocompatibility, material specifications for fracture/bend/tensile tests, etc.). The goal was to demonstrate performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. (See #8)

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The PolyCatch Retrieval Device is intended for capture and retrieval of excised polyps, foreign bodies, tissue samples and calculi during flexible or rigid endoscopy procedures.

The PolyCatch Retrieval Device is a complete one-piece device for retrieval of polyps and foreign bodies from the gastrointestinal and respiratory tracts and is a disposable instrument intended for single patient use only. The PolyCatch Retrieval Device is used through the working channel of a legally marketed endoscope. The PolyCatch Retrieval Device consists of a handle, outer sheath and a snare wire/loop to which a non-Latex pouch is attached. As the snare wire is advanced from of the outer sheath of the device, it expands to its full circumference thereby deploying the non-Latex pouch. The pouch can then be manipulated by the clinician to engage a polyp or foreign body. After the polyp or foreign body is captured within the pouch the handle is used to draw the snare wire and pouch back against the device sheath. The endoscope along with the PolyCatch is then removed together from the patient to complete the retrieval procedure.

This document is a 510(k) premarket notification for a medical device called the "PolyCatch Retrieval Device." It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document states that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis based on your request, keeping in mind that this type of regulatory submission often focuses on demonstrating equivalence to an existing device rather than presenting extensive de novo clinical trials with AI components.

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

   This document does not specify "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) that would typically be associated with an AI-enabled device's diagnostic or predictive capabilities. This is a conventional medical device a "PolyCatch Retrieval Device" which is used for the physical retrieval of polyps, foreign bodies, tissue samples, and calculi. Its "performance" would relate to its mechanical function, biocompatibility, and ability to effectively retrieve objects as intended.

   The document states:

   "Design verification data and biocompatibility testing has demonstrated that the proposed PolyCatch Retrieval Device is safe and effective."
   "Bench performance testing was conducted using a specially designed test fixture intended to simulate actual device use of the PolyCatch Retrieval Device."
   "Medi-Globe Corporation has demonstrated that the proposed PolyCatch Retrieval Device is as safe and effective as the predicate device, (Roth Net Retriever, K122462)."

   Without the full design verification and bench test reports, specific quantitative acceptance criteria and their corresponding results cannot be extracted from this summary. This document operates under the premise of "substantial equivalence" to a predicate device, meaning its performance is considered comparable to the predicate.

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 "Design verification data and biocompatibility testing" and "bench performance testing." These typically involve studies in vitro or on test fixtures, not human patient data in the way an AI study would. Therefore, concepts like sample size of a patient test set, country of origin, retrospective/prospective classification, or human data provenance are not applicable here. The "test set" in this context refers to the materials and conditions used in the bench testing. No specific sample sizes for these tests are provided in this summary.

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 is not an AI-enabled device. The "ground truth" for a device like this would be its mechanical integrity, effective capture/retrieval of test objects under simulated conditions, and biocompatibility. This does not require human expert interpretation of images or data to establish a ground truth.

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

   Not applicable, as this is not an AI-enabled diagnostic or predictive device requiring adjudication for ambiguous cases.

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-enabled device, and no human reader studies are mentioned or implied.

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

   Not applicable. The device is a physical medical instrument, not an algorithm.

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

   The "ground truth" for a physical retrieval device like this would be defined by engineering specifications and successful mechanical operation under test conditions, as well as satisfactory biocompatibility results. This does not involve expert consensus, pathology, or outcomes data in the way a diagnostic AI would.

8. The sample size for the training set

   Not applicable, as this is not an AI-enabled device, and therefore no "training set" in the context of machine learning is used.

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

   Not applicable, for the same reason as point 8.

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The SonoTip Pro and Pro Flex - TBNA Needle System 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 SonoTip Pro and Pro Flex EBUS-TBNA Needle System is a complete onepiece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. The SonoTip Pro Flex EBUS-TBNA Needle System is coupled to the working channel of a legally marketed ultrasound endoscope. The needle is then ultrasonically guided and imbedded into the desired target lesion for aspiration of the required biopsy sample. A 2-way stop-cock valve and self-locking aspiration syringe are supplied as procedural aids to provide suction to through the needle lumen and assist in sample acquisition.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SonoTip Pro and Pro Flex EBUS-TBNA Needle System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "Design verification data and biocompatibility testing has demonstrated..." but does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). This information refers to non-clinical testing.

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

There is no mention of experts or clinicians used to establish ground truth in the provided text. The evaluation is based on non-clinical data and comparison to a predicate device.

4. Adjudication Method for the Test Set

Since there is no mention of human expert evaluation or a test set involving human judgment, there is no adjudication method described in the document.

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 MRMC study was performed or is mentioned in the document. The device is a biopsy needle system, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

The device is a physical biopsy needle. No standalone algorithm performance study was performed or is relevant to this type of medical device.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" seems to be derived from engineering design verification data and biocompatibility testing results, which likely adhere to established industry standards and internal specifications, allowing for direct comparison to the predicate device's performance.

8. The Sample Size for the Training Set

Since this is a physical medical device and not an AI/software product, there is no concept of a "training set" in the context of the provided information.

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

As there is no training set mentioned, this question is not applicable. The device's performance is established through non-clinical testing and comparison to a predicate device, as described in point 7.

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The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.

The Medi-Globe SonoTip II EBUS-TBNA Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.

The provided text describes a medical device submission (510(k)) for the Medi-Globe SonoTip II EBUS-TBNA Needle System. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study proving the device meets those criteria.

The document makes a general statement about performance data:

"Design verification data has demonstrated that the proposed Medi-Globe SonoTip II EBUS-TBNA Needle System meets the same performance requirements and is as safe and effective as Medi-Globe's currently cleared predicate device."

This indicates that the device's performance was compared to a predicate device, and it was found to be "as safe and effective." However, it does not provide the specifics of:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only states the device "meets the same performance requirements" as the predicate.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging AI algorithms, not typically for a needle system.
6. If a standalone performance study was done: The wording suggests performance was evaluated relative to a predicate, not necessarily in a standalone clinical trial with specific performance metrics.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and general range of descriptive features. It does not include a detailed breakdown of specific performance acceptance criteria or the study data proving those criteria were met, which is typical for a 510(k) summary that emphasizes equivalence rather than novel performance claims backed by clinical trials.

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The SonoTip II 25-gauge Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The Medi-Globe SonoTip II 25-gauge Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.

The provided text describes a 510(k) premarket notification for the Medi-Globe SonoTip II 25-gauge Ultrasound Needle System. This submission is for a new device claiming substantial equivalence to previously cleared predicate devices. Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on equivalence to predicate devices rather than a standalone performance study with specific metrics.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific quantitative acceptance criteria or detailed performance metrics against those criteria in the manner one might expect for a new performance claim. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, meaning the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

Study Proving Acceptance Criteria

The study described is a design verification as part of a 510(k) submission for substantial equivalence.

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

   • The document states "Design verification data has demonstrated..." but does not specify a sample size for any test set nor the data provenance (e.g., country of origin, retrospective/prospective). Design verification in this context likely refers to internal testing (e.g., mechanical testing, materials testing, functional testing) to ensure the device meets its design specifications and performs comparably to the predicate. It is not presented as a clinical study with human subjects.

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

   • Not applicable. This was not a study involving expert assessment of diagnostic accuracy against a ground truth.

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

   • Not applicable. No clinical test set requiring adjudication is mentioned.

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:

   • No. This is a medical device for fine needle aspiration, not an AI-assisted diagnostic tool.

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

   • No. This is a physical medical device, not an algorithm.

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

   • Not applicable for a clinical ground truth. The "performance requirements" mentioned likely refer to engineering and functional specifications (e.g., needle integrity, fluid aspiration capability, compatibility with ultrasound endoscopes) which would be verified against design specifications, not clinical pathology or outcomes directly in a human cohort during this 510(k) process.

7. The sample size for the training set:

   • Not applicable. The submission does not refer to a training set for a machine learning algorithm.

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

   • Not applicable. (See point 7).

In summary, the K083802 submission for the Medi-Globe SonoTip II 25-gauge Ultrasound Needle System relies on demonstrating substantial equivalence to an existing, legally marketed predicate device (K070129) through design verification data. This approach means that a comprehensive clinical study with detailed performance metrics, ground truth establishment, or human reader assessments was not required or provided in the 510(k) summary, as the device's fundamental safety and effectiveness are established by its similarity to already approved devices.

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The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The SonoTip II Endoscopic Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. A feature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This feature provides the user with the ability to precisely adjust the working length of the instrument relative to the endoscope being used.

The provided text is a 510(k) summary for the Medi-Globe SonoTip II Ultrasound Needle System, a medical device for fine needle aspiration. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data for a novel artificial intelligence (AI) or software-based medical device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI/software, ground truth, expert involvement, and statistical measures like sample sizes for training/test sets) are not applicable to this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format of a table with specific, quantifiable acceptance criteria and corresponding performance metrics for the SonoTip II. The submission relies on "design verification data" demonstrating general equivalence.

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

• Sample Size: Not specified. The document refers to "design verification data" but does not detail the size or nature of any test set used.
• Data Provenance: Not specified. It's customary for such mechanical device design verification to involve in-house testing rather than external clinical data in the same way an AI device would.

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

• Number of Experts: Not applicable. This type of submission for a physical device does not typically involve expert readers for "ground truth" establishment in the sense of image interpretation or diagnostic accuracy.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "design verification data" for a needle system would likely involve engineering and functional tests (e.g., tip sharpness, flexibility, aspiration effectiveness, compatibility with endoscopes) rather than diagnostic adjudication.

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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a biopsy needle.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical instrument, not an algorithm. Its function inherently involves a human operator (clinician) manipulating it.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not specifically mentioned as "ground truth" in the context of clinical outcomes or pathology. For a device like this, "ground truth" for design verification would relate to engineering specifications and functional performance (e.g., material strength, needle penetration force, fluid aspiration volume, ease of deployment/retraction, compatibility with predicate endoscopes).

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable.

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The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.

The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.

Acceptance Criteria and Study Details for Injectra Injection Needle

This submission (K061222) pertains to the Injectra Injection Needle and demonstrates its substantial equivalence to a predicate device. The performance data focuses on verification that the new device meets established requirements and maintains safety, rather than providing complex clinical trial outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state a sample size for a test set in the traditional sense of a clinical or analytical study with a defined dataset. The performance data section refers to "Design verification data" and "Biological testing," which are typically internal engineering and laboratory tests.

• Test Set Sample Size: Not explicitly stated as a defined "sample size" for a dataset. Design verification and biological testing are usually conducted on a set number of manufactured devices or materials.
• Data Provenance: The nature of "Design verification data" and "Biological testing" suggests these are results from internal testing conducted by the manufacturer, Medi-Globe Corporation. The country of origin and whether it is retrospective or prospective are not specified, but such tests are generally prospective (performed on new designs or materials).

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

This submission does not involve expert-established ground truth for a test set in the context of diagnostic accuracy. The "ground truth" for this type of device (an injection needle) is largely based on engineering specifications, material properties, and established biological safety standards. There is no mention of external experts being used to establish a ground truth for performance.

4. Adjudication Method for the Test Set

Not applicable. The performance data described are based on objective engineering and laboratory tests, not subjective interpretations requiring an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Injectra Injection Needle is an interventional accessory device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not conducted. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Engineering Specifications and Performance Requirements: Measured against pre-defined functional parameters (e.g., fluid delivery capability, structural integrity, compatibility with endoscopes).
• Predetermined Safety Standards: Biological testing confirms the device meets accepted biocompatibility standards.
• Equivalence to Predicate Device: The primary ground truth is established by demonstrating that the new device performs identically or equally well to the legally marketed predicate device (K955558) in terms of its intended function and safety profile.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a training set.

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

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

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The Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.

The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single, double or triple lumen models and allows incremental, rotational orientation of the distal catheter tip and cutting wire. Device models are compatible with either .021 or .035" guide wires and allow simultaneous injection of contrast medium during use.

This is a 510(k) premarket notification for a medical device, the Medi-Globe Rota-Cut® Sphincterotome. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics for a novel technology. Therefore, the information requested in your prompt regarding acceptance criteria, performance data, sample sizes, ground truth, and expert involvement is largely not applicable in the context of this specific regulatory document.

Here's an explanation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) submission for the Medi-Globe Rota-Cut® Sphincterotome does not present specific quantitative acceptance criteria or detailed device performance metrics in the way a novel AI or diagnostic device would. Instead, it relies on demonstrating substantial equivalence to predicate devices.

The "Performance Data" section states: "Design verification tests have demonstrated that the proposed Rota-Cut® sphincterotomes meet the same performance standards and biocompatibility requirements and is as safe and effective as the currently cleared GIP/Medi-Globe device, (K943629/A)."

This implies that the acceptance criterion for the new device is to perform as well as or equivalently to the predicate device in terms of "performance standards and biocompatibility requirements" and be "as safe and effective." However, no explicit numerical criteria or specific performance values are listed in this document.

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

Not Applicable. No specific "test set" in the context of clinical data for performance evaluation is described. The "design verification tests" are likely referring to bench testing, engineering validation, and biocompatibility testing as per standard medical device development. No human subject data (retrospective or prospective) is mentioned as being used to prove the device's performance against specific metrics through a test set.

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

Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for any test set because there is no clinical test set described in this document to evaluate the device's diagnostic or predictive performance.

4. Adjudication Method

Not Applicable. Since there is no test set with clinical findings requiring ground truth establishment, no adjudication method is described.

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

No. This is a medical device for surgical intervention (sphincterotomy), not an imaging or diagnostic AI device. MRMC studies are typically used for assessing the impact of AI on human readers' diagnostic accuracy. This is not relevant to the Rota-Cut® Sphincterotome.

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

Not Applicable. The Medi-Globe Rota-Cut® Sphincterotome is a physical surgical instrument, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

Not Applicable. As explained above, no clinical "ground truth" for diagnostic or predictive outcomes is mentioned because the performance evaluation is based on substantial equivalence to an existing device, focusing on "performance standards, biocompatibility requirements," and being "as safe and effective." The ground truth for these types of evaluations is often established through well-defined engineering specifications, material standards, and preclinical (e.g., animal or bench) testing protocols.

8. The Sample Size for the Training Set

Not Applicable. Since the device is a physical instrument and not an AI algorithm, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for an AI algorithm, this question is not applicable.

In summary, the provided document is a 510(k) summary for a substantial equivalence claim for a physical medical device. It focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to previously cleared predicate devices. The detailed performance and clinical study information, including acceptance criteria, sample sizes, and ground truth methodologies, as typically found for novel AI/diagnostic devices, are not present in this type of regulatory submission and are not relevant to demonstrating substantial equivalence for a device like a sphincterotome. The "study" mentioned is "Design verification tests," which are engineering and biocompatibility tests intended to show equivalence to the predicate, not clinical trials with human subjects as implied by many of your questions.

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The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.

The provided text describes the SonoTip II Ultrasound Needle System and its 510(k) clearance. However, it does not contain detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or details about the studies (e.g., standalone, MRMC, or training set specifics) that would allow for a comprehensive breakdown as requested.

The document states:

• "Design verification data has demonstrated that the SonoTip II Ultrasonic Needle System meets design requirements and is as safe and effective as the predicate device."
• "The SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220)."

This indicates that the clearance was based on substantial equivalence to a predicate device (GIP/Medi-Globe GI Ultrasound Needle System (K990220)) rather than a detailed clinical performance study with specific acceptance criteria and metrics. The "Performance Data" section primarily asserts equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document refers to "Design verification data" but does not detail its source or nature.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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; an MRMC study was not done. This device is a manual medical instrument (a needle system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" 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 (needle system), not an algorithm.

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

• Not specified. Given the nature of the device (FNA needle), a typical "ground truth" for its performance might involve mechanical testing (e.g., needle sharpness, bend resistance, fluid aspiration efficiency) and biocompatibility, as well as a comparison of histological samples obtained with the device vs. the predicate, but these details are not provided.

8. The sample size for the training set

• Not applicable. This device is a physical instrument, not an AI model, so there is no "training set."

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

• Not applicable. As above, no training set.

Summary of available information:

The 510(k) clearance for the SonoTip II Ultrasound Needle System was based on demonstrating substantial equivalence to a legally marketed predicate device (Medi-Globe Ultrasound Needle System, K990220). The documentation does not provide specific performance metrics, detailed study designs, sample sizes, or information about expert involvement typically associated with a human-AI performance study. Instead, it relies on "design verification data" to assert that the device meets design requirements and is as safe and effective as the predicate.

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