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The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.

The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line. The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and reloads have a staple line that is approximately 35 mm long and a cut line that is approximately 30 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate access to the operative site. The instrument is packaged with a primary lithium battery pack that must be installed prior to use. The instrument is packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping, transporting, and installing the reload. The instrument's lockout feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.

The provided text describes the Ethicon Endo-Surgery, LLC's K141952 submission for the Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip, and Endopath Echelon™ Vascular White Reloads for Advanced Placement Tip.

However, the document is a 510(k) summary for a medical device and does not contain the specific acceptance criteria or a study with detailed performance outcomes in a table format as requested. It outlines the types of testing performed to demonstrate substantial equivalence to predicate devices, but it does not provide the quantitative acceptance criteria or detailed results required to complete the requested table.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone (algorithm only) performance details
• Type of ground truth used (beyond general 'bench testing,' 'animal testing')
• Sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to existing predicate devices, which is the primary requirement for a 510(k) submission. It lists the types of testing conducted, such as:

• Bench testing for force-to-close evaluation
• Staple height, staple form, and staple line integrity evaluation
• Animal testing for hemostasis evaluation (in acute and survival models)
• Electrical safety and electromagnetic compatibility testing
• MR compatibility testing
• Aggregate device biocompatibility testing for patient contacting materials

These tests are performed to show that the new device performs as intended and is as safe and effective as the predicate devices, but the specific acceptance criteria (e.g., "force-to-close must be X to Y range") and the quantitative results are not included in this summary document. Similarly, details regarding ground truth establishment, expert involvement, or AI-specific studies (MRMC, standalone algorithm performance) are not present, as this is a mechanical surgical stapler, not an AI/software as a medical device (SaMD).

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The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).

The provided text describes performance testing for a medical device called the "ValuTrus™ Reusable Circular Stapler and Disposable Reloads." However, it does not contain the detailed quantitative acceptance criteria and device performance results that would typically be presented in a table for an AI/CADe system. The information is more general, stating that criteria were "met" for bench and animal testing.

Therefore, I cannot fully complete a table with specific numerical acceptance criteria and reported device performance. I will extract and organize the available information as best as possible, and highlight what is missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

Missing Information: The specific numerical thresholds or qualitative attributes for "bench testing acceptance criteria" and "leak pressure acceptance criteria" are not provided in the document.

Study Details for Device Performance

The provided text focuses on the performance of a mechanical surgical stapler, not an AI/CADe system for image analysis. Therefore, many of the requested points related to AI/CADe studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I will address the relevant points based on the information provided for this mechanical device:

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

   • Bench Testing: The sample size for bench testing is not explicitly stated. The testing was conducted to demonstrate performance after "200 simulated uses."
   • Animal (Tissue) Testing: The sample size (number of animals or anastomoses) for animal testing is not specified. The data provenance is "porcine colon" (animal testing). It is implicitly prospective in nature as it's part of a device clearance application.
   • Country of Origin: Not specified.

2. 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 relates to human interpretation of data, which is not described for this mechanical device's performance studies. Ground truth here refers to physical measurements and observations.

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

   • Not applicable. This relates to discrepancies among human evaluators, which is not described for this mechanical device's performance studies.

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

   • Not applicable. This type of study applies to image-based diagnostic systems with human interpretation, not a surgical stapler.

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

   • Not applicable. There is no algorithm described for this device. Its "performance" is based on mechanical function and physical outcomes (e.g., staple line integrity).

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

   • Bench Testing: The ground truth would be direct physical measurements and observations of the device's mechanical function (e.g., staple formation, cutting ability, durability after simulated uses), as defined by engineering specifications.
   • Animal (Tissue) Testing: The ground truth was "leak pressure" of the anastomotic stoma, which is an objective physiological measurement.

7. The sample size for the training set:

   • Not applicable. This device is a mechanical stapler, not an AI/machine learning system that requires a "training set."

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

   • Not applicable. As above, no training set for an AI model is involved.

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The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The Echelon Flex Powered Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.

The instruments are packaged with a battery pack that must be installed prior to use.

The instruments are shipped without a cartridge and must be loaded prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.

The Ethicon Endo-Surgery Echelon Flex Powered Articulating Endoscopic Linear Cutters (K110385) is a surgical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML device evaluations (e.g., performance metrics like sensitivity/specificity, sample sizes for AI training/testing sets, expert adjudication, MRMC studies) are not applicable.

This device is primarily evaluated through bench testing to demonstrate its mechanical performance and functional equivalence to a predicate device.

Here's an adaptation of the requested information, focusing on what is relevant for a non-AI surgical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. For bench testing of surgical devices, sample sizes vary depending on the specific test (e.g., number of firings, units tested for articulation). These are typically statistical samples sufficient to demonstrate reliability and consistency.
• Data Provenance: The data is from bench testing presumably conducted by the manufacturer, Ethicon Endo-Surgery, LLC. The text does not specify the country of origin of the data beyond the company's location (Guaynabo, PR and Cincinnati, OH). The studies would be prospective in nature, as new devices are manufactured and tested to demonstrate performance.

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

• This concept is not applicable for the type of device and study described. Bench testing of a surgical stapler does not rely on human experts to establish "ground truth" in the way AI/ML algorithms do for image interpretation or diagnosis. The "ground truth" for mechanical performance is defined by engineering specifications and objective measurements (e.g., staple height, pull-apart force, cutting efficiency).

4. Adjudication Method for the Test Set

• Not applicable. Adjudication relates to resolving disagreements among human readers or experts, which is not a component of bench testing for a mechanical surgical device. Performance is verified against objective, measurable criteria.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance (e.g., radiologists interpreting images). This device is a surgical instrument and its evaluation does not involve diagnostic interpretation or human readers in an MRMC context.

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

• This is not applicable as the device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily objective engineering specifications and physical measurements. This includes:
  • Mechanical performance metrics (e.g., staple formation, cutting force, articulation angles).
  • Material properties.
  • Functional reliability tests.
  • Comparison to predicate device performance benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

• Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment for it. The design specifications and predicate device performance effectively serve as the "ground truth" for the device's development and testing.

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The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open, general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. The EnSeal Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is a sterile, single patient use device. The functionality is the same as the predicate devices.

The provided document, K101520, is a 510(k) summary for the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer. It claims substantial equivalence to a predicate device based on performance testing and functional similarities. However, the document does not contain the specific details required to fully address your request in terms of acceptance criteria, study design, and ground truth establishment, as the performance data section is very brief.

Here's an analysis based on the information available in the document and the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:
The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum seal burst pressure, maximum thermal spread, specific transection time, etc.). It only provides a general statement that "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." Without these specific criteria, it's impossible to create a comprehensive table of acceptance criteria and reported performance with detailed metrics.

2. Sample Size for the Test Set and Data Provenance

Missing Information: The document does not specify the sample size used for either bench or animal testing. It also does not mention the country of origin for the data or whether the studies were retrospective or prospective.

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

Missing Information: The document does not describe the establishment of a "ground truth" using experts. Performance testing for medical devices, especially electrosurgical ones, typically involves objective measurements (e.g., burst pressure, thermal spread, histological analysis) rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Missing Information: Since the document does not describe expert involvement for ground truth, an adjudication method is not applicable and not mentioned.

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

Not Applicable: The device is an electrosurgical tissue sealer, not an imaging or diagnostic device that would typically involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant or mentioned in this context.

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

Not Applicable: The device is a physical electrosurgical instrument, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Based on the nature of the device (electrosurgical tissue sealer) and the mention of "bench and animal testing," the ground truth for performance would likely be established through:

• Objective physical measurements: Such as burst pressure of sealed vessels, impedance measurements, thermal spread measurements.
• Histological analysis: Examination of tissue samples after sealing to assess cellular damage and seal integrity.
• Physiological outcomes in animal models: Such as hemostasis, healing, absence of complications.

Missing Information: The document does not explicitly detail the specific type of ground truth used for each aspect of testing or how it was established.

8. Sample Size for the Training Set

Not Applicable: This device is a traditional electrosurgical instrument, not a machine learning or AI-driven system that would typically require a "training set."

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

Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of Conclusions from the Document:

• Study Performed: Bench and animal testing.
• Purpose of Study: To ensure the devices function as intended and meet design specifications.
• Conclusion of Study: Based on this testing, and functional similarities to predicate devices (SurgRx EnSeal Tissue Sealers, K072177), the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are considered substantially equivalent to the predicate devices.
• Modifications: Differences include an improved ergonomic handle, larger shaft, jaw diameter, and jaw length/shape compared to the predicate device.

Overall, the provided 510(k) summary is very high-level regarding performance data. It states that testing was done to ensure functionality and design specifications were met, and that this supports substantial equivalence. However, it lacks detailed quantitative acceptance criteria and specific results that would typically be found in a more comprehensive study report.

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The Ethicon Endo-Surgery® 5mm Laparoscopic Multi-Feed Stapler has application for use in a variety of minimally invasive procedures for approximation of tissue.

The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is a sterile, single patient use instrument designed for use with a 5mm diameter trocar. The device places rectangular titanium staples. The staple opens to a tip to tip width of about 6.1mm (0.240 inches). Closed staple dimensions are approximately 5.5 mm x 6.1 mm (0.215 inches x 0.242 inches). The instrument shaft is 5.5mm (0.218 inches) in diameter and 457mm (18 inches) long and contains about 40 staples.

The provided text describes a 510(k) premarket notification for a new surgical stapler. The submission focuses on demonstrating substantial equivalence to a predicate device through performance data, not on establishing acceptance criteria and conducting a study to prove a device meets those criteria in the context of AI/machine learning.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device submission.

Here's an analysis based on the information available in the provided text:

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

The document does not detail specific quantitative acceptance criteria (e.g., specific staple strength, deployment accuracy rates) that the device must meet, nor does it present device performance data in a detailed, quantified table format suitable for head-to-head comparison against such criteria.

The "Performance Data" section generally states: "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device performs as intended." This is a qualitative statement of intent and outcome, not a presentation of specific criteria and corresponding results.

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

Not applicable. This is a traditional medical device submission primarily focused on mechanical performance and biocompatibility, not an AI/machine learning device submission involving test sets of data. The "bench testing and preclinical laboratory evaluations" likely involved a certain number of devices or staple deployments, but these numbers are not specified.

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

Not applicable. This concept of "experts establishing ground truth for a test set" is relevant to AI/ML where human expertise is used to label data. For a surgical stapler, "ground truth" would be established through engineering specifications, material science, and observed mechanical performance.

4. Adjudication method

Not applicable. Adjudication methods (like 2+1 or 3+1) are used in AI/ML studies to resolve discrepancies in expert labeling of data. This is not relevant to a surgical stapler's performance evaluation as described.

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

Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical surgical instrument.

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

Not applicable. This refers to the performance of an AI algorithm alone. The device is a surgical stapler, not an algorithm.

7. The type of ground truth used

For a surgical stapler, the "ground truth" would implicitly be defined by:

• Engineering Specifications: Designed dimensions, material properties, force requirements for staple formation and deployment.
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Functional Performance Expectations: The ability to approximate tissue effectively, ensure proper staple formation, and preclude unintended failure modes.
• "Pathology" in the context of a stapler might relate to post-stapling tissue analysis, but not as the primary "ground truth" for proving the stapler itself works. "Outcomes data" would be from clinical use, not the bench and preclinical studies described here.

8. The sample size for the training set

Not applicable. This concept is for AI/ML models. The "design and development were predicated on use of technology currently used in Ethicon Endo-Surgery manual stapler devices," which could be considered analogous to a "training" history or experience base, but not a quantifiable data set in the AI sense.

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

Not applicable. Similarly, the "ground truth" for the "training set" (if we consider previous stapler designs as training) would be established through the accumulated engineering knowledge, testing data, and clinical experience with those existing devices.

Summary based on the provided document:

The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler's acceptance criteria and proof of meeting them are described in terms of a substantial equivalence pathway to a predicate device (Ethicon, Inc. ENDOPATH Disposable Endoscopic Multifeed (EMS) Stapler K913469).

The study that proves the device meets "acceptance criteria" (which are not explicitly detailed in the document as quantitative metrics but are implied by safe and effective surgical stapler performance) is the "Bench testing and preclinical laboratory evaluations". These evaluations were performed to demonstrate that the device performs as intended and that its new features "do not raise any new issues relating to safety and effectiveness" compared to the predicate device. Additionally, device materials were evaluated for biocompatibility and comply with the requirements of ISO 10993-1.

The document indicates that this data supports the conclusion that the new stapler is substantially equivalent to the predicate device. No specific quantitative performance metrics, sample sizes for detailed testing, or expert reviews for data labeling are provided in this summary.

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The EES Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Ethicon Endo Surgery® Slotted Anoscope consists of a transparent plastic disposable anoscope in sterile condition. The Slotted Anoscope comprises a cylindrical body, with a closed end conical-shaped distal tip and a longitudinal open channel that accommodates a removable slide. The removable slide comprises a longitudinal open channel of 11mm in width. The body of the Slotted Anoscope has an outer diameter (OD) of 34mm. The Slotted Anoscope is a single patient use device.

The transparent characteristics of the material used in the Slotted Anoscope allows for visualization of the tissue in contact with the device in the anal canal. The opening in the removable slide provides access to tissue in the canal. The removal of the slide provides a wider margin of access to the targeted area.

The provided 510(k) summary for the Ethicon Endo-Surgery® Slotted Anoscope (K093896) indicates that it is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (such as sample size for test set, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable in this context.

The device is a simple, transparent plastic anoscope with a removable slide for physician use to examine the anal sphincter and anus. Its clearance is based on substantial equivalence to a predicate device (Sapimed Self Light Disposable Anoscope, model A.4083, K070913).

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on substantiating that the new device has "the same technological characteristics" as the predicate, with only "minor difference" in the width of the open channel. The acceptance criteria are implicitly that these minor differences do not affect safety or performance.

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

Not applicable for this type of medical device clearance. The evaluation was based on bench testing and preclinical laboratory evaluations, not a clinical study with a human test set.

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

Not applicable. No ground truth in the sense of expert consensus on clinical data was established for a test set.

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. The device is not an AI/ML algorithm.

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.)

For this device, the "ground truth" equivalent would be engineering specifications and functional performance metrics confirmed through bench testing and preclinical laboratory evaluations to ensure the device performs as intended and is substantially equivalent to the predicate. This is based on physical and functional characteristics, not clinical outcomes data or expert interpretation of images.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm, and thus no training set was used.

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

Not applicable.

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The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument. The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.

The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps Device Description is a sterile, single-use device intended for use in endoscopic procedures where fusion of The device can be used on vessels up to 3 mm vessels or tissue bundles is performed. and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps sources RF energy from an electrosurgical generator. Specifically, the Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. This device passes through endoscopes having a 3.7 mm or larger working channels.

This document describes a 510(k) premarket notification for the "Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps". This is a medical device, not an AI/ML algorithm. Therefore, many of the requested categories in the prompt, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to traditional medical device submissions.

However, I can extract information related to performance testing that demonstrates the device meets its intended use.

Here's an analysis based on the provided document:

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

The document lacks a specific table detailing acceptance criteria alongside reported performance for each criterion. It broadly states that "Bench, animal, biocompatibility, and electrical testing was performed to demonstrate that the EES device performs as intended."

Device Performance Claimed:

• Vessel/Tissue Fusion: The device can perform fusion of vessels or tissue bundles.
• Vessel Size: Effective on vessels up to 3 mm.
• Bundle Size: Effective on bundles as large as will fit in the jaws of the instrument.
• Compatibility: Designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System.
• Endoscope Channel: Requires a 3.7 mm or larger working channel.
• Tissue Manipulation: Jaws contain atraumatic "grooves" to grasp and manipulate tissue.

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 sample sizes for the bench, animal, biocompatibility, or electrical testing. It also does not explicitly mention the country of origin of the data or whether the studies were 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)

This concept of "ground truth established by experts" is not typically applicable to the performance testing of a physical medical device like electrosurgical forceps. The "ground truth" would be objective measurements of device function (e.g., burst pressure of fused vessels, thermal spread, electrical impedance).

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

Not applicable, as this refers to expert consensus for ground truth, which isn't detailed for this type of device.

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 electrosurgical device, not an AI system.

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

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

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

The "ground truth" for this device's performance would be derived from objective measurements and observations during typical medical device performance testing, including:

• Bench Testing: Mechanical properties, electrical safety, fusion strength (e.g., burst pressure), thermal effects.
• Animal Testing: In-vivo performance, tissue effect, hemostasis effectiveness, safety.
• Biocompatibility Testing: Assessment of biological response to materials (e.g., cytotoxicity, irritation, sensitization).

8. The sample size for the training set

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

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

Not applicable. This is a physical electrosurgical device, not an AI system.

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The Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

The Ethicon Endo Surgery (EES) Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Rotating Endoscopic Scissors are a sterile, single patient use, disposable instrument consisting of a flexible wire cable and scissors end effector. The end effector can be rotated independently of the shaft. When connected to an electrosurgical generator using a 4.5 mm monopolar cable (not supplied) and activated, the Rotating Scissors delivers a monopolar electrical current to the surgical site. This device passes through gastroscopes having a 2.8 mm or larger working channels. This device is supplied sterile for single-patient use.

The provided text describes a 510(k) summary for the Ethicon Endo Surgery® Rotating Endoscopic Scissors. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards, rather than reporting on a study meeting specific performance acceptance criteria like those found in AI/ML device submissions.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission type. I will fill in the relevant information available and explicitly state when a category is not applicable.

Key points to understand:

• This is a submission for a physical surgical instrument, not an AI/ML diagnostic tool.
• The "performance data" discussed is related to bench testing for safety and functionality, not diagnostic accuracy or efficacy requiring ground truth, expert consensus, or MRMC studies.
• The "acceptance criteria" are related to compliance with established medical device safety standards.

Acceptance Criteria and Device Performance Study for Ethicon Endo Surgery® Rotating Endoscopic Scissors

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document states "Bench testing was performed," which typically involves testing a defined number of devices or components according to a protocol. However, specific quantities are not provided.
• Data provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by Ethicon Endo-Surgery, Inc., located in Cincinnati, Ohio, USA. This would be considered prospective testing, as devices were manufactured and then tested.

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)

• N/A. This device does not have "ground truth" in the diagnostic sense (e.g., presence or absence of a disease). Its performance is evaluated against engineering standards and functional requirements through bench testing. Expert clinicians might be involved in defining performance requirements or evaluating usability, but not in establishing ground truth for a diagnostic test set.

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

• N/A. Adjudication methods are relevant for subjective medical assessments (e.g., image interpretation). Bench testing for medical device standards typically involves objective measurements and pass/fail criteria, not expert adjudication of results against a medical 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

• N/A. This is a physical surgical instrument, not an AI/ML diagnostic or assistive device for human readers. Therefore, MRMC studies are not applicable.

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

• N/A. This is a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.

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

• N/A. As explained in point 3, the device is evaluated against established engineering and safety standards, and functional performance on tissue surrogates, not against a medical "ground truth" for diagnosis. The "truth" in this context is whether the device meets specific engineering specifications and safety requirements.

8. The sample size for the training set

• N/A. This is a physical surgical instrument. There is no "training set" in the context of machine learning. The device design is based on engineering principles and predicate device comparison, not on data-driven model training.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable.

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The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical Dilator to allow for visualization at the stricture site.

The provided 510(k) summary (K093236) concerns the Ethicon Endo Surgery® Optical Dilator, a device indicated for the dilation of esophageal strictures under endoscopic visualization. This submission is a Special 510(k) as it details modifications to an existing predicate device (Ethicon Endo-Surgery Optical DVS Esophageal Dilator K031147). The changes are limited to the addition of a handle retainer component to secure the handle to the shaft and a change in the handle material from gray to black.

Given these minor modifications and the nature of the device, the studies conducted focus on verifying the safety and functionality of these specific changes rather than a comprehensive clinical study assessing the device's diagnostic or interventional efficacy in a clinical setting.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for either the attachment strength or biocompatibility testing. These are typically bench tests performed on a representative number of units or material samples.
• Data Provenance: Not explicitly stated but implied to be from bench testing at the manufacturer's facilities. This is not clinical data, so country of origin and retrospective/prospective distinctions are not applicable in this context.

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

• Not Applicable. The ground truth for bench tests (attachment strength and biocompatibility) is established by predefined engineering specifications and international standards (ISO 10993-1). There is no need for expert clinical consensus for these types of tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessments. Bench testing results are typically evaluated against objective, predefined pass/fail criteria.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-guided devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The modifications to this esophageal dilator do not involve AI or human interpretation in its use.

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

• No, a standalone study was not done. This type of study is relevant for AI-powered devices to assess the algorithm's performance independent of human interaction. The Ethicon Endo Surgery® Optical Dilator is a mechanical medical device, not an AI or algorithm-driven system.

7. Type of Ground Truth Used

• For Attachment Strength: Engineering specifications and design requirements (e.g., a minimum force required to detach the handle).
• For Biocompatibility: International standard ISO 10993-1, which outlines biological evaluation of medical devices.

8. Sample Size for the Training Set

• Not Applicable. This device is hardware; there is no AI algorithm to be trained, therefore no training set.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.

The provided document is a 510(k) summary for the Ethicon Endo Surgery® Rotating Hook Knife. It describes the device, its intended use, and its technological characteristics compared to a predicate device. The document also lists the performance data submitted to demonstrate compliance with various safety standards.

However, the document does not contain information about acceptance criteria for a study proving device performance, nor details of a specific study meeting said criteria in the format usually associated with clinical validation of AI/ML or diagnostic devices. Instead, it details bench testing performed to demonstrate that the device performs as intended and complies with several international standards related to medical electrical equipment, biocompatibility, and electromagnetic compatibility.

Therefore, I cannot extract the information required in your request about acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Based on the information provided, here's what can be stated about the performance data:

1. A table of acceptance criteria and the reported device performance:
   Not provided in the document. The document lists the standards the device was tested against, but not specific acceptance criteria within those standards or a table of measured performance against those criteria.

2. Sample size used for the test set and the data provenance:
   Not specified. The document mentions "bench testing," but does not detail sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The performance data described is "bench testing" against engineering and safety standards, not a study requiring expert-established ground truth.

4. Adjudication method for the test set:
   Not applicable. The performance data described is "bench testing," not a study requiring adjudication.

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

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

7. The type of ground truth used:
   Not applicable in the context of clinical/diagnostic AI studies. For bench testing, the "ground truth" would be the specifications and requirements outlined in the listed international standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2, ISO 10993-1).

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
   Not applicable. This is not an AI/ML device.

Summary of Performance Data from Document:

The document states:

• "Bench testing was performed to demonstrate that the EES device performs as intended."
• "The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1."
• "The device was tested to demonstrate compliance with the following standards:"
  • Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
  • Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment, IEC 60601-2-2, 2006/07/01
  • Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment, IEC 60601-2-18, 1996/08/01
  • Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, IEC 60601-1-2 (2004)

This indicates that the "study" for performance consisted of engineering bench tests against recognized international safety and performance standards for electrosurgical and endoscopic devices, and biocompatibility. Specific numerical acceptance criteria or performance metrics beyond "compliance" are not detailed in this summary.

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