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The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use

The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.

The provided text describes the HandXTM Monopolar Scissors, a single-use, disposable, ETO sterilized instrument. The device is intended to assist in the control of Human Xtensions laparoscopic instruments for endoscopic manipulation of tissue in various surgical procedures involving grasping, approximation, ligation, suturing, cutting, and/or coagulation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests. However, it does not explicitly list specific numerical acceptance criteria or quantitative performance results for each test. Instead, it confirms that the device passed these tests.

2. Sample sized 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 each specific bench test is not provided. The data provenance is implied to be from internal laboratory testing.
• Performance Testing - Animal (Swine Model): The number of animals used is not specified. The study involved qualified personnel performing tasks with both the subject and reference device. This appears to be a prospective study conducted in a controlled environment (animal lab). The country of origin for the data is not explicitly mentioned.

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)

• Bench Testing: The document does not mention the use of external experts to establish ground truth for bench tests. These tests are typically evaluated against engineering specifications and validated test methods.
• Performance Testing - Animal: "Qualified personnel with appropriate experience" executed the evaluation and filled out questionnaires. The specific number or detailed qualifications (e.g., years of experience, specialty) of these personnel are not provided. For thermal damage and histopathology, it is implied that experts (e.g., a pathologist) evaluated the tissue, but their number and specific qualifications are not stated.

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

The document does not describe any specific adjudication method for reconciling varying opinions, as no multiple expert readings of the test results are mentioned. For bench tests, it's typically a direct comparison to predefined criteria. For the animal study, it appears to be based on observations, measurements, and questionnaires by the "qualified personnel."

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 comparative effectiveness study was not performed. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers interpreting results. The animal study did compare the device to a reference device, but this was a functional comparison, not an assessment of human reader performance with or without AI assistance.

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

No, this question doesn't apply directly to the HandXTM Monopolar Scissors. It is a physical surgical instrument, not an algorithm. Its performance is always with a human-in-the-loop (the surgeon).

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

• Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-1, ISO 14971) and FDA guidance, with testing for specific biological endpoints (cytotoxicity, sensitization, etc.).
• Electrical Safety and EMC: Ground truth was established by compliance with international electrical safety and EMC standards (IEC 60601 series).
• Bench Testing: Ground truth was based on engineering design input requirements and validated test methods, with established predefined acceptance criteria.
• Performance Testing - Animal: Ground truth for safety was assessed by "thermal damage evaluation using temperature probes and histopathology evaluation according to FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff." For functional performance and usability, it was through direct observation during surgical tasks and post-procedure questionnaires completed by "qualified personnel." This combines objective measurements (temperature, histopathology) with subjective assessment (usability questionnaires).

8. The sample size for the training set

The concept of a "training set" is not applicable here as the device is a physical surgical instrument, not an AI/ML algorithm that requires training data.

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

Not applicable, as no training set was used.

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The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

The DANNIK Disposable Monopolar Laparoscopic Instruments are sterile single-use devices consisting of a handle, rotator knob and shaft. The handle activates the instrument jaws and scissor blades. The rotator knob provides 360 degrees of rotation for the instrument shaft and jaws. The shaft includes an external insulation that runs from the rotator knob to the instrument jaws and is provided in working diameters of 3 to 5 mm and lengths up to 33 cm. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.

The provided text describes a 510(k) premarket notification for a medical device, specifically the DANNIK Disposable Monopolar Laparoscopic Instrument.

However, the content does not include any information about acceptance criteria or a study proving that the device meets those criteria, as typically seen for AI/ML-based medical devices or devices requiring extensive performance evaluations. The submission is a "Special 510(k) Summary" which indicates a modification to a previously cleared device (from 5mm to 3mm working diameter). This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and performance study from this document. The document explicitly states:

• "There were no clinical trials performed on these devices." (Page 5, Section 8. CLINICAL TESTS)
• "NONCLINICAL TESTS: Risk analysis was conducted to assess the impact of the change on the subject device using internal design control procedures. Assessments were completed for the risk associated with Electromagnetic Energy as related to the basic safety and essential performances as detailed in IEC 60601-1 and appropriate collateral and/or particular standards. Dimensional Analysis and verification of the shaft flexural strength was completed, which showed that the devices met the same requirements as the predicate device." (Page 4, Section 7. NONCLINICAL TESTS)

This indicates that the modifications were assessed through non-clinical testing (dimensional analysis, flexural strength, risk analysis related to electrosurgical safety) to demonstrate equivalence, and not through a study with acceptance criteria measuring specific performance metrics for diagnosis or treatment effectiveness in a clinical setting against a predefined ground truth.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available or specified in the document. The filing focuses on demonstrating that the new 3mm diameter version meets the same physical/electrical safety requirements as the 5mm predicate.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of a clinical study. The non-clinical tests involved dimensional analysis and verification of shaft flexural strength; samples would be drawn from manufacturing lots for these tests, but specific sample sizes are not detailed beyond "showed that the devices met the same requirements as the predicate device." No patient data or clinical data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established as no clinical trials or diagnostic performance studies were performed.
4. Adjudication method 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. This device is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a manual surgical instrument.
7. The type of ground truth used: Not applicable in a clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications and safety standards (e.g., IEC 60601-1 for electrosurgical devices) that the predicate device also met.
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.

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The Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue.

The Applied Medical Laparoscopic Dissector is a sterile, single use, disposable surgical instrument designed for minimally invasive surgical procedures. It fits through a trocar and is used to grasp, mobilize and dissect tissue. The dissector may be connected to a standard electrosurgical generator for performing monopolar cautery. The dissector is substantially equivalent to the predicate device in size, function, performance and indications for use.

The provided text describes a 510(k) premarket notification for a medical device, the Applied Medical Laparoscopic Dissector. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria for specific performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested points regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and MRMC studies are not applicable to this type of document because the review process primarily assesses non-clinical testing and substantial equivalence.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in device validation reports or clinical study protocols, which are not detailed in this 510(k) summary. The document describes the tests performed but does not provide specific quantitative acceptance criteria or detailed outcomes for each test beyond a general "demonstrated substantial equivalence."

Conclusion from Testing: "Applied's performance and functional testing demonstrated that the Applied laparoscopic tissue dissector is substantially equivalent to the predicate device of K984240 and introduces no new safety and effectiveness."

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

The document describes non-clinical tests submitted. It does not mention a "test set" in the context of patient data or algorithm performance. The tests performed are likely engineering and bench-top tests, for which "sample size" would refer to the number of devices or components tested. This information is not provided in the summary. Data provenance is also not applicable as it refers to clinical data.

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

This information is not applicable. The tests described are non-clinical (dimensional, electrical, mechanical, thermal), which do not typically involve human expert ground truth establishment in the way clinical studies do.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical and do not involve human adjudication of results in the context of clinical outcomes or expert consensus.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human reader performance is being evaluated with and without AI assistance. This document describes a surgical instrument where the primary evaluation is substantial equivalence through non-clinical testing.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" would be established by engineering specifications, industry standards, and established metrics for material properties, electrical performance, mechanical strength, and thermal characteristics. For instance, dieletric withstand would be compared against a specific voltage standard, and clamping force against a defined range. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these tests.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."

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

This information is not applicable as there is no "training set" for this device.

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The pure Wrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

The pureWrist™ electrocautery laparoscopic instruments are sterile, single use disposable instruments for use through appropriately sized surgical trocars. The instruments consist of a rotating insulated shaft with a 5mm diameter. The distal end of the shaft has the respective end effector attached (scissors, dissector, or hook). The proximal end of the shaft is attached to an ergonomically shaped handle with a rotating knob that allows the shaft to rotate 360 degrees in either direction. The handle contains the actuation mechanism for the respective end effector. The lever on the handle is compressed and released to activate the instrument jaws or scissor blades. Each instrument has a monopolor cautery connector that extends from the bottom of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and proper generator.

The Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments underwent preclinical testing to demonstrate substantial equivalence to the predicate device, Ethicon Endo-Surgery, Inc. ENDOPATH® Endoscopic Instruments (K984240).

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document states "Pre-clinical testing was used to evaluate performance to ensure that the device can be used as designed." However, specific sample sizes for this testing are not provided in the given text.

The data provenance (country of origin, retrospective or prospective) is also not specified. Given it's preclinical testing for a medical device in the US, it's highly likely the testing was conducted in a controlled laboratory setting within the US and would be considered prospective in nature for a new device.

3. Number of Experts and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The testing involved evaluating ergonomics, tissue trauma, grasping/dissecting ability, and electrical insulation, suggesting engineers, material scientists, and potentially clinicians (e.g., surgeons) would have been involved in assessing performance.

4. Adjudication Method

The document does not describe any adjudication method (e.g., 2+1, 3+1). Preclinical testing often relies on objective measurements and established standards, with consensus among the testing team, rather than a formal adjudication process as seen in clinical trials with human readers.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. For a surgical instrument like this, the focus is on its functional performance and safety.

6. Standalone Performance (Algorithm Only)

This point is not applicable as the device is a physical electrocautery laparoscopic instrument, not an AI algorithm. Its performance is always in conjunction with a human surgeon.

7. Type of Ground Truth Used

The ground truth used for this preclinical testing would have been based on:

• Engineering specifications and design requirements: Ensuring the device met its intended mechanical and electrical properties.
• Established industry standards: For electrical insulation, tissue interaction, and ergonomic design relevant to surgical instruments.
• Comparison to predicate device performance: The acceptability was determined "relative to the predicate device," implying the predicate's known performance characteristics (e.g., its ability to grasp, dissect, and cut tissue effectively and safely) served as a benchmark.
• Qualitative assessment by experts: For aspects like ergonomics and ease of use, direct assessment by engineers or clinical users would have contributed.

8. Sample Size for Training Set

This question is not applicable as the device is a physical instrument and does not involve AI or machine learning models that require training data.

9. How Ground Truth for Training Set was Established

This question is not applicable as there is no training set for a physical surgical instrument.

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