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The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision.

The E Surgical Hawkeye Control Unit with Eyas Endoscope is an arthroscope system, consisting of the Hawkeye Control Unit (Medical Tablet plus Console Box), and the Eyas Endoscope. The Medical Tablet is a touch panel computer for the system function control, endoscope image displays and operation data storage. The Eyas Endoscope is a hand-held, single-use device for accessing the interior of a joint to capture the real-time image of the target site through a small incision. The Console Box is an interface between the Medical Tablet and Eyas Endoscope. There are 10 models of Eyas Endoscope in this system; including 2 different directions of view (0° and 30°) in combination with 5 different working lengths. All these models must be used in conjunction with Hawkeye Control Unit to perform as intended. The E Surgical Hawkeye Control Unit with Eyas Endoscope is also capable recording and storing the images in the system for later review.

This document is a 510(k) Premarket Notification from the FDA regarding the "Hawkeye Control Unit with Eyas Endoscope." It details the device, its intended use, a comparison to a predicate device, and summaries of bench testing and compliance with standards.

However, the provided text does not contain information about studies proving the device meets acceptance criteria related to a comparative effectiveness study involving AI or human readers, nor does it provide details about ground truth establishment with experts, adjudication methods, or standalone AI performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Trice medical mi-eye2, mi-eye 2 monitor (K162475)) through comparison of features, operating principles, technology, and compliance with various recognized standards (electrical safety, biocompatibility, sterilization, software lifecycle, packaging).

The "Bench Testing Summary" section describes various tests performed on the device components (Console Box, Medical Tablet, Eyas Endoscope, and their packaging) to verify their functionality and performance against specifications. These are typical engineering and quality assurance tests, not clinical performance studies for diagnostic accuracy or comparative effectiveness with human readers, especially not for an AI component.

Given the provided text, it's not possible to fully answer the request as it pertains to AI model acceptance criteria and validation studies. The device as described is an arthroscope system for visualization and image capture, not an AI-powered diagnostic tool.

Therefore, for the specific questions asked that relate to AI model validation, the answer is: This document does not contain the requested information about AI model acceptance criteria or validation studies, as the device described is an arthroscope system, not an AI-powered diagnostic or assistive tool.

If we interpret "acceptance criteria" in the context of this document as the criteria for demonstrating substantial equivalence for an arthroscope system, then the "reported device performance" is its adherence to technical specifications and relevant safety/performance standards, as summarized in the bench testing.

Here's what can be extracted based on the provided text, focusing on the device's technical acceptance and testing, not AI:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Bench Testing)

The document implicitly defines acceptance criteria through its comparison to a predicate device and its demonstrated compliance with international standards. The performance is reported as meeting these standards and having features functionally equivalent to the predicate.

1. Table of acceptance criteria and the reported device performance (Interpreted as technical and functional equivalence):

Since the device is not an AI-powered diagnostic system, the following questions cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance: Not applicable for an AI test set. The document describes bench testing on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not established here.
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 is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards, demonstrated by bench testing.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) document indicates substantial equivalence for an arthroscope system based on standard engineering and performance tests, not on AI model validation.

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The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

The application device, the Eblator Device, is an electrosurgical ablator for general arthroscopic applications. In conjunction with a general purpose electrosurgical generator, the Eblator Device provides cutting, vaporization and coagulation of target tissue by radio frequency electrosurgical energy. As with most hand-controlled surgical pencils, the Eblator Device can also be used with footswitch control when a footswitch is connected to a generator designed for footswitch control. The Eblator Device is requesting clearance for 4 models of Eblator Device, representing different combinations of electrode configurations and aspiration design. The Eblator Device models include 2 different electrode angles, 90° and 50°, as well as with or without aspiration design. Except for these characteristics, these 4 models are all identical. The Eblator Device is designed to be used with a compatible electrosurgical generator and aspiration system (aspiration model only). These devices are single use and are sold sterile.

The acceptance criteria and study proving the device meets them are summarized below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Snap Fit Strength
• Weld Integrity Test
• Probe Flexural Test
• Probe Axial Pull Force | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with IEC-60601-1, Ed 3.2, 2005 + AM1:2012 + AM2:2020; IEC 60601-2-2, Ed 6.0: 2017, and E Surgical self-enforced requirements) |
  | Electrical Testing | - Bench-top validation testing for relevant components (HF Leakage Current, HF Dielectric Strength Test, Mains Frequency Dielectric Strength Test, Housing Temperature Verification, Continuity & Activation Switch Resistance) | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 | The results demonstrated compliance of the application device to current IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 standard requirements. |
  | Biocompatibility | - Compliance with ISO 10993-1 and FDA's modified ISO guidelines | Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines. |
  | Bench-top Validation Testing (General) | - Cable Dynamic Strain Relief
• Cable Static Strain Relief
• Anchorage Test
• Fluid Ingress Test
• Visual Inspection
• Function Test
• Activation Force
• Activation Over Time
• Aspiration Tube Dynamic Strain Relief
• Aspiration Tube Static Strain Relief
• Distal Fluid Ingress Test
• Active Electrode to Inner Tube Torque Test
• Fluid Leak Test | All test requirements were met as specified by applicable standards and the test protocols. |
  | Thermal Performance (Tissue Effect) | - Measurement of thermal damage zone in ex vivo tissue compared to predicate device under same generator mode and power settings. | The thermal effects of the Eblator Device on ex vivo tissue was evaluated by measuring the size of the thermal damage zone caused by the Eblator Device compared to the size of thermal damage zone caused by the predicate device under the same generator mode and power settings. In all cases there was no clinical difference between the thermal damage caused by the Eblator Device and the predicate. Validation was conducted in three different tissues (porcine muscle, liver, and kidney). |
  | Packaging Tests | - Burst Test
• Seal Strength Test
• Bubble Leak Test
• Dye Leak Test | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with ISO 11607-1, ISO 11607-2) |
  | Shelf Life/Aging | - Accelerated Aging Evaluation Test (2-year storage) | An accelerated aging evaluation test demonstrated compliance of the Eblator Device to meet the defined product specifications after 2 year storage. (Compliance with ASTM F1980) |
  | Regulatory Guidance Compliance | - FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020). | The Eblator Device was fully tested and found to be in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020). |

Missing Information from the Provided Text:

The provided text describes a 510(k) premarket notification for a medical device (Eblator Device). Such submissions primarily focus on demonstrating substantial equivalence to a predicate device through various engineering and performance tests, rather than clinical trials or AI performance evaluations with human readers. Therefore, several points from the request are not applicable or not present in this type of document.

The document does not describe a study involving humans, AI, or ground truth developed by experts in the context of diagnostic performance. It focuses on the physical and electrical performance of an electrosurgical device.

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

• Sample Size for Test Set: Not applicable in the context of device performance testing described. The tests involve multiple units of the Eblator Device for various mechanical, electrical, and functional evaluations. For the thermal performance test, three different ex vivo tissues (porcine muscle, liver, and kidney) were used, but the number of samples or repetitions for each tissue type is not specified.
• Data Provenance: The study was a bench-top validation and ex vivo tissue study. The specific country of origin of the data is not mentioned, but it's an industry-sponsored submission to the FDA (U.S.). It is retrospective in the sense that the tests were conducted prior to submission.

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

• Number of Experts & Qualifications: Not applicable. The ground truth for the performance tests (e.g., proper function, electrical compliance, thermal damage size) is established by adherence to engineering specifications and recognized standards, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no expert review or adjudication process for the type of engineering and bench-top performance tests described. Test results are compared against predefined numerical and qualitative specifications outlined in standards and internal protocols.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., imaging AI) and involves human readers interpreting cases. The Eblator Device is an electrosurgical tool, not a diagnostic device.

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

• Standalone Study: Not applicable. The device is a surgical instrument; there is no embedded algorithm in the diagnostic sense that would perform "standalone" without human interaction. Its performance is measured as a direct physical and electrical output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is defined by engineering specifications, international and recognized consensus standards (e.g., IEC 60601 series, ISO 10993-1, ISO 11135, ISO 11607, ASTM F1980), and the FDA's specific guidance for electrosurgical devices. For the thermal performance, the ground truth was the comparative thermal damage zone to the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device requiring a training set. The "training" in this context refers to the development and iterative testing of the device during its design phase, which is not quantified by a "training set" in the sense of data science.

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

• Establishing Ground Truth for Training Set: Not applicable. As there is no training set in the AI sense, there's no ground truth established for it. The device design and performance targets are driven by engineering principles, clinical needs, and regulatory requirements.

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A Single use, non sterile dispersive electrode with or without a pre-attached cord to adhere to the infant patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The E Surgical Infant Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electro surgery between the generator, the active electrode, and an infant patient.

The provided text describes the 510(k) summary for the E Surgical Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord. Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not specify the sample size for any specific test set used to demonstrate compliance with the ANSI/AAMI HF-18 standard or ISO 10993.
   • The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any testing.

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

   • This information is not applicable and not provided. The studies described are related to compliance with engineering and biocompatibility standards, not clinical diagnostic performance requiring expert interpretation or "ground truth" in the traditional sense of medical image analysis or disease detection.

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

   • This information is not applicable and not provided. Adjudication methods are typically used in studies where human experts are making judgments that need to be resolved, such as in clinical trials or diagnostic accuracy studies. The compliance studies mentioned (ANSI/AAMI HF-18, ISO 10993) involve objective measurements against predefined standards.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices involving human readers. The E Surgical device is an electrosurgical accessory, not a diagnostic tool or an AI-assisted device.

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

   • This information is not applicable and not provided. The device is not an algorithm; it is a physical medical device. The "studies" mentioned are compliance tests against established standards for physical device performance and safety.

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

   • For the performance data mentioned (compliance with ANSI/AAMI HF-18 and ISO 10993), the "ground truth" is defined by the objective criteria and methodologies outlined within those respective standards. For example, for thermal safety, the ground truth would be defined by specific temperature thresholds and measurement protocols outlined in the ANSI/AAMI HF-18 standard. For biocompatibility, it would be the outcomes of specific tests as per ISO 10993 (e.g., cytotoxicity, irritation, sensitization).

7. The sample size for the training set:

   • This information is not applicable and not provided. The E Surgical Infant Patient Return Electrode is a physical medical device, not a machine learning or AI model that requires a training set.

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

   • This information is not applicable and not provided. As stated above, the device does not involve a training set.

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E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.

The provided text describes a 510(k) summary for E Surgical Coated Electrodes. It outlines the device's indications for use, predicate devices, and a summary of its technological characteristics. However, the document primarily focuses on regulatory approval and substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria in the way a clinical study or robust scientific experiment would.

Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not explicitly stated in the provided 510(k) summary. The summary highlights safety and performance data in a general sense, aligning with regulatory requirements rather than providing a detailed study protocol and results.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document lists "Safety and Performance Data" but these are presented as characteristics the device meets rather than clearly defined acceptance criteria with numerical performance targets and reported results against those targets.

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

• Sample size for test set: Not specified. The document does not describe a formal "test set" in the context of a clinical or comparative study. The listed performance data (e.g., coating bend test) likely refers to in-house testing, but the sample sizes for these tests are not provided.
• Data provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence and general safety/performance, the data provenance for the internal tests is not detailed (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 document does not describe a test set requiring expert-established ground truth in a clinical or diagnostic context. The performance claims are based on engineering and material characteristic tests rather than diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. No clinical or diagnostic test set requiring adjudication is 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. This device is an electrosurgical electrode, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is an electrosurgical electrode and does not involve algorithms or AI for standalone performance evaluation in that context.

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

Not applicable in the conventional sense of diagnostic performance. The "ground truth" for the reported performance criteria would be:

• ANSI/AAMI HF 18: Compliance with the standard.
• Coating integrity: Visual inspection against cracking.
• Cutting/coagulation initiation: Likely observed by engineers or trained personnel during testing.
• Easy to clean properties: Subjective assessment or a defined cleaning protocol with a pass/fail criterion.
• Biocompatibility: Documentation/certification of meeting ISO 10993.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, for the same reason as above.

In summary: The provided 510(k) document is a regulatory submission for substantial equivalence. It confirms the device meets general safety and performance requirements and is comparable to predicate devices but does not contain the detailed study protocols, sample sizes, expert involvement, or statistical analyses typically found in clinical studies or papers proving specific performance against quantitative acceptance criteria for diagnostic devices.

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A single use, non-sterile dispersive electrode with or without a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The E Surgical Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an adult patient.

Unfortunately, the provided text describes an Electrosurgical Patient Return Electrode, which is a medical device and not an AI/ML-driven device. As such, many of the requested categories related to AI/ML device evaluation (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of traditional medical hardware.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a common regulatory pathway for non-AI devices. The performance data presented relates to compliance with established industry standards for thermal safety and biocompatibility.

Therefore, I cannot provide a table with acceptance criteria and reported device performance in the context of an AI/ML device, nor can I fill in the details for AI/ML-specific study design elements.

However, I can extract the relevant performance and compliance information for this traditional device as presented:

Acceptance Criteria and Device Performance (for a traditional medical device, not AI/ML):

As this is not an AI/ML device, the following points are not applicable and cannot be extracted from the provided text:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

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