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The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules.

The apex locating function of Root ZX3 device is used for root canal measurement and working length determination.

The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.

The Root ZX3 device (also referred to by its model number RZX3) is a battery-driven apex locator with an optional dental electrosurgical unit, used in the oral cavity during dental procedures. This device has two modules: the main module is an apex locator module and the other is an electrosurgical module (high frequency [HF] module). The apex locator module is the basic module to which dental electrosurgical functions can be added by connecting the HF module.

The provided text describes the 510(k) summary for the Root ZX3 dental device, which includes an apex locating function and an optional electrosurgical function. The document details the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.

However, the provided text does not contain any information about specific acceptance criteria for a study showing device performance, or any detailed study results proving the device meets acceptance criteria. It states "No clinical tests were performed for the Root ZX3 device" and that "A performance test was conducted to confirm that Root ZX3 can locate the apex using the method that is substantially equivalent to the reference predicate devices. The high-frequency performance of this device was substantially equally to that of predicate devices, as shown in Table 2 (Comparison chart)."

The document focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to various safety and performance standards. It does not present a formal study with defined acceptance criteria and corresponding performance metrics for the Root ZX3 in the way a clinical or standalone performance study for an AI/CADe device would.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided text, as the necessary information (specific performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not present. Based on the provided information, the device's performance was evaluated through non-clinical testing and comparison to predicate devices to establish substantial equivalence.

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The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.

PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva.

The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively.

The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.

The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.

Here's an analysis of the acceptance criteria and supporting study for the PerFect® Tissue Contouring System II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify a discrete "test set" sample size for a clinical or in-vitro study involving patient data or images. The performance testing primarily focused on engineering and electrical safety standards compliance rather than a typical clinical evaluation with a test set of cases.

The provenance of data is therefore not applicable in the usual sense of clinical trial data. The compliance testing was performed by Underwriters Laboratories Inc. Melville Division in the USA.

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

This information is not applicable as the study described is primarily an engineering and electrical safety compliance assessment, not a clinical study requiring expert labeling or adjudication of medical cases.

4. Adjudication Method

This information is not applicable for the same reason as point 3.

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

No, an MRMC comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with and without AI assistance. The device is an electrosurgical unit, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not conducted. The device is a physical electrosurgical unit, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily defined by:

• Recognized International and National Electrical Safety Standards: Such as IEC 60601-1, IEC 60601-2-2, EN55011, EN60601-1-2, CAN/CSA C22.2 series. Compliance with these standards served as the basis for safety and performance "truth."
• Predicate Device Performance: The functional capabilities and safety profile of the Strobex Ultron Electrosurge Unit (K850666) served as the benchmark for demonstrating "equally effective" performance.
• Functional Testing Results: The ability of electrodes to maintain function after repeated sterilization cycles.

8. The Sample Size for the Training Set

This information is not applicable. The PerFect® TCS II is an electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in this submission.

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

This information is not applicable for the same reason as point 8.

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The Fugo Blade system is intended for incision, excision, ablation, vaporization and hemostasis of oral soft tissue e.g. excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy and frenotomy; gingival troughing for crown impressions; gingiyoplasty: gingivectomy; gingival incision and excision; hemostasis; implant recovery; incision and drainage of abscess; leukoplakia; operculectomy; oral papillectomies; pulpotomy; pulpotomy as an adjunct to root canal therapy; reduction of gingival hypertrophy; soft tissue crown lengthening; secular debridement; treatment of aphthous ulcers; vestibuloplasty; biopsy incision and excision; and lesion (tumor) removal.

The Fugo Blade for dentistry is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9.8+/- 2.0 x 106 Hz) and focused on a thin blunt cutting filament. Moreover, the EM energy from flashlight size (C cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source, then conditions it in a proprietary fashion and transfers it to the surgeon cutting filament. This column of EM energy is capable of reacting with tissue. This column of EM energy causes the molecular bonds in the tissue which come in contact with the EM field to ionize and thereby break apart, a condition that plasma physicists refer to as "plasma formation". In this way, the molecular lattice of the tissue is broken into micro-fragments, thereby creating an incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

The provided 510(k) summary for the "Fugo Blade for Dentistry" is a pre-market notification to establish substantial equivalence to a predicate device, not a report on a study proving the device meets specific acceptance criteria in the manner typically seen for novel efficacy claims. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device (Wallach Quantum 500 electrosurgical generator for surgery, K000768) and other previously cleared Fugo Blade products (K001498, K041019, K050933) for ophthalmic use.

Therefore, the acceptance criteria and study details are interpreted in the context of demonstrating substantial equivalence rather than novel performance claims against predefined metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, specific acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy) for the dental application are not explicitly stated in this document. Instead, the "acceptance criteria" are implied to be the established safety and efficacy of the predicate devices. The "reported device performance" refers to the demonstration that the Fugo Blade for Dentistry shares the same technological characteristics and clinical effects as these predicate devices.

 - [K001498](https://510k.innolitics.com/search/K001498): Statistical significance for safety and efficacy in incision/ablation/vaporization of highly delicate tissue (human lens capsule,

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Soft tissue management within the oral cavity to address the indications for incision, excision and ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue.

The MC-4A dental electrosurgical unit is an AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended a controlled power of thissue or to control bleeding during surgery in the oral cavity. An electrical to our of the tip of the tip of the electrode into tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.

The provided document, K052622 for the MACAN MC-4A Dental Electrosurgical Unit, is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical studies with acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document focuses on comparing the MACAN MC-4A to its predicate device, MACAN-Regis MC6A, across several characteristics:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of acceptance criteria or reported device performance in the way a clinical study would. Instead, it presents a "SUMMARY TABLE OF COMPARISON" demonstrating equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. No new clinical test set data was generated for this 510(k) submission. The substantial equivalence argument relies on prior claims and performance of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth for a test set was not established as no new clinical study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a dental electrosurgical unit, not an AI-powered diagnostic device, and no MRMC study was conducted.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in the context of a clinical study was established for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:
Not applicable. No new training set for an algorithm was used.

9. How the ground truth for the training set was established:
Not applicable. No training set requiring ground truth establishment was used.

In summary, the K052622 document demonstrates substantial equivalence by highlighting the identical nature of key characteristics between the new device (MACAN MC-4A) and its predicate (MACAN-Regis MC6A). It does not involve new clinical trials or performance studies with acceptance criteria as would be expected for novel devices or AI solutions.

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Soft tissue management within the oral cavity to address the indications for incision, excision and in the states in interested soft tissue. Soft tissue management while as a soft tissue.

The Radiosurge MC6A device is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended to cut or remove soft tissue or to control or cating and coughtang orcedures in the oral cavity. An electrical current passes through the tip of the blectrode into the tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.

This document is a 510(k) Summary for the MACAN Radiosurge MC6A device, an electrosurgical unit used for soft tissue management in the oral cavity. It details the device's description, compares it to predicate devices to establish substantial equivalence, and includes the FDA's clearance letter.

Here's the information requested based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" can be inferred as being substantially equivalent in clinical indication, generator electrical characteristics, observed histological effect, and physical components.

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 detail a "test set" in the traditional sense of a patient cohort or a distinct dataset with a sample size for an effectiveness study. The evaluation primarily relies on comparison with existing predicate devices and their published specifications, as well as laboratory testing and anecdotal clinical observations.

• Sample Size: Not applicable in the context of a prospective clinical trial or a structured test set with a defined sample size.
• Data Provenance:
  • Published Literature: Used for clinical indications of predicate devices.
  • Laboratory Measurements at Macan: Conducted at Macan Engineering (Chicago, IL, USA) using a production sample of the Dento-surge device.
  • Biologic Test Medium: Used for examining comparative histological effects. The specific nature or location of this test is not detailed.
  • Anecdotal Clinical Comparisons: Performed for both generator function and dispersive plates. The source or design of these "anecdotal" comparisons is not specified, but they imply observational data.
  • Physical Examination and Electrical Measurements: Conducted on predicate device components at Macan Engineering.
  • Ellman Radiosurgery Catalog (1990): Used for predicate electrode tip information.
  • Manufacturer Biocompatibility Data: Referenced for polysulfone material in the Radiosurge handpiece.
  • UL Certification: Conducted by UL (Underwriters Laboratories).

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 document does not describe a process of establishing "ground truth" through expert consensus for a specific test set. The validation approach is based on demonstrating substantial equivalence to already legally marketed devices. Therefore, it does not mention a number of experts or their qualifications in this context. The "truth" is established by comparing to devices whose safety and effectiveness have already been accepted by the FDA.

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

Not applicable. There was no explicit "test set" requiring adjudication by multiple experts. The evaluation was a comparison against predicate devices through various technical and literature-based assessments.

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/software device and no MRMC study was conducted or described. The device is a physical electrosurgical unit.

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

Not applicable. This is not an AI/software device. The evaluation focuses on the standalone performance of the electrosurgical unit and its components compared to predicate devices.

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

As mentioned, the concept of "ground truth" for a new evaluation is not directly applied in the way it might be for a diagnostic device. Instead, the "truth" or benchmark is derived from:

• Established Performance of Predicate Devices: The FDA-cleared Dento-surge 90FFP and Sensimatic 500SE, whose safety and effectiveness are already accepted.
• Published Specifications and Literature: Regarding predicate device performance and clinical indications.
• Laboratory Measurements: Direct testing of the Radiosurge MC6A against a predicate device (Dento-surge).
• Histological Effects in a Biologic Test Medium: Used to compare tissue responses. This could be considered a form of "ground truth" for tissue interaction.
• Anecdotal Clinical Comparisons: Relying on informal clinical observations.
• Manufacturer Biocompatibility Data: For materials used.
• Compliance with Recognized Standards: UL and IEC electrical safety standards.

8. The sample size for the training set

Not applicable. This is a medical device submission based on substantial equivalence to predicate devices, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a machine learning model.

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The X O Odontosurge 4 is intended for use in removing soft tissue and controlling bleeding in the oral cavity in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.

The X O Odontosurge 4 is a high frequency electrosurgery unit that is comprised of the following three principal components: Control Box, Handpiece and Cord, and seven different Electrodes contained in a separate case. The X O Odontosurge 4 is compact and easily portable. The X O Odontosurge 4 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the X O Odontosurge 4.

This document describes a 510(k) premarket notification for a dental electrosurgical unit, not a device with AI or software components requiring performance criteria based on studies, ground truth, or expert consensus. Therefore, I cannot fill in the requested table and details related to such studies.

Specifically, the document states: "There is no software utilized in the operation of the X O Odontosurge 4." This means the device does not employ Artificial Intelligence or machine learning, and thus, does not have "acceptance criteria" or "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy, algorithm performance, or human-AI effectiveness.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (ArthroCare Dental Electrosurgery System K962445) based on intended use, sterilization method, mode of operation, and general design. The only difference noted is the frequency of operation, which the manufacturer claims offers advantages.

Therefore, the questions regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the information provided in this 510(k) summary.

The device's "acceptance criteria" for regulatory purposes would have been related to engineering specifications, safety standards, and performance benchmarks common for electrosurgical units, which are not detailed in this summary. The "study" mentioned would refer to non-clinical bench testing or electrical safety testing rather than clinical performance studies of diagnostic accuracy.

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The Bonart Co., Ltd. ART-E1 Electrosurgery Unit is intended for use in dental electrosurgery (electrosection), electrosection/electrocoagulation, and electrocoagulation for serious bleeding.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding an electrosurgery unit. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or AI-related comparative effectiveness or standalone studies.

Therefore, I cannot provide the requested information based on the provided text. This document is a regulatory approval letter, not a study report.

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The Valley Forge Bi-Dent Electrosurgical System is intended for the Dental Practitioner for the cutting and coagulation of oral tissue.

The Valley Forge Bi-Dent Electrosurgical System is a Bipolar Surgical System. It is a Bipolar Coagulator/Cutting System with integrated irrigation. It incorporates the effectiveness and safety features of bipolar coagulation/cutting and irrigation packaged into one functional unit. Some of the effective safety features of the Bipolar Coagulator/Cutting System are: Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns. Bipolar Cutting/Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current. Bipolar Technology works at voltages approximately 1/10th the voltage required for monopolar technique. Localized Bipolar Cutting/Coagulation gives the surgeon precise control of the electric current at the tissue site. The System's patented waveform and exceedingly low Output Impedance provide superior Cutting/Coagulation and the absence of charring and sticking even in a dry field. Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field. The Bipolar Coagulator/Cutting System offers an Irrigation Delivery System to keep tissue moist and cool during coagulation. Because of the System's ability to work in a wet field, tissue samples removed for biopsy are not charred or desiccated. Unlike monopolar systems, the Bipolar Coagulator/Cutting System provides smooth, progressive coagulation with precise flow-controlled irrigation. The System permits the physician to cut and coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues. The waveform parameters of the Bipolar Coagulator/Cutting System are programed for the smoothest, most gentle, precise and efficient coagulation and cutting of tissue during any surgical procedure.

The provided document is a 510(k) premarket notification for the Bi-Dent Bipolar Surgical System. It primarily outlines the device's substantial equivalence to a predicate device and discusses the technology and benefits of bipolar electrosurgery, particularly in the context of the Malis Bipolar Coagulator systems.

There is no specific acceptance criteria table or formal study detailed in this document that explicitly proves the device meets specific performance metrics against pre-defined acceptance criteria.

The document focsues on:

• Substantial Equivalence: The FDA's letter states the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory determination based on comparison to existing devices, not necessarily a demonstration against novel performance criteria.
• Technological Description and Advantages: The "Summary of Safety and Effective Information" (Exhibit VI) and the attached articles by Dr. Leonard Malis describe the Bi-Dent Bipolar Surgical System's technology, its evolution from earlier Malis coagulators, and the claimed advantages of bipolar coagulation with integrated irrigation (e.g., reduced tissue damage, precise control, ability to work in a wet field, elimination of grounding pads).

Given the nature of a 510(k) submission focused on substantial equivalence, the document doesn't typically provide the kind of detailed performance study and acceptance criteria you've requested. The "proof" of meeting acceptance criteria for a 510(k) is usually the demonstration that the new device performs as intended and is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and, if necessary, performance data that shows it is "substantially equivalent."

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text, as the information is not present. Here's what I can synthesize from the document:

Absence of Specific Acceptance Criteria and Dedicated Study in the Provided Document

The provided document is a 510(k) premarket notification, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed study against specific pre-defined acceptance criteria. Therefore, the requested information regarding acceptance criteria, a comparative study proving the device meets these criteria, and detailed study parameters (like sample size, ground truth establishment, expert qualifications, etc.) is not explicitly available in the provided text.

The document discusses the benefits and technological advancements of the Bi-Dent Bipolar Surgical System (which is based on the Malis Bipolar Coagulator technology) compared to older electrosurgical methods, but this is presented as background and justification for substantial equivalence, not as the results of a formal study designed to demonstrate performance against specific, quantitative acceptance criteria.

Information that can be inferred or directly stated from the document:

• Indications for Use (Implicit Acceptance Criteria - Functional Performance): The device is intended "for the Dental Practitioner for the cutting and coagulation of oral tissue." The "acceptance criteria" in this context would be that the device effectively performs these functions safely, similarly to predicate devices.
• Reported Device Performance (Implicit):
  • "cutting and coagulation of oral tissue."
  • "Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns."
  • "minimizes damage to adjacent tissue"
  • "works at voltages approximately 1/10th the voltage required for monopolar technique."
  • "gives the surgeon precise control of the electric current at the tissue site."
  • "provide superior Cutting/Coagulation and the absence of charring and sticking even in a dry field."
  • "ability to work in a wet field"
  • "tissue samples removed for biopsy are not charred or desiccated."
  • "provides smooth, progressive coagulation with precise flow-controlled irrigation."
  • "permits the physician to cut and coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues."
  • "waveform parameters...programmed for the smoothest, most gentle, precise and efficient coagulation and cutting of tissue".
• Type of Ground Truth / Justification (Implicit): The "Summary of Safety and Effective Information" and the included articles from Dr. Malis (a neurosurgeon) rely on:
  • Expert experience and clinical observations: Dr. Malis's extensive experience over "over thirty years" with bipolar coagulation.
  • Bench testing/Engineering principles: Discussions of waveform parameters, impedance, voltage, and current flow.
  • Early animal studies (Rat brain studies mentioned in general, not specific to this device's submission): Mention of rat studies to compare unipolar vs. bipolar and to assess leakage current and damage (though these are used to explain concepts and critique methodologies, not as a direct performance study of the Bi-Dent).
  • Comparison to predicate devices: The overall 510(k) process is a comparison to legally marketed devices.

Unable to Answer Based on Provided Document:

1. A table of acceptance criteria and the reported device performance: No such table or quantitative criteria are provided.
2. Sample size used for the test set and the data provenance: No specific test set or study data are provided beyond theoretical explanations and expert opinion.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific "test set" with ground truth established by experts is detailed for this 510(k). The document highlights Dr. Leonard I. Malis, a "former Chairman of the Department of Neurosurgery at Mount Sinai School of Medicine, New York, NY and Neurosurgeon-in-Chief and Director of Neurosurgery of Mount Sinai Medical Center," as the developer and primary expert associated with the technology.
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: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used: As mentioned above, it's largely expert clinical experience, engineering principles, and theoretical comparisons rather than directly stated "ground truth" for a specific test set.
8. The sample size for the training set: Not applicable (not an AI/ML device with training data).
9. How the ground truth for the training set was established: Not applicable.

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