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The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are intended to be connected to a nerve monitoring unit, such as the Neurosign 100 Nerve Monitor, which requires a standard 1.5mm DIN 42802 touch proof connector, in order to provide an electrical path by which electrical impulses may pass from the monitoring unit to the patient, thus effecting nerve stimulation to assist its user in locating and identifying motor nerves.

The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are surface electrodes used to stimulate nerves during various surgical procedures. They may be used on the surface of the skin, or on the surface of surgically exposed tissue, and as such, they are not intended nor designed to be inserted into tissue.

This 510(k) premarket notification for the Kirwan Disposable Nerve Stimulator Probes (Models: 41-3400, 41-3401, 41-302, and 41-3403) describes a device that is substantially equivalent to legally marketed predicate devices. As such, the study focuses on demonstrating this equivalence rather than establishing novel acceptance criteria through a standalone performance study as would be required for a new technology.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a device demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily met through compliance with recognized standards and a demonstration that the device's design, materials, and function are virtually identical to the predicates. There aren't specific quantitative performance metrics reported for this device in the same way one might find for a diagnostic algorithm (e.g., sensitivity, specificity).

• ISO 10993-1 (Biological evaluation)
• IEC 60601-1 (Medical electrical equipment)
• IEC 60601-2-10 (Specific requirements for nerve and muscle stimulators)
• ISO 11137 -1/2 (Sterilization - radiation sterilization) |
  | Biocompatibility | Materials in contact with the patient must be biocompatible. | Testing for biocompatibility requirements was assured, implying compliance. |
  | Dielectric Strength | Electrical insulation properties must meet safety standards. | Testing to current dielectric strength requirements was assured, implying compliance. |
  | Sterilization | Sterilization methods must be validated and controlled. | Compliance with ISO 11137 -1/2 (Sterilization of health care products requirements for validation and routine control - radiation sterilization) is stated. |
  | Hazard Analysis | Hazards associated with the device must be identified and adequately controlled. | Safety and hazard analysis determined that the hazard conditions for the 41-34XX Series of Disposable Nerve Stimulating Probes range in the low-to-moderate level and for this reason are acceptable. This indicates that identified risks are managed to an acceptable level. |

Study Details

The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is not a clinical study designed to establish quantitative performance metrics of a new AI algorithm. Therefore, many standard AI/MDCAS study components are not applicable or explicitly mentioned.

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

   • Not applicable / Not specified. This submission relies on engineering and manufacturing verification and validation, as well as comparison to predicate devices, rather than a clinical test set with patient data for performance evaluation in the context of an AI algorithm. The testing described (dielectric strength, biocompatibility) would involve material and electrical samples, not patient data sets.

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 / Not specified. Ground truth, in the context of an AI/MDCAS device, typically refers to expert consensus, pathology, or outcomes for clinical data. This type of ground truth is not relevant for this device's 510(k) submission, which focuses on substantial equivalence of physical and functional characteristics.

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

   • Not applicable / Not specified. Adjudication methods are used to resolve discrepancies in expert-derived ground truth for clinical data, which is not part of this device submission.

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 study is not relevant for this type of device (disposable nerve stimulating probes). This device is a tool used by a clinician, not an AI diagnostic or assistive imaging tool.

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

   • No. This is not an algorithmic device. It's an electrical probe used to stimulate nerves.

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

   • For the testing performed (dielectric strength, biocompatibility, sterilization), the "ground truth" would be the established scientific and engineering standards and methodologies defined in the ISO and IEC standards listed. These standards define acceptable limits and procedures.

7. The sample size for the training set:

   • Not applicable / Not specified. This device does not use machine learning, therefore, there is no training set.

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

   • Not applicable / Not specified. As there is no training set, this question is not relevant.

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These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate hand-piece, providing for both irrigation and aspiration of the surgical site.

These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate handpiece, providing conduits for both irrigation and aspiration of the surgical site.

This document is a 510(k) summary for the Kirwan Disposable Manifold Tubing Set, a Class I device. It describes the device's intended use and demonstrates its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other diagnostic or treatment effectiveness measures.

Instead, the document focuses on regulatory compliance and safety. The "acceptance criteria" discussed are related to manufacturing standards and hazard analysis, not performance evaluation in a clinical or diagnostic sense.

Therefore, many of the requested sections regarding device performance studies, sample sizes, expert ground truth, and AI effectiveness cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the 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)

• Not applicable / Not provided. The document describes compliance with standards and a hazard analysis, not a clinical or performance study with a test set of data.

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 / Not provided. No ground truth establishment related to clinical performance is mentioned. The "ground truth" for compliance appears to be the standards themselves and the output of a hazard analysis.

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

• Not applicable / Not provided.

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 / Not provided. This is not an AI/diagnostic device.

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

• Not applicable / Not provided. This is not an AI/diagnostic device.

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

• Not applicable / Not provided in the context of clinical performance. The "ground truth" for the claims in this document is adherence to established medical device standards (ISO 11137, ISO 10993-1) and a hazard analysis.

8. The sample size for the training set

• Not applicable / Not provided. No training set for an algorithm is mentioned.

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

• Not applicable / Not provided.

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The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.

The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.

The provided 510(k) summary for the Kirwan Series of Aneurysm Clips and Appliers does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving those criteria. This type of regulatory submission typically focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting novel clinical study data or detailed performance metrics against specific acceptance criteria.

However, based on the available information, I can fill in what is present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document describes a technical assessment based on comparison to predicate devices and compliance with standards, not a clinical study with a test set of data.

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

• Not applicable. No test set or ground truth establishment by experts is described in this regulatory summary.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method 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 a surgical implant/tool (aneurysm clips and appliers), not an AI-assisted diagnostic or decision support system. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

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

• Not applicable. This device is a physical surgical product, not an algorithm.

7. The type of ground truth used:

• Not applicable. The "ground truth" in this context is adherence to manufacturing standards, material specifications, and a hazard analysis, rather than clinical outcomes or expert consensus on diagnostic data. The primary "truth" being established is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not applicable. There is no training set mentioned.

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Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.

Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.

This 510(k) submission (K062659) for Kirwan Disposable Battery-Powered Cautery relies on a different approach to demonstrate substantial equivalence than clinical studies with explicit acceptance criteria. Instead, it leverages the device's adherence to existing standards and its analogous nature to legally marketed predicate devices.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this type of submission):

Given the nature of this 510(k) for a well-established device technology, the "study" demonstrating adherence to acceptance criteria is not a traditional clinical trial or performance study with a test set of data, but rather a demonstration of compliance with recognized standards and a comparison to predicate devices.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a traditional performance study. The "test set" here refers to the device itself being evaluated against standards and predicates. The data provenance would be internal manufacturing and testing records in compliance with ISO standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device safety and sterilization is established by adherence to recognized international standards (ISO). For technological equivalence, the manufacturer's engineering and regulatory teams would assess the device against predicate designs.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Device compliance with standards and technological equivalence is typically a direct assessment, not an adjudicated review of clinical data.

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 device is a surgical instrument, not an AI-powered diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical device.

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

   • Safety and Sterilization: Ground truth is established by international standards (ISO 10993-1 for biological evaluation, ISO 11137 for sterilization) and internal hazard analysis.
   • Technological Equivalence/Performance: Ground truth for this aspect is based on the characteristics of legally marketed predicate devices (AAXXX Series, E844XXXX Series, 23X Series Cautery units) and the determination that the new device does not introduce new technological risks.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that would require a "training set."

8. How the ground truth for the training set was established: Not applicable.

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General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue where a wide range of tissue types, patient conditions and load impedances are encountered. Where applicable (i.e., Auraplus, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.

The model 28-2000, Aura, 70 Watt Bipolar Electrosurgical Coagulator and the model 28-2600, Auraplus, 70 Watt Irrigating Bipolar Electrosurgical Coagulator model 20 2.000, haraphid state bipolar generators used to supply the RF signal to electrosurgical hand-pieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Where applicable (i.e., Auraplus) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.

This document describes Kirwan Surgical Products' 510(k) submission for their Models 28-2000 and 28-2600 Aura 70 Watt Bipolar Electrosurgical Coagulators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics. Therefore, several aspects of your request cannot be fully addressed from the provided text.

Here is the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific clinical acceptance criteria (e.g., target accuracy, sensitivity, specificity) for the electrosurgical device itself, nor does it report device performance against such metrics. Instead, "acceptance criteria" are framed as compliance with recognized safety and performance standards for electrosurgical equipment.

2. Sample Size for Test Set and Data Provenance

The document does not describe a clinical performance study using a "test set" in the context of typical AI/diagnostic device evaluation (e.g., a specific set of patient cases or images). The evaluation is based on engineering and safety standard compliance, which involves testing of the device hardware and software, rather than clinical data sets. Therefore, this information is not applicable or available in the provided text.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The ground truth for this type of device (an electrosurgical coagulator) is established through technical specifications, engineering validations, and adherence to recognized performance and safety standards, rather than expert consensus on clinical cases.

4. Adjudication Method for Test Set

Not applicable, as there is no described test set of clinical cases requiring adjudication.

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

No MRMC study was done because this is an electrosurgical device, not an imaging or diagnostic device that relies on human readers and AI assistance for interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical electrosurgical unit, not a standalone algorithm. While it contains microprocessor technology, its "performance" is assessed through its electrical and functional characteristics in accordance with engineering standards, not through "algorithm-only" performance in the sense of AI.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by:

• Compliance with recognized electrical safety and performance standards (e.g., IEC 60601 series, ANSI/AAMI HF 18).
• Engineering validation of its specifications and operational parameters.
• Hazard analysis and risk management.
• Substantial equivalence to legally marketed predicate devices, implying that their proven safety and effectiveness extend to the new device given similar fundamental technology and compliance with standards.

8. Sample Size for Training Set

Not applicable. This device is not an AI/machine learning model where a "training set" of data is used in the traditional sense. The design and development process for an electrosurgical unit involves engineering design, component testing, and system integration, not training on a dataset.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and functionality would be the engineering specifications, performance requirements, and regulatory standards it was designed to meet.

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The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator, is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Its footswitch activation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard female banana jacks. The Aura 20 differs technologically from its predicates with only minor operational features designed to enhance user interface. The following are some of those features.

• While operating on both 115 and 230 VAC mains supply as its predicates, the Aura 20 does not require the placement of an external jumper in order to select between the two different voltage levels.
• Activation of the Aura 20 is via footswitch only, eliminating the optional hand switch activation of its predicates, which is viewed as a little-used option and expendable in order to simplify construction, and limit size.
• While similarly relying on solid-state electronics, the Aura 20 has been greatly simplified over its predicates by the use of microprocessor technology and modular medical-grade power supply.
• The Aura 20 uses membrane keypads instead of potentiometers (knobs) as adjustable controls for tonal volume and power level settings.

The provided text is a 510(k) summary for the Aura 20 Bipolar Electrosurgical Coagulator. It focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with safety standards.

Crucially, the document does NOT contain information about acceptance criteria, device performance, or specific studies that would typically be described in the context of clinical or performance validation studies for AI/ML devices.

The document states that "Technological safety and effectiveness is established by the fact that the Aura 20, like its predicates, offers well-proven, basic electrosurgical unit technology." and "Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following standards". It then lists relevant electrical safety standards (e.g., IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF 18).

Therefore, based solely on the provided text, I cannot complete the requested table or answer most of the questions about acceptance criteria and studies as they relate to performance or clinical outcomes. The device is not an AI/ML device, and the information is from 2003, predating the widespread use of clinical validation studies for AI.

Here's what I can extract and infer:

1. A table of acceptance criteria and the 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)

• Not applicable / Not provided. The document describes compliance with electrical safety standards and substantial equivalence, not a clinical performance study with a test set of data.

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 / Not provided. This information is for clinical ground truth, which is not discussed.

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

• Not applicable / Not provided.

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. This is not an AI device, and no MRMC study is mentioned.

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

• No. This is not an AI device.

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

• Not applicable. The "ground truth" for this device would be defined by its electrical and functional performance conforming to established engineering standards, rather than clinical outcomes or expert consensus on diagnostic tasks.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device.

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

• Not applicable / Not provided. This is not an AI/ML device.

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The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC - Bipolar System. This device is to be used to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.

The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC -Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMC -III (or equivalent) Generator to the bipolar irrigating forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.

The provided text describes the regulatory clearance for a medical device, the "Disposable Irrigation Bipolar Cord Assembly for Malis™ System CMC®-II." However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical or performance study would for a novel AI/software device. Instead, it details the testing performed to assure safety and substantial equivalence to predicate devices.

Therefore, many of the requested elements for an AI device study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device and its predicate comparison for regulatory approval.

Here's an analysis based on the provided text, focusing on the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

• 80-1163, Malis™ Integrated Irrigation Tubing and Bipolar Cord Set
• NU1060, Irrigation / Bipolar Set, for Malis System CMC-II |

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

• Sample Size: Not applicable. This document refers to engineering and quality assurance testing of a physical device, not an AI model requiring a test set of data. The "test set" here would refer to the physical units tested for biocompatibility, sterility, and electrical performance. The exact number of units tested is not specified but would typically follow established standards for medical device validation (e.g., n=3 for certain types of testing, or larger batches for sterility validation).
• Data Provenance: Not applicable in the context of clinical/imaging data. The "provenance" here relates to the manufacturing process, material sourcing, and lab conditions under which the safety and performance tests were conducted.

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

• Not applicable. This device does not involve expert-labeled ground truth for an AI algorithm. The "ground truth" for the device's performance is defined by adherence to established ISO, IEC, and ANSI/AAMI standards, which are determined by technical specifications and material properties.

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

• Not applicable. This is not a study assessing human or AI diagnostic performance. Compliance with standards is determined by objective measurements and validated procedures rather than expert adjudication of cases.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an irrigation bipolar cord assembly, not an AI or imaging diagnostic tool.

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

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

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

• The "ground truth" for this device's performance aligns with technical standards and validated test procedures.
  • For biocompatibility: ISO 10993-1 defines the accepted methods and criteria.
  • For sterility: Sterility Assurance Level (SAL) of 10⁻⁶ as per AAMI/ISO 11137 and EN 552.
  • For performance: Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18 through specific electrical and functional tests.
  • For substantial equivalence: Comparison of functional and intended use specifications against existing legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This device documentation does not involve a training set for an AI model.

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

• Not applicable. There is no training set mentioned in this document.

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The Kirwan Model 28 1500 Generator is a general purpose solid state monopolar generator with independent bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 1, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other. Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) monopolar electrosurgerygenerators and bipolar coagulators.

The document provided is a 510(k) summary for the Kirwan Model 28 1500 Electrosurgery Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data with specific acceptance criteria and performance metrics described in your request.

Therefore, the provided text does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance. The submission primarily discusses technical specifications and adherence to safety guidelines (IEC 601-1-2 and ANSI HF-18) for leakage and monitoring, but not performance metrics relative to clinical acceptance criteria.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for a training set.

The document states that the device is an "isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator" and specifies power outputs for different modes (cut, blend, coagulation). It also mentions that "Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines" and "RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines." These are safety and technical specifications, not clinical performance acceptance criteria or results of a study designed to demonstrate such.

The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance. This determination is based on comparing the device's technical characteristics and intended use to those of existing devices, rather than on new clinical effectiveness studies with the specific details requested in your prompt.

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The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.

This document describes the Kirwan 28 1000 Coagulator, specifically a 510(k) premarket notification for a predicate device. It does not contain information about acceptance criteria or a study proving a device meets those criteria.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device, not a performance study.

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The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

The provided text is a summary of safety and effectiveness for a Bipolar Suction Coagulator. It details various safety and performance standards met by the device. However, it does not contain the specific information requested about acceptance criteria, device performance metrics (sensitivity, specificity, accuracy, etc.), details of a study (sample size, data provenance, ground truth establishment, expert qualifications), or comparative effectiveness studies with AI or standalone algorithm performance.

The document primarily focuses on:

• Intended Use: Soft tissue surgical procedures requiring fluid evacuation and low-energy coagulation.
• Biological Safety: Materials tested according to ISO 10993-1.
• Sterilization Safety: Validated to a SAL of 10-6 using EtO sterilization.
• Performance Testing: Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18.
• Substantial Equivalence: To Bipolar Suction Coagulator, K960455.

Therefore, I cannot populate the requested table or answer the specific questions because the necessary data is not present in the provided input. This document describes regulatory compliance and testing for a physical medical device, not the performance metrics of a diagnostic or AI-driven system.

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