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The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal, Tubal, Palatine).
The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.

The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (UPPP tip and Suction Coagulator tip) designed to be attached to the Plasmablade ENT handpiece (cleared as the PEAK Plasmablade TnA handpiece via K083415). These devices are used with Pulsar I (K073057) and Pulsar II (K102029) Electrosurgical Generators. The devices provide radio-frequency energy for cutting (UPPP tip only) and coagulation of soft tissue and contain integrated suction for the evacuation of smoke and fluids from the surgical site. The PEAK Plasmablade ENT handpiece has integrated buttons for Cut and Coag, which may be used to operate the device, or it may be activated with an optional footswitch supplied with the Pulsar Generators.

This document, K150297, is a 510(k) premarket notification for the PEAK PlasmaBlade UPPP and Suction Coagulator. It describes the device and its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

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

Based on the provided text, the acceptance criteria are primarily related to electrical safety and performance equivalence to predicate devices. The reported device performance is that these criteria were met through non-clinical testing.

• IEC 60601-1:2005 3rd Edition And A1:2012 (Medical electrical equipment-Part 1: General requirements for safety and Essential Performance)
• IEC 60601-2-2 Edition 5.0 2009-02 (Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) |
  | Performance and Thermal Effect (in-vivo) | Equivalent to that of the predicate device, demonstrated in an in-vivo animal model utilizing GLP. |
  | Device Validation for Intended Use | Further validated through cadaveric testing. |

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

• Sample Size: The document does not specify the exact sample size for the in-vivo animal model or the cadaveric testing. It only states that these tests were conducted.
• Data Provenance:
  • In-vivo animal model: Utilized GLP (Good Laboratory Practice), suggesting controlled experimental conditions. No specific country of origin is mentioned.
  • Cadaveric testing: Conducted to validate intended use. No specific country of origin is mentioned.
  • Electrical Safety testing: Performed in accordance with international standards (IEC), implying laboratory testing.

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

This section is not applicable as the document describes a medical device (electrosurgical instrument) and its safety and functional equivalence, not an AI/ML-based diagnostic or prognostic device requiring expert-established ground truth on a test set. The validation is through engineering tests and performance comparison to established predicate devices.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. There is no mention of human subjectivity or expert review in the "test set" described (animal and cadaveric performance, electrical safety).

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

This section is not applicable. This submission is for an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool or an imaging device that would involve human readers.

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

This section is not applicable. The device is an electrosurgical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context refers to established standards and observable physical outcomes:

• Electrical Safety: Defined by compliance with international consensus standards (IEC 60601-1 and IEC 60601-2-2).
• Performance and Thermal Effect: Demonstrated by equivalence to the predefined performance characteristics and thermal effects of the predicate device in a biological model (in-vivo animal model).
• Intended Use Validation: Confirmed through cadaveric testing, ensuring the device functions as expected in a simulated surgical environment.

8. The sample size for the training set

This section is not applicable. The PEAK PlasmaBlade UPPP and Suction Coagulator is a physical medical device, not an AI/ML model that requires a training set.

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

This section is not applicable for the same reasons as point 8.

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The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

Not Found

This document is a 510(k) premarket notification letter from the FDA to Medline Industries, Inc. regarding their Medline Suction Coagulator. It confirms that the device has been found substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The letter is a regulatory approval notice, not a detailed study report. It states that the device is classified as Class II and lists the regulation number (21 CFR 878.4400) and product code (GEI) for an Electrosurgical, Cutting and Coagulation and accessories device.

The "Indications for Use" section on page 3 describes what the device is intended for (conducting monopolar electrosurgical energy and suction to remove fluids during ENT and general surgical procedures), but it does not specify performance acceptance criteria or report on any studies that demonstrate compliance with such criteria.

Therefore, I cannot provide the requested information based on the text provided.

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The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.

This 510(k) submission (K130489) is for a design and labeling change to an existing device, the PRECISION Endoscopic Infrared Coagulator™ with SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE. The submission explicitly states that there are no technology differences between the submission device and its predicate devices, and no changes to the intended use or indications for use.

Therefore, the study performed is focused on demonstrating that the design changes do not affect the safety and effectiveness of the device, rather than proving performance against new acceptance criteria for a novel technology.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a design change with no technological differences or changes to intended use, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness profile of the predicate devices. The reported performance is verification that these standards are maintained.

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

The document does not specify a quantitative sample size for the "bench testing" performed. It generally states that "Verification testing results for the design changes were completed and all tests passed."

• Sample Size: Not explicitly stated (likely refers to a number of test articles/units for bench testing).
• Data Provenance: The testing was "Bench testing," implying it was conducted in a laboratory or engineering setting by the manufacturer (Optim LLC in Sturbridge, MA). It is retrospective in the sense that it's verifying changes to an existing design, not gathering new clinical data on patients.

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

This type of information is not applicable to this 510(k) submission.

• This submission is not for an AI/ML device, diagnostic device, or a device that requires human interpretation of outputs to establish ground truth.
• The "verification testing" described is bench testing, which assesses engineering and functional performance against defined specifications, not against expert-established ground truth related to clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above. There's no interpretive test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an infrared coagulator, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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

Not applicable. This device does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is typically defined by engineering specifications, established performance parameters of the predicate device, and compliance with relevant consensus standards. For example, ground truth for power output might be a specific wattage as measured by calibrated equipment, or ground truth for light guide flexibility might be its ability to withstand a certain bend radius without damage. The document indicates verification was against the safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.

The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.

The provided text describes the 510(k) submission for the PEAK Suction Coagulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.

Therefore, the information required to populate most of the acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not available in the provided document.

Instead, the submission relies on:

• Comparison to a predicate device (Valleylab Suction Coagulator): The primary claim is that the PEAK Suction Coagulator is "substantially equivalent" due to similar output energy, delivery system, blade specifications, and the use of monopolar electrosurgery for tissue coagulation.
• Compliance with recognized standards: The device met various IEC and ISO standards related to electrical safety, electromagnetic compatibility, surgical equipment safety, sterilization, and biocompatibility.
• Histological studies: These were conducted to compare the thermal effects of the PEAK Suction Coagulator to the predicate device, aiming to show similar safety and effectiveness. The specific acceptance criteria for these histological studies are not detailed, nor are the number of samples, ground truth establishment, or expert involvement.

Here's a breakdown of what can be gathered from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified for the histological studies or laboratory/performance tests.
• Data Provenance: Implied to be laboratory tests and histological studies, conducted for this regulatory submission. No information on country of origin or whether it's retrospective/prospective.

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

• Number of Experts: Not specified.
• Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of histological comparisons, it would typically involve expert pathologist review, but the method isn't described.

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

• MRMC Study: No, this type of study is not mentioned. The device is a surgical instrument, not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between the device and a predicate device/standards.

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

• Standalone Performance: Not applicable in the context of an electrosurgical device. The device itself is a tool used by a human surgeon. Its performance is evaluated through its physical and electrical characteristics, and its effects on tissue.

7. The Type of Ground Truth Used

• For the "Safety (Thermal Effects)" criterion, the ground truth was likely derived from histological examination by qualified personnel (e.g., pathologists) comparing tissue effects between the PEAK Suction Coagulator and the predicate device.
• For other criteria, the "ground truth" would be established by compliance with published international standards (IEC, ISO) and internal design specifications.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This document describes a medical device requiring regulatory clearance based on substantial equivalence, not an AI/ML algorithm that undergoes "training."

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

• Ground Truth Establishment: Not applicable, as there is no "training set" in this context.

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The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

The Valleylab Suction Coagulators are hand held electrosurgical devices used for the coagulation of tissue and aspiration of fluids during electrosurgical procedures. The devices are activated by a plastic button with a spring contact located in the handle of the device. The suction is activated by the surgeon placing a finger over the suction vent hole also in the handle.

The Suction Coagulators are a disposable, hand held device used in electrosurgical procedures. It provides control of both monopolar coagulation of tissue and suction of fluids in a single handle. The coagulation mode of operation is activated by a depressing a plastic button located on the top of the body. The activation of suction is activated by the surgeon's finger covering the suction port. Coagulation takes place at the uninsulated end of the suction tube. The Suction coagulator consists of four main elements:
-a metal, insulated, French sized tube
-a switching mechanism
-a two piece molded plastic body
-a cord with plug
The Suction Coagulator is supplied sterile and can be used with various electrosurgical generators.

The provided text describes a 510(k) summary for the Valleylab Suction Coagulators. It details the device, its intended use, and non-clinical as well as clinical testing.

Here's the analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria with numerical thresholds. Instead, it states that:

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

• Sample Size for Test Set: Not applicable. No clinical testing was performed for this 510(k) submission to establish the safety and effectiveness of the new device itself. The submission relies on prior documented use of similar devices.
• Data Provenance: Not applicable for a test set specific to this device. The document mentions "published literature" documenting the use of similar Electrosurgical Suction Coagulators, implying retrospective evidence from various sources.

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

Not applicable. No new clinical test set was created for this submission. The effectiveness is based on existing published literature for similar devices.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set was created for this submission.

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 instrument, not an AI-assisted diagnostic or interpretative tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device is an electrosurgical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly define "ground truth" in the context of this device's performance. Instead, it relies on:

• Engineering Standards Compliance: IEC 60601-1 and IEC 60601-2-2 as benchmarks for electrical safety and performance.
• Published Literature: "Documented in the published literature" indicating "safe and effective use" of Electrosurgical Suction Coagulators in ENT procedures. This implies a reliance on clinical outcomes and expert observation from previously published studies on similar devices.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical instrument, not a machine learning model requiring a training set.

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

Not applicable. This device is an electrosurgical instrument, not a machine learning model.

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The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.

The provided 510(k) submission (K072559) for the Megadyne Suction Coagulator does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This submission is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical efficacy or performance studies with specific acceptance criteria as you might find for novel or higher-risk devices.

Here's a breakdown based on the provided text, indicating what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not present in the document. The submission discusses conformance to voluntary standards but does not list specific acceptance criteria or quantitative performance results from a device-specific study compared against those criteria.

2. Sample Size for Test Set and Data Provenance

Not present in the document. There is no mention of a test set, its sample size, or any data provenance (country of origin, retrospective/prospective).

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

Not present in the document. No information about experts, ground truth establishment, or their qualifications is provided as there is no specific performance study detailed.

4. Adjudication Method for the Test Set

Not present in the document. Since no test set or expert evaluation is described, no adjudication method is mentioned.

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

Not present in the document. No MRMC study or any comparison of human readers with/without AI assistance is mentioned. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not present in the document. This device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

Not present in the document. No ground truth establishment is described.

8. Sample Size for the Training Set

Not present in the document. As an electrosurgical device, it would not have a "training set" in the context of an algorithm or diagnostic model.

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

Not present in the document. No ground truth for training is relevant or mentioned.

Summary of what is present and relevant to safety/performance, though not matching the requested structure:

• Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices." This indicates safety and basic performance testing was done against recognized industry standards, which is a common way to demonstrate safety and effectiveness for predicate-based devices.
• Substantial Equivalence: The primary "proof" in this 510(k) is the demonstration of substantial equivalence to predicate devices (MegaDyne Suction Coagulator K946327 and Valleylab's Lectrovac K791752) based on shared technological characteristics and intended use. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

In essence, for this type of device and submission, the "acceptance criteria" are generally met by demonstrating compliance with established voluntary consensus standards and showing that the device is technologically similar and has the same intended use as a legally marketed predicate. Specific numerical performance metrics against detailed acceptance criteria from a dedicated clinical study are typically not required or provided in a 510(k) for such a device.

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Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.

This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.

The provided text describes a 510(k) premarket notification for the CONMED UltraClean™ Suction Coagulator. This document focuses on demonstrating substantial equivalence to a predicate device and does not include detailed acceptance criteria or a dedicated study proving device performance against such criteria as would typically be found for a novel device or AI/software-as-a-medical-device (SaMD).

Instead, the submission primarily relies on:

• Technological Characteristics Comparison: Stating that the proposed device is "equivalent to the identified predicate device with respect to technological characteristics and function."
• Compliance with Standards: Designed to comply with applicable sections of ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, ISO 14971, and ISO 10993.
• Biocompatibility Testing: Focusing on the new silicone coating (UltraClean™) added to the cannula tip, confirming it meets established biocompatibility requirements.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for performance evaluation are not applicable to this type of submission.

Here's a breakdown of what can be extracted and what is not present:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for "device performance" in the context of diagnostic accuracy/AI (e.g., sensitivity, specificity). The acceptance criteria are implicitly met by:
  • Demonstrating substantial equivalence to a legally marketed predicate device (K033003).
  • Complying with relevant medical device standards (ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, ISO 14971, ISO 10993).
  • Passing biocompatibility tests for the new component.
• Reported Device Performance: No specific performance metrics (like sensitivity, specificity, or precision) are reported for the device in a clinical study context. The "performance" is considered equivalent to the predicate device and safe for its intended use.

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

• Sample Size: Not applicable. This submission does not involve a "test set" in the context of evaluating a diagnostic or AI algorithm. Biocompatibility testing typically involves in vitro and in vivo animal studies, but specific sample sizes and detailed provenance are not provided in this summary.
• Data Provenance: Not applicable for a clinical test set. Biocompatibility reports are referenced but their details (e.g., specific test animal origins, retrospective/prospective) are not included.

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. No clinical "ground truth" establishment by experts is described as this is not a diagnostic device or AI algorithm requiring such validation. Biocompatibility testing follows standardized protocols, with interpretation by qualified toxicologists/biologists typically, though specific numbers/qualifications are not provided here.

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

• Not applicable. No adjudication method is described as there is no diagnostic test set requiring human review and consensus.

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 accessory, not an AI or diagnostic tool, so an MRMC study is not relevant.

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

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

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

• Not applicable for clinical performance. For biocompatibility, the "ground truth" is defined by established scientific principles and regulatory standards (e.g., ISO 10993) interpreted by lab results regarding cytotoxicity, hemolysis, etc. For functional performance, the "ground truth" is assumed to be equivalent to the predicate device's established safe and effective performance in surgical contexts.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not applicable. No training set exists for this device.

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Suction coagulator is used for coagulating tissue and removing fluid and debris from Suction coagulation is assulation can be performed independently or simultaneously.

Suction Coagulator

This letter is a 510(k) clearance for a Suction Coagulator, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only specifies the indications for use for the device.

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Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.

Monopolar Suction Coagulator

This document is a 510(k) clearance letter from the FDA for a Monopolar Suction Coagulator. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm performance.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It focuses on regulatory compliance, classification, and general controls, not on detailed performance metrics from a specific study.

Therefore, I cannot extract the requested information from the provided text.

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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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