Search Results

Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures

Laparoscopic electrodes and handles are surgical instruments with interchangeable tip inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:

• . A removable insert allows for easier cleaning and disinfection of the instrument components.
• Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
• Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
  The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.

The provided 510(k) summary for the Laparoscopic Electrodes and Handle does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria based on performance metrics. Instead, this document focuses on demonstrating substantial equivalence to predicate devices.

Here's an analysis of why the requested information cannot be fully provided from the given text:

• Type of Device: This is a surgical instrument (electrosurgical cutting and coagulation device and accessories). For such devices, "acceptance criteria" are usually related to safety and functional performance (e.g., sterilization effectiveness, electrical safety, material compatibility, mechanical integrity, cutting/coagulation performance). The document confirms compliance with a safety standard but doesn't detail performance criteria.
• Substantial Equivalence (SE) Pathway: The entire document is a 510(k) submission, which is a premarket notification where the manufacturer demonstrates that their new device is "substantially equivalent" to a legally marketed predicate device. This pathway often relies on comparison to predicate device specifications and established standards, rather than extensive de novo clinical performance studies with specific acceptance criteria as might be seen for novel analytical or diagnostic devices.

Therefore, many of the requested fields are not applicable in the context of this 510(k) summary, as it does not describe a performance study in the way a diagnostic or AI-driven device's regulatory submission would.

However, I can extract what is available and explain why other information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document primarily establishes substantial equivalence by stating that the device has no significant differences in technology, performance, or intended use from predicate devices (K970541 and K914883). It explicitly states compliance with a relevant safety standard (ANSI/AAMI HF-18). It does not provide quantitative performance metrics (e.g., specific cutting speeds, coagulation temperatures, or power outputs) against predefined numerical acceptance criteria for this specific device. Instead, the implicit acceptance criterion is "performance equivalent to legally marketed predicate devices."

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

• Test set sample size: Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy or AI performance. The evaluation is based on comparison to predicate devices and compliance with standards.
• Data provenance: Not applicable. No specific data provenance (e.g., country of origin, retrospective/prospective) is provided as there isn't a performance study dataset.

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

• Not applicable/Not provided. This information is relevant for studies that require expert consensus for ground truth (e.g., image-based AI diagnostics). This document describes a surgical instrument, not a diagnostic or AI device that would require such ground truth establishment for performance evaluation.

4. Adjudication method for the test set

• Not applicable/Not provided. As there is no test set in the context of a diagnostic or AI performance study, no 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 instrument, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study comparing human readers with 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 an electrosurgical instrument; it does not involve algorithms or AI for standalone performance evaluation in this context.

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

• Not applicable/Not provided in the traditional sense. For a medical device like this, "ground truth" for proving safety and effectiveness typically involves engineering verification and validation (e.g., material testing, electrical safety tests, sterilization validation, biocompatibility studies) and comparison to the known safe and effective performance of predicate devices. These are not explicitly detailed as "ground truth" types in this summary.

8. The sample size for the training set

• Not applicable/Not provided. This device does not use machine learning or AI that would require a "training set."

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

• Not applicable/Not provided. As there is no training set for an AI model, this information is not relevant.

In summary, the provided 510(k) summary demonstrates that the Laparoscopic Electrodes and Handle meet regulatory requirements by establishing substantial equivalence to legally marketed predicate devices and conforming to a relevant safety standard (ANSI/AAMI HF-18). It does not present a detailed performance study with explicit acceptance criteria and corresponding results in the manner one would expect for a more complex diagnostic or AI-driven medical device.

Ask a specific question about this device

The Bovie Suture Remover is used to perform suture removal procedures in health care facilities and veterinary offices. The suture removal procedures in which the sutures are located externally on the surface of the skin.

The Suture Remover consists of a rechargeable power handle, charging stand, and a sterile, single-use kit distributed in a multipack. The single-use kit includes three components, two of which are Class I devices (forceps and gauze) commonly used in predicate suture removal kits. The forceps and gauze components are substantially equivalent to those included in other Class I, Premarket notification-exempt devices. The single-use tip component is included in the sterile kit. After the handle is charged, the tip is attached to the power handle. The bottom of the tip is placed flat against the sutured skin surface so that the tip filament only touches the suture. The button is pressed, delivering heat to the filament for about 0.5 second prior to deactivating. This process is completed for all sutures, after which the suture threads are easily removed using the supplied forceps. Using a heated filament to cut the suture provides an advantage over the use of scissors to cut the suture because pulling of the suture prior to the cut is minimized.

This document is a 510(k) premarket notification for the Bovie inaFlash™ Suture Remover. It does not contain information about specific acceptance criteria, a study proving the device meets said criteria, or detailed performance metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is the basis for 510(k) clearance, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text. The document states that "Electromagnetic Compatibility testing in accordance with EN 60601-1-2 was successfully performed" and "Hazard analysis evaluations were also performed," but it does not provide the specific acceptance criteria or results of these tests, nor does it detail a clinical performance study.

Ask a specific question about this device

The Boyie Button Remote Hand Switch is intended for use to remotely activate the CUT and COAOULATION model of an election Technological generator to deliver monopolar Radiofrequency current. The switch also serves as the connection between the electrosurgical accessory and the generator.

The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory that is used to activate the CUT and COAGULATION modes of an electrosurgical generator, which operates an attached monopolar accessory. The switch also serves as the connection between a monopolar electrosurgical accessory and the generator. The Bovie Remote Hand Switch provides an alternative to the use of footswitch control to deliver RF energy to an attached monopolar accessory.

No acceptance criteria or study information for a medical device are provided in the input text. The provided documents are a 510(k) summary and an FDA clearance letter for the "Bovie Remote Hand Switch". These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria or performance study results for the new device itself.

The key points from the provided text are:

1. Device Description: The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory used to activate CUT and COAGULATION modes of an electrosurgical generator and serves as a connection between a monopolar accessory and the generator.
2. Substantial Equivalence Claim: It is claimed to be substantially equivalent to the Valleylab Inc. E0520 Trigger Switch and Cord (K970140) in operation, intended use, materials, energy source, components, and safety/performance.
3. Testing for Substantial Equivalence: "Testing performed on the Bovie Remote Hand Switch indicates that the device is substantially equivalent in its performance and method of operation to the Valleylab Inc. F.0520 Trigger Switch and Cord (K970140)."
4. Hazard Analysis: "Hazard analysis evaluations were performed on the Bovie Remote Hand Switch. There are no new hazards presented with the use of the Bovie Remote Hand Switch as compared with the predicate device."
5. Standard Compliance: Both the Remote Hand Switch and the predicate device "were designed and tested to meet the ANSI/AAMI HF18 Electrosurgical Device standard."

Without a detailed performance study or specific acceptance criteria, it is not possible to fill in the requested table or answer the specific questions about sample sizes, ground truth, expert opinions, or MRMC studies, as these types of studies are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not what this device is. The focus here is on demonstrating equivalence to an already approved device through design, materials, and compliance with a recognized standard.

Ask a specific question about this device

The Bovie IDS 300 High Frequency Electrosurgical Generator is a non-sterile reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

The IDS 300 High Frequency Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator for use in the operating arena which features both monopolar and bipolar functions which meet surgical demands for safety, flexibility, and convenience. Functions which the IDS 300 performs includes: monopolar cut; monopolar cut with hemostasis (blend); force coagulation; fulguration; and bipolar.

This document does not contain the information required to complete your request. The provided text is a 510(k) summary for an electrosurgical generator (IDS 300 High Frequency Electrosurgical Generator).

It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.

Here's what is missing:

• Acceptance Criteria Table and Reported Device Performance: The document states that "Testing which has been performed on the IDS 300 indicates that this device is substantially equivalent in performance and method of operation." However, it does not provide a table of specific quantitative acceptance criteria (e.g., power output accuracy within X%, impedance range Y-Z ohms, etc.) nor does it report the actual measured performance values of the IDS 300 against such criteria.
• Sample Size and Data Provenance for Test Set: No specific test set is described, nor is any sample size, country of origin, or retrospective/prospective nature of data mentioned.
• Number and Qualifications of Experts: No experts are mentioned in relation to establishing ground truth, as the evaluation is based on technical performance comparison, not diagnostic interpretation.
• Adjudication Method: Not applicable, as there's no diagnostic interpretation scenario.
• MRMC Comparative Effectiveness Study: There is no mention of a multi-reader, multi-case study involving human readers or AI assistance.
• Standalone Performance: The testing mentioned is for the device's functional performance, not an algorithm's standalone performance in a diagnostic context.
• Type of Ground Truth: The "ground truth" here is implied to be engineering and safety standards, and performance characteristics for electrosurgical generators, derived from predicate devices, rather than expert consensus, pathology, or outcomes data.
• Training Set Sample Size and Ground Truth: No training set is discussed as this is not an AI/ML device that requires training.

In summary, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a typical study report for a diagnostic algorithm or AI-powered device that would include the requested metrics. The "testing" referred to is likely engineering verification and validation against established standards for electrosurgical generators, ensuring safety and functional equivalence to legally marketed devices.

Ask a specific question about this device

The Aaron 950 High Frequency Electrosurgical Generator models are intended to be used for all electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures.

The Aaron 950 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current.

The provided text is a 510(k) Safety and Effectiveness Summary for an electrosurgical generator. It declares substantial equivalence to predicate devices and does not describe a study involving algorithms, AI, or performance metrics in a way that would require the specific acceptance criteria and study details requested in the prompt. The summary focuses on regulatory compliance through substantial equivalence, rather than a detailed performance study with specific quantitative acceptance criteria or a human-in-the-loop evaluation for an AI device.

Therefore, I cannot extract the requested information because the document does not contain it. The information requested (acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance for AI, etc.) is typically found in the context of performance studies for AI/ML-driven devices, not in a 510(k) summary for a traditional electrosurgical generator establishing substantial equivalence.

Ask a specific question about this device

Aaron Arthroscopy Electrodes are sterile, single-use electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.

Aaron Arthroscopy Electrodes sterile, single-use electrodes that are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.

The provided text describes a 510(k) premarket notification for the Aaron Arthroscopy Electrode. The document states that "Testing performed on Aaron Arthroscopy Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance" to the Unimed Arthroscopy Electrode (K970066).

However, the 510(k) summary does not provide specific acceptance criteria or detailed study results in the format requested. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than performing a de novo study against explicit, quantitative acceptance criteria for device performance.

Therefore, many of the requested categories about acceptance criteria, detailed study design, sample sizes, and ground truth establishment cannot be extracted from this document because they are either not publicly available or not part of the standard 510(k) summary provided.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. 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)

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing is internal to Aaron Medical Industries.

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 specified. This document pertains to a medical device's functional equivalence, not an AI or diagnostic tool requiring expert ground truth for image interpretation or disease diagnosis.

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

• Not applicable/Not specified.

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 or diagnostic imaging device.

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

• Not applicable. This is not an AI or diagnostic imaging device. The device is used by a human surgeon.

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

• Not applicable in the context of diagnostic ground truth. The "ground truth" for this device would be its ability to perform its intended functions (cutting, coagulation) reliably and safely, analogous to the predicate device, likely assessed through engineering tests, biocompatibility tests, and performance testing. The specifics are not detailed in this summary.

8. The sample size for the training set

• Not applicable. This is not a machine learning device that requires a training set.

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

• Not applicable. This is not a machine learning device.

Ask a specific question about this device

Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

The provided text describes a 510(k) premarket notification for Aaron Reusable Electrosurgical Electrodes. The submission focuses on demonstrating substantial equivalence to predicate devices and validating cleaning and resterilization processes for reuse.

Based on the provided information, the device is an electrosurgical electrode, not an AI or imaging device, and therefore the standard AI/Imaging study characteristics are not applicable. The provided text addresses traditional medical device performance and safety.

Here's an interpretation of the "acceptance criteria" and "study" based on the context of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Interpreted from 510(k) Summary)

The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices and validating the reusability claims through cleaning and sterilization processes.

Study Information (Based on a Traditional Medical Device 510(k))

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

   • The document does not specify sample sizes for the "testing performed" to demonstrate substantial equivalence or for the cleaning/sterilization validation. This level of detail is typically found in the full 510(k) submission, not the summary.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would be internal testing performed by the manufacturer to support their claims.

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

   • This question is not applicable in the context of this device and submission. "Ground truth" with expert consensus is typically relevant for diagnostic devices (e.g., imaging devices) where expert interpretation is compared. For this electrosurgical electrode, "ground truth" would be established by objective measurements (e.g., material degradation tests, sterility tests, electrical performance tests) against established engineering and medical device standards.

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

   • None. Adjudication methods are relevant for subjective assessments (like image interpretation) where multiple readers disagree. This submission focuses on objective performance characteristics validated against standards.

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

   • No. This is an electrosurgical device, not an AI or diagnostic imaging device. MRMC studies are not applicable.

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

   • No. This is an electrosurgical device, not an algorithm or AI system.

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

   • For the reusability claims: The "ground truth" would be objective testing results comparing the device's performance (e.g., electrical impedance, material integrity, sterility assurance levels) against established engineering standards (e.g., ANSI/AAMI ST46:1993, AAMI TIR 12:1994) after specified numbers of sterilization cycles.
   • For substantial equivalence: Comparison against the predicate device's known performance specifications and general safety/effectiveness requirements for electrosurgical electrodes.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable. No training set exists.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device