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Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.

The provided text is a 510(k) summary for the Bovie® Cautery Device. It mostly focuses on describing the device, its intended use, and comparing it to predicate devices, particularly highlighting safety enhancements. It does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text. The device is a cautery device, not an AI/algorithm-based diagnostic tool, so many of the questions related to AI performance metrics, ground truth, and expert studies are not applicable in this context.

Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document describes the device, its function, technology, and intended use, and compares its characteristics (materials, energy source, design for safety, disposal instructions, sterility) to predicate devices. It does not provide specific performance metrics (e.g., specific coagulation time, temperature output, or other quantitative performance benchmarks) or acceptance criteria for those metrics.

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

Not applicable. This is a medical device submission for a physical, battery-operated cautery device, not a software algorithm tested on a dataset. There is no "test set" in the context of diagnostic data.

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

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable. See point 2.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning algorithm.

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

Not applicable. See point 8.

Summary of what is available in the document regarding the device validation:

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance. This means the manufacturer is asserting that the new device is as safe and effective as existing devices on the market.

The primary method of "proving" the device meets criteria (implicitly, the criteria of safety and effectiveness similar to predicates) is through:

• Comparison of Device Characteristics: The document provides a detailed comparison table (Page 3 of 3 in the 510(k) summary) showing that the Bovie® Cautery Device shares indications for use, sterilization method, materials (patient-contacting tips and handle), and energy source with predicate devices.
• Safety Enhancements: The submission highlights design changes made for enhanced safety, specifically:
  • Easily removable battery pack (allowing for easy battery recycling and prevention of device activation after disposal).
  • Recessed activation button (to prevent inadvertent activation).
• Unchanged Core Technology: The document explicitly states that the "Cautery device technology remains mostly unchanged" and that "Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared" (Page 2 of 3). The patient-contacting tip component, cautery handle materials, and cautery tip configurations are also stated to be unchanged.

In essence, the "study" proving the device meets criteria is the detailed technical and functional comparison to already cleared predicate devices, asserting that the new device performs its intended function (stopping small bleeders in hemostasis) at least as safely and effectively, with added safety features. There are no clinical trial results or performance statistics presented in this 510(k) summary for a "test set" in the context of data analysis.

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Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology.

Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.

The provided text is a 510(k) summary for a medical device (F7255 Fiab Disposable Cautery battery powered). This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or a detailed engineering performance study would.

Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not present in the provided text.

The document states: "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that the regulatory pathway for this device at the time did not require detailed performance studies against specific acceptance criteria to demonstrate efficacy beyond what was required for substantial equivalence.

Here's a breakdown of what information can be extracted from the provided text, and what cannot:

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

• Not present. The document does not specify quantitative acceptance criteria for performance (e.g., specific temperatures, duration of heat, precision of cauterization, etc.) nor does it report specific device performance metrics against such criteria. The submission is focused on demonstrating substantial equivalence to a predicate device.

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

• Not present. No specific test set or data provenance for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and adherence to general regulations.

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 present. No ground truth establishment for a test set is discussed in the context of device performance, as there's no performance study described.

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

• Not applicable/Not present. No adjudication method is mentioned as there's no performance study with a test set.

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 present. This device is a simple battery-powered cautery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable/Not present. As mentioned above, this is not an algorithm-based device.

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

• Not applicable/Not present. Given the nature of the device and the submission type, a "ground truth" for performance comparison as in diagnostic imaging or AI is not part of this document. The "ground truth" for regulatory approval here is substantial equivalence to a legally marketed predicate and compliance with general safety and effectiveness regulations.

8. The sample size for the training set

• Not applicable/Not present. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable/Not present. No training set exists.

Summary of available information:

The provided document is a 510(k) summary for a "F7255 Fiab Disposable Cautery battery powered". The core of its regulatory submission is demonstrating substantial equivalence to an existing predicate device, the "AARON AA04 battery powered cautery".

• Intended Use (from the document): "The device is intended for use in ophthalmology." and "Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology."
• Comparison to Predicate: "The F7255 cautery has the same intended use as the predicate and do not imply new technological characteristics." This is the primary "proof" of meeting regulatory requirements for this type of submission.
• General Compliance: The document states, "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates general compliance with manufacturing and safety regulations, rather than specific performance metrics.
• Risk Assessment: "According to the risk-benefit analysis, the global residual risk has been deemed acceptable since it falls within the area between negligible risks and acceptable risks."

In essence, the "acceptance criteria" here are met by demonstrating the device is substantially equivalent to a legally marketed predicate and adheres to general safety and effectiveness requirements, rather than through specific performance metrics outlined in a detailed study within this document.

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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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The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear. Use for controlling diffuse bleeding and sculpting woven grafts.

The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear.

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Disposable Battery Powered Cautery). It establishes substantial equivalence to a predicate device and provides regulatory information.

However, this document does not contain any information regarding acceptance criteria, device performance results, study design, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Therefore, I cannot extract the information required to answer your request.

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Simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The Starion Instruments thermal cautery grasper/dissector contains handle controls that allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.

This 510(k) submission (K994019) focuses on demonstrating substantial equivalence of the Starion Instruments Thermal Cautery Grasper/Dissector to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth is not applicable.

The submission is a summary of safety and effectiveness data, as required by 21 CFR 807.92, for a Class II device. The core argument for clearance is based on its substantial equivalence to the Starion Instruments thermal cautery forceps (K990728).

Here's a breakdown of the applicable and non-applicable information based on the provided text:

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

Not applicable. The document does not describe specific numerical acceptance criteria for performance metrics (e.g., cutting speed, tissue damage, sealing strength) nor the results of specific tests against such criteria. The "performance" reported is its substantial equivalence to the predicate device in terms of intended use, target population, energy source, and principles of operation.

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

Not applicable. This is not a study comparing the device against a defined acceptance criterion with a test set. This is a regulatory submission for substantial equivalence.

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. There is no mention of a test set requiring ground truth established by experts.

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

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or imaging tool. MRMC studies are irrelevant here.

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

Not applicable. This device is a manual surgical instrument, not an algorithm.

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

Not applicable. The concept of "ground truth" as it pertains to medical device performance studies (especially for diagnostic or AI devices) is not relevant in this substantial equivalence submission for a surgical tool. The "truth" in this context is that the device functions similarly to a legally marketed predicate.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device.

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

Not applicable. As there is no training set, there is no ground truth establishment for one.

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Simultaneous cutting and cauterization of soft tissue during surgery.

Starion's Cautery Forceps and Battery Pack Power Supply are single use devices that are intended for the simultaneous cutting and coagulation of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's Cautery Forceps are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics and target population of surgical disciplines. The principle of operation is that heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument to provide cutting/cauterization.

This document is a 510(k) summary for a medical device (Cautery Forceps and Battery Pack Power Supply) and an FDA clearance letter. It does not contain a study that proves the device meets acceptance criteria. Instead, it states that the device is "substantially equivalent" to existing predicate devices based on intended use, principles of operation, basic technological characteristics, and target population.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The 510(k) process in this context relies on demonstrating equivalence rather than conducting a new performance study with specific acceptance criteria that are then proven.

To directly answer your request based on the absence of this information in the provided text:

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

• Not provided in the document. The document asserts substantial equivalence to predicate devices, but does not present specific performance metrics or acceptance criteria for the new device.

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

• Not applicable/Not provided. No explicit "test set" or performance study data is described. The clearance is based on comparison to predicate devices, not on a new performance study with a specific data set.

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

• Not applicable/Not provided. No explicit "ground truth" establishment for a performance study is mentioned.

4. Adjudication method 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 document describes a thermal cautery device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with AI assistance is not relevant or mentioned.

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

• No. This is a physical medical device, not a software algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set

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

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

• Not applicable/Not provided.

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