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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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For the simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, variable output and volume controls/indicators, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and audible tones to indicate activation of the instrument heating element.

The provided text is a 510(k) premarket notification summary and an FDA clearance letter for the Starion Instruments Universal Power Supply (UPS). This document type, particularly a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the results of a dedicated study to prove it.

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

• Type of Device: The Starion Instruments Universal Power Supply (UPS) is an AC powered unit intended for use with cautery instruments for simultaneous cutting and cauterization of soft tissue. This is a hardware device, not an AI/ML-driven device or a diagnostic tool that would typically have the kind of performance metrics (sensitivity, specificity, AUC) and ground truth methodologies associated with the requested table criteria.
• 510(k) Process: The 510(k) pathway for medical devices (Class II in this case) primarily requires demonstrating "substantial equivalence" to a legally marketed predicate device. This is often achieved through performance testing that confirms the new device meets established safety and performance standards for its type, and that its technological characteristics do not raise new questions of safety or effectiveness compared to the predicate. It does not typically involve the elaborate "study" structure implied by the questions, especially those related to AI algorithm performance evaluation.

Therefore, the document does not contain information on:

1. A table of acceptance criteria and reported device performance (in the context of sensitivity/specificity/accuracy for an AI algorithm).
2. Sample size, data provenance, or ground truth for a test set.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, human reader improvement with AI, or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

What the document does provide regarding "acceptance" implicitly:

• Intended Use: "For the simultaneous cutting and cauterization of soft tissue during surgery."
• Substantial Equivalence: The primary "acceptance criterion" met is demonstrating substantial equivalence to the predicate device (Starion Instruments Universal Power Supply, K043155) in terms of intended use, target population, energy output, and principles of operation.
• Device Features: The device features (on/off switch, LED, variable output/volume, outlets, audible tones) are described, implying these functionalities were tested to ensure they operate as intended and safely.
• Safety and Effectiveness: The 510(k) process is about ensuring safety and effectiveness. The FDA's clearance indicates they were satisfied that the device meets these general criteria based on the submitted information and comparison to the predicate.

In summary, the provided text describes a basic medical device (a power supply for cautery instruments) cleared through the 510(k) pathway, which focuses on substantial equivalence rather than the detailed performance study characteristics typically associated with AI/ML devices or diagnostic assays implied by your questions.

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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 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.

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For the simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and an audible tone to indicate activation of the instrument heating element.

The provided text is a 510(k) summary and FDA clearance letter for the Starion Instruments Universal Power Supply (UPS). It indicates that the device is a Class II medical device (thermal cautery unit) and has been found substantially equivalent to a legally marketed predicate device (Starion Instruments Surgical Power Supply, K000893).

The details requested in your prompt (acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, etc.) are typically found in a 510(k) submission's detailed safety and effectiveness section, sometimes within a "Special Controls" document, or in the Design History File of the device manufacturer. The provided public summary and clearance letter do not contain this level of detail regarding specific performance studies or acceptance criteria beyond stating substantial equivalence.

Therefore, based only on the provided text, I cannot fill in most of the requested table and study details.

Here's what can be inferred from the provided text, and what cannot:

Information Available from the Text:

• Device Name: Starion Instruments Universal Power Supply (UPS)
• Intended Use: Simultaneous cutting and cauterization of soft tissue during surgery.
• Predicate Device: Starion Instruments Surgical Power Supply (K000893)
• Regulatory Classification: Class II, Product Code HOO, Regulation Number 21 CFR 886.4115 (Thermal cautery unit)
• Basis for Clearance: Substantial Equivalence to a predicate device.

Information NOT Available from the Text:

• Specific quantitative acceptance criteria for performance.
• Results of concrete performance tests to demonstrate these criteria are met.
• Details of any specific studies (other than the implicit substantial equivalence comparison).
• Sample sizes for test sets or training sets.
• Data provenance for any hypothetical test sets.
• Number/qualifications of experts, adjudication methods.
• Whether MRMC or standalone studies were performed.
• Type of ground truth used or how it was established for any test/training data.

Why this information is not present in the provided text:

For a 510(k) submission relying on substantial equivalence to a predicate device, the primary "study" is often a comparison to the predicate device demonstrating that the new device has the same technological characteristics, intended use, and performs as safely and effectively as the predicate. While internal testing (e.g., electrical safety, EMC, functional performance) is conducted by the manufacturer, the detailed summary provided to the FDA and then released publicly for a simple Class II device like a power supply often focuses on the comparison to the predicate rather than extensive new clinical or performance studies with defined acceptance criteria in the same way a novel, high-risk device might.

The FDA's finding of "substantial equivalence" means they deemed the device to be as safe and effective as the predicate based on the information provided by the manufacturer, which would have included performance data, but this data is not detailed in the publicly available summary you've provided.

Therefore, the table and study description will largely be empty or state "Not specified in the provided document."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided document.
• Data Provenance: Not specified regarding any specific test sets. The clearance is based on comparison to a predicate device and likely internal design verification/validation testing conducted by the manufacturer (Starion Instruments Corporation, Saratoga, CA).

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

• Not applicable/Not specified. The 510(k) summary focuses on substantial equivalence to a predicate device for an electrical medical device power supply. This type of device typically relies on engineering and electrical safety testing against recognized standards rather than expert consensus on a "test set" of clinical data in the way an AI diagnostic device would.

4. Adjudication method for the test set

• Not applicable/Not specified. See point 3.

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 applicable to a universal power supply for cautery instruments. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing human performance with and without AI assistance.

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

• Not applicable. This device is a power supply, not an algorithm or an AI system. Its function is to power cautery instruments used by a surgeon.

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

• Not applicable/Not specified in the context of clinical "ground truth." For a power supply, "ground truth" would relate to its electrical and functional performance meeting engineering specifications and safety standards, as compared to the predicate.

8. The sample size for the training set

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

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

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

In summary: The provided 510(k) content is for an electrical power supply device cleared via substantial equivalence. It does not involve the types of studies (MRMC, standalone algorithm performance, AI training sets with expert-established ground truth) that your questions are designed to uncover for more complex diagnostic or AI-enabled medical devices. The "study" here is the manufacturer's demonstration to the FDA that their new UPS is as safe and effective as their previously cleared predicate device.

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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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