Search Results

The Cautery Protective Actuation System (CPAS) is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The CPAS device includes a safety cover intended to prevent inadvertent actuation of the monopolar electrocautery device, and to prevent secondary burns from a hot tip.

The Cautery Protective Actuation System device is a sterile, single-use, monopolar electrocautery pen intended to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The C-PAS device has a retractable cover, which functions to reduce the risk of inadvertent actuation that can result in burns, fires, patient impalement, or secondary contact from exposure to a hot tip. In the resting position, the cover guards both the tip and the rocker switch, and thereby prevents inadvertent actuation of the device. The "dead-man" trigger forces the user to squeeze the trigger in order to retract the safety cover and thereby access the rocker switch to actuate the monopolar electrocautery pen. The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

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

The document does not explicitly state acceptance criteria in a quantitative table format for the Cautery Protective Actuation System (CPAS). However, it implies acceptance criteria through the types of testing performed and the conclusions drawn. The primary "performance" being evaluated is safety and usability in relation to the added safety cover, and compliance with electrical safety standards.

2. Prevention of Secondary Burns: The safety cover should prevent secondary burns from a hot tip.
3. No New Risks: The addition of the safety cover should not introduce new risks to clinicians or patients. | The summative human factors validation study concluded that "the addition of the safety cover to the subject device does not introduce a new risk for either the clinician or the patients." The "dead-man" trigger mechanism (which forces the user to squeeze the trigger to retract the cover and access the rocker switch) implies the device's design directly addresses protection against inadvertent actuation and secondary burns. The "Device Description" states the cover "guards both the tip and the rocker switch, and thereby prevents inadvertent actuation." |
   | Usability/Effectiveness | 1. Safe and Effective Use: Intended users should be able to safely and effectively use the device with the safety cover.
4. Functionality: The device should function identically to a standard monopolar electrocautery pen, with the added safety benefits. | The summative human factors validation study showed that "intended users of the subject device can safely and effectively use the subject device with support from its labeling." The "Device Description" states: "The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield." |
   | Electrical Safety | The device must comply with relevant electrical safety and electromagnetic compatibility standards. | The device "complies with the following electrical safety performance standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2." |
   | Thermal Performance | The addition of the safety cover and minor geometrical/material differences should not negatively impact the thermal performance of the device. | It was determined that "no thermal effects testing was required to demonstrate substantial equivalence" because "the compatible electrosurgical unit (ESU) and blade electrode are previously FDA cleared and the specific shape of the buttons and housing are not relevant to the thermal performance of the device." This implies the acceptance criterion for thermal performance was met by demonstrating the core thermal components are unchanged and the new features do not affect it. |

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 for Test Set: The document mentions a "summative human factors validation study" but does not specify the sample size (i.e., the number of participants or uses) for this test set.
• Data Provenance: The document does not explicitly state the country of origin of the data. The study was conducted "in compliance with the FDA guidance 'Applying Human Factors and Usability Engineering to Medical Devices'". The nature of human factors validation studies implies a prospective design, where users interact with the device in a simulated or real environment.

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)

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., expert consensus on image findings) doesn't directly apply here. Instead, the "truth" in a human factors study is based on observing user interactions, task completion, and identifying use errors or difficulties.

• The document does not specify the number or qualifications of experts involved in establishing "ground truth" in the way a diagnostic study would. Instead, "truth" is derived from the observations and data collected during the human factors study by the study facilitators/observers, who are assumed to be trained in human factors methodologies.

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

Adjudication methods like 2+1 or 3+1 are typical for reconciling discrepancies in expert diagnoses for ground truth. This is not directly applicable to a human factors study on device usability.

• The document does not mention any adjudication method in the context of the human factors validation study. Data collection in human factors typically involves recording user performance, errors, and subjective feedback, which are then analyzed.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic imaging or AI systems where human "readers" interpret "cases." The CPAS is an electrosurgical device, not a diagnostic tool with "cases" for human readers.
• The study performed was a human factors validation study focused on the usability and safety of the device's added features, not a diagnostic performance study.

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

• The device is a physical electrosurgical pen with a safety mechanism. It is not an algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" performance, as opposed to human-in-the-loop performance, is not relevant or applicable here. The device inherently involves human interaction for its function.

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

As explained in point 3, the concept of "ground truth" for a human factors study differs from diagnostic studies.

• The "ground truth" for the human factors validation study was established through observations of user performance, identification of use errors, and assessment of task completion in simulated use environments, as evaluated against predefined safety and usability objectives. It's essentially empirical data derived from user interactions.

8. The sample size for the training set

• The CPAS is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design and engineering of the device are based on traditional engineering principles and human factors design considerations, not on machine learning training data.

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

• As explained in point 8, there is no training set and thus no ground truth for a training set for this device.

Ask a specific question about this device

The Medline Cautery Tip Cleaner is a disposable, single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electrosurgical instruments during the course of a surgical procedure.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Medline Cautery Tip Cleaner." This document primarily deals with the regulatory clearance of a medical device based on its substantial equivalence to a predicate device.

Critically, this document does NOT contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria as typically found in clinical trials or performance evaluations for AI/software devices.

The Medline Cautery Tip Cleaner is a physical accessory (a disposable, single-use sterile product) intended to remove eschar build-up from electrosurgical instruments. The approval is based on its similarity to existing cleared devices, not on a new study demonstrating its efficacy against specific performance metrics for an AI/software product.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Reported Device Performance: This document does not list any specific, quantifiable acceptance criteria or reported device performance metrics in the way a study for an AI algorithm would (e.g., sensitivity, specificity, AUC). The "performance" for this type of device is inherent in its physical function to clean a cautery tip.
• No Study Described: There is no mention of a study (clinical, laboratory, or otherwise) that involved a "test set," "training set," "experts," "ground truth," or "MRMC comparative effectiveness studies." The FDA clearance for this device is based on "substantial equivalence" to a predicate device, meaning it's similar enough in intended use, technology, and safety/effectiveness principles that it doesn't raise new questions of safety or effectiveness. This typically involves bench testing for basic safety and functionality (like material compatibility or sterility), not comparative performance studies against strict statistical metrics.
• No AI/Software Component: The Medline Cautery Tip Cleaner is a physical device, not an AI or software-driven device. Thus, concepts like "algorithm performance," "human readers improve with AI," or "standalone algorithm performance" are not applicable.

In summary, the provided document does not contain the type of information requested about acceptance criteria and a study demonstrating performance for an AI/software device. The document is strictly an FDA 510(k) clearance letter for a physical medical accessory.

Ask a specific question about this device

The Medline Silicone Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

Not Found

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) clearance letter from the FDA for a device named "Medline Cautery Electrode (silicone)". This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter itself does not contain the detailed technical performance data, acceptance criteria, or a description of any clinical or bench studies that were conducted to demonstrate performance. Such information would typically be found in the 510(k) submission itself, which is not provided in your input.

The document only states:

• Device Name: Medline Cautery Electrode (silicone)
• Regulation Number: 21 CFR 878.4400
• Regulation Name: Electrosurgical cutting and coagulation device and accessories
• Regulatory Class: Class II
• Product Code: GEI
• Indications for Use: "The Medline Silicone Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures."

To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the testing and performance characteristics.

Therefore, I cannot populate the table or provide information for points 1-9 as the necessary data is not present in the given text.

Ask a specific question about this device

The Medline PTFE Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

Not Found

The provided document is a 510(k) summary for a Medline Cautery Electrode (PTFE). It is a letter from the FDA determining substantial equivalence for a medical device. This document does not contain information regarding the acceptance criteria, study details, or performance of a device that uses AI. The product described is an electrosurgical cutting and coagulation device accessory, which is a physical device, not an AI or software-based system.

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device's performance based on this input.

Ask a specific question about this device

The AXIOS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.

The AXIOS Stent and Delivery System and the AXIOS Stent and Electrocautery Enhanced Delivery System are discussed below and presented in Table 5 - 1 . There have been no changes to the AXIOS Stent or the delivery systems; it is identical to the stent and delivery systems cleared in 510(k) K152572 and K150692.

AXIOS Stent:
The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen.

AXIOS Non-Cautery Delivery System:
The stent is preloaded within the AXIOS delivery catheter. The Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Delivery System is designed to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially-available 0.035-inch insulated endoscopic guidewires.

AXIOS Electro-Cautery Enhanced Delivery System:
The stent is preloaded onto the AXIOS delivery catheter. The Electro-cautery Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Electro-cautery Enhanced Delivery System is designed to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially-available 0.035-inch insulated endoscopic guidewires.

This document is a 510(k) submission for the AXIOS Stent and Delivery System, seeking to update its Indications for Use. The submission argues that no new performance data is required because the proposed changes align with existing clinical guidelines and previous IDE studies have already established safety and effectiveness for similar conditions.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This 510(k) submission is for a revised indication for use based on aligning with existing clinical guidelines and previously established safety and effectiveness through IDE studies. It is not a submission presenting new performance data against specific acceptance criteria for a new device or a significant modification requiring new performance testing.

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

This document does not describe a new test set or sample size for this specific 510(k) submission. The revision is based on:

• Data Provenance: Clinical guidelines from "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus".
• Previous Studies: IDEs G110068 and G130266, which established safety and effectiveness for similar conditions. The sample sizes and data provenance for these IDE studies are not detailed in this document.

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

This document does not detail experts used for a new test set. The basis for the revised indication relies on:

• Clinical Guidelines: "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". This consensus would have been established by a group of medical experts in the field of pancreatitis. Their specific number and qualifications are not detailed here, but such guidelines are typically developed by leading specialists (e.g., gastroenterologists, interventional endoscopists, surgeons).

4. Adjudication Method for the Test Set

Not applicable, as no new test set is described or analyzed in this 510(k) submission. The revision is based on existing clinical consensus and previous IDE study findings.

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 medical stent and delivery system, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant.

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

Not applicable. This device is a medical stent and delivery system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the revised indication is based on:

• Expert Consensus/Clinical Guidelines: The "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". This is a form of expert consensus derived from clinical research and practice.
• Outcomes Data from Previous IDEs: The safety and effectiveness were established via IDEs G110068 and G130266, which would have involved collecting patient outcomes data.

8. The Sample Size for the Training Set

Not applicable. This document does not describe a training set as it's not an AI/machine learning device. The previous IDE studies (G110068 and G130266) would have had patient cohorts, but their sizes for "training" purposes (if considered in the broader sense of informing device development) are not detailed here.

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

Not applicable. As noted above, there is no "training set" in the context of an AI/machine learning device. The "ground truth" for the device's efficacy and safety was established through the clinical outcomes and data collected during the IDE studies (G110068 and G130266). These studies would have involved clinical assessments, imaging, and potentially pathology or other diagnostic measures to define the conditions being treated and the success of the treatment.

Ask a specific question about this device

The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

The document discusses the Key Surgical® Cautery Tip Cleaner and its substantial equivalence to a predicate device. It addresses performance data primarily for sterility, functional aspects, and packaging, rather than diagnostic accuracy or AI assistance.

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

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

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

The document does not specify the sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). The tests listed are for device manufacturing and packaging quality, not for clinical performance on patients directly.

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

Not applicable. The tests performed are engineering and manufacturing quality control tests (e.g., sterility, adhesive function, packaging integrity), not clinical studies requiring expert interpretation of results to establish ground truth for a diagnostic or AI-assisted device.

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

Not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved. This document describes tests for product quality where results are determined by standardized methods.

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. The device is a "Cautery Tip Cleaner," a physical accessory for surgical tools, not a diagnostic imaging device or an AI-assisted tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not applicable. This device is not an algorithm or software; it is a physical medical accessory.

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

The "ground truth" for the tests described are the established specifications and methods outlined in recognized standards (e.g., ISO 11137-2, ISO 11607, ASTM F series). For example:

• Sterility: Ground truth is defined by the SAL 10-6 specification, confirmed using ISO 11137-2 methods.
• Functional (adhesive removal): Ground truth is the observable characteristic of being "easily removed," likely assessed against internal engineering standards.
• Packaging: Ground truth is the successful adherence to specific physical properties and integrity tests as defined by the cited ISO and ASTM standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. Since there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

The Monopolar and Bipolar Cautery Cords have been designed as an accessory to electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments include scissors, forceps, and dissectors. The cord connects to the electrosurgical generator on one end and the active instrument on the other end. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generatormating connector on the other end.

This is an electrosurgical cord, not an AI device. Therefore, the questions related to AI/algorithm performance, training sets, and expert adjudication are not applicable. The provided text describes a traditional medical device (Monopolar and Bipolar Cautery Cord) for which the acceptance criteria and performance evaluation are based on engineering and safety standards rather than diagnostic accuracy determined by AI.

Here's the relevant information based on the provided text for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This device is an accessory to an electrosurgical unit, and the performance testing described is engineering-based (dimensional, mechanical, electrical safety, simulated use), not based on a "test set" of patient data or clinical images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., diagnosis, segmentation) is not relevant for this electrosurgical cord. Performance was evaluated against engineering specifications and predicate device equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies, which is not relevant here.

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-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 AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and functional equivalence to a legally marketed predicate device. This is determined through objective measurements and tests rather than clinical diagnoses or outcomes data.

8. The sample size for the training set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Ask a specific question about this device

The Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (1S3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), and a Single-Site Port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.

The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).

This submission describes a Special 510(k) for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories, specifically focusing on the addition of a Single-Site Permanent Cautery Hook. The filing asserts substantial equivalence to a predicate device, rather than providing a new study demonstrating performance against specific acceptance criteria for a new clinical indication.

Therefore, many of the requested elements (e.g., acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not provided in this 510(k) summary as they are not typically required for a Special 510(k) where the primary claim is substantial equivalence to a previously cleared device with minor modifications.

Here's an analysis based on the provided text, indicating where information is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria or quantitative performance metrics are provided in this 510(k) summary. The submission relies on the concept of "substantial equivalence" to a predicate device.

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

The document mentions "bench and animal testing" but does not specify the sample sizes (e.g., number of tests, number of animals) or the provenance (e.g., country of origin, retrospective/prospective) for these tests.

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

Not applicable. The study involved bench and animal testing, not human expert evaluations for ground truth establishment in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. This type of study does not involve expert adjudication as typically seen in image analysis or diagnostic device studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size of Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not a study involving AI or human reader performance in a diagnostic or interpretive context. It relates to a surgical instrument.

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

Not applicable. This refers to a surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in diagnostic device evaluation (e.g., pathology, clinical outcome) is not directly applicable here. The "truth" or validation was established through:

• Bench testing: Likely involved mechanical, electrical, and functional tests against engineering specifications and predicate device performance.
• Animal testing: Involved surgical procedures in animals to demonstrate functionality, safety, and performance in a live tissue environment.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device