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The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired.

The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only.

The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator.

Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site.

These devices are sold as sterile, single-use devices.

The provided document is a 510(k) premarket notification for a medical device: the New Deantronics Trigger Switch and Cord. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets novel acceptance criteria for an AI/ML powered device.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established, effect size of human readers improving with AI) are not applicable to this document. This document deals with electrosurgical accessories, which are hardware devices, not software or AI-driven systems.

However, I can extract information related to the acceptance criteria and study that does apply to this electrosurgical accessory, focusing on performance and safety testing against established standards and the predicate device.

Here's the information extracted from the document, tailored to the context of a hardware medical device and addressing the relevant parts of your request:

Acceptance Criteria and Device Performance for New Deantronics Trigger Switch and Cord

This document (K200455) is a 510(k) premarket notification for a traditional medical device (electrosurgical accessory), not an AI-powered one. Therefore, the "acceptance criteria" and "study" are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device through engineering and performance testing, rather than clinical efficacy studies with human readers or AI algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international and domestic standards for electrosurgical devices, as well as meeting predefined performance thresholds in mechanical and electrical tests. Performance is reported as "Pass" or "Fail" for each test.

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

This document does not specify exact sample sizes for each bench test conducted. The testing described is primarily bench testing (engineering and electrical safety tests), not human subject clinical trials. The data provenance is internal testing performed by New Deantronics Taiwan, Ltd. and its contractors. The studies are prospective in the sense that they were conducted for this premarket submission.

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

Not applicable in the context of an AI/ML device. For this hardware device, "ground truth" is established by adherence to recognized engineering standards (e.g., IEC, ASTM) and predefined physical and electrical specifications. The expertise would lie in the engineers and technicians performing and verifying the tests in accordance with these standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical endpoints adjudicated by multiple experts, typically in clinical trials. For bench testing, test results are typically objective measurements against a Pass/Fail criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly used for imaging AI. This device is an electrosurgical accessory, not a diagnostic tool.

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

Not applicable. This device is a hardware accessory and does not contain an algorithm in the sense of an AI/ML model. Its performance is evaluated through physical and electrical tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is the engineering specifications and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ASTM D4169) to which the device must conform to be considered safe and effective. It's based on established physical and electrical properties, not clinical outcomes or expert consensus on a medical condition.

8. The Sample Size for the Training Set

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

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

Not applicable. As the device is not an AI/ML model, there is no training set or ground truth associated with it in that context.

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The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.

The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.

The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connectors, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of the electrosurgical pencil from which it receives the high frequency current while contacting target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.

The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.

There are two groups of laparoscopic electrodes, including non-coated and coated laparoscopic electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with non-sticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.

There are sixteen models of New Deantronics laparoscopic electrodes available.

The provided text describes the New Deantronics Disposable Laparoscopic Electrodes, non-coated and coated, and refers to non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria and reported device performance in the format of a table, nor does it detail a study that proves the device meets specific acceptance criteria as you've requested.

The document primarily focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and adherence to various recognized standards. It states that "All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses." and "A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies."

However, it does not explicitly list the "pre-defined acceptance criteria" or specific performance metrics in a structured table. Additionally, information regarding sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance data, or training set details is not present within this document.

The document mentions that the device "Passes test of 6.3 kV, according to IEC 60601-2-2, 201.8.8.3.104 Capacitive coupled HF current not exceed 50 mA" for electrical safety and "Wire electrode can survive 4 bends with no crack or failure" for mechanical safety. These could be considered acceptance criteria, but they are not presented in a comprehensive table with reported performance.

Therefore, I cannot fulfill your request for the comprehensive table and study details as the information is not provided in the input text.

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The New Deantronics Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.

The Smoke Evacuation Adapter is a single-use device provided to healthcare professionals. This device is an accessory to an electrosurgical pencil. The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator. The device components include a pencil holding clamp, an electrosurgical pencil wire holder, smoke evacuator tubing pathway to the smoke evacuator, and a connector to the smoke evacuator. The clamp secures the smoke evacuation pencil adapter to the bottom of the pencil handle. Suction to remove smoke and odors is created by a smoke evacuator device furnished by the user organization. The smoke evacuator maintains a low pressure condition by a suction pump.

This document is a 510(k) premarket notification for a medical device called the "Smoke Evacuation Adapter." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than presenting a study to prove the device meets acceptance criteria related to its performance in a clinical setting against specific, quantifiable metrics.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as this type of regulatory submission doesn't typically include a clinical study with performance metrics in the way your prompt describes.

However, I can extract information regarding non-clinical testing performed to establish safety and effectiveness for regulatory clearance.

Here's a breakdown of the available information based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding performance metrics as one would find in a clinical study for diagnostic accuracy or treatment effectiveness. Instead, it lists harmonized standards and emphasizes a comparison to a predicate device for substantial equivalence.

The "acceptance criteria" here are compliance with the listed standards and demonstrating equivalent performance and safety to the predicate device through non-clinical testing.

Information not available or not applicable based on the provided text:

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

• Not applicable/Provided: This document describes non-clinical engineering and bench testing, not a clinical study involving human or patient data with a "test set" in the context of diagnostic performance. The tests assess compliance with standards.

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/Provided: Ground truth is not established by clinical experts for this type of non-clinical device testing. Compliance with engineering and safety standards is assessed by appropriate testing methods and validated against those standards.

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

• Not applicable/Provided: No clinical adjudication method is relevant for this type of non-clinical device testing.

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/Provided: This is a physical accessory device for smoke evacuation during electrosurgery, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

• Not applicable/Provided: This is not an algorithmic device.

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

• Not applicable/Provided (for clinical ground truth): For the non-clinical tests, the "ground truth" is compliance with the specified international standards (e.g., IEC 60601-1 for safety, ISO 10993 series for biocompatibility) and performance equivalent to the predicate device as demonstrated by bench testing.

8. The sample size for the training set

• Not applicable/Provided: This is not an AI/machine learning device that involves training sets.

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

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

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Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.

New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a BiPolar Cord Set. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance metrics.
• Details of any specific studies (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information about multi-reader multi-case studies or standalone algorithm performance.
• Details about training sets for any AI/ML models.

The document is purely an administrative clearance and does not delve into the technical study details you are asking for.

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Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Disposable Hand Switching Pencil, Rocker Switch, One Piece

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The letter states that the device, "New Deantronics, Inc. Model SB 313 Disposable Hand Switching Pencil, Rocker Switch, one piece," is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device already on the market without conducting new clinical trials for this specific submission.

Therefore, I cannot provide the requested information from the given text because it is not present in the document.

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

Monopolar Suction Coagulator

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

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

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

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Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Model SB 313 PB and SB 313 PBH Disposable Hand Switching Pencil, Push Button, One Piece Body. With and Without Holster

This document is a 510(k) clearance letter from the FDA for a disposable hand switching pencil for electrosurgery. It is not a study and, therefore, does not contain information about acceptance criteria, device performance, ground truth, or study methodologies.

Here's why the requested information cannot be extracted from this document:

• Nature of the Document: This is a regulatory approval letter based on "substantial equivalence" to a predicate device. It confirms the device can be legally marketed but does not provide the underlying performance data or study details that led to that determination.
• Lack of Study Details: The letter explicitly states, "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the FDA compared the new device's characteristics (design, materials, indications for use) to a previously approved predicate device, not necessarily by conducting a new clinical study with specific acceptance criteria and performance metrics.
• Focus on Equivalence: The primary purpose of a 510(k) submission is to demonstrate substantial equivalence, not to prove meeting specific performance criteria through a detailed clinical trial or rigorous AI validation study.

Therefore, I cannot provide any of the requested information (acceptance criteria table, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) because this document does not contain that type of technical performance and study data.

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Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Monopolar Foot Control Pencil, Model # SB 112-2

The provided text is a Scan of an FDA 510(k) clearance letter for a medical device called the "Monopolar Foot Control Pencil, Model # SB 112-2." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device, rather than performance studies with defined acceptance criteria. Therefore, the information requested in the prompt (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text.

The document indicates that the device is an "electrosurgical accessory" intended "to remove tissue and control bleeding by use of high-frequency electrical current." The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are deemed comparable without requiring new clinical trials or performance studies to establish de novo acceptance criteria.

Therefore, for each of the requested points, the answer is that the information is not available in the provided document.

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Electrosurgical accessory. Hand switching, disposable pencil intended to remove the survey of the comments of and stricel overant Electrosurgicul accousery. Thanks of high-frequency electrical current.

Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster

The provided text is a 510(k) premarket notification letter from the FDA for a medical device: "New Deantronics Taiwan, Limited Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster."

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/ML device submission would. This is a traditional medical device submission from 1998, and the FDA's review process at that time, and for this type of device, focused on "substantial equivalence" to a predicate device, rather than detailed performance metrics and studies as might be found for more complex or novel technologies today.

Therefore, I cannot provide the requested information. The document explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the primary "acceptance criterion" was substantial equivalence, which is a regulatory standard, not a performance metric defined by a specific study with statistical endpoints. There's no mention of performance studies, sample sizes, experts for ground truth, or MRMC studies in this document.

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