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1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.

2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.

3. Single Use Hand Switch Monopolar Forceps (CD956)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.

4. Single Use Hand Switch Bipolar Forceps (CD957)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.

Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957.

The provided document is a 510(k) premarket notification from the FDA for Monopolar and Bipolar Forceps. It details the device's characteristics and its substantial equivalence to previously cleared predicate devices. Crucially, this document is for electrosurgical cutting and coagulation devices and accessories, not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI models, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information, are not applicable to this submission.

The document focuses on demonstrating that the new device is as safe and effective as its predicate devices, primarily through comparative performance testing data (physical, electrical, and biological properties) rather than algorithmic performance.

Here's a breakdown of the relevant information provided in the document:

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

The document doesn't present acceptance criteria in a formal table with quantitative targets for "performance" as one might expect for an AI/ML model (e.g., accuracy, sensitivity, specificity). Instead, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" is the demonstration that these characteristics are equivalent, or that any differences do not raise new safety or effectiveness concerns.

The tables (e.g., Table 1, Table 2) present a Side-by-Side Comparison (Subject-Predicate Comparison) for different models of the proposed device against their respective predicate devices. The "Result" column indicates "Equivalent" or "Not Equivalent." For items marked "Not Equivalent," an explanation is provided to argue why this difference does not impact safety or effectiveness.

Examples from the tables:

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 a "test set" in the context of an AI/ML model with a specific sample size of cases (e.g., images). Instead, it refers to performance testing on the physical device:

• "Performance Testing included comparative device use on porcine tissue: kidney, liver and muscle for both Cut mode and Coagulation mode..."
• This indicates prospective in-vitro/ex-vivo testing rather than data from human subjects.
• The origin of the tissue (e.g., country) is not specified.
• The "sample size" would likely refer to the number of porcine tissue samples or the number of tests performed, which is not numerically detailed but implied to be sufficient for the required validation per the referenced FDA guidance.

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

This concept is not applicable to this type of device submission. Ground truth for an electrosurgical device typically comes from:

• Engineering specifications and measurements: e.g., electrical safety tests, material properties.
• Established biological models: e.g., the observed effect of electrosurgical current on porcine tissue.
• Compliance with recognized consensus standards: e.g., ISO, IEC standards for sterility, biocompatibility, electrical safety.

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

Not applicable. There is no human interpretation or subjective assessment of "cases" that would require an adjudication method. The performance tests are objective measurements (e.g., resistance levels, temperature, visible coagulation effects that meet predefined criteria).

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 a medical device, not an AI/ML-driven diagnostic or assistive system.

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

Not applicable. There is no standalone algorithm. The device is a physical instrument.

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

The "ground truth" for this device's performance is established through:

• Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, ISO 11135:2014/AMD 1:2018 for sterility, ISO 10993 series for biocompatibility.
• Comparative functional testing: Performance tests on porcine tissue to demonstrate similar coagulation/cutting effects as the predicate devices.
• Material and design specifications: Data sheets for materials, design drawings, and manufacturing processes ensure the device is constructed as intended and is equivalent to predicates.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device. There is no concept of a "training set."

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

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

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The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.

The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously. The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis irrigation module 1000.

This document is a 510(k) premarket notification from the FDA for a medical device called "Single Use Irrigation Bipolar Cable." It focuses on demonstrating the device's substantial equivalence to a predicate device, not on proving new clinical effectiveness or diagnostic accuracy. Therefore, the typical "acceptance criteria" and study details you're asking about for AI/diagnostic devices (e.g., sensitivity, specificity, reader studies, ground truth establishment, sample sizes for training/test sets) are not present or applicable in this type of submission.

This document details the engineering and material equivalence of the proposed device to a legally marketed predicate device. The "performance testing" here refers to non-clinical tests to verify safety, electrical performance, sterility, and shelf life, not clinical diagnostic accuracy or AI performance.

Here's how to address your request based on the provided document:

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

The acceptance criteria here are focused on demonstrating substantial equivalence to the predicate device and meeting international safety standards. There isn't a table of quantitative performance metrics in the way you'd expect for a diagnostic or AI device.

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

For this type of device, the "test set" would refer to samples of the device itself undergoing engineering and biocompatibility testing. The document doesn't specify sample sizes for these non-clinical tests (e.g., how many cables were tested for dielectric strength or sterility).

• Data Provenance: Not applicable in the context of clinical data for AI/diagnostic devices. The data here comes from internal laboratory testing and compliance with international standards.

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

This is not applicable. "Ground truth" in this context would implicitly be the established performance parameters of the predicate device and the requirements of the relevant IEC/ISO standards. There are no clinical "experts" establishing ground truth in the sense of image interpretation or diagnosis for this specific submission.

4. Adjudication method for the test set

Not applicable. There's no human interpretation or adjudication in the context of device performance testing for substantial equivalence for this electrosurgical accessory.

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

Not applicable. This is not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is:

• The performance specifications and characteristics of the predicate device (Codman Integrated Irrigation Tubing and Bipolar Cord Set with 510(k) number K052449).
• The requirements outlined in relevant international standards (e.g., IEC 60601-1, IEC60601-2-2, IEC60601-1-2, ISO10993-1, ASTM F1980-16, ISO 11607-1:2019) for electrical safety, biocompatibility, sterility, and packaging.

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning/AI device.

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

Not applicable.

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The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

There are two main series of smoke evacuation pencil.
(1) Smoke Evacuation Fingerswitch (PS947): The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809): The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.

This document is a 510(k) premarket notification for a medical device and therefore primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical trial sense. The provided text describes non-clinical performance testing (bench testing) to support substantial equivalence.

Here's an analysis based on the information provided, specifically addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical quantitative AI/software sense (e.g., sensitivity, specificity, AUC thresholds). Instead, it compares the proposed device's characteristics and its tested performance against those of a predicate device to demonstrate substantial equivalence.

The "acceptance criteria" in this context are implicitly defined by the safety and performance standards met by the predicate device and the relevant international and national standards for electrosurgical devices and smoke evacuation systems. The "reported device performance" refers to the results of the bench testing that showed equivalence to the predicate device.

Here's a reinterpretation of the request based on the available information:

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

• Test Set (for performance testing): The document mentions "bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode".
  • Sample Size: Not explicitly stated (e.g., number of porcine tissue samples, number of tests performed). It only specifies the types of tissue.
  • Data Provenance: Porcine tissue (an animal model). The country of origin is not specified, but the applicant is based in Hong Kong, China. It is a prospective bench test, not retrospective patient data.

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

This is not applicable as the study described is a non-clinical, bench testing study, not a study evaluating human performance or diagnostic accuracy that would require expert ground truth. The "ground truth" for the non-clinical performance evaluation was laboratory measurements and objective assessments (e.g., thermal zone size measurement, electrical safety compliance, sterilization validation).

4. Adjudication method for the test set

Not applicable. This was a non-clinical bench test. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for establishing expert consensus on patient data.

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 an electrosurgical pencil with smoke evacuation, not an AI or imaging device that would involve human readers or diagnostic interpretation.

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

This is not an algorithm-only device. It's a physical medical device. The "performance" evaluated was its physical and electrical characteristics and its ability to perform cutting, coagulation, and smoke evacuation, as operated by a user in a simulated environment.

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

For the bench testing, the "ground truth" was established by:

• Laboratory measurements: Assessing thermal effects and thermal zone sizes on porcine tissue.
• Standard compliance: Verification against international and national standards (e.g., IEC, ISO, ASTM). This involves objective measurements and tests rather than expert consensus on subjective data.

8. The sample size for the training set

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

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

Not applicable, as it is not an AI/ML algorithm.

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The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode. The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure. The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.

Here's a breakdown of the acceptance criteria and study information for the "Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile)", based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly lay out acceptance criteria in a quantitative table format with corresponding reported performance for each criterion. Instead, it states that the device's performance "proved that the subject device and the predicate device are equivalent in the performance" through specific tests. The criteria are indirectly inferred from the performance tests conducted and the standards met.

Therefore, I will interpret the acceptance criteria as meeting the standards and demonstrating equivalence to the predicate device in the specified performance areas.

• IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) (General requirements for basic safety and essential performance)
• IEC60601-2-2: 2009 (Fifth Ed) (Particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories)
• IEC60601-1-2:2014 (Electromagnetic Disturbances - Requirements and Tests) |
  | Biocompatibility | Complies with ISO10993 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). |
  | Shelf Life (3 years) | Accelerated aging tests were completed and support the proposed 3-year shelf life. |

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

• Sample Size: The document does not specify a numerical sample size for the "porcine tissue: kidney, liver, muscle" used in the performance testing. It only mentions that testing was performed on these tissue types. It also doesn't specify the number of devices tested for sterility, packaging, electrical safety, or biocompatibility, beyond implying multiple units to validate processes and claims.
• Data Provenance: The data is retrospective, as the tests were conducted to demonstrate equivalence for a 510(k) premarket notification. The country of origin of the data is not specified, but the applicant is based in Hong Kong, China. The testing itself doesn't inherently imply a specific country for data collection beyond the manufacturing location.

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

This information is not provided in the document. The performance testing involved bench testing on porcine tissue and comparison to a predicate device, as well as compliance with international standards. This type of testing typically relies on predefined test methods and measurements rather than expert consensus on a "ground truth" in the way it might for a diagnostic AI device.

4. Adjudication Method for the Test Set:

This information is not provided as it's not applicable to the type of bench testing and standards compliance reported for this electrosurgical pencil. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often for diagnostic devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance with human readers, which is not the function of an electrosurgical pencil.

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

This question is not applicable to an electrosurgical pencil. This device is a physical tool used by a human surgeon; it does not involve any algorithms or AI component that would function in a standalone capacity.

7. The Type of Ground Truth Used:

For the performance tests on porcine tissue, the "ground truth" was established by direct measurement and observation of thermal effects and thermal zone sizes on the tissue, deemed equivalent to the predicate device. For other aspects, the "ground truth" was compliance with established international standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety), which define acceptable performance parameters.

8. The Sample Size for the Training Set:

This question is not applicable. The device is an electrosurgical pencil, not an AI/ML-based device that requires a training set.

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

This question is not applicable as there is no training set for this device.

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