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Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Disposable Bipolar Forceps consists of forceps pieces, forceps holder, wire. The tail end of the forceps pieces are connected with the forceps holder. The forceps holder is provided with a high frequency input wire, and the wire can be connected with the high frequency surgical equipment through a plug. The outer surface of the forceps pieces are provided with an insulation layer. Disposable Bipolar Forceps materials: forceps tips material: silver plated brass; forceps pieces material: brass; forceps pieces coating: epoxy resin; packaging: PETG tray, Tyvek lid. The structure of Disposable Bipolar Forceps is double forceps pieces. Two fingers pinch the left and right forceps pieces, so that the forceps tips gently clamp the tissues, through the high frequency current to achieve electrocoagulation hemostasis. The rebound action is realized by the rebound force of the forceps pieces.

This is a 510(k) summary for a medical device, specifically Disposable Bipolar Forceps. It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence to the FDA.

The document does not describe an acceptance criteria table or specific study results to prove a device meets acceptance criteria in the way typically expected for a diagnostic AI/ML device.

Instead, this 510(k) pertains to a physical medical device (electrosurgical forceps) and its acceptance criteria are primarily met through non-clinical testing to demonstrate performance, safety, and substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device.

Here's an attempt to answer your questions based on the provided text, acknowledging that the format of the "acceptance criteria" and "study that proves the device meets the acceptance criteria" will not align with a diagnostic AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical medical device are derived from compliance with recognized industry standards and demonstration of comparable performance to the predicate device. The document does not present a formal "acceptance criteria table" with numerical targets as might be seen for a diagnostic device's sensitivity/specificity. Instead, it lists the types of tests performed and implies that the results met the requirements of these standards and showed equivalence to the predicate.

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: Not explicitly stated as a number of "cases" or "patients" in the context of diagnostic performance. For the described non-clinical tests (electrical safety, biocompatibility, mechanical strength), the "sample size" would refer to the number of device units tested according to the specific testing protocols for those standards. This information is not detailed in the summary.
• Data Provenance: The studies are described as "Ex-vivo experimental study on Thermal Effects" and other non-clinical tests. This indicates laboratory testing, not human subject data from a specific country or retrospective/prospective clinical data.

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)

This is not applicable as the device is a physical electrosurgical tool, not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" for performance is established by objective measurements against engineering specifications and validated test methods (e.g., measuring current leakage, tissue temperature changes, mechanical force).

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

Not applicable for this type of physical medical device and its non-clinical testing. Adjudication methods are typically relevant for human interpretation in diagnostic studies.

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/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML algorithm.

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

For the non-clinical tests described:

• Electrical Safety & EMC: Ground truth is defined by the passing criteria of the referenced IEC standards.
• Biocompatibility: Ground truth is defined by the absence of toxicity, sensitization, or reactivity as measured by specific cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity assays.
• Thermal Effects: Ground truth relates to measurable tissue changes (e.g., temperature, coagulation effect) produced by the device in ex-vivo experimental settings, evaluated against established scientific principles and potentially in comparison to the predicate device's known effects.
• Mechanical Strength: Ground truth is defined by resistance to breakage or deformation under specified forces/stresses.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

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

Not applicable, as there is no training set.

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Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include: -ENT -Gynecology -Urology -General Surgery -Neurosurgery -Laryngeal Surgery -Orthopedic Surgery -Thoracic Surgery Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current. HG Innovations, as a manufacturer, does not recommend a specific procedure. Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

HG Innovations Ltd.'s electrical surgical instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, non-stick bipolar forceps and non-stick bipolar irrigating forceps (various sizes and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.

This is not a medical device that utilizes AI and therefore does not have acceptance criteria, study data, or ground truth information as typically found in AI/ML device submissions.

The provided text is a 510(k) summary for Heinrich Single Use Non-Stick Bayonet Bipolar Forceps. This is a traditional medical device (bipolar forceps) and its clearance is based on substantial equivalence to predicate devices, not on performance metrics of an AI/ML algorithm.

Therefore, I cannot provide the requested information. The document focuses on comparing the new device's features and materials to existing cleared devices (predicates) and ensuring it meets safety and effectiveness standards for such devices (e.g., electrical safety, biocompatibility, sterility).

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McPherson Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:

-Frequency range between 300 kHz-1,000 kHZ;

-Maximum generator operating voltage 600Vp.

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:

-ENT

-Gynecology

• -Urology
• -General Surgery
• -Neurosurgery
• -Laryngeal Surgery
• -Orthopedic Surgery
• -Thoracic Surgery

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.

HG Innovations, as a manufacturer, does not recommend a specific procedure.

Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters:

-Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.

The provided document describes the FDA's "Substantial Equivalence" determination for a device, not a study to prove acceptance criteria for a new AI/software medical device.

The document discusses various performance tests and comparisons to predicate devices for Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Irrigating Bipolar Forceps, which are mechanical electrosurgical accessories.

Therefore, the requested information about acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), and training set details for an AI/software device cannot be extracted from this document, as it pertains to a different type of medical device and a different regulatory review process.

The document consistently states "N/A" for "Software Verification and Validation Testing," "Animal Study," and "Human Clinical Performance Testing," further confirming that this is not an AI/software medical device submission requiring such studies.

However, I can provide a summary of the performance criteria and reported performance for the mechanical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria (General):

The document indicates that the device's performance was evaluated through various bench performance tests. These tests covered biocompatibility, electrical safety and electromagnetic compatibility (EMC), mechanical testing, sterility testing, and shelf-life testing. The report concludes that "HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary," implying that the performance data from these bench tests demonstrated substantial equivalence to the predicate devices. The details of these studies are not provided in this summary, but the results are reported as "Pass" for the relevant tests.

Information NOT Applicable/Available (as per the document's content for AI/Software specific questions):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device. The document mentions "bench performance testing" which are laboratory-based physical tests, not data-driven tests on patient sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are irrelevant for this type of mechanical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable.

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Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current.

The bipolar forceps must be operated with the following parameters:

-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.

HG Innovations Ltd.'s Electrical Surqical Instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, bipolar forceps (various lengths and designs), with preattached cables are designed to grasp, manipulate and coagulate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current.

This FDA 510(k) summary provides information for a Single Use Bipolar Forceps (K230432).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Important Note: This document is a 510(k) Summary for a medical device (bipolar forceps), not a diagnostic AI software. Therefore, many of the typical AI/ML study components like multi-reader multi-case (MRMC) studies, expert ground truth adjudication for complex interpretations, and training set details are not applicable here. The "acceptance criteria" discussed are largely related to engineering performance and biological safety, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator. Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.

SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.

This document is a 510(k) premarket notification for a medical device, the Supra Non-Stick Bipolar Forceps. It does not contain information about an AI/ML enabled device or a study proving that such a device meets acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device for a electrosurgical cutting and coagulation device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device.

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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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Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.

Titan Manufacturing Bipolar Forcep is a generic electrosurgical device (handpiece)/active accessory that is to be connected through a bipolar cable with the bipolar output of a standard, general electrosurgical generator unit (ESU) and footswitch. The bipolar cable, ESU and footswitch are not part of the subject device, therefore not included in this submission. The subject device is not an electrosurgical vessel sealer system.

Titan Manufacturing Bipolar Forceps are indicated for use in general surgical procedures; designed to grasp, manipulate, and coagulate selected tissue.

Titan Manufacturing Bipolar Forceps are to be connected through a suitable bipolar cable [not supplied by Titan Manufacturing, Inc.] with the bipolar output of a standard, general electrosurgical generator [not supplied by Titan Manufacturing, Inc.]. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch [not supplied by Titan Manufacturing, Inc.].

Titan Manufacturing, Inc., offers an extensive line of precision crafted reusable stainless steel and titanium bipolar forceps in a multitude of handle styles, lengths, and tip sizes. Titan Manufacturing Bipolar Forceps are available in styles such as but not limited to straight and bayonet styles, patterned designs such as but not limited to Semkin, Jewelers, Adson, Scoville-Greenwood, Ti Square Grip, Yargasil, Tenzel, McPherson, and Cozean, etc. Titan Manufacturing offers bipolar forceps in lengths from approximately 3 ½ inches to 10 ¾ inches ; titanium or stainless steel; insulated or non-insulated; irrigating or non-irrigating; straight, curved, angled or coaptation; and varying tip sizes from 0.2mm to 2.0mm. The product line is similar to those offered by other wellestablished bipolar forcep manufacturers [e.g., Codman, Kirwin, Faulhaber Pinzetten, Synergetics (a.k.a. Stryker), etc.].

Titan Manufacturing Bipolar Forceps are reusable medical devices, provided non-sterile and must be cleaned and sterilized prior to use. They are used with the bipolar output for standard, general electrosurgical generators (ESU). The Titan Manufacturing Bipolar Forceps are compatible with general electrosurgical generators with 4mm outlets; U.S. 2-pin plugs. Bipolar cables, ESU and footswitch are not part of the subject device.

Titan Manufacturing Bipolar Forceps are available in four (4) general model types in stainless steel or titanium: Non-insulated; Insulated; Non-insulated/Irrigating; and Insulated/Irrigating.

This document describes the premarket notification (510(k)) for the Titan Manufacturing Bipolar Forceps. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving novel safety or effectiveness claims through extensive clinical trials. Therefore, the acceptance criteria and study proving the device meets them will be based on non-clinical performance testing and comparison to legally marketed predicate devices.

Here's an breakdown of the information provided in the format you requested:

Acceptance Criteria and Device Performance for Titan Manufacturing Bipolar Forceps

The acceptance criteria for the Titan Manufacturing Bipolar Forceps were primarily based on demonstrating substantial equivalence to existing predicate devices (Titan Manufacturing's own Semkin Insulated Bipolar Forcep (K974593), Semkin Bipolar Forcep (K974594), and Cushing Bayonet Insulated Bipolar Forcep (K974595)) and meeting recognized standards for electrosurgical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since this is a 510(k) submission for substantial equivalence based on non-clinical testing, the performance metrics are primarily functional, material, and electrical safety comparisons rather than large-scale clinical endpoints. The acceptance criteria are implicit in the comparison to the predicate devices and adherence to the listed standards.

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

• Test Set Description: The "test set" in this context refers to the samples of the Titan Manufacturing Bipolar Forceps that underwent non-clinical performance and safety testing.
• Sample Size: The document does not specify exact quantitative sample sizes for each non-clinical test (e.g., how many forceps were used for biocompatibility testing, electrical safety, or thermal spread analysis). It broadly states "Nonclinical testing has been conducted to verify that the Titan Manufacturing Bipolar Forceps met all design specifications and are substantially equivalent to the predicate devices." (Page 9). Regulatory submissions often refer to standard numbers of units for these tests as per the respective test protocols and standards, but the specific numbers are not explicitly listed in this summary.
• Data Provenance: The testing was conducted internally or outsourced to accredited labs, as is typical for medical device manufacturers. The document does not specify the country of origin of the data beyond "Titan Manufacturing, Inc." The studies are prospective in the sense that the new device was manufactured and then tested to demonstrate its performance against established standards and predicate devices.

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

• "Ground Truth" in this context: For a 510(k) submission based on substantial equivalence and non-clinical testing, "ground truth" is defined by the technical specifications and performance of the predicate device, as well as adherence to recognized national and international standards (e.g., ISO, IEC, FDA guidance documents).
• Number of Experts/Qualifications: The document does not explicitly mention external experts establishing "ground truth" for the test set in the way one would for a clinical study with image annotations or disease diagnoses. The "experts" implied are the engineers, scientists, and regulatory professionals who designed the device, conducted the tests, analyzed the data, and prepared the submission, ensuring compliance with relevant standards and comparison parameters derived from the predicate devices. These individuals would possess relevant engineering, materials science, electrical safety, and regulatory expertise.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of this 510(k) submission's non-clinical testing. Adjudication typically refers to resolving discrepancies in expert opinions, especially in clinical reads (e.g., radiology studies). Here, the comparison is objective (measurements, compliance with standards) rather than subjective interpretation.

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

• MRMC Study: No. The document explicitly states: "There were no clinical trials performed on these devices." (Page 10). This means no MRMC study was conducted. MRMC studies are typically performed for diagnostic imaging devices where human reader performance is a critical endpoint. This device is an electrosurgical tool, which focuses on functional and safety performance.

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

• Standalone Performance: Not applicable. This is a physical medical device (bipolar forceps), not an algorithm or AI system. Its performance is inherent to its design, materials, and interaction with an electrosurgical generator and human user during surgery.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • Predicate Device Specifications and Performance: The primary "ground truth" for substantial equivalence is the intended use, technological characteristics, and demonstrated performance of the legally marketed predicate devices. The new device must be shown to be as safe and effective as these predicates.
  • Recognized Consensus Standards: Compliance with established international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601-2-2 for electrical safety) serves as another form of "ground truth" for safety and performance.
  • FDA Guidance Documents: Adherence to FDA guidance (e.g., "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery") provides criteria for specific tests like thermal spread.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a "training set."

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

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The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp.

The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended include:

• ENT
• Gynecology (except for use in female sterilization)
• Urology
• General surgery
• Neurosurgery
• Laryngeal Surgery
• Orthopedic Surgery
• Thoracic Surgery

The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn.

This FDA 510(k) summary for the "Adeor Medical nxt Non-stick Bipolar Forceps" focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this document does not contain data related to these aspects for an AI/ML product.

The document primarily discusses the physical characteristics, intended use, and non-clinical testing (electrical safety, wear, function (drop testing)) of surgical forceps, comparing them to legally marketed predicate devices to establish substantial equivalence.

The information provided in the document is about a traditional medical device (bipolar forceps), not an AI/ML device.

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Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.

Sutter Swyng® non-stick bipolar forceps, single-use are electrosurgical instruments. The bipolar forceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

The provided text describes a 510(k) submission for the Sutter Swyng® non-stick bipolar forceps, single-use. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against pre-defined acceptance criteria for a new AI/software device.

Therefore, many of the requested categories related to AI/software performance (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data relevant to this medical device's physical and functional properties, as described in the "Non-Clinical Performance Data" section.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

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):

• Sample Size:
  • For "Thermal effects on tissue," tests were performed in triplicate for three different types of tissue.
  • For other tests (Electromagnetic Compatibility, Electrical Safety, Mechanical Strength, Functionality, Sterilization, Shelf Life, Biocompatibility), specific numerical sample sizes are not explicitly stated in the provided text. The text refers to "performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance."
• Data Provenance: The studies were internal to Sutter Medizintechnik GmbH (Germany). The type of study (retrospective or prospective) for the bench tests is not specified, but given their nature, they would be considered controlled laboratory experiments.

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. This submission pertains to physical medical devices and their functional and safety characteristics, not AI/software performance requiring expert ground truth for classification or diagnosis. "Thermal effects on tissue" involved "visual comparison as well as digital morphometric measurement using histology," implying expert evaluation, but the number and qualifications are not specified.

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

• Not applicable. 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 an AI/software device. No MRMC study was performed.

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

• Not applicable. This is not an AI/software device.

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

• For "Thermal effects on tissue," the ground truth involved histology for digital morphometric measurement and visual comparison against the predicate device.
• For other tests, the "ground truth" refers to compliance with established international standards (IEC, ISO) and internal design specifications for safety and performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

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Faulhaber Single Use Non-Stick Bipolar Forceps sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile.

Products supplied non-sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.

The bipolar forceps have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended are

• General surgery
• Laryngeal coagulation
• Orthopedic coagulation
• Thoracic coagulation
• Neurosurgical coagulation
• Gynecological coagulation (except for use in female sterilization)
• Urological coagulation
• Ear-, Nose-, Throat coagulation

The product family "Single Use Bipolar Forceps", including Faulhaber Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Bipolar Irrigating Forceps, are intended to be used for bipolar coagulation and irrigation of tissue by physicians familiar with bipolar coagulation in medical practices and clinics.

The Single Use Bipolar Forceps are single use products and must not be reused. They are provided sterile as well as non-sterile. Products delivered non sterile must be cleaned, disinfected and sterilized before use.

For the application the Single Use Bipolar Forceps have to be connected by appropriate bipolar cable to the bipolar output of an HF generator. Bipolar cables and ESU are not part of the subject device.

The Single Use Bipolar Forceps are provided in bayonet design with non-stick tips and are identical in design, construction, materials and manufacturing to the reusable device EGON FAULHABER Bipolar Non-Stick Forceps (K101080). The principles of operation and mechanism of action are identical as well.

In addition to the cleared and leqally marketed EGON FAULHABER devices, the products are with irrigation function available. The irrigation function works via a drain running along the forceps tines from tip to handle height, the drain is connected by Luer-Lock via an irrigation tubing with an irrigation pump.

This FDA 510(k) summary describes the "Single Use Non-Stick Bipolar Forceps sterile/non-sterile" and "Single Use Non-Stick Bipolar Irrigating forceps sterile/non-sterile" and their substantial equivalence to predicate devices. However, the document does not provide acceptance criteria in a tabular format with reported device performance for specific clinical metrics. Instead, it focuses on demonstrating safety and efficacy through non-clinical performance tests and comparison to a predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not present acceptance criteria and reported device performance in a formal table with specific numerical metrics commonly associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating compliance with recognized standards and successful completion of engineering tests.

The general "acceptance criterion" implicit throughout the document is that the subject device performs as safely and effectively as the predicate devices and meets relevant electrical safety and mechanical strength standards.

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

The document describes non-clinical performance testing.

• Sample Size: The document does not specify general "sample sizes" in terms of number of devices tested for each performance test. For the thermal effects on tissue, it states "three different types of tissue (liver, kidney and muscle) were coagulated." This refers to the tissue types, not the number of devices or test repetitions.
• Data Provenance: The tests are described as in vitro or bench tests conducted "in accordance with the Guidance for industry and food and drug administration staff 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' from August 15, 2016." The location of these tests or the "country of origin of the data" is not explicitly stated, but the manufacturer is based in Germany, and European standards (DIN EN IEC) are cited. These are non-clinical, controlled tests, not derived from clinical patient data.

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

This information is not applicable to this submission. The device is a medical instrument (electrosurgical forceps), not an AI/ML device that generates diagnoses or interpretations requiring human expert "ground truth." The performance is evaluated based on objective physical, electrical, and thermal properties as per engineering standards and guidance.

4. Adjudication method for the test set

This information is not applicable. As stated above, this is not an AI/ML device evaluating clinical cases requiring expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is not an AI/ML device that assists human readers.

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

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

For this electrosurgical device, "ground truth" is established by:

• Compliance with recognized international standards for electrical safety (DIN EN IEC 60601-2-2) and biocompatibility (ISO 10993-1).
• Demonstration of mechanical integrity through drop testing.
• Demonstration of appropriate thermal effects on tissue, tested on "three different types of tissue (liver, kidney and muscle)" in comparison to a predicate device and meeting "pre-defined acceptance criteria." This could be considered a form of "bench test ground truth" where expected thermal effects are the standard.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

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

This is not applicable as this is not an AI/ML device and does not have a "training set."

In summary, the provided document describes a device submission for an electrosurgical instrument, not an AI/ML-driven device. Therefore, many of the requested details regarding AI/ML device evaluation (like expert ground truth, MRMC studies, training sets) are not relevant to this specific K182773 submission.

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