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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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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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CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps and CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps are intended for use in electrosurgery for coagulation of tissue.

The CODMAN VersaTru Disposable Non-Stick Bipolar Forceps (VersaTru Bipolar Forceps) are single use, disposable, sterile electrosurgical devices, for use in electrosurgery for the coagulation of tissue. The forceps are part of an electrosurgical system consisting of an electrosurgical bipolar generator and bipolar cord attached to the proximal end of the forceps, to provide power and deliver electrical current from the generator to the distal tips of the forceps.

This document is a 510(k) Summary for the "CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps" and "CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps". It describes the device, its intended use, a comparison to a predicate device, and performance data used to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a separate table with quantified values. Instead, it presents various test categories and states that the device "Pass"ed each one. The acceptance criteria are implicitly defined by the standards and internal requirements referenced for each test.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices) used for each individual bench test, electrical safety test, sterilization validation, shelf-life test, or biocompatibility test. It generally states that "All testing was performed on final sterile devices" and refers to applicable standards. For example, for sterilization validation, ISO standards typically dictate minimum sample sizes based on the chosen method and desired SAL.
• Data Provenance: The data provenance is described as being generated from "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" guidance, internal requirements, and international standards (IEC, ISO, ASTM). This indicates that the tests were conducted specifically for the purpose of this 510(k) submission, likely in a controlled laboratory environment. The country of origin of the data is not explicitly stated but is implicitly tied to the submitter (Medos International SARL in Switzerland) and the manufacturer testing facilities. The studies are prospective in nature, as they are part of the premarket submission process.

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

This question is not applicable to the presented document. The document describes testing of a physical medical device (bipolar forceps) against engineering and biological performance standards, not an AI or diagnostic device that requires expert ground truth labeling. The "ground truth" for these tests is defined by the physical and chemical properties measured and compared against established engineering, electrical, and biological safety standards.

4. Adjudication method for the test set:

Not applicable, as no expert adjudication was required for the types of tests described. The results are objective measurements against defined acceptance criteria (standards).

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 document pertains to the 510(k) clearance for bipolar forceps, which is a physical surgical instrument, not an AI-assisted diagnostic tool. No MRMC studies were conducted or would be relevant.

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

Not applicable. This document is for a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the various tests conducted (bench, electrical, sterilization, biocompatibility, shelf-life) is established by:

• Physical/Chemical Measurements: Direct measurements of device dimensions, electrical properties, material composition, etc.
• Biological Endpoints: Observing cellular responses (cytotoxicity), immunological reactions (sensitization), tissue irritation, systemic toxicity, pyrogenicity, and hemolysis in in vitro or in vivo (animal) models.
• Functional Performance: Testing the device's ability to perform its intended function (e.g., coagulation, non-stick properties) under simulated conditions.
• Compliance with Standards: The ultimate ground truth is compliance with the referenced international standards (IEC, ISO, ASTM) and FDA guidance documents, which set the safety and performance benchmarks.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of physical medical device clearance. This question is relevant to AI/machine learning models.

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

Not applicable. As there were no AI algorithms involved, there was no training set or ground truth for such a set.

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The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar and monopolar coagulation for general surgery where coagulation of soft tissue is needed. The bipolar forceps are used with the bipolar and the monopolar forceps with the monopolar output of standard electrosurgical generators. The EGON FAULHABER Bipolar and Monopolar 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 are: General surgery, Laryngeal coagulation, Orthopedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynecological coagulation (except for use in female sterilization), Urological coagulation, Ear-, Nose- and Throat coagulation.

The EGON:FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are reusable devices and provided non sterile. They must be cleaned and sterilized before use. Bipolar Forceps: The branches are made of stainless steel insulated with Polyamide (PA) except for the tip of the instrument. The EGON FAULHABER Bipolar Forceps are of the same basic design with differences in tip sizes and handle styles. Two types of electrical plugs are available: flat plug, or 2 pin plug. The Bipolar Forceps are to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. Non-Stick Bipolar Forceps: The Non-Stick Bipolar Forceps have the same characteristics as the Bipolar Forceps except for the special material with excellent thermal properties, applied to the tips of the forceps. Thereby difficult and time consuming cleaning of the forceps during an operation can be avoided and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. Monopolar Forceps: The branches are made of stainless steel insulated with Polyamide (PA) except for the tip of the instrument. The EGON FAULHABER Monopolar Forceps are of the same basic design with differences in tip sizes and handle styles. They are available with or with out plug socket. The Monopolar Forceps can be connected through a suitable monopolar cable with the monopolar output of an electrosurgical generator. Monopolar Forceps must only be used with monopolar coagulation current.

The provided document is a 510(k) summary for Egon Faulhaber Bipolar, Non-Stick Bipolar, and Monopolar Forceps. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new performance studies against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are substantial equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the EGON FAULHABER forceps and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices."

This indicates that the device's market clearance is based on its similarity to already legally marketed devices, not on a new study demonstrating performance against a set of predefined acceptance criteria.

The requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are typically found in clinical validation studies or performance testing reports, which are not included in this 510(k) summary.

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The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterliization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.

The DORO® Non-Stick Bipolar Forceps are for use in general surgical procedures. These devices are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

During the coagulation of tissue, the coagulated tissue may stick to the forceps. This undesirable effect can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver allov tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations.

Reusable Standard two-pin round connector cables are designed to work with all foot-switching bipolar electrosurgical generators.

The DORO® Bipolar Reusable Cables are non-sterile, reusable bipolar cables of 3 and 5 meters. They are designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch. The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twinpin connectors (2-banana plug). The cables are comprised of silicone (outer insulation), PTFE or FEP (core insulation), and Cu-wire poreless silver plated (wire).

The cable consists of a twin-pin connector (2-banana plug) that is comprised of silver plated bronze and insulated with silicone. The connector cable at the forceps end is comprised of bronze or brass - silver or nickel plated, Stainless Steel 1.4310, PP (Polypropylene or TPE).

Here's an analysis of the provided text regarding the DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables, focusing on acceptance criteria and study information:

Analysis:

The provided 510(k) Notification (K070997) does not contain a study that proves the device meets specific performance acceptance criteria in the manner typically seen for AI/ML or diagnostic devices.

Instead, this submission seeks substantial equivalence for the DORO® devices based on their similarity to legally marketed predicate devices and compliance with recognized performance standards for electrosurgical equipment. The "performance" discussed primarily relates to safety and functional standards, not to a measurement of diagnostic accuracy or clinical effectiveness against a set of predefined acceptance metrics for a novel technology.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device and submission.

Detailed Breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance/Statement
   General Safety and Effectiveness (Implicit)	Substantial equivalence to predicate devices (K51429, K992931 for forceps; K061835, K051429 for cables).
   "Non-Stick" Property (for Forceps)	"This undesirable effect [tissue sticking] can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver alloy tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations." (This is a descriptive claim, not a quantitative performance metric with a defined acceptance threshold within this document).
   Compatibility (for Cables)	"The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twin-pin connectors (2-banana plug)."
   Sterilization (by user)	"The user may sterilize these devices by using a validated and applicable sterilization process." "Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes should be used." (Implicit acceptance is that the device withstands this process and remains functional and sterile.)
   Compliance with Recognized Standards	DIN EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995); German version EN 60601-1:1990 + A2:1995; Version: 01-Mar-1996;

DIN EN 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998); German version EN 60601-2-2:2000; Version: 01-Aug-2001;
ANSI/AAMI HF18-2001: Electrosurgical Devices: Version: 01-May-2001.
(The device's performance is implicit in meeting these standards, but specific criteria and test results are not detailed in this summary.) |
| Functionality (Forceps) | "designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch." |
| Functionality (Cables) | "designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch." |
| Limitations (Forceps) | "The DORO® 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." (This is a contraindication/limitation, not a performance metric itself.) |

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

   • Not applicable / Not provided. The submission focuses on substantial equivalence to existing devices and compliance with recognized standards rather than a clinical or performance study with a test set of data. The "tests" would have been conducted against the standards themselves (e.g., electrical safety, mechanical durability, sterilization validation), but the details of those internal test sets are not in this summary.

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

   • Not applicable / Not provided. Ground truth establishment by experts is not relevant for this type of device submission where safety and functional compliance to standards are primarily demonstrated.

4. Adjudication method for the test set:

   • Not applicable / Not provided.

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, nor a diagnostic device that involves human readers interpreting results.

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

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

7. The type of ground truth used:

   • Not applicable. For this type of device, the "ground truth" would be the successful demonstration of compliance with the specified engineering and safety standards (e.g., electrical resistance within limits, mechanical strength, material biocompatibility, successful sterilization cycles), rather than clinical outcomes or expert consensus.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

   • Not applicable.

Summary of the Study (or lack thereof, in the context of typical "device performance studies"):

The 510(k) K070997 for the DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables relies on a Substantial Equivalence pathway. This means that no specific clinical or performance study (in the sense of a trial with a defined 'test set' against a 'ground truth' for an AI/ML or diagnostic device) is presented within this summary.

Instead, the "study" is an assertion of equivalence and adherence to established regulatory and engineering standards. The key elements for proving acceptance were:

• Predicate Device Comparison: The devices are compared to previously cleared, legally marketed bipolar forceps and reusable cables (e.g., Günter Bissinger Medizintechnik GmbH (K51429), e.g. Link Technology, Inc. (K992931) for forceps; Stryker Silverglide Bipolar Forceps Reusable Cables (K061835) and CLARIS bipolar forceps (K051429) for cables). The claim is that the DORO devices have the same intended use, similar technological characteristics (e.g., material for non-stick properties, cable construction, connectivity), and raise no new questions of safety or effectiveness.
• Compliance with Recognized Standards: The devices are stated to comply with several international and national standards for medical electrical equipment and electrosurgical devices (DIN EN 60601-1, DIN EN 60601-2-2, ANSI/AAMI HF18-2001). This compliance implicitly means they have undergone testing to meet the safety and performance requirements outlined in these standards.
• Sterilization Validation (by user): The document specifies a validated steam-sterilization process, implying that the device was tested to withstand and allow for effective sterilization by the end-user.

In essence, the "proof" is the argument for substantial equivalence and adherence to existing safety and performance standards for electrosurgical accessories, rather than a novel study demonstrating a new type of performance metric.

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The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.

The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This undesirable effect can almost completely be avoided by using the new CLARIS NON-STICK bipolar forceps. By applying a material with excellent thermal properties for the forceps, difficult and time-consuming cleaning of the forceps during an operation is no longer necessary and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. By using a suitable connecting cable, CLARIS NON-STICK bipolar forceps can be connected to all high-frequency electrosurgical generators generally used.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device which primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting performance study results against predefined acceptance criteria.

The document mentions compliance with general performance standards (DIN EN 60601-1, DIN EN 60601-2-2, ANSI/AAMI HF18-2001) for electrosurgical devices, but these are general safety and performance standards for the device type, not specific acceptance criteria for a particular study.

Therefore, I cannot fulfill your request for the table, sample sizes, expert details, adjudication methods, MRMC study information, standalone study information, or details about the training set.

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The Link Technology Non-Stick Bipolar Forceps product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.

The Link Technology Non-Stick Bipolar Forceps electrosurgical tool in the typical tweezers configuration. The forceps are constructed with stainless steel and coated with an electrical insulator. The uninsulated forceps tip is plated with a proprietary metallurgical alloy. The forceps are compatible with standard OEM (original equipment manufacturer) electrosurgical generators and bipolar electrode cables.

The provided text is a 510(k) summary for the Link Technology, Inc. Non-Stick Bipolar Forceps. It primarily focuses on demonstrating substantial equivalence to predicate devices based on material composition and general design, rather than outlining a study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details, such as a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not available in the provided document.

Here's an analysis based on the information that is present:

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

• Not available. The document does not specify quantitative acceptance criteria or provide specific performance metrics for the Link Technology Non-Stick Bipolar Forceps. The claim is one of "substantial equivalence" to predicate devices, particularly regarding "non-stick properties, biocompatibility, and thermal and electrical conductivity" based on material identity or similar design.

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

• Not available. No specific test set or data provenance is mentioned. The assessment relies on material equivalence and established biocompatibility 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 available. No mention of experts or ground truth establishment for a test set.

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

• Not available. No adjudication method is described.

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

• Not applicable / Not available. This device is a surgical instrument (bipolar forceps), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not applicable / Not available. This device is a physical surgical instrument.

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

• Not available in the conventional sense for a diagnostic device. The "ground truth" for this submission revolves around the properties of the materials and the design congruence with legally marketed predicate devices.
  • For the "non-stick properties, biocompatibility, and thermal and electrical conductivity," the ground truth is established by the identity of the proprietary metallurgical alloy with that used in a predicate device (Fusion Ball Tip Electrode).
  • For biocompatibility, the ground truth is established by chosen materials having an "established history of safe use in similar medical devices, literature research, and biocompatibility studies that meet the standards outlined in ISO 10993-1."

8. The sample size for the training set

• Not applicable / Not available. This is not a machine learning device.

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

• Not applicable / Not available. This is not a machine learning device.

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The ETHICON Non-Stick Bipolar Forceps are non-sterile, reusable devices intended to facilitate tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation while grasping soft tissue, including vessels up to 3mm in diameter in open surgical procedures.

The ETHICON Non-Stick Bipolar forceps are available in various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU).

The device under consideration is the ETHICON Non-Stick Bipolar Forceps.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "preclinical laboratory evaluations" but does not detail the number of units tested or specific test cases.
• Data Provenance: The data is from "preclinical laboratory evaluations". The country of origin is not specified, but the submission is to the US FDA, implying data gathered for that regulatory body. It is retrospective in the sense that the evaluations were completed before the 510(k) submission.

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

This information is not provided in the document. The study relies on "preclinical laboratory evaluations" and compliance with a technical standard, rather than expert-derived ground truth from a clinical setting.

4. Adjudication method for the test set:

This information is not provided. Given the nature of preclinical laboratory evaluations for a medical device (surgical forceps), adjudication typically involves objective measurements and adherence to test protocols, rather than a human consensus method for subjective interpretation.

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 document describes a traditional medical device (bipolar forceps) and its regulatory submission. It is not an AI/Software as a Medical Device (SaMD) and therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant or performed.

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

Not applicable. As stated above, this is not an AI/SaMD device. Performance evaluation for this device is based on its physical and electrical functionality, not algorithm performance.

7. The type of ground truth used:

The ground truth is based on objective performance specifications and adherence to the technical standard IEC-602-2.2, which sets requirements for the safety and performance of high-frequency surgical equipment. The "ground truth" here is the device's ability to mechanically grasp tissue and effectively perform bipolar coagulation as intended, verified through laboratory testing against established specifications.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI development.

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

Not applicable. As stated above, this device does not involve a training set.

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