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The Bipolar Laparoscopic Loop is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Olympus Electrosurgical Generator ESG-400.

The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.

This document describes the premarket notification (510(k)) for the PK Lap Loop, a bipolar electrosurgical device. The submission focuses on demonstrating substantial equivalence to a predicate device (PKS BiLL) rather than presenting a standalone study with defined acceptance criteria and performance metrics in the typical sense of AI/algorithmic device evaluation.

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

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

The concept of specific "acceptance criteria" for performance metrics like sensitivity, specificity, or F1-score, as seen in AI/ML device submissions, is not directly applicable here. This document is for a traditional medical device (electrosurgical loop) and focuses on demonstrating substantial equivalence to an already cleared predicate device. The "performance" is implicitly tied to demonstrating that the new device functions equivalently and safely to the predicate.

The closest to acceptance criteria are the characteristics compared between the PK Lap Loop and the predicate PKS BiLL. The reported device performance is that these characteristics are identical or similar to the predicate, implying they meet the predicate's established performance and safety profile.

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The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.

The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.

This describes the acceptance criteria and study for the LiNA Bipolar Loop, an electrosurgical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document specifies that "200mm sized loops were selected as this represented the mid-size loop for both the Bipolar Loop and Loop." It also mentions "pork and beef muscle" for simulated tissue studies and "three different generators" for cutting time assessment. However, the exact number of loops tested, the quantity of tissue samples, or the number of cuts made is not explicitly stated.
• Data Provenance: The data is non-clinical performance data from tests conducted by LiNA Medical ApS. The country of origin of the data is not explicitly stated beyond the sponsor being LiNA Medical ApS in Glostrup, Denmark. The study is prospective in the sense that the tests were conducted specifically to support this 510(k) submission for the LiNA Bipolar Loop.

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

• Not Applicable. For non-clinical performance data like this, "experts" in the sense of clinical reviewers establishing ground truth for a diagnostic output are not mentioned. The assessment of "cutting quality" was "qualitatively scored as a 5," implying an internal assessment based on predefined criteria, likely by engineering or technical personnel. The document does not specify who performed this scoring or their qualifications.

4. Adjudication Method for the Test Set

• Not Applicable. There is no mention of an adjudication method as this involves non-clinical performance testing rather than human interpretation of diagnostic data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This submission is for an electrosurgical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

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

• Not Applicable. This device is an electrosurgical instrument and does not involve AI algorithms. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" used for this non-clinical testing was based on predefined performance specifications and industry standards.
  • For cutting quality, the ground truth was a qualitative score of '5' on a scale of 1-9.
  • For cutting time, the ground truth was an acceptable deviation of ±4 seconds from the predicate device.
  • For other aspects like sterilization, biocompatibility, and electrical safety, the ground truth was compliance with relevant national and international standards (e.g., ISO 10993-1, IEC 60601) and meeting internal design requirements.

8. The Sample Size for the Training Set

• Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on validating the physical and functional performance of the device against established criteria and a predicate device.

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

• Not Applicable. As there is no training set mentioned, the establishment of ground truth for such a set is not relevant.

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The Karl Storz Bipolar Electrode is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions and septa, and benign conditions requiring endometrial ablation. Procedures include:
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation

The Karl Storz Bipolar Electrode is a single-use.cutting loop electrode that is designed to be used in combination with a 4 mm resectoscope with a 24 or 26 Fr sheath that is connected to a generator via a high frequency cable.

The provided document is a 510(k) summary for the Karl Storz Bipolar Electrode. It aims to demonstrate substantial equivalence to predicate devices, not to perform a standalone study with acceptance criteria related to clinical performance or AI performance. Therefore, many of the requested data points (such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and AI-related details) are not applicable to this type of submission.

The document focuses on demonstrating the safety and performance equivalence of the subject device to predicate devices through technical characteristics, bench studies, and adherence to established standards.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity) but rather in terms of meeting established safety and performance standards for electrosurgical devices and demonstrating equivalence to predicate devices.

For GYNECARE VERSAPOINT II (K111751): "There is no significant technological difference between the predicate and subject device. Both devices are bipolar and have the same intended use. Both uses a generator for the source of energy." |
| Safety Standard Conformance | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment). | "The Safety and performance equivalence are demonstrated by the testing of IEC 60601-1..." "Both the predicate and subject device have undergone and passed IEC 60601-2-2 to demonstrate the equivalence to the essential performance of the HF equipment and accessories. For additional safety requirements equivalence, both subject and predicate devices have also undergone and pass IEC 60601-1 and IEC 60601-2-18." |
| | Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). | "The Safety and performance equivalence are demonstrated by the testing of... IEC 60601-2-2..." "Both the predicate and subject device have undergone and passed IEC 60601-2-2 to demonstrate the equivalence to the essential performance of the HF equipment and accessories." |
| | Compliance with IEC 60601-2-18 (Particular requirements for the basic safety and essential performance of endoscopic equipment). | "The Safety and performance equivalence are demonstrated by the testing of... IEC 60601-2-18." "For additional safety requirements equivalence, both subject and predicate devices have also undergone and pass IEC 60601-1 and IEC 60601-2-18." |
| Biocompatibility | The device must meet biocompatibility requirements. | "In addition, both predicate and subject devices have undergone sterilization, biocompatibility testing and non-clinical conformance standard testing..." |
| Sterilization | The device must meet sterilization requirements. | "In addition, both predicate and subject devices have undergone sterilization, biocompatibility testing and non-clinical conformance standard testing..." |
| Performance Equivalence (Bench Studies) | Demonstrated equivalence in gas product comparison and visual depth of thermal penetration compared to predicate devices. | "Two bench studies, Comparison of Gas Product and Visual Depth of Thermal Penetration, are used to demonstrate the performance substantial equivalence of the subject and predicate devices." "The test results presented in the testing report of abovementioned testing have demonstrated the substantial equivalence in both safety and performance of the predicate and subject device." |

Since this is not an AI/software device, the following points are not applicable:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable (N/A) - This is a physical electrosurgical device, not a diagnostic AI/software. Performance was assessed through bench testing and conformance to standards, not through clinical test sets of patient 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)
N/A - Ground truth for this type of device typically refers to engineering specifications, validated test methods for physical properties, and adherence to recognized standards. It does not involve expert consensus on medical images or clinical outcomes in the same way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - Adjudication methods are relevant for clinical trials or studies where there's a need to resolve discrepancies in expert interpretations, which is not the case for this device's testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A - This device does not involve human readers interpreting images, nor does it involve AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is primarily based on:

• International Electrotechnical Commission (IEC) Standards: IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 define the acceptance criteria for safety and essential performance of electrosurgical equipment.
• Bench Testing Results: Comparative data from controlled laboratory bench studies (Gas Product comparison and Visual Depth of Thermal Penetration) serve as objective measures of performance to establish equivalence.
• Material Specifications and Design: Adherence to predicate device features, dimensions, body contact, and insulation materials forms part of the "ground truth" for technological equivalence.
• Biocompatibility and Sterilization Standards: Established industry and regulatory standards for these aspects.

8. The sample size for the training set
N/A - There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established
N/A - No training set, no ground truth needed to be established for it.

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The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.

The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.

The provided text describes a Special 510(k) Notification for the Gyrus ACMI PKS™ BiLL™ (Bipolar Laparoscopic Loop). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo clinical study establishing new performance metrics. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of AI-driven diagnostics is not fully applicable. However, I will extract and present the available information regarding performance and evaluation, interpreting "acceptance criteria" as successful completion of the described evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Pre-clinical Evaluation: Three (3) physicians participated in the pre-clinical evaluation. The evaluation used "extirpated tissue (Human Uterine)." While the number of tissue samples isn't explicitly stated, the context implies mock procedures were performed.
  • Other tests (Bench, Biocompatibility, Electrical): These tests typically involve discrete units of the device or its components. Specific sample sizes are not provided but are generally determined by established engineering and regulatory standards for each test type (e.g., a certain number of devices for electrical safety, specific material samples for biocompatibility).
• Data Provenance: Not explicitly stated, but the submission is from "Olympus Surgical Technologies of America · Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772" (USA) and "Gyrus Medical, Ltd. Fortran Road, St. Mellons Cardiff CF3 OLT" (ERN: 9617070, indicating UK/European entity). Given the submission to the FDA, it is processed for the US market. The tissue used was "Human Uterine" but the exact source (country, hospital) is not specified. The study is retrospective in the sense that it evaluates a device not intended to gather new diagnostic insights but to confirm its performance against a predicate.

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

• Number of Experts: Three (3) physicians.
• Qualifications of Experts: Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond being described as "Physicians." They were involved in the pre-clinical evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense of diagnostic interpretation or a consensus-building process for ground truth. In the pre-clinical evaluation, each of the three physicians individually completed 32 questions after a mock procedure. The "adjudication" or decision on user acceptance was based on the collective positive feedback: "All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations." There's no indication of a formal 2+1 or 3+1 adjudication for conflicting opinions as would be seen in a diagnostic study.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for an electrosurgical device, not an AI-driven diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device's evaluation.

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

• Not applicable. This is an electrosurgical device, not an algorithm. There is no "standalone" algorithmic performance to evaluate. The device itself is a tool operated by a human.

7. The Type of Ground Truth Used

• Pre-clinical Evaluation: The ground truth for the user acceptance aspect of the pre-clinical evaluation was the individual and collective professional opinion/satisfaction of the three evaluating physicians. For the device performance within the mock procedure, it was based on the physicians' subjective assessment against their expectations and needs.
• Other Tests (Bench, Biocompatibility, Electrical): The "ground truth" for these tests is defined by established engineering standards, regulatory requirements (e.g., IEC 60601, ISO 10993), and the device's own pre-defined product specifications and user requirements. Successful adherence to these standards and specifications serves as the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device itself is not an AI algorithm that requires a training set. The "training set" concept does not apply here.

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

• Not applicable. As there is no training set for an AI algorithm, determining its ground truth is not relevant here.

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The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. Procedures include:

• . Excision of intrauterine myomas
• ◆ Excision of intrauterine polyps
• . Lysis of intrauterine adhesions
• Incision of uterine septa
• . Endometrial ablation

The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System (VERSAPOINT II System) is the next generation of the currently-marketed GYNECARE VERSAPOINT™ Bipolar Electrosurgery System (VERSAPOINT System). This electrosurgical system utilizes bipolar technology specifically designed to provide a range of gynecological surgical treatments, including vaporization to ablate and excise tissue, thermal coagulation of tissue and hemostasis of blood vessels. The VERSAPOINT II System is comprised of four main elements: the VERSAPOINT II Generator, the VERSAPOINT II 4mm Angled Loop Electrode, the VERSAPOINT II Footswitch, and the VERSAPOINT II Connector Cable. The VERSAPOINT II System offers five bipolar output modes: Ablation (VC [VaporCut]) – for tissue removal and cutting Enhanced Ablation (VP [VersaPulse]) - an enhanced version of the Ablation (VC) output mode attained by use of short-duration high power pulses Blended Ablation (BL) – simultaneous ablation and coagulation (the generator rapidly switches between ablation and coagulation output modes) Enhanced Blended Ablation (VBL) – a variant of the VP output mode that rapidly switches the output ON and OFF to deliver blended ablation/coagulation Coagulation (DES [Desiccate]) - for thermal coagulation and hemostasis

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that performance was evaluated against the predicate device to demonstrate "substantial equivalence." The acceptance criteria were based on similar performance to the legally marketed predicate. Specific numerical targets or ranges for the acceptance criteria are not explicitly detailed in the provided text, but the study aimed to show that the new device's performance was comparable.

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

• Test Set Sample Size: Not explicitly stated for each study. The text mentions "Two bench studies and one animal study." While these studies form the "test set" for demonstrating substantial equivalence, the specific number of samples or animals used in each is not provided.
• Data Provenance: The animal study was conducted "in compliance with the Good Laboratory Practices regulation, 21 CFR Part 58," indicating a prospective, controlled study design typically involving animal subjects. The location (country of origin) of these studies is not specified. Bench studies are inherently controlled laboratory evaluations.

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

Not applicable. The studies described are performance-based evaluations of the electrosurgical system's physical effects (tissue necrosis, gas generation, tissue removal, hemostasis) rather than diagnostic or interpretative tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for this type of performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for diagnostic devices where human readers interpret images or data, and the AI's assistance to these readers is being evaluated. The GYNECARE VERSAPOINT™ II is an electrosurgical system, not a diagnostic imaging or interpretive aid.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies conducted can be considered "standalone" in the sense that they evaluated the device's inherent performance characteristics (like thermal effects, gas generation, tissue removal) independently of human cognitive interpretation or decision-making. The device is a surgical tool, and its performance is assessed by its direct effects on tissue.

7. Type of Ground Truth Used

The "ground truth" for these studies was based on direct measurement and observation of the physical effects of the electrosurgical system.

• Bench Studies: Involved direct measurements of thermal margin, depth of tissue necrosis, volume of gas generated, and tissue removal rate in controlled laboratory settings.
• Animal Study: Involved direct observation and measurement of tissue effects and hemostasis performance in a living model. This would likely include histological analysis and quantitative measurements of tissue damage or desired surgical outcomes.

8. Sample Size for the Training Set

Not applicable. The GYNECARE VERSAPOINT™ II is an electrosurgical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "hardware and software updates" mentioned likely refer to engineering and control system logic modifications, not a data-driven learning model.

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

Not applicable, as there is no "training set" for an AI algorithm in this context. The "updates" were likely developed based on engineering principles, predicate device performance data, and design specifications, rather than a data-driven training process.

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The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation/sectioning of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.

The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0

Here's an analysis of the provided text regarding the PKS™ BiLL™ device, focusing on the requested acceptance criteria and study information:

PKS™ BiLL™ Device Study Analysis

The provided 510(k) summary for the PKS™ BiLL™ device does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical sense of a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and pre-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with numerical targets are provided in the document. The performance assessment is primarily qualitative, stating that:

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

The document mentions "Preclinical testing" and "Bench and preclinical testing". It states that this testing was done to validate mechanical design, usability, and software selection, and the performance was compared against the predicate LiNA Loop.

• Sample Size for Test Set: Not specified. The document does not provide a number of devices or subjects used in this testing.
• Data Provenance: The nature of the "preclinical testing" suggests in-house laboratory or animal testing. The country of origin of this data is not explicitly stated, but being a US-based manufacturer, it's reasonable to infer the testing was conducted in the US or by its contracted facilities. The testing is prospective in nature, as it's being conducted to validate the new device.

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

Not applicable. The "preclinical testing" described for this device focuses on engineering performance characteristics (electrical, mechanical, sterilization, biocompatibility, and functional "cut and user performance requirements") rather than diagnostic accuracy or clinical outcomes that would typically involve expert ground truth establishment for a test set. There's no mention of experts establishing a ground truth for this type of performance testing.

4. Adjudication Method

Not applicable. As the "preclinical testing" primarily involves engineering and functional performance, clinical adjudication methods like 2+1 or 3+1 for ground truth are not relevant to the described studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on substantial equivalence based on technological features and in-vitro/pre-clinical performance compared to predicates, not on the improvement of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/Not relevant. This device is an electrosurgical instrument, not an AI algorithm. Its performance is inherent to its design and how it interacts with the G400 Workstation Generator, meaning "standalone" performance without human interaction (as in, no one is operating the laparoscopic loop) is not a practical concept for this device type. The "cut and user performance requirements" inherently involve human interaction for usability.

7. Type of Ground Truth Used

For the described preclinical testing, the "ground truth" implicitly refers to:

• Engineering specifications and regulatory standards: (e.g., IEC 60601, ISO 10993, ISO 11607, ISO 11137).
• Performance characteristics of the predicate device (LiNA Loop): The new device's performance was "compared against the performance characteristics of the predicate LiNA Loop" and found to "exhibit comparable performance characteristics."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on established electrosurgical principles and mechanical design.

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

Not applicable. See point 8.

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The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.

The modular bipolar forcep set provides precise grasping and axial holding placement of the jaws, performs thorough hygiene, and site irrigation can be achieved without using additional instruments.

The provided document is a 510(k) summary for a medical device (Bipolar Forcep Set) seeking clearance for market. It does not describe AI device performance or a study proving an AI device meets acceptance criteria. Instead, it discusses the substantial equivalence of a new medical instrument to previously cleared predicate devices.

Therefore, I cannot extract the requested information about AI device acceptance criteria or performance from this document. The document primarily focuses on:

• Device Description: Bipolar forcep set (modular)
• Intended Use: Coagulation of tubes, tissue, and vasculature under endoscopic vision, including female sterilization.
• Technological Characteristics: Changes to insulation and addition of a cleaning port, but otherwise identical to a previously cleared device.
• Substantial Equivalence: Claimed to pre-enactment devices and K981321.
• Performance Data: No FDA performance standard, but tested against ANSV AAMI standard HF18 and IEC601-2-2, and biocompatibility tests. No clinical tests were performed.

All the requested fields regarding acceptance criteria and study details for an AI device are not applicable to the content provided.

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Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.

The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study plan with the granularity required to fill out all the fields in your request for the "BiCOAG Coagulating Forceps" or the "Tubal Sterilization device".

However, based on the information available, here's what can be extracted and inferred:

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

The document mentions "Performance testing has been submitted to support the safety and functional performance of the submitted devices." and "Clinical studies evaluating histological results have been conducted using the same Wolf Bipolar generator to demonstrate equivalent effectiveness to the currently available Tubal sterilization Wolf Kleppinger Forceps."

While specific quantitative acceptance criteria are not detailed, the primary performance criterion appears to be equivalent effectiveness to the predicate device, the "Tubal sterilization Wolf Kleppinger Forceps," as demonstrated by histological results.

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. The document only mentions "Clinical studies evaluating histological results have been conducted."
• Data Provenance: Not explicitly stated. We don't know the country of origin or if the studies were retrospective or prospective.

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)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

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

• Adjudication Method: Not specified.

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

• MRMC Study: This is a Class III medical device (tubal sterilization forceps), not an AI-powered diagnostic device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context. The study focuses on the device's physical performance in a surgical procedure, not its interpretation by human readers.

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

• Standalone Study: This is a surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device's performance is inherently tied to its use by a human surgeon.

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

• Type of Ground Truth: The document explicitly states "Clinical studies evaluating histological results have been conducted." This indicates that histology/pathology was the primary method for determining the effectiveness (e.g., successful tubal occlusion).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would involve engineering design, prototyping, and testing, not data-driven machine learning.

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

• How Ground Truth for Training Set was Established: Not applicable (as explained in point 8).

In Summary:

The provided 510(k) summary focuses on establishing substantial equivalence for a surgical instrument (tubal sterilization forceps). The key evidence presented revolves around performance testing for safety and functional performance, and clinical studies using histological results to demonstrate equivalent effectiveness to a predicate device. The information is very high-level and lacks the granular details typically found in summaries for diagnostic devices or AI algorithms regarding study designs, sample sizes, and expert evaluations.

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