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1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.

This FDA 510(k) summary (K213831) describes the Olympus PK Electrosurgical Instruments (PK Needle, PK Spatula, PK J-Hook). The submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277. The document states that the devices themselves are unchanged from their original clearances in terms of intended use, design, performance, and technological characteristics.

Therefore, the study information requested is based on the original clearances of these devices (K142154 for PK Needle, K142289 for PK Spatula, and K142350 for PK J-Hook) and the specific testing performed for the current submission to confirm compatibility with the new generator.

Here's the breakdown of the acceptance criteria and study information provided in the document:

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

The document does not provide a specific table of quantitative acceptance criteria with reported numerical device performance as typically expected for software or diagnostic device studies. Instead, it refers to compliance with recognized consensus safety standards and successful completion of non-clinical testing.

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 relates to electrosurgical instruments and their compatibility with a new generator. The testing described is primarily non-clinical (electrical, mechanical, functional). Therefore, the concept of a "test set sample size" as applied to patient data or images (common in AI/ML devices) is not directly applicable here. The document mentions "testing was conducted" on the subject device. Details on the specific number of devices tested for each non-clinical performance category are not provided within this summary.

Data provenance: Not applicable as this submission primarily concerns non-clinical hardware compatibility performance rather than patient data analysis.

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. Ground truth, in the context of expert review for medical imaging or diagnostic devices, is not relevant for this type of electrosurgical instrument compatibility submission. The "ground truth" for electrosurgical instruments is their ability to perform cutting and coagulation safely and effectively, and this is assessed through engineering testing against established standards.

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

Not applicable. Adjudication methods are typically used for expert consensus on clinical findings in diagnostic studies. This is a non-clinical performance and compatibility submission.

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 or a diagnostic device. It is an electrosurgical instrument.

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. The performance of the device is described as "algorithm only" in the sense that its electrosurgical function is inherent to its design and energy delivery, rather than requiring human interpretation of an output. However, it is an instrument used by a human surgeon.

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

Not applicable in the typical sense. The "ground truth" for this device's performance is established by engineering specifications, recognized international safety and performance standards (e.g., IEC 60601 series, ISO 14971), and the original performance characteristics of the predicate devices. Performance is measured against these technical benchmarks.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable. This is not a machine learning device that requires a training set.

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The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.

This device is not intended to be used for tubal ligation or female sterilization.

Both predicate PK AIM and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM instrument is to be used only with the Olympus ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.

The provided text describes a 510(k) premarket notification for the "PK AIM" device, a cutting and coagulation instrument. The submission aims to expand the device's intended use based on its substantial equivalence to previously cleared predicate devices.

However, the provided document DOES NOT contain the type of detailed information requested regarding specific acceptance criteria, comprehensive device performance data tables, sample sizes for training and test sets, expert qualifications, ground truth establishment methods, or the results of MRMC studies that would typically be found in a clinical study report or a more detailed performance evaluation section of a submission.

The document primarily focuses on demonstrating substantial equivalence by comparing the proposed device's design, materials, and technological characteristics to its predicates and summarizing performance testing that supports the expanded indications.

Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what information is available and indicate where the information is missing.

Request Details and Available Information from Document:

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

• The document does not explicitly state quantitative acceptance criteria (e.g., "sealing success rate must be > X%") or provide a detailed table of reported device performance against such criteria.
• Instead, it states that "All study endpoints were met" for lymphatic sealing and "Bench Ex Vivo Design Verification testing demonstrated that the requirements defined in the protocol were met."
• For the lymphatic sealing study, the reported performance is qualitative:
  • Proposed PK AIM: "All vessels sealed with the proposed PK AIM test article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
  • Predicate OFJ: "All vessel seals with the OFJ control article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
• The conclusion for the device's equivalence to the predicate OFJ in lymphatic sealing is "The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon."
• For the bench/ex-vivo tissue study, the conclusion is "This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ."

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

• Lymphatic Sealing Study (Test Set):
  • Sample Size: 1 animal (porcine model).
    • 15 mesenteric lymph vessels sealed with the test device (PK AIM).
    • 16 mesenteric lymph vessels sealed with the control device (Thunderbeat OFJ).
  • Data Provenance: Acute GLP (Good Laboratory Practice) study conducted by American Preclinical Services (APS) in Minneapolis, MN (USA). This is a prospective animal study.
• Bench/ex-vivo tissue study (Test Set):
  • The document states "ex-vivo swine liver, swine kidney and bovine cardiac muscle tissue" but does not specify the number of tissue samples or seals performed.
  • Data Provenance: GLP ex-vivo study conducted by American Preclinical Services (APS). This is a prospective bench study.

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

• Number of Experts: One "study surgeon."
• Qualifications of Experts: The document states "The study surgeon evaluated each seal..." but does not provide details on the qualifications or experience of this surgeon.

4. Adjudication method for the test set

• The document states: "The study surgeon evaluated each seal immediately post seal and then again 30 seconds to one minute post seal."
• This suggests a single evaluator (the study surgeon). Therefore, there was no multi-expert adjudication method mentioned (e.g., 2+1 or 3+1). The "ground truth" seems to be based on the real-time observation and assessment by the single study surgeon during the procedure.

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 MRMC study was done. This document describes the testing of an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a medical device (electrosurgical instrument), not an algorithm. The "performance" is the physical effect of the device on tissue, assessed by a human surgeon.

7. The type of ground truth used

• For the Lymphatic Sealing Study: Real-time expert observation and assessment by a single study surgeon (clinical endpoint observation: integrity of seal, tissue sticking, char, leakage of lymph, hemostasis). This is a direct physical outcome as ground truth.
• For the Bench/ex-vivo tissue study: Comparison of tissue changes from the test device to the predicate, likely assessed visually or histologically, and confirmed against defined protocol requirements (design verification). This is a direct physical outcome comparison.

8. The sample size for the training set

• This information is not applicable/not provided as this is a physical device submission, not an AI/machine learning device that would require training data. The "training" for this device would be its design and manufacturing processes, which are validated, not "trained" in the sense of machine learning.

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

• Not applicable, as this is not an AI/machine learning device.

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The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes.

The provided text is a 510(k) summary for a medical device (Olympus PK AIM) and focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe a study that involves human readers, AI assistance, or complex ground truth establishment methods typically found in studies for AI/ML-based diagnostic devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and the nature of ground truth beyond engineering specifications, are not applicable to the information contained within this document.

The document describes performance testing of the device itself (electrical, physical, mechanical characteristics), not an AI algorithm's diagnostic performance.

Here's a breakdown of the applicable information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets its specifications. The general statement is that "All performance testing passed or met prescribed acceptance criteria." Specific quantitative results are not provided in this summary, but the categories of testing and their objectives serve as the acceptance criteria.

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

• Sample Size for Test Set: Not specified quantitatively. The document states "Summary of bench, Performance Testing (no clinical testing was conducted)." This implies that samples of the device were subjected to the physical and electrical tests listed, but specific numbers of units tested are not provided.
• Data Provenance: Not applicable in the context of clinical data. This is bench testing of a physical medical device.

The study described is retrospective in the sense that the testing was performed on the device prototypes/pre-production units to demonstrate substantial equivalence for regulatory submission.

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

Not applicable. "Ground truth" in this context refers to the defined engineering specifications and international standards which the device must meet, rather than expert interpretation of medical images or conditions. The tests measure objective physical and electrical properties.

4. Adjudication method for the test set

Not applicable. Testing involves engineering and laboratory measurements against predefined specifications, not human adjudication of subjective interpretations.

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

Not applicable. This device is an electrosurgical tool, not a diagnostic imaging device involving human readers or AI assistance in interpretation. No MRMC study was performed.

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

Not applicable. This device does not contain an AI algorithm. Its performance is related to its physical and electrical functions, not computational interpretations.

7. The type of ground truth used

The "ground truth" for this device's performance testing is established by engineering specifications, international performance standards (e.g., ISO, IEC, ASTM), and comparison to the established performance of the predicate device. For instance, HF leakage must meet a certain maximum value as per a standard, or power outputs must be comparable to the predicate.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

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The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.

This document describes a 510(k) premarket notification for the PK AIM electrosurgical cutting and coagulation device. The submission aims to demonstrate substantial equivalence to existing predicate devices, specifically for the additional claim of sealing vessels up to 3.0 mm in diameter.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds, as would be common for diagnostic AI/ML devices with performance metrics like sensitivity, specificity, or AUC. Instead, the performance testing focuses on demonstrating that the subject PK AIM is substantially equivalent to its predicates, particularly for the new vessel sealing claim, meaning its performance is comparable and raises no new safety or effectiveness concerns.

However, we can infer some performance metrics from the Summary of Performance Testing section:

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

The studies described are in vivo animal studies and ex vivo bench testing, not human patient data.

• Ex Vivo Bench Testing:

  • Sample Size: Not explicitly stated as a total number of vessels, but it confirmed sealing of 1.00 mm to 3.49 mm size arteries.
  • Data Provenance: Laboratory bench testing. (No country of origin specified, but typically conducted internally or at specialized testing facilities).
  • Retrospective/Prospective: Prospective.

• Acute GLP Study (Swine Model):

  • Sample Size: Quantities of 11 and 12 blood vessels were sealed by the subject PK AIM and predicate PK OMNI, respectively.
  • Data Provenance: Swine model, likely a controlled laboratory setting (GLP - Good Laboratory Practice implies a standardized, prospective study).
  • Retrospective/Prospective: Prospective.

• Chronic GLP Study (Swine Model):

  • Sample Size: 11 animals survived a minimum of 21 days. The number of vessels sealed per animal is not specified but would be multiple.
  • Data Provenance: Swine model, controlled laboratory setting (GLP).
  • Retrospective/Prospective: Prospective.

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

The document does not describe the use of human experts to establish "ground truth" in the context of diagnostic performance (e.g., radiologists reviewing images). Instead, the studies involve direct observation, measurement, and pathological analysis by scientific personnel.

• Ex Vivo Bench Testing: Ground truth is established by objective measurements (e.g., visual confirmation of sealing, burst pressure measurements using pressure gauges/equipment). This does not involve expert consensus in the human interpretation sense.
• Acute and Chronic GLP Studies:
  • Histopathology Report: A Histopathology Report is attached to the acute study, implying pathological assessment. This would typically be performed by a veterinary pathologist or similar qualified expert in animal tissue analysis. The number of pathologists is not specified.
  • Necropsy Pathology: A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites was performed in the chronic study. This would also be conducted by a veterinary pathologist. The number of pathologists is not specified.
  • Animal Health Report: An Animal Health Report attached to the chronic study, suggesting assessment by a veterinarian or animal care expert.
  • Qualifications: "GLP Study" implies that all personnel involved in the study (including pathologists and veterinarians) would meet specific qualifications and adhere to good laboratory practice standards.

4. Adjudication Method for the Test Set:

Not applicable in the AI/ML diagnostic sense. The studies rely on objective measurements and pathological assessments, where "adjudication" between human readers is not a concept employed. Discrepancies in pathological findings, if any, would be resolved through standard pathology practices (e.g., review by a senior pathologist, consensus discussion).

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

Not applicable. This device is an electrosurgical instrument, not an AI/ML diagnostic tool intended to assist human readers in interpreting data. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.

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

Not applicable. The PK AIM is a physical surgical device, not a software algorithm. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

• Ex Vivo Bench Testing:
  • Direct Physical Measurement: Burst pressure of sealed arteries, direct observation of sealing, measurement of artery size.
• Acute and Chronic GLP Studies (Swine Model):
  • Pathology: Gross examination, histopathology (microscopic examination of tissue samples), necropsy pathology.
  • Outcomes Data: Animal survival, qualitative assessment of health, comparison of sealed vessel sites to control.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's functionality comes from its engineering design and manufacturing.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

The PK J-Hook is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active "J" shaped tip and is activated via buttons on the handle, or by a foot pedal. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator.

This document describes a 510(k) premarket notification for the "PK J-Hook," an electrosurgical cutting and coagulation device. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission does not involve proving the device meets acceptance criteria in the same way an AI/ML medical device would be evaluated for its diagnostic or prognostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously approved device.

Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable to this 510(k) submission. Below, I will address the applicable points and explain why others cannot be answered from the provided text.

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

For a 510(k) for an electrosurgical device, the "acceptance criteria" are typically related to meeting established performance standards for electrosurgical devices and demonstrating equivalence to a predicate device across various parameters. The reported performance is generally a confirmation that the device meets these standards and functions equivalently.

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

The document mentions "performance tests" and "bench testing." These are likely laboratory tests on physical samples of the device. The exact sample size for these tests is not specified in the provided text. The data provenance is internal testing by Gyrus ACMI, Inc. specific to the device being submitted. It is prospective testing of their device samples.

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

This concept is not directly applicable to a 510(k) for an electrosurgical device. "Ground truth" in this context would be established by objective physical measurements and adherence to engineering and medical device standards rather than expert clinical consensus on interpretations or outcomes. The performance tests would be evaluated against pre-defined engineering specifications and relevant ISO/IEC standards.

4. Adjudication method for the test set

Not applicable in the context of this 510(k) submission for an electrosurgical device. Performance is assessed against objective engineering and safety standards, not by an adjudication process as would be used for subjective interpretations or diagnostic outcomes.

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 conducted.

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 (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be defined by engineering specifications, established medical device standards (e.g., ISO, IEC), and objective physical measurements. For example, for "cutting and coagulation equivalency," the ground truth would be the measurable performance of the predicate device under controlled laboratory conditions. For "biocompatibility," the ground truth is defined by the passing criteria of the ISO 10993 series of standards.

8. The sample size for the training set

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

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

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

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The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

The PK Needle is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active blunt needle shaped tip and is activated via a button on the handle, or by a foot pedal. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator.

This document is a 510(k) premarket notification for a medical device called the "PK Needle." It's a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to existing legally marketed devices, and it primarily focuses on device safety and performance characteristics for regulatory approval rather than clinical study results establishing diagnostic or therapeutic accuracy against ground truth.

Therefore, many of the requested categories are not applicable to this type of document because it details the physical and functional characteristics of an electrosurgical device, not a diagnostic AI or image analysis system.

Here's an analysis based on the provided document:

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

The document describes several performance tests, but it does not specify explicit "acceptance criteria" in a quantitative, tabular format as one might expect for a diagnostic device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted and the device performed "substantially equivalent" to its predicate.

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 detail specific sample sizes for tests like "cutting equivalency" or "expected forces." The tests appear to be bench tests of the device itself rather than studies involving human subjects or clinical data sets on a large scale. Data provenance is not applicable as these are engineering and materials tests, not clinical data studies. The tests are prospective in the sense that they are performed on the manufactured device.

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 device is an electrosurgical instrument, not a diagnostic device where "ground truth" would be established by experts interpreting medical images or pathology. The "truth" here relates to engineering specifications and performance characteristics.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for bench testing of device functionality.

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-assisted diagnostic or image interpretation device.

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

Not applicable. This is a physical electrosurgical instrument for direct surgical use.

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

The "ground truth" for this device's performance is based on engineering specifications, material science standards (e.g., biocompatibility), and functional tests designed to mimic its intended use (e.g., cutting equivalency). It's not based on clinical "outcomes data" or "pathology" in the context of diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable.

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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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