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Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

The system is composed of four main components:

• An obturator that facilitates insertion of the system through an incision.
• A cannula with bolster and attached balloon, encased within a perforated sheath.
• A seal which maintains insufflation.
• An inflation bulb that is used to manually inflate and deflate the balloon.

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The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens

The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device consists of an intraperitoneal Alexis retractor and retroperitoneal Alexis retractor that are placed transvaginally to create a pathway to the peritoneum and retroperitoneum. A GelSeal cap attaches to the retractors at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

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The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures.

The Voyant Open Fusion and Voyant 5mm Fusion devices are advanced bipolar instruments that use RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the devices' jaws. Each device features a mechanical, user-actuated blade for the division of sealed tissue.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Voyant Open Fusion Device and Voyant 5mm Fusion Device.

It's important to note that the provided documents (FDA 510(k) summaries) typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed, comprehensive reports on a device's standalone performance or comparative effectiveness studies with human readers. Therefore, some of the requested information may not be explicitly present or might be inferred from the context of a 510(k) submission.

Acceptance Criteria and Reported Device Performance

The documents state that both devices "met all acceptance criteria" and "met the predetermined acceptance criteria" for various tests. However, the specific quantitative acceptance criteria and the precise performance metrics achieved are not explicitly detailed in the provided text. The submission focuses on stating that the criteria were met, implying satisfactory performance relative to either internal company standards, recognized industry standards, or performance established by the predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

1. Sample Sizes and Data Provenance

• Test Set (Clinical/Animal):

  • Animal Testing: "large porcine animal models" were used. The exact number of animals or vessels tested is not specified.
  • Burst Pressure Testing: Used "vessels representative of the devices' indications." The number of vessels is not specified.
  • Data Provenance: The studies were conducted by Applied Medical Resources Corp. (presumably within the US, as they are a US-based company submitting to the FDA). The studies appear to be prospective in nature, designed specifically to test the devices.

• Training Set (for Software/AI, if applicable): Not applicable. This device is an electrosurgical tool, not an AI/software-based diagnostic or imaging device in the sense that would require a large training dataset for pattern recognition. The software verification mentioned refers to the control software embedded within the device, not a machine learning algorithm trained on data. Therefore, questions 8 and 9 are not directly relevant in this context.

2. Number of Experts and Qualifications for Ground Truth

• Animal Testing: The evaluation of "hemostasis and signs of hematoma" would likely involve veterinary professionals or researchers with expertise in animal pathology and surgical outcomes. However, the number and specific qualifications of experts establishing ground truth are not provided in this summary.

• Other Testing: For burst pressure, thermal spread, electrical safety, and mechanical testing, the ground truth is established by objective physical measurements and engineering standards, not typically by expert consensus in the same way as a diagnostic medical image.

3. Adjudication Method for the Test Set

Given the nature of the studies (engineering performance, animal model outcomes), formal adjudication methods like "2+1" or "3+1" (common in clinical trial assessments for subjective endpoints or equivocal findings) are not mentioned and generally not applicable to these types of objective performance tests. The results would be based on direct measurements and observations, typically verified by technical experts.

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

• No: An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how AI assistance impacts human reader performance in interpreting images or data. The Voyant devices are surgical tools, and their effectiveness is measured by their physical performance (sealing vessels, minimizing thermal spread), not by human interpretation of their output.

5. Standalone Performance Study (Algorithm Only)

• Yes (Implied for the device system): The performance testing described (burst pressure, thermal spread, animal studies, EMC, electrical safety, mechanical testing) assesses the device's inherent functionality and capabilities. While the software is a component, the "standalone" performance here refers to the device system itself without direct human "in-the-loop" decision-making augmentation, but rather as an operated tool. The software verification specifically assesses the algorithm/software components in a standalone context.

6. Type of Ground Truth Used

• Objective Measurements and Observation/Pathology in Animal Models:
  • Burst pressure: Objective physical measurements.
  • Thermal spread: Objective physical measurements/histology (implied).
  • EMC/Electrical Safety: Compliance with objective engineering standards.
  • Mechanical Testing: Objective performance metrics.
  • Animal testing: Direct observation of hemostasis and absence of hematoma, potentially supported by pathology or histological evaluation of tissue.

7. Sample Size for the Training Set

• Not applicable: As discussed above, this device does not utilize machine learning in a way that requires a "training set" of data for algorithm development. The "software" refers to control logic, not AI models.

8. How Ground Truth for Training Set was Established

• Not applicable: (See point 7).

Summary of Gaps in Information (from the perspective of the original prompt):

The provided 510(k) summary is designed to demonstrate substantial equivalence, not to provide a full scientific publication with detailed methodologies and results for each test. Key quantitative details like exact sample sizes for animal/vessel testing, specific numerical acceptance thresholds (e.g., minimum burst pressure in mmHg, maximum thermal spread in mm), and the precise qualifications of evaluators are not included in this high-level summary. This is typical for a 510(k) submission, where the focus is on the conclusion that acceptance criteria were met and substantial equivalence was achieved.

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The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

Acceptance Criteria and Study for the Voyant Maryland Fusion Device

This document describes the acceptance criteria and the studies that demonstrate the Voyant Maryland Fusion Device meets these criteria. It focuses on the information provided in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests conducted for the Voyant Maryland Fusion device and states that the device "met the predetermined acceptance criteria" for each. However, the specific quantitative acceptance criteria for each test are not explicitly defined in the provided document. The performance is generally reported as meeting pre-determined criteria and being "substantially equivalent" to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact sample sizes for each test are not explicitly mentioned in the provided text.
  • Burst pressure testing: "vessels representative of the devices' indications" were used.
  • Thermal spread testing: No specific sample size given for tissues.
  • Animal testing: "large porcine animal models" were used, but the number is not specified.
• Data Provenance: The text does not specify the country of origin for the data. The studies appear to be prospective as they were conducted as part of the device evaluation for 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the number of experts used to establish ground truth or their qualifications for any of the performance tests.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The document focuses on the performance of the device itself, not human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study (algorithm/device only without human-in-the-loop performance) was completed for the Voyant Maryland Fusion device. The entire "Discussion of Performance Testing" section details laboratory and animal studies of the device's technical capabilities and clinical performance without human interaction being assessed as part of the primary endpoint.

7. Type of Ground Truth Used

• EMC, Electrical Safety, Mechanical Testing, Simulated Repeated-Use Testing, Software Verification: Ground truth for these tests would be based on engineering specifications, regulatory standards (e.g., IEC 60601 series), and predefined functional requirements.
• Burst Pressure Testing: Ground truth would be based on quantitative measurement of burst pressure of the sealed vessels, likely compared to a control or predicate device, and potentially established physiological limits for vessel integrity.
• Thermal Spread Testing: Ground truth would be based on quantitative measurement of tissue damage (e.g., area of necrosis), likely determined histologically or via thermal imaging, and compared to the predicate device.
• Animal Testing: Ground truth would be based on direct observation of physiological outcomes (e.g., hemostasis, presence/absence of hematoma, long-term seal quality, adverse effects on adjacent structures) by veterinary professionals or researchers, potentially supported by pathology (e.g., histological examination of sealed tissues post-mortem).

8. Sample Size for the Training Set

The provided text does not mention any "training set." This type of terminology is typically associated with machine learning or AI algorithm development. The Voyant Maryland Fusion device is described as an electrosurgical device with an "updated software script," but not as an AI-powered diagnostic or assistive tool that would require a distinct training set for algorithm development. The software verification focuses on its design, implementation, and performance, not on learning from data.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable based on the provided document. The software verification was likely based on standard software engineering principles and testing against established functional requirements and specifications.

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The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired.

The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.

This FDA 510(k) summary for the Voyant 5mm Fusion Device and Voyant Maryland Fusion Device (K193292) does not contain information about a study with acceptance criteria and observed device performance in the way a clinical trial or algorithm performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K141288, K172624, K182653). The core argument for safety and efficacy relies on the fact that the subject devices are identical in material and technological characteristics to the predicates, and thus, the existing performance, sterility, shelf life, and electrical testing of the predicate devices are leveraged.

Therefore, the requested tables and details regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific submission as it's not a de novo study for a novel device or AI algorithm.

However, I can extract the acceptance criteria and "results" as presented in the document based on the performance testing of the predicate devices, which are deemed sufficient for the subject devices due to identical design.

Here's a breakdown of the information that is available (or not available) based on your request, framed within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission based on identical design, the "acceptance criteria" are implied by the standards and successful results achieved by the predicate devices. The document states that the predicate devices "met all acceptance criteria" for the listed tests.

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

• Sample Size: Not specified in the document for any of the tests. The document refers to "representative vessels" and "surgical sites" for the bench and animal testing, respectively, but does not provide numbers.
• Data Provenance: The data comes from prior testing associated with the predicate devices (K141288, K172624, K182653). The document does not specify the country of origin or if the studies were retrospective or prospective, though animal and bench testing are typically prospective experiments.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This submission is not evaluating an AI algorithm or diagnostic device requiring expert interpretation of results to establish ground truth. The tests are laboratory-based (biocompatibility, electrical, mechanical, bench) and animal studies, which have objective endpoints.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, no expert consensus or adjudication process is described for these types of engineering and biological tests.

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

• No. This document does not describe any MRMC study. The device is an electrosurgical tool, not a diagnostic imaging device that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a surgical instrument. This concept is not applicable.

7. Type of Ground Truth Used:

• For biocompatibility tests: Standardized laboratory assays based on cell viability, immune response, etc.
• For electrical tests: Measurement against established IEC standards.
• For mechanical tests: Objective measurements of force, integrity, and electrical continuity.
• For bench testing: Measurements of burst pressure and thermal spread, which are objective physical parameters.
• For animal testing: Histological examination, observation of hemostasis, and absence of hematoma, likely evaluated by veterinary pathologists or study investigators based on established criteria.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable.

In summary: This 510(k) submission explicitly states that the subject devices are identical to predicate devices and therefore leverages the prior testing data of those predicates. It does not present new studies with a detailed breakdown of acceptance criteria and performance for a novel device or AI algorithm, but rather relies on the successful historical performance of prior substantially equivalent devices.

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The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

The Acceptance Criteria and supporting study information are derived from the "Discussion of Performance Data" and "Comparison with the Predicate Device" sections of the provided text.

Here's a breakdown of the requested information:

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:
  • Baekelandt et al. (2018) study: n=70
  • iNOTESs Society Registry data: n=906
• Data Provenance: The document does not specify the country of origin for either dataset.
  • Baekelandt et al. (2018): Randomized, single-center, single-blinded trial (Prospective).
  • iNOTESs Society Registry data: Registry data (Likely prospective, though details aren't fully specified).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies report "acceptable rates of peri- and post-operative complications," implying clinical assessment, but the number or qualifications of experts involved in determining these outcomes are not detailed.

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

This information is not provided in the document.

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 that involved AI vs. human readers. The studies described (Baekelandt et al. and iNOTESs Registry) are clinical performance studies of a medical device (Transvaginal Access Platform), not an AI diagnostic tool. They compare different surgical approaches or document outcomes with the device.

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

• Not applicable. The device is a physical surgical access platform, not an algorithm. Therefore, no standalone algorithm performance study was performed.

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

• The ground truth for the clinical performance criteria ("acceptable rates of peri- and post-operative complications") appears to be clinical outcomes data, likely assessed by healthcare professionals involved in the care of the patients. This would include direct observation, patient follow-up, and review of medical records for complications.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant Electrosurgical Generator in laparoscopic procedures where the ligation of vessels and tissue bundles is desired.

The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288, K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

This document is a 510(k) Premarket Notification from the FDA for a medical device, the Voyant Maryland Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's efficacy against a defined set of acceptance criteria in a clinical or diagnostic setting. Therefore, a direct answer to the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device validation cannot be fully provided from this document alone.

However, based on the provided text, we can infer and construct some approximations related to performance testing in the context of device safety and efficacy demonstration for a 510(k) submission.

Re-interpretation of Acceptance Criteria and Performance Study for a 510(k) Device:

For a 510(k) device, "acceptance criteria" largely revolve around demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical performance testing conducted to support this claim of substantial equivalence.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a non-diagnostic device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this electrosurgical device, the acceptance criteria are implicitly related to demonstrating performance that is substantially equivalent to the predicate device, particularly in terms of vessel sealing and minimizing thermal spread. Specific quantitative acceptance criteria or thresholds are not explicitly listed in this summary, but the outcome of the tests indicates equivalence.

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

• Test Set Sample Sizes: Not explicitly stated for any of the tests (burst pressure, thermal spread, chronic survival study). The document mentions "vessels representative of the devices' indications" were used.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (in vitro, ex vivo, or animal studies as implied by "chronic survival study") and retrospective as they are conducted for a regulatory submission. They are not human clinical trials in the traditional sense discussed for diagnostic AI.

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

This information is not applicable in the context of this device and its 510(k) submission. The "ground truth" here is objective physical measurements (like burst pressure, thermal spread, mechanical force) or direct observation of biological outcomes (hemostasis, hematoma) in pre-clinical models, not expert interpretations of medical images or patient data.

4. Adjudication Method for the Test Set

This is not applicable. As there are no human readings or interpretations involved in establishing the "ground truth" (instead, it's objective physical or biological measurements), no adjudication method (e.g., 2+1, 3+1) is described or needed.

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

This is not applicable. This is an electrosurgical device, not a diagnostic AI algorithm that assists human readers. Therefore, an MRMC study and effects on human reader performance are irrelevant.

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

This is not applicable in the sense of an "algorithm." The device itself has functionality (e.g., vessel sealing, tissue division). The performance studies conducted (burst pressure, thermal spread, chronic survival) are essentially "standalone" evaluations of the device's physical and functional capabilities, not an algorithmic output.

7. Type of Ground Truth Used

The ground truth used for performance evaluation appears to be:

• Objective Biophysical Measurements: Burst pressure, thermal spread, mechanical jaw force.
• Biological Outcome Data: Observation of hemostasis and absence of hematoma, and lack of adverse effects on adjacent structures from the "chronic survival study."
• Compliance with Standards: Electrical safety and EMC standards (IEC 60601 series).

8. Sample Size for the Training Set

This is not applicable. This document describes an electrosurgical device, not an AI/machine learning model that requires a "training set." The "software script" mentioned is likely embedded control software, not adaptive AI.

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

This is not applicable for the same reasons as point 8.

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The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired.

The Applied Medical Voyant Electrosurgical Generator (ESG) is a tabletop radiofrequency (RF) power supply designed for use in electrosurgery. It operates outside the sterile field and is equipped with a receptacle for Voyant hand piece devices. The ESG enclosure is constructed of various metals and polymers and houses all electrical hardware and software components. The front panel features an LCD and buttons for the navigation, adjustment, and selection of ESG settings.

This document is a 510(k) Premarket Notification from the FDA regarding the Voyant Electrosurgical Generator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI/ML device that requires extensive acceptance criteria for predictive performance.

Therefore, many of the requested elements for an AI/ML device cannot be found in this document because they are not applicable to the type of device and study presented. The "device" in question is an electrosurgical generator, not an AI model.

Here's a breakdown of the information that can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria in the format typically seen for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by demonstrating "substantial equivalence" to a predicate device. The performance is assessed through various engineering and system tests comparing the subject device to its predicate.

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

This information is not provided in the document. The testing described (burst pressure, thermal spread, electrical safety, software testing) suggests engineering and bench testing, not a clinical "test set" of patient data as would be used for an AI/ML model. The provenance would be the lab where testing was conducted, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable/provided. Since this is not an AI/ML diagnostic device, there is no "ground truth" established by human experts in the sense of image interpretation or disease diagnosis. The "ground truth" for the engineering tests would be derived from the physical properties and measurements from the predicate device and the subject device.

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

This is not applicable/provided. No adjudication method for expert review of a test set is mentioned, as it's not relevant to this type of device 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

There was no MRMC study done. This is not an AI-assisted diagnostic device. The study focused on the substantial equivalence of the electrosurgical generator itself, not on improving human reader performance. In fact, the document explicitly states: "No chronic survival or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance."

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

This is not applicable. This is not an algorithm, but an electrosurgical generator. Its performance is inherent to its electrical and mechanical design.

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

The "ground truth" (or basis for comparison) in this context is the performance of the legally marketed predicate device. For specific tests:

• Burst pressure and thermal spread: Measured physical properties directly compared to the predicate.
• Electrical safety and EMC: Compliance with international standards (IEC 60601 series).
• Software: Verification against software requirements.

8. The sample size for the training set

This is not applicable/provided. There is no "training set" as this is not an AI/ML device.

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

This is not applicable/provided. As above, there is no AI/ML training set.

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The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

Applied Medical's Dissecting Balloon System consists of a rigid cannula with an inflatable balloon attached at the distal end that achieves separation of tissue planes during laparoscopic surgery. The system is provided sterile. The system includes three main components: An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon

This document is a 510(k) Premarket Notification for the Applied Medical Resources Corp. Dissecting Balloon System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria in a clinical setting. The "performance testing" section describes bench-top functional assessments and biocompatibility, which are primarily aimed at showing that the new device functions similarly and is as safe as the predicate, not necessarily that it achieves a specific clinical outcome with a quantifiable performance metric.

Therefore, many of the requested elements regarding clinical performance studies, such as sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable in the context of this 510(k) submission.

Here's a breakdown of the information that can be extracted or deduced from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit, quantifiable acceptance criteria with corresponding device performance metrics in a clinical context. The "performance testing" section describes functional equivalence testing.

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

• Sample Size: Not specified for the functional performance bench testing.
• Data Provenance: The document describes "side-by-side bench top testing," which implies laboratory-based, prospective testing conducted by the manufacturer. No information on country of origin for clinical data is applicable as it's not a clinical study.

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

• Number of Experts: Not applicable. The "ground truth" for functional performance was likely established by engineers or technicians assessing the physical properties and operation of the devices in a bench-top setting, not clinical experts.
• Qualifications of Experts: Not specified or applicable in the human reader / clinical context.

4. Adjudication Method for the Test Set:

• Not applicable. The bench-top testing would have involved objective measurements or direct observation of device function, not an adjudication process by human readers or clinical experts.

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

• No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through bench-top testing and biocompatibility, not clinical effectiveness studies involving human readers or AI.

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

• Not applicable. This device is a mechanical surgical tool (dissecting balloon system), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used:

• Functional Performance: The ground truth for functional performance was based on direct observation and measurement of the device's physical operation and its ability to perform its intended mechanical functions (insertion, tissue separation, visualization, deflation, removal) in a bench-top setting, compared to the predicate device. It is not clinical ground truth like pathology or outcome data.
• Biocompatibility: The ground truth was established through adherence to the FDA's guidance document and international standard ISO 10993-1, with results based on laboratory tests for cytotoxicity, irritation, sensitization, and systemic toxicity.

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As there's no AI model or training set, this information is not relevant.

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The GelPOINT® Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

GelPOINT Path is inserted into the anal canal to establish access to the rectum and lower sigmoid colon in preparation for transanal endoscopic surgery. The access channel lumen may be closed off with an airtight cap. The cap allows for insufflation of the surgical site. The cap is constructed of a gel material through which multiple sleeves may be placed. These sleeves establish ports that allow passage of a laparoscope and laparoscopic instruments without loss of insufflation. GelPOINT Path was previously cleared in access channel lengths ranging from 4.5cm to 15cm. The proposed clearance for the access channel length is 3.5cm to 15cm.

This document is a 510(k) summary for the GelPOINT® Path Transanal Access Platform, a medical device. It's a regulatory submission to the FDA, not a study report that details acceptance criteria and performance data in the typical sense of a clinical trial.

Therefore, many of the requested categories simply do not apply to this type of document because it describes a line extension of an already cleared device, not a new device requiring extensive de novo performance testing. The main argument for substantial equivalence is based on the lack of impact of the new feature (shorter access channel length) on already established safety and effectiveness.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable:

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

This document does not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This is because the submission is for a line extension of an already cleared device (K110792 and K133393). The argument is that the proposed change (shorter access channel length) does not impact the performance specifications already established for the predicate devices.

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

Not applicable. This submission is for a line extension of a device. It refers to performance testing done for the predicate devices (K110792 and K133393) but does not provide details on their sample sizes or data provenance. No new testing of this nature was conducted or reported for this specific submission (K171701).

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 type of information is not relevant to a 510(k) submission for a line extension of an existing mechanical device. There is no "ground truth" to establish through expert review in the context of diagnostic accuracy for this device.

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

Not applicable. There was no test set requiring adjudication in the context of this 510(k) 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 device is a transanal access platform, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is a transanal access platform, not an AI algorithm.

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

Not applicable. There is no concept of "ground truth" in the context of diagnostic accuracy for this mechanical device's 510(k) submission. Safety and effectiveness would be established through performance testing related to its mechanical function, biocompatibility, sterility, etc. (as mentioned for the predicate devices), not through comparison to a diagnostic ground truth.

8. The sample size for the training set

Not applicable. This device is a transanal access platform; there is no "training set" in the context of machine learning or AI.

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

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

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