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LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required. Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. PISTOL Type has pistol grip handle design. TRUMPET Type has Trumpet grip handle design. The electrode offers three types: L-HOOK, SPOON and J-HOOK Type. All three electrode types are compatible with the PISTOL Type and the TRUMPET Type. The L-Hook & J-Hook electrode tip has a sharp contact surface that facilitates cutting especially for thin and long tissue. The SPOON electrode tip is mainly used for large area tissue and also for hemostasis procedure as well. The voltage should not exceed 175Vrms (300Ω standard), and set to minimum power (100W, 3002 standard). The connector of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode).

The provided text is a 510(k) summary for the LAP-iX electrosurgical accessory. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new clinical application.

Therefore, the information requested in your prompt regarding acceptance criteria, specific study design details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) is not present in the provided text.

The document states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified device. The device passed all of the tests based on pre-determined pass/fail criteria." However, it does not explicitly list the acceptance criteria or the detailed results demonstrating how the device met them beyond a general statement of passing.

The document lists the following performance tests conducted for the LAP-iX:

• Air tightness
• Continuity
• Dielectric Strength
• HF Leakage Current
• Tensile Strength
• Cut & Coagulation Button Function
• Electrode Cover
• Suction & Irrigation Test
• Thermal Effect Study

Additionally, it mentions validation tests for:

• Sterilization Validation Test in accordance with ISO11737-1
• Shelf Life Validation Test in accordance with ASTM F 1980
• Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Ethylene Oxide Sterilization Residuals, Skin Sensitization, Irritation).

In summary, the provided document indicates that performance and validation tests were conducted and the device passed, but it does not furnish the specific acceptance criteria or the detailed study results that would allow for a table comparing acceptance criteria to reported device performance. It also lacks the detailed information on study design, ground truth establishment, or expert involvement typically found in clinical performance studies for AI/software devices. This document is a regulatory submission for a medical device and not a peer-reviewed research paper.

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The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.

The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used. It is provided sterile, for Rx only and single use.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) clearance letter for a LAP-iX Suction Irrigation device. This is a conventional medical device used in laparoscopic and endoscopic procedures for surgical suction and irrigation.

The "Performance Data" section (page 4, point 7) lists general verification, validation, and testing activities, including:

• Sterilization Validation Test in accordance with ISO11737-1
• Shelf Life Validation Test in accordance with ASTM F 1980
• Biocompatibility Tests in accordance with ISO 10993 (specifically ISO 10993-5 for Cytotoxicity, and ISO 10993-7 for Ethylene Oxide Sterilization Residuals, ISO 10993-10 for Skin Sensitization and Irritation)
• Performance Tests: Air tightness, Suction and Irrigation Test

It states that "The device passed all of the tests based on pre-determined pass/fail criteria." However, it does not provide the specific acceptance criteria that were pre-determined, nor does it detail the results of these tests (e.g., specific values for air tightness, suction, or irrigation performance).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these are typically relevant for AI/ML device evaluations and are not present in this document for a traditional physical medical device.

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Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.

During the laparoscopic surgery, the smoke generated by the electrocautery dims the surgeon's vision, affecting the operation and causing the smoke to have a negative effect on the surgeon. It is used in connection with a laparoscopic trocar body or a single port used to expand the surgical site during laparoscopic surgery. This product filters smoke generated when the tissue is cauterized through the laparoscopic trocar body and a single port. The connecting part of the Trocar body or single port is 4.25 * 5.04mm in diameter. The device is consisted of 35cm tubing, a body with filters and an adaptor.

The provided text describes a 510(k) premarket notification for a medical device called "Smoklean," a passive smoke evacuation system for laparoscopic procedures. The document details the device's intended use, comparison to a predicate device, and performance data from various tests. However, it does not contain the specific acceptance criteria for these tests or a detailed study report that proves the device meets those criteria with specific performance metrics (e.g., specific filtration efficiency percentages, or quantitative measures of visual clarity).

Therefore, based on the provided text, I cannot complete all sections of your request. I will extract the information that is present and indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document lists types of performance tests (e.g., "Smoke particulate filtration verification test," "Deodorization: Ammonia," "Deodorization: Formaldehyde") but does not provide the specific quantitative acceptance criteria or the numerical results achieved by the device against those criteria.

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

Missing Information: The document lists "Performance Tests" but does not specify the sample size used for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not detailed for the performance tests.

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

Not Applicable for this type of device and performance testing. The "ground truth" for a smoke evacuation system generally refers to measurable physical properties (like filtration efficiency, odor reduction) rather than expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not Applicable for this type of device and performance testing, as it doesn't involve subjective interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done, as this is a smoke evacuation device, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop) performance was done. The "Performance Data" section lists various tests performed directly on the device, such as "Smoke particulate filtration verification test," "Deodorization: Ammonia," and "Deodorization: Formaldehyde." These are objective, standalone tests of the device's physical capabilities.

7. Type of Ground Truth Used

The ground truth for the performance tests would be based on objective, measurable physical and chemical standards, such as:

• Pre-defined concentrations of particles or gases (e.g., ammonia, formaldehyde) for filtration/deodorization tests.
• Standardized methods for measuring particle counts, gas concentrations, tensile strength, sterility, etc.
• Industry standards (e.g., ISO) for sterilization and biocompatibility.

8. Sample Size for the Training Set

Not Applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training set" concept is relevant for machine learning models.

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

Not Applicable. As above, this device does not use an AI/ML algorithm that requires a training set.

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The LAP-iX Suction Irrigation provides suction to a surgical site during laparoscopic and endoscopic procedures.

The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation).

This document describes the LAP-iX Suction Irrigation device, which provides suction and irrigation to a surgical site during laparoscopic and endoscopic procedures. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for a novel AI-based diagnostic device.

Therefore, the following information will be structured to extract what is available from the provided text, while also explicitly stating what is not present given the nature of the submission (a 510(k) for a physical medical device, not an AI/ML algorithm).

Acceptance Criteria and Study for LAP-iX Suction Irrigation Device

The submission for the LAP-iX Suction Irrigation device (K173111) is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a novel technology or diagnostic accuracy. The "acceptance criteria" here are implicitly meeting the standards demonstrated by the predicate device and satisfying various regulatory performance tests.

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

Since this is a physical device attempting to show substantial equivalence, the "acceptance criteria" are generally that the device performs safely and effectively, and is as safe and effective as the predicate device. The document does not provide specific quantitative acceptance criteria or detailed performance reports with numerical values, but rather lists the types of tests performed and states that the "test results support that the subject device is substantially equivalent to 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)

The document does not specify the sample sizes (e.g., number of devices or units) used for each individual test (e.g., Sterilization Validation, Biocompatibility tests, Performance tests like Tensile Strength). It only states that "The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices."

The data provenance (country of origin, retrospective/prospective) is not mentioned for these tests. The device manufacturer is Sejong Medical Co., Ltd. in Paju-si, Gyeonggi-do, Republic of Korea, suggesting the testing likely occurred in or was arranged by the manufacturer, but this is not explicitly stated.

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 section is not applicable to this 510(k) submission. The LAP-iX Suction Irrigation is a physical medical device (an accessory for laparoscopic/endoscopic procedures) and does not involve AI or algorithms that require expert interpretation or ground truth establishment in the context of diagnostic accuracy. The tests performed are engineering and biological evaluations, not diagnostic assessments.

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

This section is not applicable. As explained above, this device does not involve human interpretation of outputs that would require an adjudication method.

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

This section is not applicable. An MRMC study is relevant for AI-powered diagnostic aids. This 510(k) pertains to a physical surgical instrument, not an AI diagnostic algorithm.

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

This section is not applicable. This is a physical device, not an algorithm.

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

This section is not applicable in the context of diagnostic "ground truth." The "ground truth" for this device's performance would be the objective results obtained from the engineering and biological tests (e.g., sterility achieved, material strength, biocompatibility within limits). There is no "pathology" or "outcomes data" to establish a ground truth for diagnostic accuracy.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is a physical device and not an AI/ML algorithm.

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

This section is not applicable. As there is no training set, there is no ground truth establishment for it.

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LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required. Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. Each type also offer both Unlock Type and Lock Type. There are 8 models in total. The electrode offers two types: L-HOOK and SPOON Type. The voltage should not exceed 175Vrms (3002 standard), and set to minimum power (100W, 3002 standard). The connector (banana jack) of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode).

The provided document is a 510(k) summary for the LAP-iX electrosurgical accessory. It outlines the device's indications for use, its description, and the performance data that supports its substantial equivalence to a predicate device. However, it does not describe an AI-based device, nor does it conduct a study where device performance is measured against acceptance criteria in the way typically expected for AI/ML medical devices.

The document discusses various performance tests relevant to an electrosurgical device, such as sterilization validation, shelf-life validation, biocompatibility tests, and electrical/mechanical performance tests. These are to ensure the LAP-iX is safe and effective for its intended use, and substantially equivalent to its predicate.

Therefore, many of the requested categories for AI/ML device studies cannot be addressed using the provided text.

Here's a breakdown based on the information available and an explanation where information is not available due to the nature of the device:

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

The document lists performance tests, but it does not specify acceptance criteria in a quantitative manner as typically seen for AI/ML device performance (e.g., sensitivity, specificity thresholds). Instead, it states that tests were performed "in accordance with" standards or for specific engineering parameters.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices." This implies that the device successfully met the internal acceptance criteria set for each test, which were designed to demonstrate its safety and effectiveness in line with the predicate device and relevant standards.

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: The document does not specify the sample size for individual performance tests. For instance, it doesn't say how many units were tested for sterilization or tensile strength.
• Data Provenance: Not specified. These are engineering and bench tests, not clinical data sets from specific countries. The manufacturer is in the Republic of Korea.
• Retrospective/Prospective: Not applicable as this submission pertains to an electrosurgical accessory, not a diagnostic or prognostic data-driven 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 not an AI/ML diagnostic or predictive device that requires expert-established ground truth for a test set. The "ground truth" for these tests would be the physical properties of the device meeting predetermined engineering specifications and international standards.

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

Not applicable. Adjudication methods are typically for clinical studies, especially those involving expert review of diagnostic images or interpretations. The tests performed are engineering and laboratory tests.

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 device.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's performance tests would be the established engineering specifications, safety standards (e.g., ISO, electrical safety limits), and functional requirements for an electrosurgical device accessory. It does not involve expert consensus on medical findings, pathology, or outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.

The provided document is a 510(k) summary for the LapBag®, a sterile specimen retrieval pouch. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested fields related to AI performance, expert ground truth, adjudication, and clinical study details cannot be filled directly from this document. The document describes engineering and biocompatibility tests to ensure the device itself is safe and performs as intended compared to a predicate, not clinical accuracy or AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for performance similar to how an AI algorithm would be evaluated. Instead, it lists the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices."

Study Proving Device Meets Acceptance Criteria:
The study described is a series of laboratory and bench tests comparing the LapBag® to a predicate device (MGB Disposable Retrieval Bag/LAPBAG, K093194). The objective was to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a novel medical AI algorithm. The tests show the LapBag® is comparable in physical, mechanical properties, and biocompatibility. The main difference highlighted is that LapBag® has a wider range of pouch sizes, and comparison tests (Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test) were performed to confirm equivalence despite this difference.

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

The document does not specify a "test set" in the context of clinical data or AI evaluation. The "tests" mentioned are engineering and material verification tests.

• Sample Size: Not explicitly stated for each test, but standard statistical sampling would be used for material and product testing.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based and conducted by the manufacturer, Sejong Medical Co., Ltd. (Republic of Korea).

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 the context of expert consensus for imaging or clinical diagnosis is not relevant to this type of device (a surgical retrieval bag). The "ground truth" for the material and performance tests would be the established scientific and engineering principles and standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in clinical studies, typically for diagnostic or screening devices. This is a material and performance validation for a surgical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this device. This is a surgical accessory, not a diagnostic imaging device or AI algorithm intended to assist human readers.

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

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and biocompatibility tests, the "ground truth" is defined by:

• International standards (e.g., ISO 11737-1, ISO 10993 series).
• Established scientific and engineering principles for material strength, leak integrity, and biocompatibility.
• Comparison to the performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI/machine learning device.

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The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.

This document is a 510(k) summary for the Laport® Trocars. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in a quantitative, statistical manner typically seen for complex AI/ML medical devices. Therefore, much of the requested information regarding statistical studies, expert adjudication, and sample sizes for training/test sets is not available in this document.

However, I can extract the information that is present and highlight the type of testing performed.

Type of Device: Surgical Trocar (not an AI/ML device)

Given that this is a 510(k) submission for a surgical trocar, physical and chemical performance tests are presented, not diagnostic or AI-driven performance metrics. Therefore, many of the questions related to AI/ML device testing (e.g., MRMC studies, ground truth establishment for AI, training set size) are not applicable or detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical trocar, acceptance criteria are generally qualitative or based on passing specific physical, chemical, and biological tests. The document describes the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices," implying successful completion of these tests. Specific numerical acceptance criteria or performance values are not provided in this summary.

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

• Sample Size (Test Set): Not explicitly stated in the document for any of the performance tests. For animal testing, it mentions "micropigs" but not the number of animals used.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study is described as "Non-Clinical(Animal) test using micropigs," implying a prospective animal study.

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

• For the non-clinical (animal) tests, it states "The operator (expert veterinarian) scored the experience." This indicates at least one expert, but the exact number and detailed qualifications (e.g., years of experience) are not provided beyond "expert veterinarian." This is not a "ground truth" establishment in the sense of clinical disease diagnosis, but rather an expert evaluation of device performance.

4. Adjudication method for the test set

• Not applicable/Not described. The expert veterinarian "scored the experience," suggesting a single evaluation per test, not a consensus or adjudication process involving multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No. This type of study is relevant for diagnostic devices (especially AI/ML image analysis) where human reader performance is being evaluated or compared. It is not applicable for a surgical trocar.

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

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

7. The type of ground truth used

• The concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, outcomes data) is not relevant for this device. For the performance tests, the "truth" is determined by meeting engineering specifications, ISO standards, and the assessment by an expert veterinarian for handling characteristics in an animal model.

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

Summary specific to the provided document:

The provided document describes a 510(k) submission for a surgical trocar (Laport®). The "acceptance criteria" discussed are primarily compliance with ISO standards for sterilization, biocompatibility, and various physical and mechanical performance tests (e.g., appearance, measurement, leakage, extraction). A non-clinical animal test was also conducted, where an "expert veterinarian" evaluated the device's insertion, fixation, extraction, intraperitoneal pressure management, and convenience for laparoscope use.

The document states that all tests demonstrated that the device is "substantially equivalent to the predicate devices." However, it does not provide quantitative performance metrics, specific numerical acceptance thresholds, or statistical analysis of the test results. The sample sizes for these tests are also not specified in this summary. This is typical for 510(k) summaries for such devices, where the focus is on demonstrating equivalence through a battery of standard tests rather than detailed statistical clinical trials, especially if it's not a novel technology or an AI/ML device.

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