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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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