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The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery.

The intended use for the 12 mm & Stapler Accessories is unchanged from what was cleared in K140553 (EndoWrist Stapler 45, Stapler 45 Reloads). They are being submitted again in this 510(k) to clear them for use with the subject device, da Vinci® Xi (IS4000) 12 mm Endoscope.

The indications for use for the 12 mm Endoscope Sterilization Tray is a modification of the indication statement for the Endoscope Sterilization Tray (K133942). The model numbers for the 12 mm Endoscope have been added. Steris V-Pro was also validated and therefore added to the indication statement. Finally, the maximum weight of the tray and endoscope has been adjusted to reflect the weight of the modified subject devices. The resulting indications for use for the 12 mm Endoscope Sterilization Tray are as follows:

The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles:

• · STERRAD 100NX sterilization system using the Express cycle
• · STERRAD 100S sterilization system using the Standard cycle
• Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · Steris V-PRO 1 using the V-PRO cycle

The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

The Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories use the existing endoscopic imaging system submitted in K131861 (cleared March 28, 2014). The 12 mm rigid endoscopes come in both 0° and 30° angles for use through 12 mm ports.

Entry to the body cavity and maintenance of pneumoperitoneum are facilitated through the use of a12 mm & Stapler cannulae (both standard and long lengths), blunt obturators (also in standard and long lengths) and the 12 mm & Stapler Cannula Seal.

The Endoscope Sterilization Tray (an accessory to the 12 mm endoscope) is a thermoformed plastic tray with silicone inserts, a plastic lid, and a stainless steel cover. The tray, lid, and cover contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci 12 mm endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100S. STERRAD 100NX Express and Steris V-Pro sterilization systems.

The provided document is a 510(k) summary for the Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria for a new type of device. Therefore, the document does not contain a typical "acceptance criteria" table with specific performance thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic device) and reported device performance against those thresholds in the way one might expect for a diagnostic or AI-powered device.

Instead, the acceptance criteria for this device are implicitly tied to meeting the design requirements and demonstrating functionally acceptable performance and equivalence to predicate devices through various tests.

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

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

As mentioned, there isn't a table of explicit quantitative acceptance criteria with numerical performance metrics for the endoscope's primary function in the way you might see for a diagnostic device. The acceptance criteria are broadly defined by meeting design requirements and ensuring clinically acceptable performance. The reported performance is that all tests "PASSED," indicating the device met the predefined pass/fail criteria (which are not explicitly detailed numerically in this summary).

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

• Design Verification (12 mm Endoscope): Sample sizes up to six units were used.
• Design Verification (12 mm Endoscope Sterilization Tray): Sample sizes up to four units were used.
• Reliability (Life, 12 mm Endoscope): A sample size of nine was used.
• Animal Testing (Design Validation): Testing was conducted across three labs using three porcine.
• Animal Testing (Device Comparison): Two porcine were used in various setups (pelvic, upper GI, kidney).
• Animal Testing (Surgeon Evaluation): Testing was completed across three labs, utilizing canines or porcine.

Data Provenance: The document does not specify the country of origin of the data. The animal testing and usability studies appear to be prospective in nature, as they involve conducting new tests and evaluations on the 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)

• For the Animal Testing (Surgeon Evaluation), six independent, external surgeons served as evaluators to complete vision assessments. Their specific qualifications (e.g., years of experience, specialization) are not detailed in this summary, but they are described as "independent, external surgeon evaluators."

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

The document does not explicitly state an adjudication method (like 2+1, 3+1) for establishing ground truth or resolving discrepancies in performance evaluations. The surgeon evaluations mention "All evaluators found each vision criteria clinically acceptable and safe for the subject device," suggesting a consensus or individual assessment against predefined criteria rather than a multi-reader adjudication process for a discrete 'ground truth'.

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, an MRMC comparative effectiveness study was not done. This document pertains to a surgical endoscope and its accessories, not an AI-assisted diagnostic or image interpretation device. There is no mention of AI or human readers improving with AI assistance.

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

• No, a standalone algorithm-only performance study was not done. This device is an endoscope for human surgeons, not an algorithm.

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

• For the performance tests, the "ground truth" seems to be established by predetermined "objective pass/fail criteria" defined in protocols, visual inspections, functional testing, and "clinically acceptable performance" as assessed by external surgeons (a form of expert consensus for clinical utility).
• For the animal studies, the "ground truth" for the device's performance against user needs and intended use was based on its ability to complete various surgical and visualization tasks.

8. The sample size for the training set

• This document describes performance testing for a physical medical device (an endoscope and its sterilization tray). It does not involve machine learning or AI algorithms with "training sets." Therefore, this question is not applicable.

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

• Not applicable, as there is no training set for an AI algorithm mentioned in this document.

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The Intuitive Surgical EndoWrist Stapler 45. Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The subject 12 mm & Stapler Bladeless Obturator (Bladeless Obturator) is used with the 12 mm & Stapler Cannula (Cannula) and 12 mm & Stapler Cannula Seal (Cannula Seal) to facilitate placement of the Cannula in the body wall. The Bladeless Obturator consists of three components - a shaft, a handle, and two latches that allow it to latch onto the Cannula Seal. The handle is made of Radel R-550 while the shaft and the two latches are made of stainless steel. The subject device is a reusable device and is offered in two lengths (standard and long) to match the Cannula lengths and meet users' needs.

The document provided is a 510(k) summary for the Intuitive Surgical 12 mm & Stapler Bladeless Obturators. It describes the device, its intended use, and the performance data used to demonstrate substantial equivalence to a predicate device. However, this document does not contain the level of detail requested in your prompt regarding acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or detailed ground truth methodologies typically found in AI/ML device submissions.

Here's what I can extract and confirm, and what cannot be provided based on the given text:

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

The document states that "Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its intended use." However, specific quantitative acceptance criteria and corresponding reported device performance values are not provided in this summary. Instead, it lists the types of tests performed:

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 mentions "tests with an animal model were performed" for design validation. However, the sample size for this animal model study is not provided. Data provenance (country of origin, retrospective/prospective) is also not 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 type of information is typically relevant for studies involving human interpretation (e.g., medical imaging assessment). Since this device is a surgical accessory (obturator), and the performance testing described involves mechanical and physical attributes, as well as an animal model, the concept of "experts establishing ground truth" in the way it's used for AI/ML performance evaluation (e.g., radiologists reviewing images) does not directly apply here. The "ground truth" for these types of tests would be established by the physical and functional specifications of the device.

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

Not applicable in the context of the device and testing described. Adjudication methods are typically used in studies where there's variability in human expert assessment (e.g., multiple radiologists disagreeing on a diagnosis), which is not the nature of the tests for this surgical accessory.

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 is an AI/ML specific study design. The document describes a traditional medical device (surgical obturator) and its performance validation, not an AI/ML algorithm. Therefore, an MRMC study and AI-assisted human reader improvement are not applicable and not mentioned.

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

This is an AI/ML specific concept. The device is a physical surgical tool; it is not an algorithm, so standalone algorithm performance is not relevant.

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

As explained in point 3, the "ground truth" for this type of device's performance would be derived from:

• Mechanical specifications: e.g., precise dimensions, force tolerances for axial load bearing.
• Functional requirements: e.g., maintaining insufflation, not catching on tissue.
• Animal observation: For the animal model study, the "ground truth" would be the direct observation of the obturator's interaction with tissue and its latching mechanism working as intended (or not).

8. The sample size for the training set

This is an AI/ML specific concept. The device is a physical surgical tool; it is not an AI/ML algorithm, so 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 this device.

In summary: The provided document is a 510(k) summary for a traditional medical device (a surgical obturator). It outlines performance testing (design verification and validation) to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed statistical and methodological information (e.g., specific acceptance criteria values, sample sizes for test sets, expert qualifications, AI/ML-specific study designs like MRMC or standalone performance, and detailed ground truth establishment) that would be present in a submission for an AI/ML-driven device. The information provided is typical for a Class II non-AI device where engineering and animal model testing are the primary means of demonstrating safety and effectiveness.

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