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XNY Disposable Gastric Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.

The XNY Disposable Gastric Calibration Tubes are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch. The device has the advantages of accurately determining residual gastric capacity and easy positioning, and it can be connected to a suction device to extract the gas or liquid in the patient's stomach.

The XNY Disposable Gastric Calibration Tube is a Class II medical device used in gastric and bariatric surgical procedures. The 510(k) summary provides information on the device's acceptance criteria and performance through various bench tests.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the exact sample size used for each individual test or the overall test set. The tests performed are bench studies ("non-clinical assessments") which are typically conducted in a laboratory setting. There is no information provided about the country of origin or whether the data is retrospective or prospective, as these are not relevant for bench testing of this type of device.

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

This information is not applicable to the provided data. The listed tests are objective, performance-based bench tests that do not involve expert interpretation or subjective ground truth establishment like in clinical image analysis or diagnostic studies. The acceptance criteria are based on measurable physical properties and functional performance, not expert consensus.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where subjective interpretations or disagreements among experts need to be resolved to establish a ground truth. The tests performed for this device are objective bench tests with pass/fail criteria.

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 information is not applicable. The device is a "Disposable Gastric Calibration Tube," which is a physical surgical tool and not an AI-powered diagnostic or assistive technology that would involve human readers or image interpretation.

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

This information is not applicable. The device is a passive physical medical instrument, not an algorithm or software-based system.

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

The "ground truth" for the performance tests of this device is based on objective, measurable physical and functional properties as defined by the acceptance criteria. For example, the firmness is measured in Newtons, aspiration function by volume and time, and dimensions by standard measurements. Biocompatibility relies on established ISO standards.

8. The sample size for the training set:

This information is not applicable. This device is a physical medical instrument, not a machine learning model, and therefore does not have a "training set" in the context of AI development. The "training" for a manufacturing process would involve quality control and process validation, which is distinct from an AI training set.

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

This information is not applicable, as there is no "training set" for this type of medical device as described in the context of AI.

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The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.

The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, are basic equipment used during laparoscopic surgical, which consist of Puncture Needle, Puncture Sleeve, Injection Valve, Cap and Safety lock. They are available in multiple configurations, including bladed type, bladeless type and optical type. In order to obtain access to the surgical site during laparoscopic surgery, the Puncture Needle is introduced into Puncture Sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the Injection Valve at its proximal end and once the abdominal/thoracic wall is punctured, the puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. Generically, puncture needle and sleeve are available in a range of lengths and diameters to accommodate different sizes surgical instrument

Here's an analysis of the provided text regarding the acceptance criteria and study that proves the device meets them, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes performance tests and states that the proposed devices performed comparably to predicate devices, concluding "no adverse indications or results." The "performance" column below summarizes the tests performed and the general findings.

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

• Sample Size for Test Set: Not explicitly stated for any of the performance or biocompatibility tests. The document only mentions "an in vivo study was conducted on porcine model" without specifying the number of animals or trials.
• Data Provenance: The tests were conducted by the manufacturer, Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. The in vivo study was done on a porcine model, indicating animal testing. The specific country where these tests took place is not stated, but the manufacturer is based in China. The data is prospective for the tests conducted to support this submission.

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

• This information is not provided in the document. The statement "results demonstrated that the performances of the proposed device are substantial equivalent to those of the predicate device" implies internal evaluation of test results, but no details on experts or their qualifications for establishing a "ground truth" are given for these types of tests (e.g., force measurements, leak resistance, biocompatibility).

4. Adjudication Method for the Test Set

• This information is not provided as these are objective performance and biocompatibility tests, not subjective interpretations requiring adjudication.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was done."

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

• This question is not applicable to this device. This is a physical medical device (trocar), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the objective measurements and established standards for physical device performance (e.g., force values, leak rates, biological response to materials, sterility assurance levels) as defined by international standards (ISO, ASTM, USP) and general safety/performance requirements for medical devices. The comparison is also made against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

• This question is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Stapler has application in the resection of tissue for abdominal. gynecological, pediatric and thoracic surgical procedures.

The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance and biliary structures.

The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.

The Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids.

The Disposable Linear Stapler places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 90mm staple line length for use in various applications. Two staple sizes (3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.

Disposable Circular stapler place a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. It is available in 20, 22, 24, 26, 29, 32mm six specifications. Two staple sizes (4.7mm and 5.6mm) are available to accommodate various tissue thicknesses.

Disposable Endoscopic Linear Cutter Stapler and Cartridge places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.

Disposable Linear Cutter Stapler Cartridge places a two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.5mm. It may be reloaded and fired up to 5 times for a total 6 firings in a single procedure.

Disposable Circular Stapler for Hemorrhoids is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The device is available in 34mm with 4.6mm staple.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance in the format you specified.

The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed study proving the device meets specific acceptance criteria in the way you've outlined.

Here's what the document does provide and why it doesn't fit your request:

• Non-Clinical Test Conclusion: It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It lists several ISO and ASTM standards that the device complies with, in areas such as biological evaluation, sterilization residuals, irritation/hypersensitivity, bacterial endotoxins, and seal strength of packaging.
• No Clinical Study: It explicitly states, "No clinical study is included in this submission."
• Comparison Tables (Tables 1-5): These tables compare the proposed devices (various staplers) with predicate devices on technical characteristics like product code, regulation number, intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization method, endotoxin limit, and labeling. This comparison is to establish "substantial equivalence," not to detail acceptance criteria and performance against those criteria as a standalone study.

Therefore, I cannot extract:

1. A table of specific acceptance criteria and reported device performance. The document only mentions compliance with standards.
2. Sample size, data provenance, number of experts for ground truth, adjudication method, or ground truth type for a test set of a performance study.
3. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance.
4. Sample size and ground truth establishment for a training set.

The document's purpose is to demonstrate that the new devices are as safe and effective as already marketed devices, primarily through comparison of technical characteristics and adherence to general performance standards, rather than presenting a novel performance study against defined acceptance criteria.

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