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The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.

The provided text does not describe the acceptance criteria or a study proving that a device meets specific acceptance criteria related to an AI/ML medical device.

Instead, the document is an FDA 510(k) summary for a linear cutting stapler and loading unit, which is a physical surgical device, not an AI/ML product. The summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests (e.g., biological evaluation, seal strength, ex-vivo tissue tests) and comparisons of technological characteristics (e.g., product code, intended use, staple height, materials).

Therefore, I cannot extract the information required for an AI/ML device study, such as sample size for test sets, data provenance, number of experts, MRMC studies, or ground truth establishment methods for an AI model.

The sections that are present in the document and relate to device performance are:

Acceptance Criteria/Performance Testing (Non-Clinical Tests):

• Ex-vivo tissue test was conducted on porcine stomach and intestine tissue.
  • Test items evaluated: Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test, and Force Required to Fire Stapler Test.
• Jugular vein test was conducted on a porcine model for thin tissues (less than 2.5mm staple height).
  • Evaluated: Burst pressure and closed staple formation.
• Biological evaluation: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), USP 43-NF38 (Pyrogen Test), USP 42-NF 37 (Bacterial Endotoxins Tests).
• Material properties: ASTM F88/F88M-15 (seal strength).
• Sterilization validation: ISO 11137-2 (sterilization dose).

Reported Device Performance:

The document states, "The test results demonstrated that the proposed device complies with the following standards" and lists the standards. It implicitly states that the performance met the requirements of these standards. For the ex-vivo and jugular vein tests, it notes what was evaluated but does not provide specific quantitative results or acceptance criteria values for these tests in this summary.

Regarding AI/ML specific information, the document explicitly states:

• "No clinical study is included in this submission." This means no human-in-the-loop or standalone clinical performance trials were conducted or are reported here, which would be typical for AI/ML validation.

In summary, none of the specific AI/ML related questions can be answered from this document because it pertains to a mechanical surgical stapler, not an AI/ML medical device.

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The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.

The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.

This document describes the FDA's 510(k) clearance for the easyPPH™ Hemorrhoidal Stapler for Single Use (K183477). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving independent acceptance criteria for a novel AI/imaging device. Therefore, many of the requested elements for describing a study proving an AI device meets acceptance criteria are not applicable in this context.

However, I can extract the relevant information regarding the non-clinical tests used to support the substantial equivalence claim.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

The document primarily relies on non-clinical performance and biocompatibility tests to demonstrate substantial equivalence to a predicate device. It doesn't explicitly state distinct "acceptance criteria" with numerical thresholds alongside "reported device performance" in a table format for each test. Instead, it states that the tests verified that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The implication is that the proposed device's performance in these non-clinical tests was comparable to or within acceptable limits relative to the predicate.

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

• Sample Size: Not specified for each non-clinical test. The document states "performance tests were performed on both proposed device and predicate device" but does not quantify the number of units tested.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific labs). These were non-clinical, in-vitro/bench tests. The applicant is Ezisurg Medical Co., Ltd. located in Shanghai, China, suggesting the testing was likely conducted in China. The data would be considered prospective for the purpose of this submission.

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

• This is not applicable as this is a medical stapler device, not an AI or imaging device requiring expert consensus for ground truth on a test set. The "ground truth" for the non-clinical tests would be the objective measurements obtained through standard test methods.

4. Adjudication Method for the Test Set

• Not applicable for non-clinical bench testing.

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. The study was non-clinical.

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

• Not applicable. This is not an AI algorithm. Its performance is inherent to the physical device.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" was established by objective laboratory measurements based on recognized standards (e.g., ISO, ASTM, USP) for properties like staple dimensions, firing force, tensile strength, and biocompatibility. The comparison was primarily against the predicate device's characteristics and the device's own design specifications.

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.

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The easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.

The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure.

The easyCS™ Circular Stapler for Single Use places 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. The stapler is available in 21mm, 29mm, 31mm and 33mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

The provided document is a 510(k) Summary for medical stapling devices (easyLC™ Linear Cutter Staplers and easyCS™ Circular Stapler). It describes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices, but does not include information about clinical studies or acceptance criteria for AI/algorithm performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document indicates:

Clinical Test Conclusion (Section 7):

• "No clinical study is included in this submission."

This means the submission relies entirely on non-clinical (bench and biocompatibility) testing to demonstrate substantial equivalence.

Non-Clinical Test Conclusion (Section 6):
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The tests included:

• Standards Compliance:
  • ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
  • ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
  • ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
  • USP 38-NF 33 Bacterial Endotoxins Tests
  • ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
  • ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
  • USP 39-NF 34 Pyrogen
• Bench Tests (on porcine stomach and intestine):
  • Pressure Resistance Test
  • Closed Staple Dimension Test
  • Staple Formation Test
  • Force Required to Fire Stapler Test
• Biocompatibility Tests:
  • Cytotoxicity
  • Irritation
  • Skin sensitization
  • Pyrogenicity

Ground Truth for Non-Clinical Tests:

• The ground truth for these non-clinical tests is inherently defined by the physical and biological properties being measured (e.g., pressure resistance in standard units, staple dimensions, visual inspection of staple formation, force measurements, and standard assays for biocompatibility). There are no "experts" establishing ground truth in the sense of medical image interpretation; rather, the tests themselves provide objective measurements against established scientific and engineering standards.

Training Set:

• This concept is not applicable as this is a mechanical device, not an AI/ML algorithm.

In summary, the provided document does not contain the information required to answer your questions because it describes the regulatory submission for a physical medical device (staplers) based on non-clinical testing, not an AI-powered diagnostic or assistive device that would have acceptance criteria related to algorithm performance.

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The devices are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of easyEndoTM Linear Cutting Stapler and Loading Units for Single Use are available in three staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm and 4.8mm. Reloads of easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use are available in four staple sizes to accommodate various tissue thickness: 2.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.

The provided text is a 510(k) summary for the easyEndo™ Linear Cutting Stapler and Loading Units, a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical performance and design comparisons. It does not present a study with specific acceptance criteria that the device meets numerically, as would be expected for an AI/ML device.

Therefore, I cannot fully answer your request by filling out the table and detailed points as it's designed for an AI/ML device evaluation. The information provided is a premarket notification for a traditional medical device, where "acceptance criteria" are typically met through adherence to recognized standards (e.g., ISO, ASTM, USP) and direct comparison to predicates.

Here's a breakdown of why and what information can be extracted/inferred:

Why the Request Cannot Be Fully Answered as Posed:

• No AI/ML Component: The device is a mechanical stapler, not an AI/ML system. Therefore, concepts like "algorithm only without human-in-the-loop performance," "effect size of human readers improving with AI," "training set," "ground truth for training set," "number of experts for ground truth," and "adjudication method" are not applicable.
• "Acceptance Criteria" Different: For a traditional device like this, "acceptance criteria" are implied by compliance with performance standards and the demonstration of equivalence to legally marketed predicate devices. There isn't a specific quantitative "accuracy" or "performance metric" with a numerical threshold tied to the device's function that is then measured in a study. The "performance test" section describes what was tested, but not the specific thresholds for "acceptance."
• No "Study" as Defined for AI/ML: The document describes "non-clinical tests" (bench testing) and states "No clinical study is included in this submission." This means there wasn't a comparative clinical trial to measure human-in-the-loop performance or standalone performance in a real-world setting against a defined ground truth.

Extracted Information (and why some points are N/A):

Based on the provided text, here's what can be addressed:

• Device Name: easyEndo™ Linear Cutting Stapler and Loading Units for Single Use, easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use

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

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