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Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.

The provided document is a 510(k) summary for a medical device called "Standard Staple-Line Reinforcement (SSLR23)". It describes the device, its intended use, comparison to a predicate device, and a summary of performance testing. However, it does not include information about acceptance criteria and reported device performance in a table format, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested.

The document states: "Pre-determined performance specifications were evaluated, tested and verification/validation activities were completed to demonstrate that the subject device... met the defined criteria. Testing on the subject device included reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility per applicable parts of ISO 10993-1, Biological evaluation of medical devices. Sterilization and packaging validation activities were also completed to support this submission."

It also explicitly says: "No clinical studies were required to support this 510(k) submission."

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a detailed study with specific acceptance criteria and performance metrics for a standalone device or comparative effectiveness.

Here's a breakdown of why I cannot fulfill each requested point:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. While it mentions "pre-determined performance specifications were evaluated" and "met the defined criteria", it does not list these criteria or the specific performance results in detail.
2. Sample sized used for the test set and the data provenance: This is not specified. The document mentions "testing on the subject device" but gives no details about sample sizes or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-driven ground truth establishment for a test set is mentioned. The testing appears to be primarily engineering/laboratory-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no adjudication process involving human review of test set results is described.
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. The device is a "Staple-Line Reinforcement" which is a physical surgical mesh, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states that "No clinical studies were required to support this 510(k) submission," implying that the testing was primarily non-clinical (e.g., bench testing, biocompatibility). It doesn't detail standalone performance in a clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, as the testing described ("reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility, sterilization and packaging validation activities") would likely rely on physical measurements and standardized test methods rather than clinical ground truth sources like pathology or outcomes data.
8. The sample size for the training set: Not applicable. The device is a physical medical device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® Stapler in vertical sleeve gastrectomy pouch creation for the application, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Tapered Bougie, 38Fr (STB38) is a non-sterile, single patient use device. The device comprises a tube with a rounded tip featuring drainage holes, and a tapered balloon at the distal end. The proximal end of the Standard Tapered Bougie, 38Fr (STB38) includes a standard Luer lock valve for balloon inflation/deflation using the 60mL/CC syringe (provided) and a 7.5mm inner diameter straight tube for connection to operating room suction, Standard Bougie Hand Pump (SBHP) or tapered tip syringe.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Standard Tapered Bougie, 38Fr (STB38)". It outlines the device's characteristics, intended use, and comparison to a predicate device.

However, this document does NOT contain information about acceptance criteria for an AI/ML-based device, nor does it describe a study involving human readers, ground truth establishment by experts, or any MRMC (Multi-Reader Multi-Case) studies.

The "Performance Data" section (VII) lists various engineering and bench tests performed on the physical device (e.g., Dimensional Verification, Drainage Flow Rate Verification, Tensile Strength Verification, Biocompatibility Testing). These are typical performance tests for physical medical devices and do not relate to the performance of an AI/ML algorithm or its impact on human reader performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI/ML device based on the provided text, as the text describes a physical device, not an AI/ML system.

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