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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 Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material.

The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

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This document is a 510(k) summary for a medical device, specifically a Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2). It outlines the FDA's determination of substantial equivalence. However, it does not contain information related to software algorithm performance, clinical study acceptance criteria, or the details of a study proving a device meets such criteria.

The document primarily focuses on:

• Regulatory Clearance: The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: The intended purpose of the surgical gowns (protection from microorganisms, body fluids, particulate matter) and their compliance with ANSI/AAMI PB70:2012 for liquid barrier performance (Level 2).
• Sterilization Method: Validation of ethylene oxide (EtO) sterilization.
• Device Models: A list of different models based on size, sterility, and whether they include hand towels and wrap.

Therefore, I cannot provide the requested information about acceptance criteria and study details from the provided text, as this document is a regulatory approval letter, not a performance study report.

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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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The STANDARD BOUGIE SB38 is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie (SB38) is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide. The Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.

This document is a 510(k) premarket notification for a medical device called the "Standard Bougie, 38 Fr. and Hand Pump" (K212728). The purpose of the submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of quantitative benchmarks for a novel diagnostic or treatment device. Instead, the submission for this Class II surgical accessory focuses on demonstrating substantial equivalence to a predicate device by comparing their technological characteristics and performing verification and validation activities.

The "acceptance criteria" are implicitly met if the device demonstrates equivalent performance and safety to the predicate device and introduces no new safety concerns. The "reported device performance" is demonstrated through nonclinical testing to ensure the added hand pump accessory does not negatively impact the device's original functions (suction, drainage, irrigation, insufflation, sizing) and maintains its safety profile.

Here's a summary derived from the "Overview of Substantial Equivalence" table and the "Performance Data" section:

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

The document primarily describes nonclinical performance data (bench testing) for the accessory component (Standard Bougie Hand Pump) and confirms the existing data for the main device (Standard Bougie SB38) remains applicable.

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers, as this is a nonclinical study. The "test set" refers to the devices or accessories subjected to the specified engineering tests (Transit and 1 yr Accelerated Aging, Performance Testing, Pressure Decay, Insufflation, Reliability Testing). The number of units tested per test is not detailed.
• Data Provenance: This is a submission for a medical device by Standard Bariatrics, Inc. located in Cincinnati, OH. The data would originate from internal company testing and validation activities. The document does not specify if any of the testing was conducted outside the U.S.
• Retrospective or Prospective: Not applicable as this is nonclinical (bench) testing of a medical device accessory, not a clinical study involving patients or patient data.

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 as the document describes nonclinical (bench) testing of a surgical accessory, not a diagnostic device that requires expert interpretation for establishing ground truth (e.g., radiologist for imaging, pathologist for tissue samples). The "ground truth" here is defined by engineering specifications, risk assessments, and established testing methodologies.

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

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human readers interpreting data where consensus is needed to establish ground truth. The tests described are objective engineering 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

This is not applicable. A multi-reader multi-case (MRMC) comparative effectiveness study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) assistance for human interpretation. The Standard Bougie and Hand Pump is a surgical accessory, not an AI-powered diagnostic tool.

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

This is not applicable. This question refers to the performance of an AI algorithm independent of human input. The device is a physical surgical tool with a mechanical accessory, not an algorithm.

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

The "ground truth" for this device, in the context of its nonclinical performance evaluation, is based on:

• Engineering specifications and design requirements: The device's ability to meet its functional requirements (e.g., insufflation pressure, reliability, transit resistance, aging effects) as defined by its design.
• Risk assessment: The demonstration that the device (especially the new accessory) does not introduce unacceptable risks.
• Comparison to predicate device: The fundamental "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it performs as safely and effectively.

8. The sample size for the training set

This is not applicable. A "training set" refers to data used to train machine learning models. This document describes the regulatory submission for a physical medical device, not an AI/ML product.

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

This is not applicable for the same reason as above (not an AI/ML product).

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The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are sterile and non-sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.

The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

Not Found

The provided text describes the regulatory clearance of a surgical gown and does not contain information about the acceptance criteria or a study related to a medical device's performance in terms of accuracy, sensitivity, specificity, or other typical performance metrics for diagnostic or AI-powered devices.

The document states that the "Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities." This indicates that the acceptance criteria for the gown's barrier performance are the Level 3 requirements of ANSI/AAMI PB70:2012. However, the document does not provide the specific reported performance values or details of the study that proves the device meets these criteria. It only asserts that it "meets" them.

Therefore, I cannot fill in the requested table or answer most of the questions as the necessary information is not present in the provided text.

Here's a breakdown of what cannot be extracted from the text:

• 1. A table of acceptance criteria and the reported device performance: The acceptance criterion mentioned is "Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance." However, the reported device performance against this standard (e.g., specific test results, values for hydrostatic pressure, impact penetration, etc.) is not detailed in the document.
• 2. Sample sized used for the test set and the data provenance: Not applicable as specific performance testing details are not provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 document is about surgical gowns, not an AI-powered diagnostic device or an AI assistance system.
• 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a surgical gown would be its physical barrier properties as measured by standardized tests.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document focuses on the regulatory clearance process for a medical device (surgical gowns) based on its compliance with established industry standards for barrier performance (ANSI/AAMI PB70:2012 Level 3) and sterilization validation (ethylene oxide process according to ISO 11135-1). It does not delve into the detailed results of the tests performed to demonstrate this compliance.

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The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS ™ stapler in vertical sleve gastrectorny pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The provided text describes the regulatory clearance of the "Standard Bougie, SB38" device and outlines its characteristics and comparison to a predicate device, along with a list of performance tests conducted. However, it does not provide detailed acceptance criteria or the specific results of those performance tests. The document states that "Standard Bougie SB38 performance testing has been submitted in this 510(k)", and then lists the types of tests. It concludes that "The conclusion drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device." but does not present the data itself.

Therefore, for aspects requiring specific numerical data, sample sizes, expert qualifications, or details of a study (like an MRMC study or standalone performance), the information is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document only lists the types of performance tests conducted. It doesn't specify the acceptance criteria for each test or the quantitative results achieved by the device against those criteria.

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

Not available in the provided text. The document lists performance tests but does not specify the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

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

Not applicable/available. The performance tests mentioned (Drainage Flow Rate Verification, Balloon Strength Verification, Balloon Size Verification, Balloon Firmness Verification, Tensile Strength Verification, Reliability Testing) appear to be engineering/mechanical tests rather than studies involving expert assessment of medical outcomes or images. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic device studies does not apply here.

4. Adjudication Method for the Test Set

Not applicable/available. As the tests are engineering/mechanical in nature, an adjudication method (like 2+1, 3+1) is not typically used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC comparative effectiveness study. The device is a "bougie," which is a physical medical instrument used as a sizing guide and for other functions during surgery, not a diagnostic imaging or AI device that would typically undergo an MRMC study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used

Not explicitly stated, but implied as engineering/physical measurements. For the listed performance tests (e.g., strength, size, flow rate), the ground truth would be based on precise physical measurements and engineering specifications, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable. As there is no training set for a physical device, this question is not relevant.

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The device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.

This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Sample Sizes: The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of masks tested for BFE, PFE, etc.). It only provides the average results for some tests.
• Data Provenance: The tests were conducted to support a submission from Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China. The data is from non-clinical laboratory testing performed on the physical samples of the medical masks. Since these are performance tests of a physical product, they are by definition prospective with respect to the testing itself, i.e., new samples are manufactured and then tested.

3. Number of Experts and Qualifications

• This document describes non-clinical performance testing of a physical device (medical mask). Therefore, it does not involve human expert consensus for establishing ground truth or evaluating diagnostic performance. The "ground truth" here is based on the standardized test methods and their defined outcomes.

4. Adjudication Method

• Not applicable. This is not a study requiring adjudication of expert opinions for ground truth. The tests are objective measurements based on standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This document explicitly states: "No clinical study is included in this submission." The testing is purely non-clinical, focusing on the physical and performance characteristics of the mask. An MRMC study would be relevant for diagnostic imaging AI, where human readers interact with AI.

6. Standalone Performance

• The reported performance data (BFE, PFE, Differential Pressure, etc.) represents the standalone performance of the device itself, as measured by standardized laboratory methods. It's important to note that "standalone" in this context refers to the device's inherent physical properties, not an "algorithm only without human-in-the-loop performance" typical of AI devices.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by international and national standard test methodologies (e.g., ASTM F1862/F1862M-17, ASTM F2101-2019, ASTM F2299/F2299M-03, EN 14683:2019, 16 CFR 1610, ISO 10993 series). These standards define the procedures and acceptance criteria for classifying the mask's performance.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical mask, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the manufacturing process would be ensuring the production consistently meets quality standards, which is demonstrated by the non-clinical tests on production samples.

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

• Not applicable. As stated above, this is not an AI/ML device requiring a "training set" with established ground truth labels by experts. The performance is assessed against established engineering and safety standards.

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The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.

• (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.

• The tray is intended for sterilization of non-porous loads.

• Do not stack trays during sterilization.

• The tested Tray represents the worst case validated load of 667.52 grams.

• Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.

The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.

The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.

The provided document is a 510(k) Summary for a medical device called the "Standard Sterilizable Tray." It outlines the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The document describes non-clinical testing for a sterilization tray, which is a physical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects for AI/ML device performance (like "human readers improve with AI," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," and "training set details") are not applicable to this submission. The information provided focuses on the physical and functional performance of the sterilization tray.

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

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

The document specifies the types of tests conducted (e.g., biocompatibility, cleaning validation, sterilization validation, transport simulation) but does not provide specific sample sizes (e.g., number of units tested) for each test.

• Data Provenance: The tests are described as non-clinical laboratory tests performed by the manufacturer (Implant Direct Sybron Manufacturing, LLC) to demonstrate the device's performance. The document does not specify the country of origin of the data beyond being associated with this manufacturer's testing, nor does it classify the data as "retrospective" or "prospective" in the typical sense for clinical studies; these are laboratory validation studies.

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

This question is not applicable to this type of device and study. The "ground truth" for a sterilization tray's performance is established by objective measurements and standardized test methods (e.g., chemical analysis for cleanliness, biological indicators for sterilization efficacy, visual inspection for degradation/damage, etc.), not by expert interpretation of images or clinical outcomes.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, where multiple human experts interpret data to create a consensus ground truth. For the physical and functional testing of a sterilization tray, results are typically determined by objective measurements and adherence to 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 question is not applicable. An MRMC study is designed for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission concerns a physical medical device (sterilization tray) and its non-clinical performance characteristics, not an AI/ML algorithm.

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

This question is not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no "algorithm only" performance to evaluate.

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

The "ground truth" for this device's performance is established by adherence to recognized international and industry standards (ISO, ASTM, TIR) and specific measurable criteria outlined within those standards for:

• Biocompatibility (cytotoxicity)
• Durability and continued performance over useful life (reprocessing cycles)
• Cleaning efficacy (residual protein and TOC)
• Sterilization efficacy (6-log reduction of biological indicators)
• Transportation durability (no damage)

These are objective, quantifiable measures derived from standardized laboratory tests, not subjective interpretations or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm. There is no "training set."

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

This question is not applicable for the same reasons as #8.

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The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

The Standard Trocar is a single-patient-use disposable trocar manufactured from biocompatible medical plastics. The device is comprised of a trocar cannula, obturator, 5 mm adaptor, and introducer sheath. The Standard Trocar is a sterile, single patient use surgical instrument intended to establish a port of entry for 19mm outer diameter instruments to be used during minimally invasive procedures. The 5 mm adaptor provides the means for the trocar to also be used with 5 mm diameter instruments. The trocar is compatible with commercially available laparoscopic instruments. In addition, as Standard Bariatrics develops additional laparoscopic instruments, the Standard Trocar will accommodate those devices. The Standard Trocar is sterilized using gamma irradiation and provided to the user in a Tyvek tray with peel lid.

The provided text describes the 510(k) premarket notification for the "Standard Trocar" and compares it to a predicate device, the "Applied Medical Modular Trocar." This document is a regulatory submission to the FDA, not a study report on an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.

The document discusses performance testing for a medical device (trocar) in terms of its physical and mechanical properties, biocompatibility, and usability, demonstrating substantial equivalence to a predicate device. It does not involve any AI components, ground truth, expert consensus for AI model evaluation, or MRMC studies.

Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML device evaluation.

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The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide.

The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The provided text is a 510(k) summary for the Standard Bougie device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

The "Performance Data" section (VII) lists several types of verification and testing, such as "Drainage Flow Rate Verification," "Balloon Strength Verification," and "Device Usability." These tests are likely related to the physical and functional performance of the bougie itself, not to an AI system's diagnostic accuracy or a human-AI team's effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them from the provided text. The document describes a medical device (a bougie) used in bariatric surgery, not an AI or imaging diagnostic device.

To answer your request, I would need a different document that details the development, validation, and performance studies of an AI-powered medical device.

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