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The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Skeletal Dynamics Proximal Humerus Fixation System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

This document is a 510(k) K242436 FDA clearance letter for the Skeletal Dynamics Proximal Humerus Fixation System. It primarily focuses on demonstrating substantial equivalence to existing devices through performance testing, rather than reporting on a study with acceptance criteria and device performance as typically seen for AI/ML-based devices. Therefore, a direct response to some of the requested categories (like number of experts, adjudication method, MRMC study, training set details) will not be available in this document.

Here's the information extracted from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This device is a mechanical fixation system, not a software or AI/ML device that uses a "test set" of data in the common sense. The "testing" refers to mechanical performance testing of the hardware components.

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

Not applicable. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this hardware device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for evaluating human or AI interpretations of medical images or data, not for the mechanical testing of orthopedic implants.

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

No. This document does not mention any MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device (orthopedic implant), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this mechanical device is based on established engineering standards and measurements as defined by ASTM F382-17 for plates and ASTM F543-23 for screws. The comparison is made against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.

The Proxima Model-100 is an electronic oxygen conserving device designed for use in a hospital environment. It incorporates a sensitive pressure sensor to detect inhalation, an electronic valve to deliver precise volume of oxygen and a graphical touch screen interface. In pulsed mode the Proxima delivers flows equivalent to 1 to 15 liters per minute of continuous oxygen flow. The volume of each bolus is calculated such that the patient receives the equivalent of the set volume regardless of how slow their breath rate is. To make sure the patient receives oxygen, even if inhalation is not detected, the Proxima automatically changes from pulsed to continuous oxygen flow at the set flow rate if inhalation is not detected for 15 seconds. Proxima displays a warning message to indicate low battery, low oxygen supply pressure, dislodged cannula, lack of inhalation and low nasal airflow. The Proxima is powered using an external 9-volt DC power supply and includes an internal back-up battery. The Proxima is for use with a customer supplied, dual lumen demand nasal cannula, for example the Salter Labs 4807 or similar, to ensure proper patient usage.

The provided text is a U.S. FDA 510(k) summary for a medical device called "Proxima". It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence for regulatory clearance.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or algorithmic performance study, as typically seen for AI/ML-enabled devices.

The "acceptance criteria" section you're asking for typically refers to the pre-defined performance thresholds (e.g., minimum accuracy, sensitivity, specificity, or clinically relevant metrics) that an AI/ML algorithm must meet on a test set to be considered acceptable. The "study that proves the device meets the acceptance criteria" would detail the methodology of that study, including test set characteristics, ground truth establishment, expert involvement, and the actual performance metrics achieved by the device.

The provided document focuses on bench testing for the Proxima device, which is an oxygen conserving device, not an AI/ML diagnostic or prognostic tool. The performance testing mentioned (ISO 80601-2-67) evaluates physical parameters like pulse volume, breath rate, oxygen delivery, continuous flow, leak compensation, and breath trigger pressure. These are engineering and functional performance tests for a hardware device, not a performance study for an AI/ML algorithm.

Therefore, based solely on the provided text, I cannot extract the information required to populate your requested table and answer questions 1-9 about AI/ML device performance studies. The document describes a traditional medical device clearance, not an AI/ML device.

If the "Proxima" device were an AI/ML product, the information would typically be found in sections detailing clinical performance studies, often in the "Performance Data" or "Clinical Data" sections of a 510(k) summary, which are absent or not relevant in this document for the type of device described.

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The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.

The Proximal Humerus Plating System is an internal fixation plate system to be used for proximal humerus fractures. The system consists of plates, screws, and locking caps. The Proximal Humerus Plates are available in two lengths, and are side-specific. The Proximal Humerus Plating System Screws are 3.5mm in diameter and available in various lengths.

This document describes a 510(k) premarket notification for the "Proximal Humerus Plating System," a metallic bone fixation device. The submission primarily relies on non-clinical performance testing to establish substantial equivalence, common for Class II devices of this nature.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes (number of plates/screws tested) for mechanical testing. It mentions "non-clinical (laboratory/performance) testing." The data provenance is laboratory testing, not from human subjects or patient data.

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

Not applicable. The ground truth for this device is based on compliance with engineering standards (ASTM F382-99 and ASTM F543-07) and mechanical testing data, not expert human interpretation of medical images or conditions.

4. Adjudication Method for the Test Set:

Not applicable. There was no human expert adjudication involved in establishing the "ground truth" for the mechanical performance of this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The device is a surgical implant, and its effectiveness is determined by its mechanical properties and surgical outcomes, not by reader performance in interpreting imaging data.

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

Not applicable. This device is a physical medical implant, not an algorithm or AI-powered system, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used:

The ground truth used is based on engineering standards and mechanical testing data. Specifically, the device's performance was compared against the requirements and methodologies outlined in ASTM F382-99 for bone plates and ASTM F543-07 for bone screws.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant; therefore, it does not involve a "training set" in the context of machine learning or AI.

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 DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

The technological characteristics of the DePuy Proximal Tibia Plating System are similar to the predicate devices including design and material.

This document is a 510(k) summary for a medical device called the "Proximal Tibia Plating System." It describes the device's intended use and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

The document states: "The DePuy Proximal Tibia Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised." This indicates that the demonstration of substantial equivalence relied on pre-clinical data, likely bench testing or engineering analyses, rather than clinical studies involving human subjects or extensive performance evaluations against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Based on the provided text, the following information is NOT available:

1. A table of acceptance criteria and the reported device performance: This document only describes the device and its intended use, not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: No test sets or clinical data are mentioned. The equivalence is based on "pre-clinical data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication is mentioned.
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 device is a bone fixation system, not an AI-powered diagnostic tool, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm.
7. The type of ground truth used: Not applicable, as there's no clinical performance study described.
8. The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.

The provided text describes a medical device submission (510(k)) for the Proximal Humerus Scaffold Fixation System (PHSFS). This is a device for surgical fixation, not an AI/ML powered device, therefore the typical metrics for AI/ML device evaluations (like sensitivity/specificity, AUC, agreement with ground truth, MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth) are not applicable in this context.

This document describes a medical device, not an AI/ML powered device. Therefore, the standard AI/ML acceptance criteria and study components requested in the prompt (e.g., sensitivity, specificity, MRMC studies, training/test set sizes, expert qualifications) are not relevant to this content.

Instead, the acceptance criteria for this type of device are primarily based on substantial equivalence to a legally marketed predicate device and compliance with recognized consensus standards.

Here's an interpretation of the provided information in the context of a 510(k) submission for a non-AI medical device:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A) for an AI/ML context.
• For a mechanical medical device, "test set" typically refers to the physical units subjected to material and mechanical testing. The document does not specify the number of units tested, but rather refers to ASTM standards and "multi-parameter comparison of mechanical performance" implicitly requiring testing on a sufficient number of samples to demonstrate compliance and equivalence.
• Data Provenance: The data comes from the manufacturer's (TOBY Orthopaedics) internal testing and comparisons, implicitly conducted in the USA (where the company is located and the submission is made to the FDA). The data is retrospective in the sense that it evaluates the device after its design and manufacturing, but for a 510(k), it's a pre-market submission demonstrating intended performance.

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

• Not Applicable (N/A) for an AI/ML context.
• For this type of device, "ground truth" is established by adherence to engineering standards (e.g., ASTM) and demonstrated performance relative to a predicate device. This is typically evaluated by engineers and materials scientists with expertise in biomechanics, materials science, and medical device design. The document does not specify the number or qualifications of individuals who performed or reviewed these tests, but it is implied they were qualified professionals.

4. Adjudication Method for the Test Set

• Not Applicable (N/A) for an AI/ML context.
• For a mechanical device, "adjudication" usually refers to the process of reviewing test results against predefined acceptance criteria. This would typically involve internal quality control and regulatory affairs professionals from the manufacturer, and subsequently, the FDA reviewers in the Office of Device Evaluation. The document doesn't detail the internal adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC study was NOT done. This type of study is specific to AI/ML devices or diagnostic imaging interpretation where human readers' performance is being evaluated.
• For this mechanical device, comparative effectiveness is demonstrated by showing "substantial equivalence" of technological and performance characteristics to a predicate device.

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

• Not Applicable (N/A). This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

• Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is compliance with established engineering material standards (ASTM F136-02a, ASTM F899-07) and the known, safe, and effective performance of the legally marketed predicate device (Synthes LCP Proximal Humerus Plate). The ground truth for materials is defined by the ASTM specifications, and for functional performance, it is defined by the predicate device's established mechanical properties.

8. The sample size for the training set

• Not Applicable (N/A) for an AI/ML context. There is no "training set" for a mechanical device. The design and manufacturing processes are refined through engineering development, prototyping, and testing, but not in the "training" sense of machine learning.

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

• Not Applicable (N/A) for an AI/ML context. As there is no training set as understood in AI/ML, this question does not apply. The materials and performance characteristics of the device were chosen based on established engineering principles, regulatory requirements, and the characteristics of the predicate device.

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The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The PROXIMATE PPH Hemorrhoidal Circular Stapler (PPH03) is available in a 33mm diameter size only. The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).

The provided document is a 510(k) summary for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone algorithm-only performance study.
• Type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states that the "Technological and Performance Characteristics The technological and performance characteristics of the device remain unchanged." This indicates that the device being submitted is a modification or re-submission of an existing device (or one substantially equivalent to an existing device) and therefore, extensive new clinical performance data to meet specific acceptance criteria is typically not required or presented in this type of submission. The FDA's review in this case focuses on ensuring that the device is as safe and effective as a legally marketed predicate device.

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The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired.

The provided text describes a 510(k) submission for the PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories. However, it does not contain information about acceptance criteria, device performance, sample size for testing or training, expert qualifications for ground truth, or adjudication methods.

The submission is primarily focused on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and clinical evidence in the form of published clinical data and other information, rather than a new clinical study with specific performance metrics and acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis based on the available information:

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

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

• Sample Size: Not specified. The submission refers to "Published clinical data and other information" without detailing specific studies or sample sizes.
• Data Provenance: 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)

• Not applicable/Not specified. The submission relies on existing clinical data and the substantial equivalence principle, not a new test set with expert-established ground truth.

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

• Not applicable/Not specified.

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, this is not an AI-based device, and no MRMC study is mentioned.

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

• Not applicable. This is a surgical stapler, not an algorithm.

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

• Not explicitly stated for this 510(k) submission itself. For the "Published clinical data" referenced, it would typically involve clinical outcomes data from surgical procedures where the device was used.

8. The sample size for the training set

• Not applicable/Not specified. This is a hardware device, not a machine learning model requiring a training set.

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

• Not applicable.

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The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids, from which the name of the modified device is derived.

The provided text describes a 510(k) submission for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (PPH03). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be seen in a de novo or PMA application.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Preclinical testing," which typically refers to bench testing or animal studies, not human clinical trials. No specific sample size for a "test set" (human subjects) is mentioned. No data provenance in terms of country of origin or retrospective/prospective human data is provided since human clinical studies are not detailed.

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

Not applicable. The "ground truth" in this context would likely be based on technical specifications and performance metrics aligned with the predicate device, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process for a "test set" of human data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe human reader performance or AI assistance.

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

Not applicable. This device is a surgical stapler, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on the functional equivalence to the predicate device in terms of its ability to cut and staple intraluminal tissue. This would likely be assessed through engineering specifications, material testing, and potentially animal model performance mimicking the predicate's known capabilities.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI model requiring a training set.

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

Not applicable. As above, this is a mechanical device, not an AI model.

Summary from the provided text:

The submission for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories is a 510(k) application, which primarily aims to demonstrate substantial equivalence to an existing predicate device (PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories, K991030). The "study" mentioned is "Preclinical testing," which focused on demonstrating that the new device could perform its intended function (cutting and stapling intraluminal tissue) in a manner similar to the predicate device. The acceptance criteria essentially align with the functional performance of the predicate device. No human clinical trials, expert reviews for ground truth, or AI-related performance metrics are detailed in this 510(k) summary.

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The ENDOPATH and PROXIMATE Linear Cutters and Staplers are intended for use in multiple open or minimally invasive surgical procedures for the transection and resection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures. Specific indications are provided in specific instrument product insert labeling.

The ENDOPATH ETS Endoscopic Linear Cutter and ETS FLEX Endoscopic Articulating Linear Cutter have application in general, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS Flex45 Endoscopic Articulating Linear Cutters , the ETS Compact Flex45 Articulating Linear Cutters are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.

The ENDOPATH ETS Flex45 No-Knife Articulating Linear Staplers and the ETS Compact Flex45 No-Knife Articulating Linear Staplers are intended for transection, and /or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.

The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, resection of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic and other minimally invasive surgical procedures for transection, resection of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The PROXIMATE ACCESS 55 Articulating Linear Staplers have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection and resection of tissues.

The PROXIMATE Linear and Vascular Linear Cutters with Safety Lockout have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The PROXIMATE Linear Four Row Stapler with Safety Lockout have application in gastrointestinal and thoracic surgery for transection and can be used with staple buttressing materials, such as bovine pericardium.

The PROXIMATE Reloadable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.

The PROXIMATE Reloadable Vascular Linear Stapler has application for use on internal tissue that can easily be compressed to 1.0 mm in thickness. The staplers may also be used to ligate pulmonary vessels.

The ENDOPATH and PROXIMATE Linear Cutter models are sterile single use instruments that deliver staples while simultaneously dividing tissue between rows. The ENDOPATH No-Knife Stapler and PROXIMATE Stapler models are sterile single use instruments that deliver staples, but do not cut. Depending upon the particular model, they deliver 2 to 3 staggered rows of staples, 2 double-staggered rows, or 2 triple-staggered rows of staples. Staple line lengths vary between 35 mm and 100 mm. These instruments may be used in either open or endoscopic procedures, depending upon the design. Some instruments are reloadable and, if so, they may be reloaded with various reloads (i.e. vascular/thin, standard, thick) depending on the thickness of tissue that is to be transected or resected. Vascular models use specific vascular reload cartridges. The instruments may be reloaded a number of times according to product insert instructions for a maximum number of firings per instrument. Some instruments have articulating heads and flex features. The length of the shaft may vary as well. A safety lock-out feature on linear cutter instruments prevents a used reload from being fired again. The common element among all these instruments is that they are all mechanical surgical stapling devices.

The provided text describes a 510(k) premarket notification for "ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers". Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and specific numerical performance data against those criteria. The acceptance criteria for a 510(k) are generally implicit: the device must be as safe and effective as a legally marketed predicate device. The performance data described is a summary to support this claim, particularly for a revised indication (pulmonary vessels).

Beyond the provided text, specific numerical acceptance criteria (e.g., staple line integrity, burst pressure, or tissue thickness range) would typically be found in the full 510(k) submission, internal design verification and validation documents, or industry standards applied to surgical staplers.

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

• Sample Size: Not explicitly stated. The document only mentions "Animal testing."
• Data Provenance: Animal testing. The country of origin is not specified, but the submission is to the U.S. FDA. The testing would be prospective in nature as it's designed to evaluate the device's performance.

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. For animal testing, the "ground truth" would likely be established by the observed physiological outcomes, successful stapling, and lack of adverse events, assessed by veterinary or surgical experts involved in the study.

4. Adjudication Method for the Test Set

• This information is not provided in the document. In animal studies, adjudication would typically involve veterinary pathologists or surgeons evaluating the results.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, rather than a mechanical surgical stapler. The evaluation here is based on physical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, this is not applicable. The device is a mechanical surgical stapler, not an algorithm. Its performance is inherent to its design and how it's used by a human surgeon.

7. Type of Ground Truth Used

• The ground truth used was based on physiological outcomes and direct observation of device performance during animal testing (e.g., successful transection, anastomoses creation, hemostasis, and absence of leaks or defects in the stapled tissue). The specific details of what was considered "satisfactory performance" are not elaborated upon.

8. Sample Size for the Training Set

• This concept is not applicable to a traditional mechanical surgical device like a stapler. There is no "training set" in the context of machine learning. The device's design and manufacturing processes are refined through engineering, material science, and prior testing, not through a data-driven training set in the AI sense.

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

• This concept is not applicable for the reasons stated above.

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The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories is available in a 33 mm diameter size only. The instruments allow the surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed to facilitate insertion, operation and removal.

The provided text is a 510(k) summary for a medical device called the PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories. It describes the device, its intended use, and indicates that pre-clinical laboratory evaluations were performed to ensure acceptable performance. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria.

The available performance data section states: "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in pressure holding capability, staple form and height as well as other stapling parameters."

This is a very high-level statement and does not provide the necessary details to answer the request in full.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies based solely on the provided text.

Here's how I would present the information based on the input, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text only states that performance was "acceptable" and comparable to a predicate device. It does not specify the quantitative acceptance criteria (e.g., "pressure holding capability must be > X mmHg" or "staple height must be Y ± Z mm"). Without these details, a complete table cannot be generated.

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

The document mentions "Pre-clinical laboratory evaluations" but does not specify the sample size used for these tests.

• Sample Size (Test Set): Not specified.
• Data Provenance: Pre-clinical laboratory evaluations. The country of origin is not explicitly stated, but the device manufacturer is based in Cincinnati, Ohio, USA. It is a prospective evaluation as it was performed to ensure the device "can be used as designed."

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

The document describes "Pre-clinical laboratory evaluations," which typically involve engineering and bench testing, not subjective expert evaluation of data. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or clinical outcomes is not relevant or detailed in this context.

4. Adjudication method for the test set

Given that the evaluations were "pre-clinical laboratory" studies focusing on physical properties like "pressure holding capability, staple form and height," adjudication methods like 2+1 or 3+1 are not applicable. These methods are usually for subjective assessments or disagreements in clinical diagnoses. The document does not describe any such adjudication process.

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

• MRMC Study: No, an MRMC study was not performed. This device is a surgical stapler, not an AI-assisted diagnostic tool for human readers.
• Effect size of human readers with/without AI: Not applicable, as this is not an AI-powered diagnostic device.

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

• Standalone Performance: Not applicable for this device. This is a mechanical surgical device, not an algorithm. The "performance data" refers to the device's physical and mechanical performance.

7. The type of ground truth used

The "ground truth" for the pre-clinical laboratory evaluations would have been based on:

• Engineering specifications and design requirements (for stapling parameters, form, height).
• Quantitative measurements (e.g., pressure gauges, calipers for staple dimensions).
• Comparison against the performance of the legally marketed predicate device (PROXIMATE® Curved and Straight Intraluminal Staplers).

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Performance evaluations for mechanical devices analyze test samples (e.g., a batch of staplers, or multiple firings). The document does not specify this sample size.

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

Not applicable, as there is no "training set" for this type of mechanical device.

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