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The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.

The G3™ Active Plate® Miniature System is a straight plate and locking screw system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device.

The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.

This document describes a medical device, the G3™ Active Plate® Miniature System, and its substantial equivalence to predicate devices, rather than outlining acceptance criteria and a study to prove a device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the information requested in the specified format regarding acceptance criteria and performance studies. The provided text is a 510(k) summary for a bone fixation system, which focuses on demonstrating substantial equivalence to previously cleared devices through material, geometric, and mechanical performance comparisons, not a clinical study with an AI algorithm.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria for an AI Device: The document is about a physical bone fixation plate and screws, not an AI/ML algorithm. Therefore, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• No Reported Device Performance for an AI Device: Similarly, there is no performance data for an AI algorithm because the device itself is a mechanical implant.
• No Test Set/Ground Truth/Experts/Adjudication/MRMC/Standalone Study: These are all concepts relevant to the evaluation of AI/ML diagnostic or prognostic tools. The provided document does not discuss any such studies or evaluations.
• No Training Set Information: There is no AI training set because this is not an AI/ML device.

In summary, the provided text does not contain the type of information related to AI/ML device acceptance criteria and performance studies that your questions are designed to extract.

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The G3™ Acive Plate® Small Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to

The G3TM Active Plate® Small Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plate and screw are intended to be used for fracture fixation. All implantable components are manufactured from medical grade stainless steel and silicone elastomer the same as the subject device. The screws are 3.5 mm diameter and come in lengths ranging from 10 to 90 mm. The plates range in size from 6 hole to 18 hole. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

The provided text is a summary of a 510(k) premarket notification for a medical device called the G3™ Active Plate® Small Fragment System. It details the device's intended use, classification, and claims of substantial equivalence to previously cleared devices based on various performance tests. However, it does not include information about acceptance criteria for a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which seems to be the focus of the request.

The request asks for information related to the acceptance criteria and a study that proves a device meets acceptance criteria, particularly for a device that seems to involve AI or algorithmic performance (given the questions about sample size for test/training sets, ground truth, experts, MRMC studies, and standalone performance). The provided document describes a metallic bone fixation appliance, not an AI-driven device.

Therefore, I cannot fulfill the request as it is posed because the provided document does not contain the type of information required for an AI/algorithm performance study.

Here's why the provided text doesn't contain the requested information:

• Type of Device: The G3™ Active Plate® Small Fragment System is a physical implant for fracture fixation, not a digital diagnostic or prognostic tool.
• "Acceptance Criteria" in this context: For this implant, "acceptance criteria" generally refer to design specifications, material properties, biocompatibility, and mechanical performance (stiffness, fatigue, pullout, torsion, torque) of the physical product, as demonstrated through bench testing (e.g., ASTM F543, ASTM F382). It does not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI devices.
• "Study" Information: The document refers to "Performance Testing" which included mechanical tests (stiffness, fatigue, pullout, torsion, torque, and construct fatigue). These are bench tests on the physical device components, not clinical studies involving human readers, ground truth established by experts, or AI algorithm performance.
• Missing Information Categories: All categories in your request (Table of acceptance criteria/performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are entirely irrelevant to the type of device and testing described in the provided document.

To summarize, the document details the regulatory clearance of a surgical implant based on its physical properties and mechanical performance, demonstrating substantial equivalence to predicate devices through bench testing. It does not describe an AI/algorithmic device or a study involving human readers, clinical data interpretation, or ground truth establishment relevant to AI performance.

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The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to

The subject G3™ Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from stainless steel (316L) and medical grade titanium alloy (Ti-6Al-4V-ELI). The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath made from silicone that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the G3™ Active Plate® Large Fragment System.

It's important to note that this document is a 510(k) summary for a medical device (bone fixation system), not an AI/software as a medical device (SaMD) submission. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable to this type of device and submission. The "device" in this context is a physical orthopedic implant.

Acceptance Criteria and Study Details for G3™ Active Plate® Large Fragment System

1. Table of Acceptance Criteria and Reported Device Performance

For a physical orthopedic implant like the G3™ Active Plate® Large Fragment System, performance is measured against established mechanical standards rather than typical statistical metrics like sensitivity/specificity for AI. The acceptance criteria are implicit in meeting or exceeding the performance of predicate devices or established ASTM standards.

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

• Sample Size (Test Set): The document does not specify exact "sample sizes" in terms of number of devices tested. For mechanical testing, samples are typically a set number of devices (e.g., 6 or 12 per test condition) to allow for statistical comparison to failure criteria or predicate performance. This information is usually detailed in the full test report, not the 510(k) summary.
• Data Provenance: The studies are mechanical laboratory tests performed on physical devices, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

• Not Applicable. This is a physical device submission undergoing mechanical testing, not a diagnostic or AI device requiring expert-established ground truth from clinical images or data. Performance is measured against engineering standards and against predicate device performance.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing of a physical device, there is no expert adjudication process for the test set. Results are quantitative measurements interpreted against established standards.

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

• No. An MRMC study is relevant for diagnostic performance, typically for imaging or other interpretation tasks performed by human readers. This is a physical orthopedic implant.

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

• No. This refers to AI/software performance. This device is a physical bone fixation system.

7. The Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: For mechanical testing, the "ground truth" is typically defined by:
  • ASTM Standards: Established specifications for mechanical properties (e.g., minimum fatigue strength, stiffness range).
  • Predicate Device Data: Performance data from an already legally marketed, substantially equivalent device that the new device aims to match or exceed.
• Not Applicable to pathology, outcomes data, or expert consensus in the human health context.

8. The Sample Size for the Training Set

• Not Applicable. This concept is for AI/machine learning models. For a physical device, there isn't a "training set" in the same sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training.

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

• Not Applicable. As there is no "training set" for this physical device, this question is irrelevant.

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The system is intended for use in adult and pediation: transitional adolescent B (18 years to

The G3TM Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

The provided document is a 510(k) summary for the G3™ Active Plate® Large Fragment System, which is a bone fixation device. It is a submission to the FDA for market clearance, not a study evaluating device performance against pre-defined acceptance criteria in the way one would for a diagnostic or AI-driven device.

Therefore, the information typically found in acceptance criteria and study designs for such devices (like accuracy, sensitivity, specificity, sample size, ground truth establishment, expert qualifications, etc.) is not applicable to this submission.

This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, the G3™ Active Plate Large Fragment System (K142938). The primary argument for substantial equivalence rests on the fact that the subject device is "identical in every way except for the process by which the sliding element is manufactured."

Instead of a typical performance study, the submission references mechanical testing that was previously performed on the predicate device. The underlying assumption is that since the only change is a manufacturing process for a sub-component, and the form, fit, and intended function remain the same, the previous mechanical testing results are still valid and applicable.

Here's a breakdown of what can be extracted, even though it doesn't align with the requested format for a diagnostic/AI device:

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

• Acceptance Criteria: While not explicitly stated as "acceptance criteria" in the context of a new performance study, the underlying criteria for substantial equivalence are that the subject device performs at least as well as the predicate device in terms of mechanical properties and safety.

• Reported Device Performance:

  • Performance Tests Performed (on predicate device): Stiffness, fatigue, pullout, torsion, torque, construct fatigue, and wear.
  • Standards Referenced: ASTM F543 and ASTM F382.
  • Conclusion: The submission asserts that "Since the subject and predicate are identical in every way except for the process by which the sliding element is manufactured, this testing also applies to the subject device and thus the subject device is substantially equivalent to the predicate."

  Table (Re-interpreted for this context):

  Performance Metric (Tested on Predicate)	Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Performance (Inferred for Subject Device)
  Stiffness	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
  Fatigue	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
  Pullout	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
  Torsion	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
  Torque	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
  Construct Fatigue	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
  Wear	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.

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

• This information is not provided. The performance data discussed refers to mechanical testing of physical device components, not a clinical test set of 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)

• Not applicable. Ground truth in this context would refer to material properties and mechanical performance, which are established through standardized engineering tests, not expert human review.

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

• Not applicable for mechanical 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-driven device or diagnostic tool.

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

• Not applicable. This is not an algorithm.

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

• The "ground truth" for the mechanical testing would be defined by the specifications and measurement results obtained from applying the ASTM F543 and ASTM F382 standards to the physical devices.

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning model.

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

• Not applicable.

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The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to

The G3 ™ Active Plate ® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in a silicone elastomer sheath that is bonded to both the plate and sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

The provided text describes a 510(k) premarket notification for the G3™ Active Plate® Large Fragment System, a medical device for bone fixation. However, it does not contain the specific detailed information typically found in a study proving the device meets particular acceptance criteria, especially for AI/ML device performance.

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, material, geometry, and mechanical testing (stiffness, fatigue, pullout, torsion, torque, construct fatigue, and wear) according to ASTM F543 and ASTM F382. It also notes biocompatibility evaluation per ISO 10993-1.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study cannot be extracted from this document, as it outlines a submission for a traditional mechanical medical device, not an AI/ML product.

I will fill in the table and address the questions to the best of my ability based on the provided text, indicating where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes mechanical performance testing to demonstrate substantial equivalence, rather than traditional "acceptance criteria" with specific thresholds for sensitivity, specificity, or other AI/ML metrics. The performance is assessed against predicate devices.

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

• Sample Size for Test Set: Not specified. The document mentions "mechanical testing" and "construct fatigue testing" per ASTM standards, but does not provide details on the number of samples or specimens used for these tests.
• Data Provenance: Not applicable in the context of clinical data. The tests are in vitro mechanical tests.

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

• Not applicable. This device is a mechanical implant, not an AI/ML diagnostic or image analysis device that would require expert-established ground truth from clinical data. The "ground truth" for mechanical testing is derived from standardized test methods and measurement equipment.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are relevant for expert review of clinical data, not for in vitro mechanical 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

• No, an MRMC study was not done. This is a mechanical device, not an AI/ML diagnostic tool.

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

• Not applicable. This is a mechanical device, not an AI/ML algorithm.

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

• The "ground truth" for the performance testing is based on standardized mechanical testing methodologies (e.g., ASTM F543, ASTM F382) which provide quantitative measurements of properties like stiffness, fatigue life, pullout strength, etc. The performance is then compared against established predicate devices.

8. The sample size for the training set

• Not applicable. This document is for a mechanical device, not an AI/ML device that requires a training set of data.

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

• Not applicable. This document is for a mechanical device, not an AI/ML device.

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