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The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones.

Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint.

Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

The System consists of titanium alloy intramedullary (IM) nails locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.

The provided document is a 510(k) premarket notification for the Emerge Medical IM Nail System. It describes the device, its indications for use, and a comparison to predicate devices. However, this document does not describe acceptance criteria for software performance or a study proving that a device meets such criteria.

The "Performance Data" section explicitly states: "Clinical data were not needed to demonstrate substantial equivalence." Instead, it refers to "Dimensional analysis and mechanical testing (ASTM F-1264 and ASTM F-543)" for demonstrating that the device performs as well as or better than the predicate device. This pertains to the physical and mechanical properties of the intramedullary nails, screws, and end caps, not to any software or algorithmic performance.

Therefore, I cannot provide the requested information about acceptance criteria for device performance, especially those related to a study proving such criteria are met by a software-driven or AI-enabled device. The document describes a physical medical device (intramedullary nail system).

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The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma
Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
Arthrodeses and osteotomies with soft tissue problems; failures of total joints
Neutralization of fractures stabilized with limited internal fixation
Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
Unilateral rectilinear bone segment transport or leg lengthening

The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.

The provided text describes the 510(k) summary for the Emerge Medical External Fixation System. It details the device, its indications for use, and a comparison to a predicate device. The performance data section is brief, stating that testing was conducted per ASTM 1451-02 (2001).

Based on the provided information, I can extract the following:

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

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

The document does not specify the sample size used for the test set or the data provenance. It only states that "Performance testing was conducted per ASTM 1451-02 (2001)". ASTM standards are generally laboratory-based mechanical testing protocols rather than clinical studies with 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. The performance testing described is mechanical testing against an ASTM standard, not an evaluation of clinical images or diagnoses that would require expert ground truth.

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

Not applicable. This is mechanical testing, not a clinical study requiring adjudication of expert interpretations.

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 a medical device (external fixation system), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a medical device, not an algorithm. The performance testing is for the physical device itself.

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

The "ground truth" for the performance testing was adherence to the specifications and performance characteristics defined by the ASTM 1451-02 (2001) standard. This is a mechanical engineering standard.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

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The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Emerge Medical Distal Radius Set will include 6 and 9 locking hole head variations with pairs of locking and non-locking holes in the shafts to be used with a variety and screws to be FDA cleared and offered as a system of implants to be used for internal bone alignment and fixation of fractures of the radius. The system features plates with six and nine hole head variations with three and five hole shafts, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139-12).

The provided document describes a 510(k) premarket notification for the "Emerge Medical Distal Radius Set," a device intended for bone fixation. However, the document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving their fulfillment.

This type of submission (510(k)) typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel devices or PMAs. The performance data presented is limited to non-clinical (FEA) testing.

Therefore, most of the requested information cannot be extracted from this specific document. Below is an attempt to answer what can be inferred from the provided text, and explicitly state what is missing.

Acceptance Criteria and Device Performance Study for the Emerge Medical Distal Radius Set

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for static and dynamic bending (e.g., minimum load capacity, maximum deformation) are not provided in the document.
• The exact numerical performance results (e.g., stress values, displacement) of the FEA for the Emerge Medical device or the predicate are not detailed. Only a qualitative "worst-case scenario" comparison and a conclusion of sufficiency are given.

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

• Sample Size: Not applicable in the traditional sense of a clinical or human-subject test set. The performance evaluation was conducted using Finite Element Analysis (FEA), which is a computational method. It likely involved a digital model of the device.
• Data Provenance: Not applicable. FEA is a simulation method.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This study involved non-clinical FEA and did not rely on expert ground truth establishment for a test set. Design and engineering expertise would have been involved in setting up and interpreting the FEA.

4. Adjudication Method for the Test Set

• Not applicable. There was no human-reviewed test set requiring adjudication.

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

• No. No MRMC comparative effectiveness study was conducted or mentioned. This device is a bone fixation appliance, not an imaging or diagnostic AI/ML device that would typically undergo such a study.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, in spirit, but not an "algorithm" as typically conceived for AI/ML. The "standalone" performance here refers to the mechanical performance of the device itself, evaluated through FEA, without human interaction during the test. The FEA model computationally determined the device's mechanical characteristics.

7. Type of Ground Truth Used

• Engineering Principles and Predicate Device Data. For the FEA, the "ground truth" for comparison and validation would typically involve:
  • Established biomechanical engineering principles.
  • Material properties of medical-grade stainless steel (ASTM F139-12).
  • Potentially, existing mechanical performance data or design specifications of the predicate devices for comparative analysis, although this is not explicitly detailed. The statement that the predicate was the "worst-case scenario" implies a comparison to known performance characteristics, either simulated or from prior testing.

8. Sample Size for the Training Set

• Not applicable. The performance evaluation was a non-clinical FEA, not an AI/ML algorithm that requires a training set. The FEA model itself is "designed" based on engineering specifications rather than "trained" on data.

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

• Not applicable. There was no "training set" in the context of AI/ML. The FEA model's foundational data (material properties, geometry, boundary conditions) are established through engineering design, material science data, and biomechanical specifications.

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The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems:

The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Emerge Medical Small Fragment Locked Plating System Line Extension is not intended for use with active or latent infection, osteoporosis, insufficient quantity of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, and patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Emerge Medical Small Fragment Locked Plating System Line Extension consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia. The system features a single plate design, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139-12), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, specifically focusing on what is not present in the document for AI/software-based devices:

It's important to note that the provided document describes a physical medical device (a bone fixation system), not an AI/software-based device. Therefore, many of the typical criteria and study types associated with AI device validation (like expert consensus, radiologists, MRMC studies, training/test sets, ground truth establishment) are not applicable and are consequently absent from this submission.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this type of medical device (a substantial equivalence determination for a 510(k) submission) is demonstrating that it is as safe and effective as a legally marketed predicate device. This is primarily achieved through showing similar technological characteristics and equivalent performance.

Study Details (Relevant to Physical Device Validation - Not AI/Software)

As this is not an AI/software device, the questions related to AI-specific validation (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication, MRMC, standalone performance, type of ground truth) are not directly applicable.

Instead, the study conducted for this device is a non-clinical performance evaluation:

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For this physical device, the evaluation was primarily through finite element analysis (FEA), which is a computational modeling technique. There isn't a "test set" in the sense of patient data. The "data provenance" would refer to the engineering and materials specifications used in the FEA.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through engineering standards, material science, and computational modeling principles, not clinical expert consensus on patient data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this is not an AI-assisted diagnostic or prognostic device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for evaluating performance would be engineering and biomechanical principles, material properties (ASTM F139-12 for stainless steel), and comparison to established predicate device performance. The FEA would be validated against these physical principles and potentially prior physical testing data for similar devices to ensure its accuracy.
7. The sample size for the training set: Not applicable for a physical device validated via FEA.
8. How the ground truth for the training set was established: Not applicable.

Summary for AI-Specific Questions (based on device type):

• 1. Sample sized used for the test set and the data provenance: Not applicable. The "study" was Finite Element Analysis (FEA) of the device's mechanical properties.
• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 4. 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, not done. This is a physical bone fixation device.
• 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not done. This is a physical bone fixation device.
• 6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Engineering and biomechanical principles, material properties, and performance data from predicate devices.
• 7. The sample size for the training set: Not applicable.
• 8. How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes a 510(k) submission for a physical medical device (bone plating system) and its validation through non-clinical mechanical testing (Finite Element Analysis) against predicate devices. The acceptance criteria revolve around substantial equivalence in design, materials, indications for use, and mechanical performance to legally marketed predicate devices. The validation methods are appropriate for a physical implantable device, but fundamentally different from those required for AI/software-based devices.

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The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems:

The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.

The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.

The Emerge Medical Periarticular and Locking Large Fragment System is not intended for use with active or latent infection, osteoporosis, insufficient quantity or quality of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Emerge Medical Periarticular and Locking Large Fragment System consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia and femur. The system features four (4) types of plates (4.5mm Locking Proximal Tibia Plate, 4.5 Locking Condylar Plate, Locking 4.5mm Narrow and Broad Plate, Locking T-Plate), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.

This document describes the regulatory submission for the Emerge Medical Periarticular and Locking Large Fragment System, primarily focusing on its substantial equivalence to predicate devices. It is not a study that evaluates a device's performance against detailed acceptance criteria in the context of an AI/human-in-the-loop system. Instead, it's a 510(k) premarket notification for a medical implant system based on mechanical testing and comparison to existing devices.

Therefore, many of the requested categories for AI/clinical study evaluation are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria: The acceptance criteria for this device, as presented in the document, are broadly defined as demonstrating "sufficient strength for its intended use" and, more importantly, "substantial equivalence to legally marketed predicate devices." The specific numerical thresholds or comparative tolerances are not explicitly stated in this text but would have been part of the underlying ASTM F382-99 and ASTM F543-13 standards and the FEA study.

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

This was a Finite Element Analysis (FEA) study, not a study with a "test set" of patient data.

• Sample Size for Test Set: Not applicable in the context of human or imaging data. The "test set" refers to the worst-case plates and screws chosen for FEA simulation. The document mentions "worst-case plates and screws" but does not specify how many distinct FEA models or variations were run.
• Data Provenance: Not applicable in the context of human data. The "data" comes from FEA simulations, which are computational models based on engineering principles and material properties.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing via FEA does not involve human expert consensus in the way clinical AI studies do. The "truth" is established by the validated engineering principles and material science used in the FEA models and the comparison to established ASTM standards and predicate device performance.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The study was conducted by Emerge Medical and reviewed by the FDA's Division of Orthopedic Devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing and FEA results are objective measurements/simulations, not subject to human adjudication in the typical clinical study sense. Compliance with ASTM standards and comparison to predicate devices would be the "adjudication."

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 comparative effectiveness study was not done. This submission is for mechanical hardware, not an AI-assisted diagnostic or treatment planning tool.

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

• Standalone Performance: No, this is not an algorithm, so standalone performance is not applicable. The "performance data" is the mechanical strength of the physical device as simulated by FEA.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material science (ASTM F139 medical grade stainless steel), and performance standards (ASTM F382-99, ASTM F543-13). The primary "truth" being established is the substantial equivalence to existing predicate devices already approved for market, implying their safety and effectiveness.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of an engineering analysis of a physical implant. The FEA models are built based on the device design and material properties.

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

• How Ground Truth for Training Set Was Established: Not applicable. There is no "training set" or "ground truth" in the AI/clinical sense. The "ground truth" for the FEA models themselves would be the physical properties of the materials and the validated equations/algorithms within the FEA software.

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The indications for the Emerge Medical Bone Plate System are as follows for the four subsystems:

The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomics, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.

The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations of small bones and bone fragments including tarsals, metatarsals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.

The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomics, non-unions, deformations, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones.

The Emerge Medical Modular Foot System is intended for fixation of fractures, ostcotomics, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.

The Emerge Medical Bone Plate System consists of stainless steel and titanium components including locking plates, cortex screws, cancellous screws, and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.

The provided document is a 510(k) summary for a medical device called the "Emerge Medical Bone Plate System." This type of summary describes the device and its intended use, but does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for software or AI-driven medical devices.

Instead, for implantable hardware like bone plates, the "study" referred to here is a series of non-clinical mechanical performance tests. The acceptance criteria for such devices are generally established by demonstrating "substantial equivalence" to predicate devices through these mechanical tests, rather than clinical performance metrics like sensitivity or specificity.

Therefore, many of the requested points are not applicable or cannot be answered from the provided text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in the provided text. Mechanical tests typically use a certain number of samples, but the exact count is not disclosed here.
• Data provenance: Not applicable in the context of device performance in a clinical setting. The tests are non-clinical, likely performed in a lab setting.

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

• Not Applicable. For mechanical testing of orthopaedic implants, "ground truth" is established by the engineering standards themselves (e.g., ASTM F382, ASTM F543) and the measured physical properties of the device, not by expert interpretation.

4. Adjudication method for the test set

• Not Applicable. No adjudication method is described as the "test set" refers to mechanical test results against engineering standards.

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 type of study is not relevant for a mechanical bone plate system. MRMC studies are typically for diagnostic or screening devices evaluated by human readers (e.g., radiologists) with or without AI assistance.

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

• Not Applicable. This is not an algorithm or AI-driven device.

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

• The ground truth for this device's performance is based on established engineering standards and physical measurements of mechanical properties. The "acceptance" is that these measurements demonstrate the device's strength is sufficient for its intended use and substantially equivalent to predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. There is no "training set" or corresponding ground truth for this mechanical device.

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The Emerge Medical Large Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone.

The Emerge Medical Small Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.

The Emerge Medical Small and Large Non-Locking Fragment Plate System consists of stainless steel components. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The plates are provided non-sterile.

Here's a breakdown of the acceptance criteria and the study details for the Emerge Medical Small and Large Non-Locking Fragment Plate System, 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 provided text describes non-clinical mechanical testing and does not refer to human subject data or a "test set" in the context of clinical trials or AI/algorithm performance. Therefore, details about sample size (patients/cases) or data provenance (country, retrospective/prospective) are not applicable here. The testing was performed on the device itself.

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

Ground truth, in this context, would relate to the established standards or methods for evaluating the mechanical properties of bone plates. The text does not mention human experts involved in establishing a "ground truth" for the mechanical tests. The testing was performed according to a modification of a recognized standard (ASTM F382-99 (2008)).

4. Adjudication Method for the Test Set:

Not applicable, as this was mechanical testing, not a clinical study involving human assessment or adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This is a medical device (bone plate) and the performance data consists of mechanical strength testing, not an assessment of human readers with or without AI assistance.

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

Not applicable. This device is a physical bone plate, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.

7. Type of Ground Truth Used:

The ground truth used for evaluating the device's performance was the modified ASTM F382-99 (2008) standard for dynamic four-point bending. This standard provides a recognized methodology for assessing the mechanical strength of bone fixation devices.

8. Sample Size for the Training Set:

Not applicable. This device is a physical bone plate, not an 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 this type of medical device.

In summary, the provided document focuses on the mechanical performance of a bone plating system, demonstrating its equivalence to existing predicate devices through non-clinical laboratory testing. The evaluation does not involve clinical studies with human participants, AI algorithms, or the associated concepts of test sets, training sets, or expert ground truth as typically applied in AI/clinical performance assessments.

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The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The System consists of stainless steel plates (including straight, reconstruction, periarticular t-plates, humerus, one-third tubular), standard cortex screws, locking cortex screws, standard cancellous screws, and washers. The plates are available in a variety of styles and lengths with the number of holes varying depending on plate length, and include threaded locking holes and non-threaded dynamic compression slots. The screws and plates are provided non-sterile. The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The provided document is a 510(k) premarket notification for the "Emerge Medical Small Fragment Locked Plating System," which is a metallic bone fixation device. This type of device is an orthopedic implant, not an AI/ML medical device, and therefore the concepts of acceptance criteria related to algorithmic performance, study designs like MRMC studies, ground truth establishment, and training/test sets are not applicable in this context.

The "Performance Data" section explicitly states: "Mechanical testing performed according to ASTM F382 demonstrated that the device performs as well as or better than the predicate device. Clinical data were not needed to demonstrate substantial equivalence."

This indicates that the regulatory clearance for this device was based on mechanical equivalency to existing predicate devices, not on the performance of a diagnostic or assistive algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, as it is not applicable to this submission.

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The Emerge Medical Locking One-third Tubular Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The System consists of stainless steel components including locking plates and standard cortex screws, locking cortex screws and standard cancellous screws and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.

The provided text describes a medical device, the "Emerge Medical Locking One-third Tubular Plate System," and its 510(k) summary, which outlines its substantial equivalence to a predicate device. However, it does not contain information related to an AI/ML powered device, acceptance criteria related to such a device, nor any study proving an AI/ML device meets certain acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them, as the provided input pertains to a traditional medical device (bone plates and screws) and its mechanical performance, not an AI/ML-powered device.

The document explicitly states under "PERFORMANCE DATA": "Mechanical testing performed according to ASTM F543 and ASTM F382 demonstrated that the device performs as well as or better than the predicate device. Clinical data were not needed to demonstrate substantial equivalence." This indicates that the regulatory clearance was based on mechanical testing, a common approach for such devices, rather than a study involving human readers, AI assistance, or complex ground truth establishment as would be relevant for an AI/ML product.

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The Emerge Medical Solid Bone Screws are intended to provide bone fixation in the management of osteotomies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.

The Emerge Medical Bone Fixation screws consist of cancellous, cortical and shaft screws with washers, as needed, in a variety of sizes to accommodate differing anatomic requirements. The screws are provided non-sterile.

This 510(k) submission (K122489) is for Emerge Medical Solid Bone Screws, which are bone fixation devices. The information provided heavily emphasizes the substantial equivalence of the device to its predicates rather than detailed performance metrics that would typically be associated with software or AI-driven devices. Therefore, the questions related to AI/software performance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and stand-alone performance are not applicable in this context.

Here's an analysis 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

• Sample Size for Test Set: Not explicitly stated as a number of samples in the traditional sense for algorithm testing. The testing was physical, involving "screw variations in material, diameters, lengths, partial versus full threads, and drive types." The number of individual screws tested for each variation is not provided.
• Data Provenance: Not applicable in the context of clinical data for this device. The testing was conducted in vitro (static tests) and not on patient data.

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

• Not Applicable. This submission pertains to a physical bone fixation screw, not a device requiring expert interpretation of medical images or data to establish ground truth for a test set. The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM 543).

4. Adjudication Method for the Test Set

• Not Applicable. As the “ground truth” is based on objective mechanical testing against a standard (ASTM 543), there is no need for expert adjudication in the classic sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

• Not Applicable. This is a physical medical device (bone screw), not an AI/software device. No human readers or AI assistance are involved in its primary function or testing as described.

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

• Not Applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• Mechanical Testing Standards: The ground truth for performance relied on established engineering and material standards, specifically ASTM F543 ("Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications" or similar, applied to the performance of bone screws). The "ground truth" is that the device must meet or exceed the mechanical performance characteristics (e.g., torsion, bending, fatigue strength) demonstrated by the predicate devices or specified by the ASTM standard.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/software device. There is no concept of a "training set."

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

• Not Applicable.

Summary of the Study Proving Acceptance Criteria:

The study involved static mechanical tests performed according to ASTM F543. These tests were conducted on various configurations of the Emerge Medical Solid Bone Screws, including variations in material (Titanium alloy ASTM F136; Stainless steel ASTM F138), diameters, lengths, partial versus full threads, and drive types. The results of these tests demonstrated that the device "performs as well as or better than the predicate devices" (Synthes K112583 and K061621) against the established mechanical performance standards.

The acceptance criteria centered on demonstrating substantial equivalence to predicate devices in:

• Technological characteristics (intended use, material, general design, sizes).
• Mechanical performance as measured by static tests.

The submission explicitly states, "Clinical data were not needed to demonstrate substantial equivalence for these devices," which is typical for Class II devices like bone screws when robust mechanical equivalence to established predicates can be shown through in vitro testing.

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