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Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity (including the mandible and maxilla).

The Leibinger® Micro Dynamic Mesh is a titanium mesh available in different shapes, thicknesses, and perforation patterns to treat a variety of clinical applications. The material can be cut with scissors for precision fit, is malleable for three-dimensional adaptations, and is perforated to permit fluid exchange. The mesh is attached to bone by screws. The titanium construction allows for radiological identification but produces negligible artifacts on CT or MRI.

The provided text is a 510(k) summary for the Micro Dynamic Mesh, a titanium mesh used for craniomaxillofacial skeletal reconstruction. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

Here's an analysis based on the available information:

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

The document does not detail specific acceptance criteria or performance metrics for the Micro Dynamic Mesh. Instead, it relies on demonstrating substantial equivalence to already marketed predicate devices. This means the device is considered acceptable if its intended use, materials, design, and operational principles are equivalent to the predicate devices.

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

No specific test set or clinical study data is provided in this 510(k) summary. The demonstration of substantial equivalence typically relies on comparative analysis with predicate devices and possibly bench testing, but not clinical trials with sample sizes for performance evaluation in the way requested.

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

Not applicable. No test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical titanium mesh, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

Not applicable. This device is a physical titanium mesh, not an algorithm.

7. The type of ground truth used

Not applicable in the context of a performance study for this type of device. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices. The new device aims to be "substantially equivalent" to those.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a training set.

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

Not applicable. This is not a machine learning or AI device.

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The Type 3 Femoral Components are intended to be used in primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. These stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These femoral stems are designed to be press fit into the proximal femur.

The Type 3 Femoral Components are a series of Titanium femoral stems intended to be used for primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These stems are modular, with varying proximal body and distal stem sizes to accommodate various anatomical requirements. These femoral stems are designed to be press fit into the proximal femur. These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which conforms to the requirements of ASTM specification F 136.

The provided text is related to a 510(k) premarket notification for a medical device called "Type 3 Femoral Components." It details the device's intended use, materials, classification, and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for performance metrics, nor does it describe a study involving human readers, ground truth establishment, or sample sizes in the context of device performance in a clinical or AI-assisted scenario.

The only performance-related statement is: "Testing has demonstrated that the fatigue load carrying capacity of the Type 3 Femoral stems exceeds the minimum ISO load requirements." This is a engineering/mechanical performance test, not a clinical study involving human readers or AI.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, training set sample sizes, or how training set ground truth was established. These details are typically found in documents describing clinical trials, software performance evaluation, or AI model validation, which is not the nature of this 510(k) summary.

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The Intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.

The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called and A-1 "Ilpped tible incorro the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation this froo radio lound lount in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized periou, the United to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The Duracon® and terminally ottomized by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, for Okla Figh Molocation on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking in thisklesson from on on on one Duracon® inserts which have been previously released.

The provided text is a 510(k) summary for a medical device (Duration® II Duracon® Tibial Inserts) and does not describe artificial intelligence performance or a study comparing AI to human readers. Therefore, I cannot extract the requested information about AI acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader, multi-case studies.

The document focuses on demonstrating substantial equivalence of a new style of tibial inserts to previously marketed versions, primarily through material property testing and comparison of intended use.

Here's a breakdown of what the document does provide, although it doesn't align with the AI-centric questions:

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

2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses material testing, not a dataset for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is defined by material standards (ASTM F-648, ASTM D2765-90) and analytical methods (FTIR, ESR) for which expert consensus in the AI sense is not relevant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material testing results are objective measurements against defined 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: Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used: Material property standards (ASTM F-648, ASTM D2765-90) and analytical measurements (FTIR, ESR).

8. The sample size for the training set: Not applicable. There is no training set for an AI model.

9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.

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The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.

The purpose of this submission is to describe an additional style of System 12® acetabular Inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® If process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The acetabular insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The System 12® Acetabular Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

These System 12® inserts are identical in design to the previously cleared System 12® inserts: they are available in a range of outer diameter sizes to mate with the respective acetabular shell, and 22.0, 22.2, 26, 28, and 32mm inner diameters to mate with Howmedica femoral heads. These inserts are available in a neutral, 10°, and 15° hooded design. The locking mechanism of this style of acetabular insert is identical to the previously released System 12® acetabular inserts.

The manufacturer, Howmedica, sought to introduce an additional style of System 12® acetabular inserts, the Duration® II, which are stabilized/sterilized using a process involving gamma radiation, heated oven stabilization, and ethylene oxide sterilization. The main purpose was to demonstrate substantial equivalence to previously cleared System 12® acetabular inserts.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Details of the Study Proving Device Meets Acceptance Criteria:

The provided document describes a bench testing and material characterization study to support the substantial equivalence of the Duration® II Acetabular Inserts.

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

   • Test Set Sample Size: Not explicitly stated for each specific test (e.g., number of samples for FTIR, ESR, tensile modulus). However, for the hip wear simulator, multiple samples would have been run to generate the reported average and standard deviation (198.60 ± 31.9 mm³ and 310 ± 40.8 mm³). The "an average total wear" suggests multiple iterations, but the exact number of tested inserts is not specified.
   • Data Provenance: The study was conducted by Howmedica, implying retrospective, in-house laboratory testing within the United States (the contact address is Rutherford, NJ). It is not clinical data.

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

   • Not applicable. This was a laboratory-based material science and mechanical performance study, not a clinical study requiring expert ground truth for diagnostic accuracy. The "ground truth" here is the physical measurement of material properties and wear rates using established scientific methods and standards.

3. Adjudication Method for the Test Set:

   • Not applicable. As a laboratory study, results are based on instrumental measurements and adherence to specified test protocols (e.g., ASTM standards). There is no "adjudication" in the sense of reconciling human expert opinions.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This device is a component of a medical implant, and the study focused on material and mechanical performance, not a diagnostic or treatment effectiveness study requiring human reader assessment.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, the described study assesses the "standalone" performance of the Duration® II material and its components in a laboratory setting. This means the device's inherent properties and performance (wear rate, strength, cross-linking, oxidation) were evaluated directly, without human interaction influencing the measurement results or interpretation in a real-world clinical scenario. The hip wear simulator, for example, tests the device's mechanical wear performance independent of a human's input or interpretation.

6. Type of Ground Truth Used:

   • The "ground truth" used for this "device" (material) is based on standardized physical and chemical measurements and comparative laboratory testing against a predicate device or control. This includes:
     • Material properties: Adherence to ASTM F-648, FTIR for oxidation, ESR for free radicals, modified ASTM D2765-90 for gel content, and tensile modulus measurements.
     • Mechanical performance: Hip wear simulator testing provides quantitative wear rate data.

7. Sample Size for the Training Set:

   • Not applicable. There is no explicit "training set" in this context. The study describes the characterization and testing of the final product material. While manufacturing process parameters are optimized, the document does not detail a separate "training" phase for the material itself in the way an AI algorithm has a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there was no "training set" in the conventional sense of machine learning. The "ground truth" for the material's properties (e.g., meeting ASTM F-648 standards) is established by the specifications defined by the standard itself and verified through appropriate analytical and mechanical testing methods.

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The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.

The purpose of this submission is to describe an additional style of System 12® acetabular inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® Il process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The acetabular insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The System 120 Acetabular Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

These System 12® inserts are identical in design to previously cleared System 12® inserts: they are available in a range of outer diameter sizes to mate with the respective acetabular shell, and 22.0, 22.2, 26, 28, and 32mm inner diameters to mate with Howmedica femoral heads. These inserts are available in a neutral, 10°, and 15° hooded design. The locking mechanism of this style of acetabular insert is identical to previously released System 12® acetabular inserts.

The provided text summarizes a 510(k) submission for the Duration® II System 12® Acetabular Inserts. This device is an additional style of acetabular insert intended for use in total hip arthroplasty, and the submission focuses on its manufacturing process (Duration® II Stabilization and gas plasma sterilization) and its substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "marketing claims" in the document, which are essentially performance standards the device aims to meet.

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

The document does not explicitly state the sample sizes for the individual tests (e.g., FTIR, tensile modulus, ESR). It refers generally to "Testing was performed in accordance with the draft FDA guidance on UHMWPE."

• Data Provenance: The studies appear to be prospective laboratory/in vitro testing conducted by Howmedica. The country of origin of the data is not specified beyond being generated by the applicant (Howmedica, located in New Jersey, USA). There is no mention of human clinical data or retrospective patient data.

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

This section is not applicable to this submission. The "ground truth" for the tests described is based on established engineering and materials science standards (ASTM, FTIR, ESR, hip wear simulation) rather than expert clinical consensus or interpretation of patient data. The results are objective measurements.

4. Adjudication Method for the Test Set

This section is not applicable. As the tests are objective material property and wear measurements, there is no need for an adjudication method by human observers.

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 section is not applicable. The device is a medical implant (acetabular insert), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI performance is irrelevant.

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

This section is not applicable. As mentioned above, the device is a medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Objective material property measurements against established industry standards (ASTM F-648, modified ASTM D2765-90).
• Quantitative analytical techniques such as FTIR (Fourier-transform infrared spectroscopy) for oxidation and ESR (Electron Spin Resonance) for free radicals.
• Standardized in vitro wear simulation using a hip wear simulator.

Essentially, the "ground truth" is derived from scientific and engineering measurements and established test methods.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set." The materials themselves are manufactured and tested, not "trained."

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

This section is not applicable, as there is no training set for this device.

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The intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.

The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The Duracon® Condylar and A-P lipped Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA quidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices. As will be discussed later, this additional style of insert demonstrated significantly less wear when compared to air irradiated UHMWPE.

These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking mechanism that is identical to those Duracon® inserts which have been previously released.

The provided text describes the acceptance criteria and the study results for the Duration® II Duracon® Tibial Inserts - Gas Plasma Sterilization Device.

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 the data provenance

• Sample size for test set: The excerpt specifically mentions a "Duracon® A-P lipped tibial insert (large, 19mm)" being tested. While it provides an average wear rate with a standard deviation, it does not explicitly state the number of samples (n) used to calculate this average for both the Duration® II and the conventionally gamma sterilized inserts.
• Data provenance: The data is described as "in vitro tests" using a "multiaxial knee joint simulator." This indicates the data is from prospective laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submission is to the FDA in the USA, implying the testing likely adheres to U.S. or international standards.

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

• This question is not applicable to this study. The "ground truth" for this device is not established by expert consensus on images or clinical outcomes, but by objective physical measurements (e.g., wear rate, material properties) conducted in a laboratory setting according to engineering standards (ASTM).

4. Adjudication method for the test set

• This question is not applicable to this study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human experts are making judgments, often in medical imaging or clinical trial outcome assessment. The reported study involves direct measurement of material properties and wear in a simulator.

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, a MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant to the evaluation of a physical orthopedic implant.

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

• This question is not applicable to this study. This device is a physical implant, not an algorithm. The "standalone performance" here refers to the physical properties and wear characteristics of the material itself, which were tested in a simulator without human intervention in the 'reading' process.

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

• The ground truth for this study is based on objective, quantitative physical measurements of material properties (e.g., conformance to ASTM F-648, gel content, tensile modulus, ESR for free radicals) and in vitro wear testing in a knee simulator.

8. The sample size for the training set

• This question is not applicable to this study. This is a direct physical device evaluation, not a machine learning model, so there is no "training set."

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

• This question is not applicable for the same reason as above; there is no training set for a physical device evaluation.

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The Hoffmann® II Miami Post is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. It is to be used to provide a hybrid construct combing any 6mm external fixation ring to the Hoffmann® II rod to rod and pin to rod clamps. The post will extend the use of the Hoffmann® II External Fixation System to Hybrid frames that utilize circular rings with 6mm mounting holes.

The Hoffmann® II Miami Post is designed to connect rings with 6mm holes to Hoffmann®II rod to rod and pin to rod clamps. This Post attaches the circular fixation rings to the external fixations rods. The Post is manufactured from Stainless Steel and is machined from bar stock.

The provided text is a 510(k) summary for the Hoffmann® II Miami Post, a component of an external fixation system. It states that "Testing of this device demonstrates substantial equivalence to another predicate ring system." However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) as requested.

Therefore, I cannot provide a detailed answer to your request based on the given information. The document focuses on demonstrating substantial equivalence through similarities in intended use, materials, design, and operational principles, rather than presenting a detailed performance study against specific acceptance criteria.

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The Zeta MultiZone Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral and tibial fractures. The system includes two styles of femoral nails, tibial nails, reconstruction nails, screws and end caps. The nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.

This 510(k) submission (K982958) concerns the Zeta MultiZone Locking Nail System, an intramedullary fixation rod system for femoral and tibial fractures.

Based on the provided documents, it is important to note that this is a traditional 510(k) submission for a medical device (intramedullary nail system), not an AI/ML-powered diagnostic device. Therefore, many of the requested criteria related to AI/ML performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone AI performance, are not applicable to this type of submission.

The "acceptance criteria" for this device are established by its substantial equivalence to legally marketed predicate devices, as determined by the FDA. This means the device is deemed safe and effective because its intended use, materials, designs, and operational principles are similar to existing devices.

Here's an analysis based on the provided information, addressing the relevant points and indicating where information is not applicable:

1. Table of acceptance criteria and the reported device performance

   Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (based on equivalence)
   Intended Use Equivalence: The device's intended use must be similar to legally marketed predicate devices.	The Zeta MultiZone Locking Nail System is intended for temporary stabilization of various types of fractures, malunions, and nonunions of the femur and tibia. This is equivalent to the intended uses of the predicate devices.
   Materials Equivalence: The materials used must be the same or offer equivalent biocompatibility and mechanical properties as predicate devices.	Fabricated from either titanium alloy or stainless steel, materials commonly used in predicate intramedullary nailing systems.
   Design Equivalence: The design and operational principles must be similar to predicate devices. This typically involves demonstrating similar mechanical properties and features (e.g., nail styles, diameters, lengths, locking mechanisms).	The system consists of round nails with proximal and distal holes for cross-locking, available in varying diameters and lengths. This design is considered equivalent to Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System, and Gamma Locking Nail System. The ability to be inserted using opened/closed techniques and statically/dynamically locked is also considered equivalent.
   Performance Equivalence: Device performance (e.g., mechanical strength, fatigue life) must be demonstrated to be equivalent or superior to predicate devices through engineering analyses and/or testing. (While not explicitly detailed in this summary, such testing would have been part of the full submission).	The submission claims "substantial equivalence... based on an equivalence in intended use, materials, designs and operational principles." This implies that the performance aspects relevant to the device's function (e.g., structural integrity, fixation capabilities) were demonstrated to be comparable to or meet accepted standards for the predicate devices. Specific performance metrics are not provided in this summary.

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

   • Not applicable. This submission relies on substantial equivalence to predicate devices, not a clinical study with a "test set" in the context of diagnostic performance or AI model validation. The "testing" would have been primarily engineering bench testing to demonstrate mechanical properties, which doesn't typically involve a "test set" or data provenance in the same way.

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 establishment by experts is not a component of a 510(k) for this type of implantable device. The evaluation is based on engineering principles and comparison to existing devices.

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

   • Not applicable. No adjudication method for a "test set" is relevant for this type of device submission.

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-powered diagnostic device, so MRMC studies and AI assistance are irrelevant to this submission.

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

   • Not applicable. This is a mechanical implantable device, not an algorithm.

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

   • Not applicable. The "ground truth" for this device's acceptance is its demonstrated equivalence in design, materials, and performance (via bench testing and engineering analysis) to existing, legally marketed predicate devices, which have a history of safe and effective use.

8. The sample size for the training set

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable. There is no "training set" or associated ground truth establishment for this type of device.

Summary for K982958: Zeta MultiZone Locking Nail System

The FDA's review and determination of substantial equivalence for the Zeta MultiZone Locking Nail System were based on a comparison of its intended use, materials, designs, and operational principles to several predicate devices already on the market (Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System, and Gamma Locking Nail System). This is the standard pathway for typical Class II medical devices in a 510(k) submission. The provided documents do not contain information related to AI/ML performance evaluation, clinical study data beyond what would support substantial equivalence, or the specific details of bench testing that would have been included in the complete submission to justify the equivalence claims.

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The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.

The Zeta MultiZone SCN Locking Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade titanium alloy.

This 510(k) premarket notification for the Zeta MultiZone SCN Locking Nail does not contain the information required to fulfill your request. The document describes a medical device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include details on:

• Acceptance criteria for device performance.
• Any specific study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, or ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.

The provided text is a 510(k) summary and the FDA's response letter, which focus on regulatory clearance based on substantial equivalence, rather than detailed performance study reports.

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The Howmedica Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients, but is not intended for use in the mandible and/or full load bearing procedures.

The Howmedica Leibinger Resorbable Fixation system consists of a series of plates and mesh in varying configurations and lengths which are attached to the bone using screw fixation. The plates are available in two thicknesses (1.0mm and 1.5mm). The mesh is also available in two thicknesses (0.7mm and 1.2mm). Additionally, there are two screw diameters of 1.5mm and 2.0mm and a third emergency screw with a 2.5mm diameter. These plates and screws are intended for use in the fixation bones of the craniofacial and midfacial skeleton affected by trauma or for The plates and mesh can be contoured by heating. reconstruction. The system can be used in both adult and pediatric patients.

This document describes a 510(k) submission for a medical device and does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text pertains to the "Howmedica Leibinger Resorbable Fixation System," a bone plating system. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (LactoSorb Trauma Plating System and Luhr® Pan Fixation System) rather than outlining specific performance acceptance criteria and a study to meet them.

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Study: The document is a 510(k) summary, which is a premarket notification to the FDA. It primarily asserts that the new device is "substantially equivalent" to existing legally marketed devices. This typically involves demonstrating similar intended use, technological characteristics, and safety and effectiveness, often through comparison to predicate devices and material testing, rather than a clinical study with defined acceptance criteria for a novel performance metric.
• Focus on Substantial Equivalence: The text explicitly states, "The substantial equivalence of this device is based on similarities in intended use, design and operational principles to the LactoSorb Trauma Plating System (Biomet) and the Luhr® Pan Fixation System (Howmedica)." It also mentions, "Testing was performed to demonstrate an equivalence in performance to the LactoSorb Trauma Plating System (Walter Lorenz subsidiary of Biomet)." This "testing" is for equivalence, not for meeting novel performance criteria specific to this device against a predefined benchmark.
• Lack of Clinical Study Details: There are no details about a clinical trial, patient populations, outcome measures, statistical analysis, or comparison to a ground truth, which would be necessary to describe a study proving acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided 510(k) summary.

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