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The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system. the XIA Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint which is fused; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as a pedicle screw fixation system, the XIA Spine System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

The XIA Spine System is a spinal fixation device for the noncervical spine. It consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. The components are manufactured from titanium.

The provided text describes a 510(k) summary for the XIA Spine System. It focuses on the device's indications for use and its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because it is a regulatory submission for premarket notification (510(k)) and not a study report.

Here's what can be extracted based on the information given:

Acceptance Criteria and Device Performance (Based on the 510(k) Summary)

Missing Information from the Provided Text:

1. Sample size used for the test set and the data provenance: Not applicable. The submission refers to "bench testing," not a clinical test set with patient data. No details about the number of devices or iterations tested are provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing doesn't typically involve human experts establishing ground truth in this manner.
3. Adjudication method 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. This is not an AI/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
6. The type of ground truth used: For the "bench testing," the ground truth would be the pre-defined mechanical functional requirements or engineering specifications that the device needed to meet.
7. The sample size for the training set: Not applicable. This is not an AI device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to pre-existing devices through comparisons of intended use, materials, designs, operational principles, and bench testing to meet mechanical requirements. It does not describe a clinical study with patients that would typically involve many of the detailed inquiries above, especially those related to AI or clinical effectiveness.

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The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.

The Howmedica Humeral Intercalary System consists of a stem section with a body that may be attached to: 1) another stem section with body; or 2) a proximal bone cap. The stem section of the Humeral Intercalary System is fluted, and is available in diameters of 9mm and 11mm, with multiple body lengths. Both the stem segment and the proximal bone cap contain lap joints, which are joined by the use of machine screws that are available in diameters of 3 - 5 mm, and lengths of 15-20 mm. The attachment of one stem segment to another stem segment is used when there is bone loss/resection of the mid-section of the humerus. The distal stem segment is cemented into the distal segment of the humerus, and the proximal portion is cemented into place in the proximal fragment of the humerus. The stem segments are joined by the use of the machine screws noted above. If the proximal portion of the humerus is not present or has been resected, the bone cap segment is used proximally. There are suture holes in the bone cap to allow the passage of sutures to anchor the device proximally to the shoulder girdle (if this remains in place), or to the chest wall. The distal stem segment is cemented in place in the distal segment of the humerus. The bone cap is attached to the distal stem segment by the use of the screws noted above. These components will be manufactured from titanium allov (Ti-6Al-4V) which conforms to ASTM F-136.

This document describes a 510(k) premarket notification for the Howmedica Humeral Intercalary System, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers or standalone AI performance.

Instead, this document focuses on demonstrating substantial equivalence to predicates based on intended use, material, design, and relative indications and contraindications. The "study" mentioned is "Physical and Finite Element Analysis testing of the device," which is a type of engineering and biomechanical testing, not a clinical study to assess diagnostic performance or reader improvement.

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

Here is what can be inferred or directly stated from the document, with explanations for what cannot be found:

1. 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):

• Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" here refers to the physical device prototypes or models used for engineering analysis. No human participants or patient data are mentioned for this type of testing.
• Data Provenance: Not applicable. The "testing" refers to lab-based physical and finite element analysis.

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 for engineering tests (physical and finite element analysis) is based on established engineering principles, material properties, and biomechanical models, not expert consensus from medical professionals in a diagnostic context.

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

• Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical data, which is not the type of testing described here.

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 comparative effectiveness study was not done. This device is a physical implant (Humeral Intercalary System), not a diagnostic algorithm or AI-assisted tool. Therefore, the concept of "human readers improve with AI" is not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For the "Physical and Finite Element Analysis testing," the "ground truth" would be the theoretical and empirical mechanical properties of the materials, the design specifications, and established biomechanical principles. It is not related to clinical outcomes, pathology, or expert consensus on medical images.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of what the document does provide regarding device evaluation:

The document indicates that the Howmedica Humeral Intercalary System underwent Physical and Finite Element Analysis testing. These are engineering studies designed to evaluate the mechanical integrity, stress distribution, and potential failure modes of the device under simulated physiological conditions. The success of these tests (though specific results are not provided in this summary) contributed to the FDA's "substantially equivalent" determination, implying the device meets appropriate safety and performance standards for its mechanical function. The substantial equivalence was also based on its similarity in intended use, materials, design, and indications/contraindications to existing, legally marketed predicate devices.

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The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. 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, tibial and humeral fractures. This line extension is to include a humeral nail, cross-locking screws and end caps. The humeral 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 document is a 510(k) summary for a medical device, specifically the Zeta MultiZone Locking Nail System. It describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through clinical studies. The summary focuses on equivalence in intended use, materials, designs, and operational principles to predicate devices.

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The Leibinger Burr Hole Covers are designed to be used with fixation screws to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps.
The Leibinger Two and Four-Hole Straight Plates are intended for fixation of small bones, including the craniofacial skeleton and midface bones, the fixation of facial bones following elective osteotomies and internal fixation of fractures of the hand.
The Leibinger Temporal Gap Plates are intended for use with patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provide fixation and stabilization of cranial bone flaps.

The Burr Hole Cover has a segmented plate-like structure. These Burr Hole Covers are 0.5mm thick and are comprised of four different configurations.
The Titanium Two and Four-Hole Straight Plates are holed plates which are attached to bone using screw fixation. They are similar in design to the straight plates of the Wurzburg Titanium Mini Bone Plating System. These plates are 0.5mm thick.
The Titanium Temporal Gap Plates are holed plates which are attached to bone using screw fixation. The configurations vary to accommodate the level of reconstruction required for the patient's anatomy.

The provided text describes 510(k) submissions for several medical devices: "Burr Hole Covers", "Craniomaxillofacial Plates" (specifically "Two and Four-Hole Straight Plates"), and "Temporal Gap Plates". These are medical devices used for bone fixation and reconstruction, not AI/ML-driven diagnostic devices.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details), which are typically relevant for AI/ML diagnostic device studies, cannot be found in the provided documents.

The documents focus on demonstrating "substantial equivalence" to predicate devices based on intended use, materials, design, and operational principles, as required for 510(k) clearances for traditional medical devices. There is no mention of any performance studies involving patient data or expert evaluations in the context of an AI/ML device.

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The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, hone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

This G/K line extension includes solid femoral nails (SFN) and solid tibial nails STN) which may be used with cross-locking screws for intramedullary nailing of femoral and tibial fractures, respectively. The nails can be inserted with or without reaming using an opened or closed technique. They can be locked statically or dynamically. Also, there is an optional nail plug available to prevent tissue infiltration. All of the components are fabricated from medical grade stainless steel.

The provided text describes a 510(k) submission for a medical device called the "G/K Locking Nail System," an intramedullary rod. This document is a regulatory submission for market clearance, which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics as one might find for a novel or high-risk device.

Based on the provided text, there is no information to complete the requested sections regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

Here's why and what can be inferred:

• Substantial Equivalence: The core of a 510(k) submission like this is to show that the new device has the same intended use, materials, designs, and operational principles as existing, legally marketed predicate devices. This means that extensive new clinical studies with specific performance acceptance criteria are often not required. Instead, the focus is on demonstrating that the new device is as safe and effective as the predicate devices.
• Lack of Performance Data: The 510(k) summary and the FDA letter explicitly state that the device's substantial equivalence is based on its similarity to "Synthes' Universal Femoral Nail and Unreamed Tibial Nail and Orthofix's Tibial Nailing and Femoral Nailing Systems." There is no mention of specific performance data, studies, or clinical trials conducted for this specific device to establish new acceptance criteria.
• Device Type: Intramedullary rods are mechanical devices. Their performance is generally assessed through engineering tests (e.g., strength, fatigue, biocompatibility) and comparison to the predicate device's specifications, rather than through studies involving expert reads or ground truth derived from pathology in the way an AI diagnostic device would be.

Therefore, since the document describes a 510(k) clearance based on substantial equivalence to predicate devices, there are no acceptance criteria or detailed study results of the type requested for clinical performance evaluation.

If this were an AI/ML-driven device or a device requiring new clinical performance studies, then the requested information would be prominently featured. Since it's not, the sections below cannot be filled from the provided text.

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

• No information available in the provided text. The 510(k) submission for this mechanical device focuses on substantial equivalence to predicate devices, not on meeting new quantitative performance acceptance criteria through a specific study.

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

• No information available in the provided text. No test set or clinical study data is described for this specific device.

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. This device is an intramedullary rod, not a diagnostic tool requiring expert ground truth for a test set.

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

• Not applicable. No test set or adjudication method 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 is a mechanical orthopedic implant, not an AI-assisted diagnostic device.

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

• Not applicable. This is a mechanical orthopedic implant, not an algorithm.

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

• Not applicable. The concept of "ground truth" as it relates to diagnostic performance or AI evaluation is not relevant for this mechanical device. Device performance would be assessed through engineering and biocompatibility testing, potentially compared to predicate device specifications.

8. The sample size for the training set

• Not applicable. This is a mechanical orthopedic implant, not a machine learning model requiring a training set.

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

• Not applicable. This is a mechanical orthopedic implant, not a machine learning model.

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The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.

The Extracranial Radiotherapy System is a device consisting of a carbon fiber table, a patient support cushion and lateral support panels, stereotaxic plates and related fasteners and assembly tools. During treatment the patient lies supine on the fitted cushion. Four stereotaxic plates surround the patient during CT imaging, with one plate between the support cushion and the table, two placed laterally and one above the patient. Target positioners on the support assembly are used to align the table with the linear accelerator coordinate axes and to verify the target point for treatment.

The provided text is a 510(k) summary for the Extracranial Radiotherapy System. While it describes the device, its intended use, and substantial equivalence to predicate devices, it does not contain information about specific acceptance criteria, a detailed study proving performance, sample sizes for test/training sets, expert qualifications, or adjudication methods.

The document states that the "Extracranial Radiosurgery System, the STP Complete Module/ZD Stereotaxic Frame and the Marker System for Stereotaxic Navigation demonstrate similar treatment accuracy during testing with CT images." However, it does not elaborate on the specific acceptance criteria for "similar treatment accuracy" or the details of that testing.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, or information about ground truth establishment based on the provided text.

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The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary ingromented reconstruction of the proximal femur and acetabulum, respectively.

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum. These devices are identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface.

This 510(k) summary (K982248) is for a medical device regulatory submission, not a study evaluating device performance against acceptance criteria. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be directly extracted from this document, as it is not a clinical study report.

The document discusses the regulatory clearance of a hip prosthesis with a coating, asserting substantial equivalence to previously cleared devices. Substantial equivalence is the primary "acceptance criteria" for 510(k) submissions, meaning the new device is as safe and effective as a legally marketed predicate device.

Here's an attempt to answer what can be gleaned from the provided text, and where the information is explicitly not present:

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

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

• Not applicable / Not provided. This document is a regulatory submission based on substantial equivalence, not a clinical study report requiring a test set of patient data. The "data presented" mentioned by the FDA likely refers to engineering testing, material characterization, and comparisons to predicate devices, rather than a clinical outcomes study with a test set of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth establishment by clinical experts for a test set is not part of this 510(k) substantial equivalence submission.

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

• Not applicable / Not provided. Adjudication methods are relevant for clinical studies, which is not what this document describes.

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 / Not provided. This device is a hip implant, not an AI diagnostic tool. Therefore, an MRMC study 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 / Not provided. This is not an AI algorithm.

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

• Not applicable in the context of a "test set" for performance evaluation. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective. The new device is compared against the predicate's known characteristics and regulatory status. Material characterization and engineering testing would have their own "ground truths" (e.g., measured material properties against specifications).

8. The sample size for the training set

• Not applicable / Not provided. This is not a machine learning model.

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

• Not applicable / Not provided. This is not a machine learning model.

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The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.

The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.

The provided text describes a 510(k) summary for a medical device, the Reliance® Long Stem Femoral Components. It focuses on establishing substantial equivalence to previously marketed devices rather than detailing a specific study to prove the device meets acceptance criteria through performance metrics as might be found in clinical trials or software validation studies.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. This document highlights engineering testing (fatigue load capacity) rather than detailed clinical performance studies in the way modern AI/software device submissions would.

Here's what can be extracted based on the provided text, and where information is not available:

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 specified. The document mentions "testing" for fatigue load, but does not provide details on the number of units tested, the statistical methods, or the sample size used.
• Data Provenance: Not applicable in the context of this engineering test. This refers to material and mechanical testing, not clinical data from patients.

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

• Number of Experts: Not applicable. Material and mechanical testing (like fatigue) typically relies on standardized test methods and machine measurements rather than expert consensus on a "ground truth" derived from clinical assessment.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This type of study assesses human reader performance (often with and without AI assistance) across multiple cases, which is not relevant for the mechanical testing of a hip prosthesis.

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

• Standalone Performance: Not applicable. This device is a physical implant, not a software algorithm. The "standalone" performance here refers to the device's mechanical integrity, which was assessed, but not in the context of an algorithm or AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the fatigue testing, the "ground truth" would be defined by the ISO standard's minimum load requirements and the physical measurements obtained from the mechanical testing equipment. For the material, it's compliance with ASTM F 799. This is objective, measurement-based truth, not expert consensus, pathology, or outcomes data in a direct clinical sense for performance evaluation.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The key study mentioned is mechanical fatigue testing. The document states:

• "Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements."

This inference of meeting an acceptance criterion (exceeding ISO standards) is based on this engineering study. The 510(k) submission relies on this and the direct material compliance (ASTM F 799) to establish substantial equivalence to predicate devices, rather than a prospective clinical trial proving superior patient outcomes for a novel technology.

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The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.

This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.

The provided text is related to a 510(k) submission for Rogachefsky Distal Radius Plates. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

This type of document (510(k) summary) does not typically include detailed studies involving a "device performance" comparison against "acceptance criteria" through clinical trials, expert review, or AI assistance as would be expected for a diagnostic or AI-powered device.

Instead, the core of a 510(k) submission is to demonstrate substantial equivalence to an existing predicate device based on similarities in intended use, material, design, and operational principles. Clinical effectiveness studies with detailed performance metrics, ground truth establishment, and expert adjudication are usually reserved for de novo classifications, PMAs, or when significant new indications or technologies are introduced that render equivalence to existing devices difficult to prove.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not present or applicable in this specific 510(k) summary.

However, I can extract the information that is available from the document:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or report detailed "device performance" data from a study for this device against such criteria. The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to predicate devices.

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

Not applicable/Not provided. The document describes a medical device (distal radius plates), not a diagnostic or AI system that would typically undergo testing with a "test set" of patient data. Equivalence is based on design, materials, and intended use.

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

Not applicable/Not provided. No test set requiring ground truth established by experts is described for this type of device submission.

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

Not applicable/Not provided.

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/Not provided. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

Not applicable/Not provided. This is a medical implant, not an algorithm.

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

Not applicable/Not provided.

8. The sample size for the training set

Not applicable/Not provided. This relates to machine learning models, which is not what this document describes.

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

Not applicable/Not provided.

Summary of what is provided regarding equivalence and regulatory acceptance:

• Device: Rogachefsky Distal Radius Plates (volar and two dorsal plates, 1.0 mm thick, made of titanium alloy Ti 6Al 4V)
• Intended Use: Internal fixation of fractures of the distal radius.
• Predicate Devices:
  • Leibinger Radius Reconstruction Plate System [RRPS] (Howmedica K961496) - specifically for bone screws, and implied as a general predicate for distal radius plating.
  • Alta® Tibial/Upper Extremity Plating System Metaphyseal T Plate (Howmedica K885250) - as a predicate for plating systems.
• Basis of Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
• Regulatory Acceptance: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976. This determination allows the sponsor to market the device, subject to general controls and GMP regulations.

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The Exeter II Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

The Exeter Intramedullary Bone Plug is a molded acrylic device that is designed to be placed in the femoral canal prior to the insertion of a femoral stem. The bone plug restricts the migration of bone cement down the femoral canal and permits cement pressurization within the canal. The Bone Plug is a cone shaped device available in a range of diameters to accomodate various anatomical requirements. The distal portion of the plug is designed with circumferential ridges that create an interference fit between the plug and the femoral canal. Slots are cut into the ridge portion of the bone plug to allow the plug to compress slightly during insertion down the canal. The body of the plug contains a threaded portion for use with an insertion instrument.

The provided text describes a 510(k) submission for a medical device called the "Exeter Intramedullary Bone Plug." The submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of regulatory submission. The document explicitly states: "The substantial equivalence of the Exeter Bone Plug is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter II Distal Centralizer (K974054)."

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

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

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence: Equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to predicate devices.	The device is described as having the "same design as the currently marketed device" and is stated to be substantially equivalent to K933077 and K974054 based on the criteria listed. No specific performance metrics (e.g., bone cement restriction percentage or pressurization values) are provided.

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

   • Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not new performance data from a test set.
   • Data Provenance: Not applicable.

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 assessment by experts for a test set is not described in this type of submission.

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

   • Not applicable.

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

   • Not applicable. This is not an AI-assisted diagnostic device.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • Not applicable. The "ground truth" in this context is the performance and safety established for the predicate devices, which is what the new device is compared to for substantial equivalence. No new ground truth data is generated for this specific submission as it relies on equivalence.

8. The sample size for the training set

   • Not applicable. This is not a machine learning device.

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

   • Not applicable.

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