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The Eminent Spine 3D Titanium Pedicle Screw System is designed to provide immobilization and stabilization to the thoracic, lumbar and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 or 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.

The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps, and cross connectors with lock screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to 600mm in various increments. The radius of curvature of the pre-contoured rods is 154mm throughout the entire series. Cannulated polyaxial screws are available in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm diameters and in lengths ranging from 40mm to 60mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods.

All components are manufactured from Ti6Al4V ELI. The screw is made specifically from Ti6Al4V ELI per ASTM F3001 and the tulip, set cap, rod, and cross link systems are made specifically from Ti6Al4V ELI per ASTM F136. The devices are sold non-sterile.

The provided document is an FDA 510(k) clearance letter for a medical device, the "Eminent Spine 3D Titanium Pedicle Screw System." This letter is a regulatory document, not a clinical study report.

Therefore, none of the information requested about acceptance criteria and study proving device performance (points 1-9) can be found in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This equivalence is primarily demonstrated through mechanical testing (listed on page 6) and comparison of technological characteristics (page 6), rather than clinical performance studies involving human subjects or AI algorithms.

Specifically, the document mentions:

• Mechanical Testing:
  • Static torsion, static compression bending, and dynamic compression bending according to ASTM F1717
  • Torsional strength, driving torque, and axial pullout according to ASTM F543
  • Static cantilever bending according to ASTM F2193
  • Dynamic cantilever bending modified from ASTM F2193
• Conclusion: "The results support the substantial equivalence of the subject device compared to predicate devices."

This type of submission typically relies on non-clinical data (e.g., bench testing) to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device, and does not usually include the detailed clinical study data points requested (such as sample size for test/training sets, expert adjudication, MRMC studies, or AI algorithm performance).

In summary, the provided text does not contain the information necessary to address the specific questions about acceptance criteria and clinical study performance for human readers or AI, as it pertains to a mechanical medical device cleared through substantial equivalence based on bench testing.

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The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyhosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intents diagnosed with: spondylolisthesis / spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Eminent Spine Scoliosis Deformity Pedicle System consists of rods, polyaxial screws with set caps, and cross connectors with locking screws. Additionally, the system consists of rod connectors and iliac bolts with their respective locking screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to various increments. Cannulated polyaxial screws are available in 6.0mm to 12.5mm diameters and in lengths ranging from 40mm to 110mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods. Rod connectors are offered in 3 types and the iliac bolts are offered in 1 type. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy per ASTM F136.

The provided document describes a medical device, the "Eminent Spine Scoliosis Deformity Pedicle Screw System," and its 510(k) premarket notification. The document focuses on establishing substantial equivalence to predicate devices, primarily through technological characteristics and mechanical testing.

However, the provided text does not contain information directly related to the acceptance criteria and study proving device performance in the context of an AI/software-based medical device. The device described is a physical implant (pedicle screw system), and the studies mentioned are mechanical tests, not clinical performance studies involving a test set, ground truth, experts, or AI algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this information is not present in the provided text.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance for an AI/software component.
• Sample size and data provenance for a test set.
• Number and qualifications of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance metrics.
• Type of ground truth used (e.g., pathology, outcomes data) for an AI model.
• Sample size and ground truth establishment method for a training set.

The document solely focuses on mechanical testing of the physical pedicle screw system to demonstrate its substantial equivalence to previously cleared devices.

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The Eminent Spine Sl Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroillitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

The Eminent Spine Sacroiliac (SI) Screw System is intended for sacroiliac joint fixation for conditions including degenerative sacroiliac joint disruption. The Eminent Spine SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136 using traditional machining methods, as well as 3D-printed titanium alloy Ti-6AI-4V ELI per ASTM F3001. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy. The cannulated screws have open and porous graft windows for the Ø8.5, Ø10.0, Ø11.5, and Ø13.0mm options to allow bone growth through the implant. Optional locking crowns/locking fangs are included for all of the available screw diameters to aid in conforming to patient anatomy.

The provided text is a 510(k) summary for the "Eminent Spine SI Screw System." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information regarding acceptance criteria, reported device performance data, study design, sample sizes, ground truth establishment, or expert qualifications as would be typical for a clinical or performance study evaluating an AI/ML powered medical device.

The "Non-Clinical Testing" section mentions mechanical testing per ASTM F3574, but it only states that the results "support that the strength of the subject SI Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." It does not provide specific acceptance criteria or performance metrics in a way that would allow filling out the requested table.

Therefore, I cannot provide the detailed information requested in the prompt because the necessary details are not present in the provided text. The document is for a traditional medical device (a screw system), not an AI/ML powered device, and thus the type of performance evaluation details requested (e.g., effect size of human readers with AI, standalone algorithm performance) are not applicable or included.

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The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The provided text describes a 510(k) premarket notification for the "Eminent Spine 3D Lumbar Interbody Fusion Systems." This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than outlining acceptance criteria and a detailed study proving the device meets those criteria in the context of a typical AI/medical device performance study.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

The document mentions "acceptance criteria" not for clinical or diagnostic performance, but for mechanical testing.

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

This information is not provided in the document. The document refers to mechanical testing, not clinical studies involving 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)

This information is not applicable as the document describes mechanical testing of an implantable device, not an AI or diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable as the document describes mechanical testing.

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

This information is not applicable as the document describes mechanical testing of an implantable device, not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes mechanical testing of an implantable device.

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

For the mechanical testing, the "ground truth" would be established by the physical testing standards (ASTM F2077, ASTM F2267) and their specified measurement methods and acceptable limits. It's not a biological "ground truth" as typically discussed in diagnostic studies.

8. The sample size for the training set

This information is not applicable as the document describes mechanical testing of a physical device, not an AI algorithm.

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

This information is not applicable as the document describes mechanical testing of a physical device.

Summary of the Study:

The "study" described in this 510(k) summary is a series of mechanical tests designed to ensure the Eminent Spine 3D Lumbar Interbody Fusion Systems possess adequate strength and stability for their intended use. These tests were conducted according to ASTM standards (F2077 for static and dynamic testing, F2267 for subsidence), and an additional test for expulsion. The conclusion is that the device "performs as well as or better than the chosen acceptance criteria," which are implicitly defined by compliance with these ASTM standards and any internal specifications. The purpose of these tests is to demonstrate that the new device is mechanically equivalent to the predicate devices and safe for its intended surgical application, not to evaluate diagnostic performance or AI effectiveness.

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The Eminent Spine 3D Cervical Interbody Fusion is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Eminent Spine 3D Cervical Interbody Fusion System is comprised of various sizes and configuration to accommodate individual patient anatomy. The device is a hollow rectangular shaped block, which is available in a parallel or lordotic configurations. The device is hollow to allow for placement of bone graft. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device.

This submission is to introduce additively manufactured versions of the implants to the existing Eminent Spine Copperhead Interbody Fusion System.

This document is a 510(k) premarket notification for the Eminent Spine 3D Cervical Interbody Fusion System. It aims to prove the substantial equivalence of the new device to existing predicate devices.

Here's the breakdown of the acceptance criteria and the study information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "mechanical testing" and "results," but does not specify the sample size for the test set used in the mechanical tests.
The data provenance is from mechanical testing of the device, likely conducted in a laboratory setting. The country of origin and whether it was retrospective or prospective is not mentioned for the mechanical testing data.

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

This information is not applicable as the study presented is a mechanical performance study, not a clinical study involving expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable for a mechanical testing study.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical substantial equivalence of a medical implant, not an AI-assisted diagnostic tool.

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

This information is not applicable as this is not an AI algorithm.

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

For the mechanical testing, the "ground truth" is established by the specified ASTM standards (F2077 and F2267) and potentially by comparing the performance to the predicate devices. These standards define the acceptable mechanical properties for such devices.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" for AI or other data-driven modeling in this device submission. The device is a physical implant, and the testing described is mechanical.

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

This information is not applicable as there is no training set mentioned or implied in the provided document.

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The Eminent Spine Standalone ALIF Interbody Fusion is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The Eminent Spine Standalone ALIF Interbody Fusion System is a stand-alone interbody fusion device intended to be used with screws which accompany the spacers for fixation. Hyperlordotic implants (≥25 lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I Spondvlolisthesis. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with autograft and/or allogenic bone graft composed ofcancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Standalone ALIF devices are inserted through an anterior lumbar approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6Al-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136.

This document describes a medical device, the Eminent Spine Standalone ALIF Interbody Fusion System, and its substantial equivalence to predicate devices, based on mechanical testing. It does not describe an AI/ML powered medical device. Therefore, I cannot provide an answer that includes information that is not present in the original document, such as:

• Acceptance criteria table with reported device performance for an AI/ML system
• Sample size used for the test set and data provenance (for an AI/ML system)
• Number of experts used to establish ground truth and their qualifications (for an AI/ML system)
• Adjudication method (for an AI/ML system)
• Multi-reader multi-case (MRMC) comparative effectiveness study information
• Standalone performance (algorithm only) for an AI/ML system
• Type of ground truth used (for an AI/ML system)
• Sample size for the training set (for an AI/ML system)
• How ground truth for the training set was established (for an AI/ML system)

The provided text focuses on the physical and mechanical characteristics of an interbody fusion device, not on the performance of an AI/ML algorithm.

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The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile.

The provided FDA 510(k) summary is for a medical device called the "Cervical Stand-Alone System," which is an anterior cervical interbody fusion system. This documentation primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than presenting a clinical study with detailed acceptance criteria for an AI/software device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance for an algorithm) are not applicable to this type of device and submission. This is a physical implant, not an AI or software-based medical device.

However, I can extract the relevant "acceptance criteria" (which in this context refers to the performance standards the physical device must meet) and the "study" that proves it.

Here's the information based on the provided text, with clarifications where the questions are not relevant to this type of device:

Device Name: Cervical Stand-Alone System

Device Type: Intervertebral Body Fusion Device (physical implant)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary does not explicitly state numerical "acceptance criteria" values prior to presenting the results. Instead, it states that the device was tested per specific ASTM standards. The "reported device performance" is summarized as the device being "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices" based on these tests. The specific numerical results are not provided in this summary document.

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

• Sample Size for Test Set: Not specified in the document. This would refer to the number of physical devices or test specimens used in the mechanical tests. For mechanical testing of implants, sample sizes are typically small, determined by statistical requirements for engineering studies.
• Data Provenance: The data is from non-clinical mechanical testing conducted on the device itself. It is not patient data, nor is there a concept of "country of origin" as it relates to clinical data. The tests were performed to ASTM (American Society for Testing and Materials) standards.

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

Not applicable. This is a physical device subject to mechanical engineering tests, not a diagnostic or AI device requiring expert ground truth for interpretation of clinical conditions. The "ground truth" for these tests would be the physical properties and failure points measured by specialized testing equipment.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in clinical studies or for establishing ground truth in diagnostic AI performance evaluation. This document describes mechanical device testing.

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

Not applicable. This is a physical medical implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Not applicable. This question pertains to AI algorithms. The Cervical Stand-Alone System is a manufactured physical implant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering measurements against specified ASTM (American Society for Testing and Materials) standards. This involves measuring force, displacement, and cycles to failure under various loading conditions. It is not expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy, but rather the physical and mechanical integrity of the implant.

8. The sample size for the training set

Not applicable. This refers to training data for an algorithm. This device is a physical product, not an algorithm.

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

Not applicable. This refers to establishing ground truth for algorithmic training data.

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The Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Cervical Plate System is an anterior cervical plating system that consists of plates and selftapping screws. The implants are available in a variety of shapes to accommodate the anatomical condition of patients. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

Here's a breakdown of the acceptance criteria and study information for the Cervical Plate System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the mechanical performance data leads to the conclusion that the device is "substantially equivalent" to the predicate device. However, it does not explicitly provide numerical acceptance criteria or specific numerical results for these tests. It only states that the device's strength is "sufficient" and comparable to predicate devices.

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The studies mentioned are mechanical performance tests (in vitro), not clinical studies involving human patients or data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

4. Adjudication Method for Test Set

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a physical medical device (Cervical Plate System) through in vitro testing, not on evaluating the effectiveness of an AI algorithm or human reader performance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device described is a physical implant (Cervical Plate System), not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by ASTM F1717 standards for static and dynamic mechanical properties of spinal intervertebral body fixation orthoses. The document states "The Cervical Plate System has been tested in the following test modes: - Static compression bending per ASTM F1717 . - Static torsion per ASTM F1717 ● - Dynamic compression bending per ASTM F1717".

8. Sample Size for Training Set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI or machine learning system that requires training data.

9. How Ground Truth for Training Set Was Established

This information is not applicable for the same reason as above; there is no training set mentioned or implied for this mechanical device.

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The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.

The Eminent Foot Plate System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features twenty four (24) types of plates (Evans, Metatarsal, Metatarsal Left, Metatarsal Right, Metatarsal Step Left, Metatarsal Step Right, PMO Right, PMO Right, PMO Wedge Left, PMO Wedge Right, Osteotomy Left, Osteotomy Right, Osteotomy Wedge Left, Osteotomy Wedge Right, Osteotomy L Left, Osteotomy L Right, Peanut Slotted, Utility, Utility Long, Lis' Franc, Calcaneus, Calcaneus Long, and Forefoot H), 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 titanium (ASTM F136), and offered in various widths and lengths. Plates and screws are provided non-sterile.

The provided text describes the 510(k) summary for the Eminent Foot Plate System, a medical device for internal bone fixation. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance testing.

Here's an analysis of the provided information, specifically addressing the requested points:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported device performance values. Instead, it describes mechanical tests performed and concludes that the "strength of the Eminent Foot Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria were met by demonstrating non-inferiority to the predicate devices in these mechanical tests.

The information available for a table is limited to the types of tests performed:

Missing Information: The actual quantitative results (e.g., bending strength values, fatigue life cycles, torque values, pullout forces) for both the subject device and the predicate devices are not provided in this document. This makes it impossible to create a more detailed table with specific numerical acceptance criteria and performance data.

Study Details for Demonstrating Acceptance Criteria:

The document does not describe a clinical study or a study involving human subjects or expert review. The "study" here refers to non-clinical mechanical testing.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test. The wording "The Eminent Foot Plate System has been tested in the following test modes" implies that samples of the device were subjected to these tests. Without further detail, specific numbers are unknown.
   • Data Provenance: The tests are likely performed in a controlled laboratory environment by the manufacturer or a third-party testing facility (like Empirical Testing Corporation, mentioned in the letter's address). The data is non-clinical/bench testing data. Country of origin is not specified but presumed to be a regulated environment relevant to the US market. The data is prospective in the sense that the device was manufactured and then tested to demonstrate performance.

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

   • Not applicable. This section describes mechanical bench testing, not a study involving human experts or ground truth establishment in a diagnostic or clinical context. The "ground truth" for these tests would be the established ASTM standards themselves, and the measurement of physical properties.

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

   • Not applicable. Adjudication methods like 2+1 are used in clinical studies or image interpretation where human expert disagreement needs to be resolved. This is mechanical testing against established standards.

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 device is a bone fixation system, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

   • Not applicable. This device does not involve an algorithm or AI.

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

   • The "ground truth" for the mechanical tests would be the physical properties and performance characteristics of the device measured against the requirements of the cited ASTM standards (ASTM F382 and ASTM F543) and compared to the performance of predicate devices. There is no expert consensus, pathology, or outcomes data involved in these specific tests.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, no training set is relevant for this type of device and testing.

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The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the treatment of the thoracolumbar spine (T1-L5). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the bifurcation of the great vessels in the treatment of the lumbosacral (L1-S1) spine. The Diamond Rattlesnake System is intended to provide temporary stabilization as an adjunct to fusion using a lateral approach in skeletally mature patients for the treatment of the following acute and chronic instabilities and deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudarthrosis, spondylolysis, spondylolisthesis, deformity (scoliosis, kyphosis, and or lordosis), spinal stenosis, fracture (including dislocation and subluxation), tumor, or failed previous spine surgery.

The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System consists of a variety of plates and screws. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The plates are manufactured in a variety of configurations with lengths of 21 to 33mm in a single level plate and 64 to 76mm in a two level plate. Additionally, the non-locking screws are provided in diameters of 5.5mm with lengths of 25 - 50mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

The document describes a 510(k) submission for the Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System. This is a spinal intervertebral body fixation orthosis, a medical device used for temporary stabilization as an adjunct to fusion in the lumbar and thoracolumbar spine.

It's important to understand that a 510(k) submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical claims or efficacy through extensive clinical studies in the same way a PMA (Pre-Market Approval) process would. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing designed to show the new device performs at least as well as the predicate device(s) in specific mechanical properties.

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

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

Note: The document explicitly states "The results of these studies show that the subject Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." The specific numerical acceptance criteria (e.g., minimum load, cycles to failure) are not detailed in this summary, but are implied to be derived from the predicate device performance and the ASTM F1717 standard.

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 for Test Set: Not explicitly stated. For non-clinical (mechanical) testing of medical devices like this, sample sizes are typically determined by statistical validation requirements for the specific test (e.g., 5-10 samples per test condition to achieve statistical significance). The document only mentions "Nonclinical testing was performed..."
• Data Provenance: Not specified. This is non-clinical lab testing, not human data. The testing would have been conducted in a laboratory setting, likely in the US (where Eminent Spine, LLC and Secure BioMed Evaluations are located).
• Retrospective or Prospective: Not applicable as this is non-clinical mechanical testing, not a clinical study involving human subjects or data.

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 in this context. "Ground truth" and "experts" as described (e.g., radiologists) are relevant for clinical studies, particularly those involving image interpretation or clinical diagnosis. For a spinal implant's mechanical testing, the "ground truth" is established by adherence to recognized engineering standards (like ASTM F1717) and the physical measurements obtained during the tests.

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

• This question is not applicable for non-clinical mechanical testing. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations or clinical outcomes.

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 question is not applicable. This describes a spinal implant, not an AI software or imaging system that would involve human readers.

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

• This question is not applicable. This device is a physical spinal implant, not an algorithm.

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 principles and standards for mechanical testing (ASTM F1717). The performance of the device is compared against the known or expected performance of legally marketed predicate devices under these standardized test conditions.

8. The sample size for the training set

• This question is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. Training sets are typically used for machine learning or AI models.

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

• This question is not applicable for the same reason as point 8.

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