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The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.

The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can be operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "side-by-side testing," but does not specify the sample size for the test set (i.e., how many instruments were tested or how many measurements were taken).

The data provenance is not explicitly stated beyond being part of a non-clinical test conducted by Kalitec Direct, LLC. It is a retrospective study as it's a submission for a 510(k) premarket notification.

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

Not applicable. This study appears to be a technical performance validation against a standard (ASTM F2554) and a predicate device, rather than an evaluation requiring expert clinical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As this was a technical performance validation, there would not typically be an adjudication method in the sense of resolving discrepancies between expert opinions. The performance was measured against the ASTM standard and the predicate device.

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

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical performance validation.

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

Yes, in essence. The study focuses on the "dimensional accuracy" of the "Kalitec Navigated Instrument System" in conjunction with the Medtronic StealthStation® System. This is a technical performance assessment of the device itself, rather than an evaluation of human performance with or without the device. While a human surgeon would ultimately use the instruments, the test described is about the instrument's accuracy, not a surgeon's performance using it.

7. The Type of Ground Truth Used

The "ground truth" for the test set was:

• Dimensional accuracy as defined by ASTM F2554. This is a recognized standard for evaluating dimensional accuracy.
• Performance of the legally marketed predicate device (Medtronic® StealthStation® system and predicate device). The Kalitec system's performance was compared to this established benchmark.

8. The Sample Size for the Training Set

Not applicable. This device is a navigated instrument system, not an AI/ML algorithm that requires a training set in the typical sense. The device's functionality is based on its mechanical design and interaction with the navigation system, not on learning from a dataset.

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

Not applicable. See point 8.

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The TiWAVE-C™ Porous Titanium Cervical Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

The TiWAVE-C™ Porous Titanium Cervical Cages are intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.

This is a medical device, specifically an intervertebral body fusion device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI, standalone algorithm performance, sample size for training sets, and adjudication methods for experts) are not applicable.

However, based on the provided text, I can extract information regarding the device's non-clinical acceptance criteria and the study performed to prove it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TiWAVE-C™ Porous Titanium Cervical Cage are based on demonstrating safety and performance equivalence to predicate devices through various mechanical and sterilization tests, adhering to industry standards.

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

The document does not specify the exact sample sizes (e.g., number of individual cages) used for each mechanical and sterilization test. However, it indicates that "the following tests were independently performed on the device," implying that multiple device samples were subjected to these tests to meet the relevant ASTM or ISO standards.

• Data Provenance: The tests were "independently performed on the device," suggesting that the testing was conducted in a laboratory setting (likely by the manufacturer or a contracted third-party lab) to evaluate the physical characteristics and performance of the TiWAVE-C™ Porous Titanium Cervical Cages themselves, rather than collecting data from human subjects or existing patient records. Therefore, it is prospective data generation from device testing, not retrospective. Country of origin for data is not explicitly stated but implied to be related to the submitter (Kalitec Direct, LLC in Orlando, FL, USA).

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 type of device submission. There were no human experts establishing ground truth for a test set in the context of diagnostic accuracy or clinical interpretation. The "ground truth" for the device's performance is established by its compliance with recognized mechanical, material, and sterilization standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This question is not applicable. No human adjudication was involved in evaluating the technical performance and safety of an intervertebral body fusion device based on mechanical and sterilization testing. The results are based on objective measurements against predefined 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

This question is not applicable. The device is a physical intervertebral body fusion cage, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

This question is not applicable. The device is a physical intervertebral body fusion cage, not an AI algorithm.

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

The "ground truth" for this device's acceptance is based on:

• Engineering Standards: Compliance with established mechanical testing standards (e.g., ASTM F2077, ASTM F2267) for intervertebral body fusion devices. These standards define the expected performance characteristics (e.g., strength, durability).
• Material Specifications: Conformance to material standards (e.g., ASTM F3001 for Titanium Grade 23).
• Sterilization and Biocompatibility Standards: Compliance with standards for sterilization methods (e.g., AAMI/ANSI/ISO 11137-2) and cleanliness (e.g., cytotoxicity, bioburden, bacterial endotoxin).
• Predicate Device Equivalence: The primary ground truth is also the demonstration of "substantial equivalence" to legally marketed predicate devices through comparative testing and analysis of design, materials, and intended use. The performance of the predicate devices, which are already deemed safe and effective, serves as the benchmark.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device.

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

This question is not applicable. There is no "training set" for this physical medical device.

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The CosmoLock Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor. pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:
Ti-6Al-4V per ASTM F136 Co-28Cr-6Mo per ASTM F1537 Commercially Pure Ti per ASTM F67

This document is a 510(k) Premarket Notification from the FDA regarding the "CosmoLock Pedicle Screw System." It explicitly states that no clinical studies were performed for this device. Therefore, it is impossible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study was conducted or presented in this document.

The document focuses on demonstrating substantial equivalence to previously approved predicate devices based on non-clinical tests (static and dynamic compression, static torsion) and similarities in intended use, design, materials, and mechanical safety/performance.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable. No clinical performance criteria or results are reported, as no clinical study was performed. The non-clinical tests' results are stated as indicating equivalence to predicate devices, without specific performance metrics or acceptance criteria for those metrics.
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 for clinical testing. For non-clinical tests, "samples" refer to the physical devices tested, not patient data. The document does not specify the number of devices tested for static and dynamic compression/torsion. Data provenance is not relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (pedicle screw system), not an AI/imaging device requiring human reader studies. No clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical study was performed. The "ground truth" for the device's safety and effectiveness relies on its substantial equivalence to previously cleared devices, supported by non-clinical mechanical testing results.
8. The sample size for the training set: Not applicable. No AI/machine learning component. No clinical study for training.
9. How the ground truth for the training set was established: Not applicable. No AI/machine learning component. No clinical study for training.

In summary, this document is a regulatory submission demonstrating substantial equivalence for a physical medical implant based on non-clinical mechanical testing, not clinical performance data or studies involving human subjects.

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The Matira™ Anterior Cervical System is interior interbody screw fixation of the cervical spine from C2 to Tl. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.

The Matira Anterior Cervical System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Matira Anterior Cervical System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping, fixed or variable configurations), and associated instruments. Bone screws inserted into the vertebral body of the cervical spine using System implant components are made from titanium alloy.

This document is a 510(k) premarket notification for the Matira™ Anterior Cervical System. It does not contain information about an AI/ML device or its acceptance criteria and study data.

The document describes a medical device for spinal fixation and explicitly states under "Clinical Test Summary" that "No clinical studies were performed." Therefore, there is no information in this document to address your request regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies involving human readers or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (mechanical tests on plates and screws per ASTM standards) and similarities in intended use, design, materials, and technology.

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The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, or scoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Ocata Anterior Cervical System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.
The Ocata Anterior Cervical System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping, fixed or variable configurations), and associated instruments.
Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The Ocata™ Anterior Cervical System implant components are made from titanium alloy.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ocata™ Anterior Cervical System.

Upon reviewing the provided document, it becomes clear that this is a 510(k) submission for a medical device (spinal implant), not an AI/ML software or diagnostic device. Therefore, the questions related to AI performance metrics, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes for AI are not applicable to this submission.

The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices based on non-clinical mechanical testing.

Here's the information extracted and adapted to the context of a medical implant:

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

For medical implants like the Ocata™ Anterior Cervical System, "acceptance criteria" and "reported device performance" are typically defined by recognized standards for mechanical and material properties. The submission states that tests were conducted according to ASTM standards. The acceptance criteria are implicitly that the device's performance meets or exceeds the requirements of these standards and is comparable to previously cleared predicate devices.

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 in the summary for each specific test (e.g., how many plates were tested for compression). However, mechanical testing for medical devices typically involves a statistically relevant number of samples to demonstrate consistency.
• Data Provenance: The tests are non-clinical, mechanical tests. This means the data is generated in a laboratory setting, not from human or animal subjects. The location of the testing facility is not specified, but it would have been performed by or for Kalitec Direct, LLC.
• Retrospective or Prospective: Not applicable as these are laboratory-based mechanical tests.

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

Not applicable. "Ground truth" in the context of this device refers to the established mechanical properties and material standards (e.g., ASTM F1717, ASTM F543, ASTM F136). The "experts" involved are engineers and materials scientists who perform and interpret these tests according to recognized industry standards, rather than medical experts establishing diagnostic ground truth.

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

Not applicable. Mechanical testing results are objective measurements that are compared against predefined numerical criteria outlined in the relevant ASTM standards. There is no human adjudication process involved in assessing test results in the same way there would be for image interpretation by clinicians.

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 implant, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device is a physical 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 standards and material specifications (e.g., ASTM F1717 for static and dynamic compression and torsion, ASTM F543 for screw properties, ASTM F136 for implant material, ASTM F899 for instrument material). The device's performance is deemed acceptable if it meets these standards and is shown to be equivalent to the predicate devices which have already demonstrated safety and efficacy through their own testing and market history.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable. See point 8.

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The Kalitec Direct InSePtion™ MIS Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The Kalitec Direct InSePtion™ MIS Fixation System is not intended for standalone use, and is intended for use with autograft or allograft.

The Kalitec Direct InSePtion110 MIS Fixation System implant is a posterior non-pedicle supplemental fixation device utilized to achieve supplemental fusion in the non-cervical spine. The system is made of titanium alloy and includes eight color coded sizes, ranging from 8 mm to 18 mm.

The provided text is a 510(k) summary for the Kalitec Direct InSePtion™ MIS Fixation System, a medical device for spinal fixation. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does NOT contain any information about: studies proving device performance against acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications or numbers, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established beyond referencing "radiographic studies" for disc degeneration.

The "Performance Testing" section states: "Testing performed on this device indicates that the Kalitec Direct InSePtionTM MIS Fixation System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks. Finite Element Analysis was also performed to characterize device performance."

This indicates mechanical/physical performance testing against engineering standards (ASTM F1717), not clinical or algorithmic performance against diagnostic or clinical utility criteria. The tests mentioned are mechanical integrity tests for spinal implants.

Therefore, I cannot provide the requested information for a study on "device meets acceptance criteria" as it pertains to AI/algorithm performance or clinical diagnostic accuracy, because this document describes a mechanical implant and its mechanical performance testing for substantial equivalence, not a diagnostic device involving AI or expert interpretation of medical images.

Based on the provided text, the device is a physical spinal implant, not an AI/software medical device.

Thus, I cannot fill out the requested table or answer the questions related to AI studies, ground truth, expert consensus, MRMC studies, or training/test sets for an algorithm. The acceptance criteria here would relate to the mechanical properties and safety of the implant itself, not its diagnostic accuracy or utility with human readers.

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The CosmoLock Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.

Here's an analysis based on the provided text:

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)

This information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are not specified.

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/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.

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

This information is not applicable/provided. No clinical studies were performed.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document states, "No clinical studies were performed."

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

This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.

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

The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.

8. The sample size for the training set

This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.

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

This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.

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The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.

Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:
Maintain adequate disc space until fusion occurs.

The provided document is a 510(k) Summary for the INTESS™ Cervical Cage. This type of document is a premarket notification to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics like a typical AI/software device. For a traditional medical device like the INTESS™ Cervical Cage, "acceptance criteria" are usually met by demonstrating that the device's functional and safety characteristics are comparable (substantially equivalent) to already approved devices.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device (with details like sample sizes, expert ground truth, MRMC studies, etc.) does not directly apply to this 510(k) submission for a physical implant.

However, I can extract the information relevant to the equivalence demonstration for the INTESS™ Cervical Cage:

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

Since this is a 510(k) to demonstrate substantial equivalence, "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is a demonstration that the INTESS™ Cervical Cage performs comparably to these predicates in non-clinical tests.

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 applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of physical devices tested. This information is typically detailed in the test reports referenced by the ASTM standards, but not usually in the 510(k) summary itself. The document states "The following tests were conducted," implying a sufficient number of devices were tested to meet the ASTM standards.
• Data Provenance: Not applicable for a non-clinical mechanical test summary.

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 from human experts is not used for mechanical testing of a physical implant. The "ground truth" for mechanical performance is established through adherence to recognized ASTM standards and the associated testing methodologies.

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

Not applicable. This device's evaluation did not involve human adjudication of test results in the way an AI/software device would. The mechanical tests have pass/fail criteria based on engineering specifications.

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

No. This is a physical implant, not an AI/software device. No MRMC study was performed.

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

No. This is a physical implant.

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

The "ground truth" for the non-clinical tests is based on established engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F2026, ASTM F560) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. There is no training set for a physical implant.

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

Not applicable. There is no training set for a physical implant.

Summary of the Study (Equivalence Demonstration):

The study conducted to support the INTESS™ Cervical Cage was a series of non-clinical bench tests designed to demonstrate the device's mechanical integrity and material properties.

• Tests Performed:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
• Materials Conformance: Zeniva ZA500 PEEK conforming to ASTM F2026 and Unalloyed tantalum conforming to ASTM F560.
• Conclusion: The results of this testing indicated that the INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
• Clinical Studies: No clinical studies were performed.

In essence, for this device, "acceptance criteria" are met by demonstrating that its physical and mechanical properties, as measured by standard engineering tests, are comparable to those of already approved predicate devices.

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The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The INTESS Lumbar Cage was developed as implants for the stabilization of the lumbar spinal column. The INTESS implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.

The provided text is a 510(k) summary for a medical device called the INTESS Lumbar Cage. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.

However, the provided document explicitly states under "6. CLINICAL TEST SUMMARY": "No clinical studies were performed".

This means that the document does not contain any information about:

• Acceptance criteria for device performance based on clinical data.
• A study that proves the device meets specific performance criteria through clinical data.
• Sample sizes for test sets (as no test set from a clinical study was used).
• Number of experts, their qualifications, or adjudication methods for ground truth (as no clinical ground truth was established through expert review).
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (clinical).
• Training set size or how its ground truth was established (as no AI/algorithm training was performed or reported).

The 510(k) summary focuses entirely on non-clinical testing (static and dynamic compression, subsidence, and expulsion) to demonstrate substantial equivalence based on mechanical safety and performance and material properties to legally marketed predicate devices, rather than clinical performance (e.g., efficacy or safety in patient outcomes).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in a clinical context, as the document explicitly states no clinical studies were performed. The acceptance criteria and "proof" presented are entirely based on the equivalence of mechanical properties to existing devices.

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The ODALYS™ Pedicle Screw System is a pedicle screw system 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ODALYS™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ODALYS™ Pedicle Screw System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.

The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.

Materials: The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

Function: The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

The provided text describes the ODALYS™ Pedicle Screw System, a medical device, and its acceptance criteria as determined by the FDA's 510(k) clearance process.

Here's an analysis of the acceptance criteria and the "study" (non-clinical tests) used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "test set" in the context of human data. The testing performed was non-clinical, involving mechanical tests of the device. The sample size for these mechanical tests (e.g., number of screws or constructs tested for each configuration) is not provided in the summary.
• Data Provenance: The data provenance is from non-clinical laboratory testing (mechanical testing per ASTM standards). There is no information regarding country of origin or whether it's retrospective or prospective, as it pertains to physical device testing, not human 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. The "ground truth" for this device, in the context of the 510(k) submission, is its mechanical performance and material properties. This is established by adherence to recognized ASTM standards for medical devices, rather than expert consensus on a dataset. The results are compared to predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective mechanical testing results comparing the device to accepted standards and predicate device performance.

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 Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ODALYS™ Pedicle Screw System is a physical implant, not an AI-based diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device is a physical implant; there is no AI algorithm associated with it.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Compliance with recognized industry standards (ASTM F1717 and ASTM F136).
• Substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and function, as demonstrated by meeting or exceeding the mechanical performance and material specifications of those predicates.

8. The Sample Size for the Training Set

This section is not applicable. The ODALYS™ Pedicle Screw System is a physical pedicle screw system, not an AI or machine learning device that requires a "training set."

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

This section is not applicable for the same reason as point 8. There is no training set for this device.

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