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BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and fusion surgical technique. The tapered nose design provides ease of insertion while the convex superior and flat inferior surfaces replicate the patient's vertebral anatomical architecture for maximum surface contact. The cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in two widths, one depth, seven heights, and three lordotic angles.

The provided document is a 510(k) summary for a medical device called "BEE Cages" (Cervical Cages), seeking to demonstrate substantial equivalence to a predicate device. It details product information, intended use, and a summary of non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "non-clinical tests" and "clinical evidence" without specifying explicit test set sample sizes for the mechanical tests or the clinical evidence portion.

• Non-clinical (Mechanical) Tests: Performed on the BEE Cervical Cages. The sample size for these specific tests (ASTM F2077, ASTM F2267) is not explicitly stated, but these standards typically involve multiple samples to ensure statistical validity.
• Clinical Evidence: The document states that "Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the development of fusion." No details are given regarding the country of origin, whether it was retrospective or prospective, or the number of patients/cases involved in this clinical evidence.

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

This information is not provided in the document. The document refers to "clinical evidence" but does not detail how the ground truth for this evidence was established, nor the involvement or qualifications of experts in that process.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study is not mentioned in the document. The document focuses on demonstrating substantial equivalence through non-clinical mechanical testing and general clinical evidence related to fusion, not a comparative analysis of human reader performance with or without AI assistance.

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

This question is not applicable as the device is a physical intervertebral body fusion device, not an AI algorithm. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

• Non-clinical (Mechanical) Tests: The "ground truth" for the mechanical tests is based on the results obtained from standardized ASTM test methods (ASTM F2077 for intervertebral body fusion devices and ASTM F2267 for measuring load-induced subsidence). The acceptance criteria are implicitly derived from these standards and comparison to predicate device performance.
• Clinical Evidence: The ground truth for the "clinical evidence" regarding fusion development is based on clinical outcomes reported in the evidence provided. The exact nature of this outcome data (e.g., imaging reports, surgical reports, patient follow-up) that confirmed fusion is not detailed beyond the statement itself. Pathology or direct outcomes data details are not specified.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

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

This question is not applicable as the device is a physical medical implant.

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Vertu® & Vertu® Ti-Bond devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. Implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Crystal® & Crystal® Ti-Bond devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The Vertu and Vertu Ti-Bond Cervical Interbody System is composed of an implant body made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580 and fixation screws made from Ti-6Al-4V per ASTM F136 or ISO 5832-3 with a Nitinol clip conforming to ASTM F2063. All implant bodies have a titanium insert lining the internal surface of the screw holes conforming to ASTM F136 or ISO 5832-3. The implant body is generally boxshaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. Each screw hole is lined in its internal surface with a titanium ring insert. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.

The Crystal and Crystal Ti-Bond Cervical Interbody devices are generally a box-shaped device with various holes located throughout its geometry to allow for packing of bone graft material. The body of the implant is made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580. Superior and inferior surfaces of the device have teeth that help keep the device from migrating once placed in its desired location.

This FDA 510(k) Premarket Notification document (K153352) describes the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. Per the document, "No changes were made to the existing Vertu. Vertu Ti-Bond. Crystal Ti-Bond devices nor were any new components added to the system. Therefore, no additional testing was required or performed." This implies that new acceptance criteria and a study to prove these devices meet those criteria were not established for this specific submission. Instead, the document relies on the substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be directly extracted from the provided text for this specific K153352 submission:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated as new criteria or performance data were generated for this submission. The device is determined to be substantially equivalent based on existing data and characteristics of predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable as a new test set was not created for this submission. The submission references previous clearances (K122771, K133218, K073351) for the predicate devices, which would have had their own testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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. These are interbody fusion devices, not AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The provided document (K153352) is a 510(k) premarket notification for expanded indications for the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. The FDA determined the device is substantially equivalent to legally marketed predicate devices. The basis for this determination is that no changes were made to the existing devices, and no new components were added, thus no additional testing was required or performed for this specific submission. The substantial equivalence is argued based on a comparison of indications for use, technological characteristics, surgical technique, design features, and instrumentation to established predicate devices.

The acceptance criteria and performance data for the original clearances of these devices and their predicates would be found in the associated 510(k) submissions (K122771, K133218, K073351, K150053, K142264, K133653), which are not included in this document.

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The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (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 cages.

The ALTA Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in two material choices: PEEK and titanium. The PEEK implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.

This document is a 510(k) premarket notification for the ALTA Cervical Interbody Spacer. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and efficacy through clinical trials. Therefore, the information typically requested about acceptance criteria and detailed study designs for AI/medical imaging devices is not present here.

Specifically for your questions:

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

   • This document does not contain quantitative acceptance criteria and reported performance metrics in the way one would see for an AI/imaging device. The device's "performance" is demonstrated through non-clinical mechanical testing, showing equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.

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

   • No clinical "test set" data in the context of an AI/imaging device is provided. The non-clinical tests (static/dynamic compression, torsion, subsidence, expulsion) involve mechanical samples of the device itself.
   • The document explicitly states: "No clinical studies were performed."

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. There is no clinical test set requiring expert-established ground truth.

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 implant, not an AI/imaging diagnostic device.

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

   • Not applicable. This is a medical implant, not an AI/imaging diagnostic device.

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

   • For the non-clinical tests, the "ground truth" is based on established ASTM standards for mechanical properties (e.g., F2077 for compression and torsion, F2267 for subsidence). The device's performance is compared against these standards or against the performance of predicate devices as per those standards.

8. The sample size for the training set

   • Not applicable. There is no AI model or "training set."

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

   • Not applicable. There is no AI model or "training set."

Summary of Device Performance (from the provided text, related to non-clinical testing):

Conclusion: The provided document describes a 510(k) submission for a cervical interbody spacer. The device received clearance based on demonstrating "substantial equivalence" to existing predicate devices, primarily through non-clinical mechanical testing and comparison of design, materials, and intended use. No clinical studies were performed, and thus, no data regarding acceptance criteria, test set, training set, expert consensus, or AI performance metrics are included.

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The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). 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 additional supplemental 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 Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK were developed as implants for the stabilization of the cervical and lumbar spinal column. The 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 during and after surgery.

Here's an analysis of the provided text regarding acceptance criteria and study information for the Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK devices.

Based on the provided FDA 510(k) summary, these devices are intervertebral body fusion devices, and the submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria from a clinical study for a novel AI/software function.

Therefore, most of the requested fields related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this particular device submission. The "acceptance criteria" here refer to the regulatory standards and testing required for this type of medical implant to demonstrate safety and effectiveness equivalent to existing devices.

1. Table of Acceptance Criteria and 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)

• Test Set Sample Size: Not applicable. The testing described is non-clinical mechanical testing of the physical implant, not a study involving patient data or a "test set" in the context of AI/software performance.
• Data Provenance: Not applicable. The data comes from benchtop mechanical testing, not human subjects.

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 as typically defined for AI/software (e.g., diagnostic labels) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles.

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

• Not applicable. There was no clinical or expert-based adjudication in the context of this submission. The "adjudication" for mechanical testing is based on whether the device passed the specified ASTM standards.

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

• Not applicable. No MRMC study was performed as these are physical medical implants, not AI/software for interpretation.

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

• Not applicable. No algorithm-only performance study was conducted.

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

• Not applicable. The "ground truth" for this submission are the established ASTM standards for mechanical testing of intervertebral body fusion devices.

8. The sample size for the training set

• Not applicable. There was no "training set" in the context of an AI/software algorithm.

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

• Not applicable. There was no "training set" or corresponding ground truth to establish.

Summary of the Study:

The provided document describes a 510(k) premarket notification for three intervertebral body fusion devices: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK.

The study relied on non-clinical mechanical testing to demonstrate "substantial equivalence" to previously marketed predicate devices, as is common for Class II medical devices in the 510(k) pathway.

Specifically, the following analyses were conducted:

• Static and dynamic compression per ASTM F2077
• Static and dynamic torsion per ASTM F2077
• Subsidence per ASTM F2267

The manufacturer, Osteomed Implantes, LTDA, concluded that the DICOM PEEK, DIMEI PEEK, and TLIF PEEK devices are equivalent to the predicate devices based on similarities in principles of operation, technology, materials, and indications for use, supported by the results of these non-clinical evaluations.

No clinical studies were performed. The submission explicitly states this.

Ground Truth for Non-clinical Testing: The ground truth for this type of testing is adherence to the specified ASTM international standards (ASTM F2077 for compression/torsion and ASTM F2267 for subsidence), which are recognized benchmarks for evaluating the mechanical properties of intervertebral body fusion devices. The devices are expected to meet or exceed the performance of the predicate devices under these test conditions.

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Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.

The Crystal® device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

Mosaic®:
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in sketally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.

Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level ( C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Crystal:
Crystal is an intervertebral body fusion device for use in cervical spinal surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

Mosaic:
The Mosaic Spinal Implant System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry for the placement of graft material. Additionally, it has teeth on its superior and inferior external surfaces to keep the device from migrating once placed in its desired location. The box-shaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration.

Vertu:
The Vertu Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration.

Here's a breakdown of the acceptance criteria and study information for the Crystal®, Mosaic®, and Vertu® intervertebral body fusion devices, based on the provided FDA 510(k) summary:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way a de novo or PMA application might. Therefore, the "acceptance criteria" here are essentially the performance metrics of the legally marketed predicate devices, and the "study" is the non-clinical testing performed to show equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implied to be the performance of the predicate devices. The "reported device performance" demonstrates that the subject devices perform comparably to these predicates.

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

The document does not explicitly state the sample sizes (e.g., number of units tested) for each mechanical test. The data provenance is derived from non-clinical bench testing conducted to support the substantial equivalence claim. There is no mention of country of origin for this testing, but it is typically conducted by the manufacturer or a contract research organization.

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

Not applicable. This submission relies on non-clinical bench testing and comparison to predicate device performance, not on expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

Not applicable for non-clinical bench testing focused on mechanical properties.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Studies No clinical studies were performed."

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

This is not applicable as the device (intervertebral body fusion device) is a physical implant, not a software algorithm. The document explicitly states: "Software Verification and Validation Testing The device does not contain software. Therefore no software verification and validation testing were performed."

7. The Type of Ground Truth Used

The ground truth used is based on the established performance characteristics and safety profile of the predicate devices and recognized consensus standards (e.g., ASTM, ISO) for material and mechanical testing. For the wear debris, the ground truth for comparison was specifically the predicate Calix PC (K112036).

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set.

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When used as a cervical intervertebral fusion device, the Coveris Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior systems) cleared for use in the cervical spine.

The Camber Spine Coveris Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The Coveris Cage of intervertebral body fusion devices are made from the PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Here's an analysis of the acceptance criteria and study information for the Camber Spine Coveris Cage (K133529) based on the provided text:

Acceptance Criteria and Device Performance (Non-Clinical Study)

The provided document describes physical and mechanical tests demonstrating the device's substantial equivalence to predicate devices. It states that "The results of these studies showed that the Coveris Cage met the acceptance criteria." However, the exact numerical acceptance criteria for each test are not specified in the provided text. The table below lists the tests performed and the general statement about meeting acceptance criteria.

Study Details:

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

   • The document describes non-clinical (mechanical) testing, not a study involving human or animal subjects that would typically have a "test set" and "data provenance" in the traditional sense of a clinical or AI study.
   • The tests were performed on the Camber Spine Coveris Cage device itself to evaluate its mechanical properties and compare them to predicate devices. The sample size for these mechanical tests (e.g., number of cages subjected to each test) is not specified.
   • Data provenance (country of origin, retrospective/prospective) is not applicable as this was a device's physical characteristic testing, not patient data.

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

   • This is not applicable as the study involved mechanical testing of a medical device, not a diagnostic or AI-driven assessment requiring expert-established ground truth. The "ground truth" for these tests would be the physical and mechanical properties measured and compared against established ASTM standards and predicate device performance.

3. Adjudication method for the test set:

   • This is not applicable given the nature of the mechanical testing performed.

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

   • No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of device (intervertebral body fusion cage). This device is a physical implant, not an AI diagnostic tool.

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

   • No, this is not applicable as the device is not an algorithm or AI system.

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

   • The "ground truth" here is the established performance standards for intervertebral body fusion devices, as defined by ASTM international standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877) and the performance characteristics of legally marketed predicate devices. The device's performance was measured against these mechanical and material benchmarks.

7. The sample size for the training set:

   • This is not applicable. There was no "training set" as this was not an AI or machine learning study.

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

   • This is not applicable as there was no training set. The "ground truth" for assessing device performance was based on recognized engineering standards and comparison to predicate devices, as elaborated in point 6.

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The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. The Daytona Anterior Cervical Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Daytona Anterior Cervical Cage system was developed as an intracorporeal implant for anterior cervical spondylodesis. The Daytona Anterior Cervical Cage is a system of wedge shaped implants and instruments designed for anterior cervical interbody fusion (ACIF). To prevent migration, the Daytona Anterior Cervical Cage has teeth on its superior and inferior surfaces.

The provided document is a 510(k) summary for the Daytona Anterior Cervical Cage, a medical device. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.

However, the document explicitly states: "No clinical studies were performed."

Therefore, it is not possible to provide information about acceptance criteria and a study proving the device meets those criteria, as no such clinical study was conducted or reported in this document. The device's clearance was based on demonstrating substantial equivalence to already marketed devices through non-clinical (mechanical) testing.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria related to clinical performance are mentioned, as no clinical studies were performed. The non-clinical tests were conducted "per ASTM F2077 and ASTM F2267," which implies adherence to those standards, but specific pass/fail criteria or detailed performance results (beyond the statement that they were conducted) are not given for these tests.
2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set.
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 requiring ground truth established by experts.
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 device is an implant, not an AI diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth needed for this type of device submission.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) clearance for the Daytona Anterior Cervical Cage was based on demonstrating substantial equivalence to predicate devices through non-clinical bench testing, not clinical studies involving human patients or complex data analysis with AI.

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The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.

The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The AVS® Anchor-C Cervical Cage is a hollow, rectangular-shaped PEEK Optima® LT1 (per ASTM F2026) cage assembled to a titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) plate and has one tantalum marker (per ASTM F560). It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima® LTI cage portion consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided (AVS® Anchor-C Fixation Screws). The AVS® Anchor-C Fixation Screws are constructed from titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) and possess clips (also constructed from titanium alloy Ti6Al4V per ASTM F136 and ISO 5832-3) that mate with internal features located within the AVS® Anchor-C Cervical Cage. Once fully seated into the holes, the screws are designed to lock into the titanium plate.

The provided document describes the Stryker Spine AVS® Anchor-C Cervical Cage System, a medical device. It focuses on the mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than the performance of an AI system. Therefore, many of the requested fields regarding AI system performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS® Anchor-C implant system and demonstrated substantially equivalent performance to the identified predicate device systems."

The acceptance criteria are implicitly defined by the successful demonstration of "substantially equivalent performance" to predicate devices based on the mechanical tests listed. The document does not provide specific numerical acceptance thresholds or reported performance values for the device itself. Instead, it indicates that the device met the criteria by performing comparably to already approved devices.

Table of Acceptance Criteria and Reported Device Performance:

Additional Requested Information:

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

• Sample Size: The document does not specify the sample size for each mechanical test. Mechanical tests typically use a small number of physical samples (e.g., 3-6) per test condition to represent the device.
• Data Provenance: The data is from mechanical testing of the device, performed in compliance with FDA guidance. The country of origin of the data is not specified but is implicitly associated with the manufacturer (Stryker Spine, located in New Jersey, USA). The data is prospective, generated specifically for this 510(k) submission.

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

• Not Applicable. This device is a physical implant, and the "ground truth" for mechanical testing is based on the physical properties and performance measured against established engineering standards (ASTM and ISO). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for this type of submission.

4. Adjudication method for the test set:

• Not Applicable. As this is mechanical testing of a physical device, there is no adjudication method in the context of human interpretation or AI output. The evaluation is based on engineering measurements and comparisons to 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:

• Not Applicable. This is not an AI-enabled device or a diagnostic imaging device requiring human reader studies.

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 or AI system.

7. The type of ground truth used:

• For the mechanical tests, the "ground truth" is defined by the objective measurements obtained from the various tests (e.g., compression strength, shear strength, expulsion resistance) and their comparison to the performance of predicate devices as per the relevant ASTM and ISO standards and FDA guidance.

8. The sample size for the training set:

• Not Applicable. This is a physical medical implant. There is no training set in the context of machine learning or AI.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

The Trabecular Metal™ Fusion Device is an interbody fusion device comprised wholly of Trabecular Metal. The Trabecular Metal™ Fusion Device is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrae onto another.

The Trabecular Metal™ Fusion Device is offered in three cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The height is measured at the posterior aspect of the device is tranezoidal in shane and is offered in lordotic and non-lordotic configurations, i.e., with 7 degree and 0 degree profiles. The superior and inferior surfaces of the device have a pattern of ripples and a central hole in the device extending in the superior-inferior direction for placement of bone graft. Additionally, certain parts of the proposed system contain a central slot on the anterior surface to allow interface with a central inserter.

The provided document is a 510(k) summary for a medical device (Trabecular Metal™ Fusion Device), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria for an algorithm's performance, details of a study demonstrating such performance, or other specific metrics typically associated with AI/ML device evaluations.

Therefore, I cannot provide the requested information in the format requested. The document describes a traditional medical device (an intervertebral body fusion device) and demonstrates its substantial equivalence to predicate devices through mechanical testing and an animal study, not through assessment of an AI algorithm's performance.

Here's a summary of the available performance data for the Trabecular Metal™ Fusion Device, as presented in the document:

The study did not involve an AI/ML powered device and therefore does not have acceptance criteria or performance metrics related to AI. The performance data provided is for the physical medical device itself.

Performance Data for the Trabecular Metal™ Fusion Device:

• Mechanical Testing:

  • Tests Performed: Axial Compression - Static and Dynamic, Torsion - Static and Dynamic (per ASTM F2077), Expulsion (as recommended by FDA guidance), and Subsidence (per ASTM F2267).
  • Acceptance Criteria & Reported Performance: The document states, "The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance." Specific numerical acceptance criteria or reported values are not detailed in this summary. These "predetermined requirements" would typically be derived from standards and predicate device performance.

• Animal Study:

  • Purpose: To compare the host bone response of the Trabecular Metal Fusion Device to a predicate device (Crystal by Spinal Elements, made from PEEK) in anterior cervical discectomy and interbody fusion procedures.
  • Findings: "Histological results confirmed definitive bone ingrowth and showed that The Trabecular Metal cervical interbody fusion implant supports bone growth into and around the implant margins."
  • Sample Size, Ground Truth, etc.: The document does not provide details on the sample size of animals used, the specific methodology of histological analysis, or who established the ground truth for bone ingrowth.

In summary, the provided document relates to a physical medical device and its mechanical and biological performance, not the performance of an AI/ML algorithm.

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Intervertebral Body Fusion Device: The Eminent Spine Interbody Fusion (Sidewinder. Python and Cottonmouth) 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 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 with autograft to facilitate fusion. The Eminent Spine Interbody Fusion System (Copperhead) 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-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Vertebral Body Replacement Device: The Eminent System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The Eminent Spine Interbody Fusion System will be offered in four (4) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) Copperhead, anterior cervical approach 2) Sidewinder, transforaminal lumbar approach 3) Python, posterior lumbar approach and 4) Cottonmouth, anterior lumbar approach.

Here's an analysis of the provided text regarding the Eminent Spine Interbody Fusion System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) premarket notification and subsequent FDA clearance letter. For interbody fusion devices (Class II medical devices), clearance is typically based on demonstration of substantial equivalence to a previously legally marketed predicate device, rather than a full clinical trial with "acceptance criteria" in the sense of a new drug or novel high-risk device. The primary "study" referred to here is generally a mechanical test study to demonstrate that the new device performs equivalently to the predicate devices in terms of biomechanical properties.

Eminent Spine Interbody Fusion System: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

As per the nature of a 510(k) submission for this type of device, explicit "acceptance criteria" for clinical outcomes (e.g., fusion rates, pain reduction scores) and specific "reported device performance" in a clinical trial are not provided nor required. Instead, the acceptance is based on demonstrating substantial equivalence through mechanical testing.

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

• Test Set (Mechanical Testing): The document states "Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device." However, specific sample sizes (e.g., number of implants tested) for these mechanical tests are not provided in this summary document.
• Data Provenance: The mechanical test data would have been generated in a prospective manner, specifically for this submission, likely within a laboratory setting. The origin is implicitly the applicant (Eminent Spine). This is not human clinical data, so country of origin for patients is not applicable.

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

• For mechanical testing, the "ground truth" is established through standardized engineering test protocols (e.g., ASTM standards for spinal implants) and objective measurements. There isn't a concept of "experts" establishing ground truth in the same way as in clinical image interpretation. The testing itself, conducted by engineers or technicians in a certified lab, provides the data supporting substantial equivalence.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are relevant for clinical studies, particularly those involving subjective assessments or disagreements among readers/experts. Since the "study" referred to here is mechanical testing, no such adjudication method is applicable or mentioned. The results are based on objective physical measurements and adherence to engineering standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance in interpreting medical images. For a spinal implant system like the Eminent Spine Interbody Fusion System, such studies are not part of the 510(k) clearance process. The device itself is a physical implant, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. A "standalone" performance study refers to the isolated performance of an algorithm or AI system without human intervention. The Eminent Spine Interbody Fusion System is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance claim is derived from objective physical measurements and engineering standards (e.g., ASTM) applied to the device and predicate devices. These standards define the expected biomechanical behavior for interbody fusion devices in terms of strength, fatigue, and other relevant properties. The comparison against predicate devices establishes the basis for substantial equivalence.

8. The Sample Size for the Training Set

• This concept is not directly applicable to a 510(k) for a physical implant based on mechanical testing. "Training set" refers to data used to train an algorithm or AI model.
• If we consider the design and manufacturing process, the "training" aspect would relate to the iterative design and engineering process, where prototypes are tested, refined, and potentially re-tested, drawing upon established engineering principles and data from similar devices. However, this isn't a "training set" in the context of AI.

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

• As explained in point 8, the concept of a "training set" and associated "ground truth" in the AI/machine learning sense is not relevant for this medical device clearance based on pre-clinical mechanical testing for substantial equivalence. The "ground truth" for evaluating the design of such a device is rooted in biomechanical principles, material science, and the performance characteristics of previously cleared, safe, and effective predicate devices.

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