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The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying 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 non-operative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.

The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying 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 non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.

The Synthes ACIS is a radiolucent cervical intervertebral body fusion device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.

The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral body fusion device. The Vertebral Spacer CR is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.

The Synthes Vertebral Spacer CR is available in a range of heights, and is available in three different sagittal profiles. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material, i.e., autograft.

The provided text describes two medical devices, Synthes ACIS and Synthes Vertebral Spacer CR, and their 510(k) submissions to the FDA. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for artificial intelligence (AI) or an algorithm. Instead, it details the non-clinical performance (bench testing) of these intervertebral fusion devices.

Therefore, most of the requested information regarding AI device acceptance criteria and study details cannot be extracted from the provided text.

Here is what can be inferred or stated based on the provided document:

Acceptance Criteria and Device Performance (based on non-clinical testing)

Information NOT Available from the provided text:

The document clearly states: "Clinical data and conclusions were not needed for this device." This implies that the device achieved substantial equivalence based solely on non-clinical testing against predicate devices. Therefore, the following AI-specific study details are not applicable or provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical or AI-specific test sets were used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for image interpretation or diagnosis was established.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes traditional medical device approval based on non-clinical bench testing and substantial equivalence to existing predicate devices, not an AI or algorithm-driven device with corresponding performance criteria and studies.

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The Eclipse-C Vertebral Spacer System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device.

The provided text describes a 510(k) submission for the Apollo Spine Eclipse Vertebral Spacer-Cervical, aiming to add an additional footprint size to an already cleared device. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria based on human or AI performance.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria table and reported device performance.
• Sample size for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth for the test set.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect size for AI assistance.
• Standalone (algorithm only) performance study details.
• Type of ground truth used for performance evaluation.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation from the document:

The submission explicitly states its purpose: "The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device." It then compares the subject device to the predicate device (K101588) and concludes: "The dimensional differences between the subject device and the predicate are not considered significant because the new size does introduce a new worst case condition...and therefore does not raise new questions regarding safety and effectiveness of the device."

Regarding performance, the document says: "In consideration of design control activities including risk analysis the non-clinical performance testing performed on the Eclipse Vertebral Spacer Cervical (K101588) including static compression, static torsion, subsidence, and expulsion are applicable in the characterization of the new size because the new size does not introduce a new worst case condition..., therefore additional mechanical testing on the new size is not warranted."

Finally, it summarizes: "Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate device."

This indicates that the submission relies on the existing safety and effectiveness data of the predicate device and argues that the minor dimensional change does not warrant new performance studies or acceptance criteria beyond established engineering and design principles for substantial equivalence. The document does not describe any studies involving human readers, AI, or clinical outcomes that would require acceptance criteria in the context of diagnostic or prognostic performance.

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When used as an Intervertebral Body Fusion System:

The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required.

When used as a Vertebral Body Replacement Device:

The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from TI-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Lumbar acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. The device contains serrations on the superior and inferior surfaces and includes positioning pins that are advanced during placement. Pins are used to aid in the positioning and to allow for radiographic confirmation during device placement.

This document describes a 510(k) premarket notification for the "Eclipse Vertebral Spacer-Lumbar," an intervertebral body fusion device and vertebral body replacement device. This summary focuses on the safety and effectiveness studies, which are primarily non-clinical bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of Acceptance Criteria: The document explicitly states that "Test results for each of the above studies confirm that the Eclipse Vertebral Spacer is substantially equivalent to the predicate devices." For a 510(k) submission, "substantial equivalence" means the new device is as safe and effective as a legally marketed predicate device. Therefore, the implied acceptance criteria for each test is that the Eclipse Vertebral Spacer's performance must not be significantly different from, and ideally match or exceed, the performance of the identified predicate devices in these specific mechanical and material tests. The guidance document "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (FDA, June 12, 2007) would provide the specific test parameters and potentially quantitative acceptance ranges for such devices, against which the predicate and new device would be compared.

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

• Sample Size for Test Set: Not specified, as this refers to the number of physical device units tested in the non-clinical bench studies.
• Data Provenance: The studies are non-clinical bench tests. The document does not specify the location where these tests were conducted, nor if they were retrospective or prospective, as these terms are generally not applicable to bench testing.

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

• Not applicable. For non-clinical bench testing, "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM standards) and objective physical measurements. Expert consensus in a medical context (like for image interpretation) is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or when reviewing medical images. This document describes mechanical bench testing only.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral spacer), not an AI/software device that assists human readers.

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. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Mechanical and Material Properties: The ground truth for these non-clinical tests is based on the established mechanical and material properties of the predicate devices and the requirements outlined in the FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This involves objective measurements of static and dynamic compression, shear forces, subsidence, and wear debris analysis.

8. The Sample Size for the Training Set:

• Not applicable. This submission describes non-clinical bench testing for a physical implant. There is no "training set" in the context of machine learning or AI algorithm development.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

The provided text describes a 510(k) premarket notification for the Apollo Spine Eclipse Vertebral Spacer-Cervical, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical testing and does not involve a study related to AI or a device that uses algorithms/software for performance evaluation.

Therefore, many of the requested points regarding AI/algorithm performance and clinical study design are not applicable to this submission.

Here's an analysis of the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the Eclipse Vertebral Spacer-Cervical, as presented in this 510(k) submission, are based on demonstrating mechanical equivalence to legally marketed predicate devices by conforming to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices.

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 document summarizes mechanical testing, not a clinical study involving human patients. Therefore, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not applicable in their traditional sense for clinical data. The "samples" would refer to the Eclipse Vertebral Spacer devices manufactured for testing. The summary does not specify the number of devices tested for each mechanical test. The testing was performed in the context of a premarket notification in the USA.

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. The "ground truth" for mechanical testing is established by the specified ASTM standards and the measurements obtained during testing in a laboratory setting by qualified engineers/technicians, not by medical experts forming a consensus.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if there's a disagreement) are relevant for clinical studies involving reader interpretations, not for mechanical bench testing.

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

Not applicable. This device is a passive implant (intervertebral spacer) and does not involve AI or software for interpretation, nor a human-in-the-loop scenario. The submission is for a physical medical device.

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

Not applicable. As noted above, this device does not incorporate an algorithm or AI component.

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

For the mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the referenced ASTM standards (e.g., maximum load, cycles to failure, displacement limits). The device's performance is measured against these engineering specifications, and against publicly available data for predicate devices.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set or AI model involved.

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The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following partial replacement of a diseased vertebral body.

The Pioneer Vertebral Spacer is a medical device and its predicate device is K043206.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This 510(k) submission primarily relies on bench testing (mechanical and chemical information) and demonstrated substantial equivalence to a predicate device (K043206).
• The document does not mention a "test set" in the context of clinical data, human subjects, or image-based evaluations. Therefore, there is no sample size for a test set and no data provenance in terms of country of origin or retrospective/prospective human data.

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

• Not applicable. There is no mention of a test set involving expert review of clinical cases.

4. Adjudication method for the test set:

• Not applicable. There is no mention of a test set involving adjudication.

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 MRMC study was done. This device is a passive vertebral spacer, not an AI-powered diagnostic or assistive tool.

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

• No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established through engineering principles, material science testing (mechanical and chemical data), and comparison to the characteristics and performance of a legally marketed predicate device. There is no biological or diagnostic ground truth (like pathology or outcomes data) directly mentioned as part of the submission for this type of device.

8. The sample size for the training set:

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

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone.

The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy.

The provided text describes a medical device, the Pioneer Vertebral Spacer, and its regulatory clearance (K043206) in 2005. The information focuses on the device's description, intended use, classification, and substantial equivalence to a predicate device, rather than performance studies with quantitative acceptance criteria typically associated with AI/ML devices. Therefore, a direct answer to all points of your request for acceptance criteria and study details pertaining to AI/ML performance is not possible as this document does not contain that information.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device. Instead, it states:

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

Not applicable. This document describes a physical medical implant device, not an AI/ML system that would typically have a "test set" of data. The clearance is based on mechanical and chemical properties, as well as comparison to a predicate device.

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

Not applicable. Ground truth for an AI/ML model for diagnostic or classification tasks is not relevant here. The "ground true" for this device would be its mechanical and material properties as validated through engineering tests and its clinical effectiveness as observed in surgical use, which is not detailed in this summary.

4. Adjudication method for the test set

Not applicable. As there is no test set for an AI/ML model, there is no adjudication method.

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 surgical implant, not an AI-assisted diagnostic or decision support tool. Therefore, an MRMC study and
the concept of "human readers improving with AI assistance" are not relevant.

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

Not applicable. This is a physical device, not a standalone algorithm.

7. The type of ground truth used

For this device, the "ground truth" would relate to its structural integrity, biocompatibility, and ability to achieve its intended mechanical functions (e.g., restoring vertebral height, providing stability). This would be established through:

• Engineering testing: Mechanical (e.g., strength, fatigue) and chemical (e.g., material composition, biocompatibility) tests according to ASTM standards.
• Predicate device comparison: The EBI CAS Spine Spacer System (K042268) serves as the safety and efficacy benchmark.

8. The sample size for the training set

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

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

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical implant and does not contain the type of information related to AI/ML device performance, such as test sets, ground truth establishment for AI, or human-in-the-loop studies. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, backed by presented mechanical and chemical information.

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The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine Vertebral Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5). It is intended to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The device is intended for use with supplemental fixation systems such as Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

The provided document is a 510(k) summary for the Stryker Spine Vertebral Spacer. It discusses the device's intended use, materials, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device met those criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML device evaluations.

The "study" referenced in this document is a technological comparison and mechanical testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s. This is a very different type of "study" than what would be conducted to evaluate the performance of an AI/ML powered medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the format typically used for AI/ML device evaluations, because this document predates such rigorous performance evaluation requirements for AI/ML devices and describes a different type of medical device (an implant, not an algorithm).

However, I can extract information relevant to the device's regulatory acceptance based on the document.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Inferred from regulatory context, not explicit numerical targets):

  • Substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
  • Compliance with FDA's Guidance for Spinal System 510(k)'s, September 27, 2000.
  • Mechanical and biological safety and effectiveness demonstrated through testing (though specific test results are not detailed).

• Reported Device Performance: The document states that the "Stryker Spine Vertebral Spacer is substantially equivalent to its predicate devices." This is the primary reported "performance" metric in a 510(k) context. Specific quantitative performance data (e.g., in terms of strength, fatigue life, biological compatibility) from the underlying testing mentioned by the company is not provided in this summary.

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

• Not Applicable in the AI/ML sense. This document pertains to a physical implant. The "test set" would typically refer to the samples used in mechanical testing (e.g., number of implants tested for compression, fatigue, etc.) or in-vitro/in-vivo biocompatibility studies. This information is not provided in the 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data provenance. The "data" here would be from mechanical and biocompatibility testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This device is a physical implant, not an AI/ML algorithm requiring expert interpretation of outputs.
• The FDA reviewers (e.g., Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices) are experts involved in the regulatory approval process, but they are not establishing ground truth for evaluating an algorithm's performance.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to resolving discrepancies in expert interpretations for AI/ML ground truth.

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

• Not applicable. This type of study focuses on the impact of an AI algorithm on human reader performance.

6. Standalone Performance:

• Not applicable in the AI/ML sense. The "device" itself (the vertebral spacer) has standalone performance in terms of its mechanical properties and biocompatibility, but this is not typically expressed in terms of metrics like sensitivity/specificity for an algorithm. The 510(k) process ensures the device itself is safe and effective when used as intended.

7. Type of Ground Truth Used:

• For a physical implant, the "ground truth" for its performance would be established through a combination of:
  • Mechanical Testing Standards: Adherence to established industry standards for strength, fatigue, etc.
  • Biocompatibility Testing: In-vitro and sometimes in-vivo studies to assess material safety.
  • Clinical Literature/Experience: Relying on the known performance and safety profiles of similar predicate devices.
• The 510(k) summary indicates compliance with FDA's Guidance for Spinal System 510(k)'s. This guidance would outline the necessary tests and criteria to establish "ground truth" for mechanical and biological safety.

8. Sample Size for the Training Set:

• Not applicable. This is an AI/ML specific term.

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

• Not applicable. This is an AI/ML specific term.

In summary, the provided document is a regulatory submission for a physical medical device (vertebral spacer) and addresses "substantial equivalence" to predicate devices rather than the performance metrics typically associated with AI/ML systems. The "study" mentioned refers to engineering and compliance testing against established guidance for spinal implants, not a clinical performance study using a test set of data as would be done for an AI/ML device.

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The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti System is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Vertebral Spacer Ti can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of: vertebral body replacement devices comprised of a variety of fixed heights and cross-sections. supplemental fixation currently cleared for use in treating patients for tumor, trauma or fractures of the vertebral body and manual surgical instrumentation used to prepare the anatomy and implant the Vertebral Spacer Ti. There are no unique surgical instruments required for implantation of the submitted device system.

This document describes the Synthes Vertebral Spacer Ti, a titanium vertebral body replacement device. The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as demonstrating this substantial equivalence through comparison and testing against a recognized standard or predicate.

Here's the breakdown of the information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a new AI device or diagnostic, the "acceptance criteria" are based on demonstrating mechanical soundness and substantial equivalence to an already cleared predicate device. The performance is assessed against recognized standards for spinal implants.

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

This is not applicable to this 510(k) premarket notification for a mechanical spinal implant. There is no "test set" in the context of diagnostic accuracy for AI or clinical images. The "testing" primarily involved mechanical bench testing of the device's physical properties. The data provenance would be laboratory testing rather than patient data.

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

This is not applicable. "Ground truth" in the context of expert consensus on patient data or pathology is not relevant for the regulatory clearance of a mechanical spinal implant through a 510(k) pathway. The "ground truth" for material and mechanical performance relies on established scientific and engineering standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the diagnostic or clinical sense requiring expert adjudication.

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

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

This is not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this mechanical spinal implant, the "ground truth" for its performance relies on:

• Material specifications: Conformance to industry standards like ASTM F67 and F1295.
• Mechanical engineering principles: Adherence to established biomechanical testing protocols outlined in FDA guidance documents (e.g., "Guidance for Spinal System 510(k)s").
• Predicate device performance: The previously cleared Synthes Vertebral Spacer Ti (K020152) serves as the benchmark for established safety and effectiveness.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI model.

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

This is not applicable for the same reasons as #8.

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The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Ti Spacer System can be packed with bone.

The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of:

• vertebral body replacement devices comprised of a variety . of fixed heights and cross-sections.
• supplemental fixation currently cleared for use in treating . patients for tumor, trauma or fractures of the vertebral body and
• manual surgical instrumentation used to prepare the . anatomy and implant the Vertebral Spacer Ti.

There are no unique surgical instruments required for implantation of the submitted device system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Vertebral Spacer Ti:

The provided document is a 510(k) premarket notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed acceptance criteria and standalone performance studies for novel devices.

Based on the provided text, the information available is limited regarding explicit acceptance criteria and a detailed study report. However, we can extract some relevant points.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In 510(k) submissions, acceptance criteria are often framed implicitly by the substantial equivalence argument and adherence to recognized standards. For mechanical devices like spinal implants, the "Guidance for Spinal System 510(k)s" would outline specific mechanical tests (e.g., compression, fatigue, subsidence) and acceptable performance limits, likely referencing ASTM or ISO standards. The document only confirms that such testing was presented, not the specific results or the predefined acceptance values.

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

This information is not provided in the document. The document refers to "Mechanical testing," which implies laboratory-based, non-clinical tests. There is no mention of a human test set or clinical data for this specific device.

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

This information is not applicable/not provided. As "mechanical testing" was performed, the "ground truth" would be established by engineering standards and measurements, not medical expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool.

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 physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

For the "Performance Data" section, the ground truth was based on engineering standards and measurements from mechanical testing. The document states that testing was "in accordance with the 'Guidance for Spinal System 510(k)s', September 27, 2000." This guidance would specify the appropriate methods for determining the mechanical properties and performance (e.g., strength, stiffness, fatigue life) of spinal implants.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI/ML product that requires a "training set."

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

This information is not applicable/not provided.

Summary of the Study Mentioned:

The primary "study" mentioned for the Vertebral Spacer Ti is mechanical testing. This testing was conducted:

• In accordance with: "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000.
• Purpose: To demonstrate the device's mechanical performance and support the claim of substantial equivalence to the predicate device (Synthes SynMesh System, K003275).
• Basis of Substantial Equivalence: The filing argues that the new device's "technical characteristics and performance" are similar to the predicate device. This implies that the mechanical testing results were comparable or met the same performance expectations as the predicate device and the relevant guidance.

It's crucial to understand that for a 510(k) substantial equivalence submission for a physical implant, the focus is largely on non-clinical performance (like mechanical testing, material biocompatibility, and sterilization) and a comparison of design and indications for use to a previously cleared device. Extensive clinical studies with defined acceptance criteria for patient outcomes, expert consensus on images, or AI performance metrics are typically not required for this regulatory pathway unless the device presents novel technology or significant differences from a predicate.

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