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The VALEO® C+CSC with Lumen Interbody Fusion Device 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Valeo® C+CSC with Lumen Interbody Fusion Device consists of cervical spine interbody fusion devices, as well as instrumentation designed specifically for the implantation of these implants. The Valeo C+CSC with Lumen is manufactured from Amedica's Silicon Nitride ceramic material and is provided sterile.

This document describes the Valeo® C+CSC with Lumen Interbody Fusion Device and its acceptance criteria, focusing on performance and biocompatibility testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly set by the "PASS" result, meaning the device met all applicable requirements of the specified standards.

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

The document does not explicitly state the sample sizes used for each specific test in the performance testing. It only states that "Testing performed on this device indicates that the Valeo C+CsC with Lumen Device is substantially equivalent to the Valeo Spacer System-C devices cleared under K142264. ASTM F2077 and ASTM F2267 performance standards were adhered to and all applicable requirements were met. Any deviations to the standards are noted at appropriate sections." This implies that the sample sizes were in accordance with the specified ASTM and ISO standards for mechanical and biocompatibility testing, respectively.

Data provenance: The tests were conducted internally or by a contracted lab to meet regulatory requirements for a medical device cleared in the U.S.

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

This type of testing (mechanical and biocompatibility) does not typically involve human experts establishing "ground truth" in the same way clinical studies or diagnostic AI evaluation would. The "ground truth" is established by the specifications and acceptance criteria defined within the ASTM and ISO standards themselves. Compliance is verified by technical experts in materials science, biomechanics, and toxicology. The document does not specify the number or qualifications of these technical experts.

4. Adjudication Method for the Test Set

Not applicable for this type of performance and biocompatibility testing. Results are determined by adherence to established test protocols and comparison against pre-defined acceptance criteria within the 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. This is a premarket notification for an interbody fusion device, not a diagnostic or AI-powered device that involves human readers.

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 a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Engineering Standards: Established criteria within ASTM F2077 (for mechanical testing) and ASTM F2267 (for subsidence and expulsion).
• Biocompatibility Standards: Established criteria within ISO 10993 series (various parts) and ANSI/AAMI ST72:2011 (for bacterial endotoxin testing).
  Compliance with these standards forms the basis for demonstrating safety and effectiveness for a physical implant.

8. The Sample Size for the Training Set

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

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

Not applicable.

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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 Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of nonsterile, single-use implants fabricated from Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion Devices are used to provide structural stability and 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 Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The provided document is a 510(k) premarket notification for Amendia Interbody Fusion Devices, which are medical devices used in spinal fusion procedures. This type of regulatory document focuses on establishing substantial equivalence to existing legally marketed devices, rather than proving efficacy or meeting specific diagnostic performance criteria through clinical studies in the same way a diagnostic AI device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data specific to an AI/diagnostic device is not applicable to this document.

This document describes a medical device (surgical implants) and its intended use, material composition, and mechanical performance testing (engineering analysis and ASTM standards) to demonstrate equivalence to predicate devices, not the diagnostic performance of a software algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, indications, material, and mechanical performance (engineering analysis, ASTM F2077, ASTM F1877), not diagnostic accuracy metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" in the context of an interbody fusion device. The document refers to "performance testing" based on engineering analysis and ASTM standards, which would involve physical specimens of the device, not a dataset of patient images or information.
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 diagnostic accuracy is not relevant for an interbody fusion device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in diagnostic interpretation, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic accuracy is not relevant.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) and does not contain the type of information requested about acceptance criteria and studies typical for AI/diagnostic software performance.

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The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with titanium alloy screws (Ti6A14V, ASTM F136) and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F560). The STALIF C-Ti™ is identical to this design with a titanium plasma spray coating (CPT) per ASTM F1580) on the device endplates.

The provided text is a 510(k) summary for a medical device (STALIF C® and STALIF C-Ti™ intervertebral body fusion cages). This document details a regulatory submission for expanding the indications for use of an already cleared device, not the initial approval or a study explicitly proving acceptance criteria for a new device's performance.

Therefore, the information typically requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory document.

Here's what can be inferred and what is explicitly stated:

• Device Type: The STALIF C® and STALIF C-Ti™ are intervertebral body fusion cages, which are physical implants. The "performance" in this context mainly refers to biomechanical properties, materials, and clinical safety/efficacy when used in the human body, not an AI algorithm's diagnostic performance.
• Purpose of Submission: The current 510(k) (K150053) is to expand the indications of the device to allow its use in multilevel cervical procedures (one or two contiguous levels). The original device (K142079) was already cleared for single-level use.
• "Study that proves the device meets the acceptance criteria": For this specific submission, the "study" primarily consists of:
  • Clinical literature review: To assess additional safety concerns for multilevel use.
  • PearlDiver reimbursement data: To investigate risks and benefits.
  • Cadaveric biomechanical testing: Conducted to support substantial equivalence.

Given this context, I cannot fill out the requested table or answer most of your detailed questions because they pertain to diagnostic AI performance studies, which are not applicable to this physical implant's regulatory submission.

However, I can extract the following relevant information based on the provided text:

Acceptance Criteria and Device Performance (Not applicable in the AI sense for this implant)

This document does not present acceptance criteria for an AI algorithm's performance or a device performance table for diagnostic metrics. Instead, the "performance" discussed relates to the biomechanical and safety aspects of the physical implant for its expanded indication. The device is deemed "substantially equivalent" to its predicate based on design, material, and performance, which implies meeting established safety and effectiveness standards for such devices.

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

• Not applicable / Not explicitly stated for AI diagnostic performance. The document focuses on demonstrating substantial equivalence for an expanded indication (multilevel use) of a physical implant. The "acceptance criteria" for a 510(k) submission are met by showing the device is as safe and effective as a legally marketed predicate. Performance is demonstrated through biomechanical testing and clinical literature review, not in terms of AI metrics.

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: "Cadaveric biomechanical testing was conducted." The specific number of cadavers or samples is not provided.
• Data Provenance: Not specified for the cadaveric testing. The clinical literature review and PearlDiver reimbursement data are mentioned, but details on provenance (country, retrospective/prospective) are not provided.

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

• Not applicable. This pertains to a physical implant, not an AI diagnostic device. Ground truth in this context would implicitly relate to established biomechanical standards and clinical outcomes for spinal fusion, which are assessed by relevant specialists (e.g., orthopedic surgeons, biomechanical engineers), but specific numbers and qualifications of experts for a "ground truth" establishment are not mentioned for this type of submission.

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

• Not applicable. Adjudication methods are typically for expert interpretation of diagnostic data, which is not the focus here.

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

• No. An MRMC study is not mentioned as this is a physical medical implant, not an AI diagnostic tool.

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

• Not applicable. This is a physical implant.

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

• For the cadaveric biomechanical testing, the "ground truth" would be established biomechanical principles and measurements related to spinal stability and fusion construct integrity.
• For the clinical literature review and PearlDiver data, the "ground truth" would be derived from a synthesis of published clinical outcomes data and real-world reimbursement trends related to spinal fusion procedures.
• Specific, explicit statements on "ground truth" definition are not in the document.

8. The sample size for the training set

• Not applicable. No AI algorithm is being trained here.

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

• Not applicable. No AI algorithm is being trained here.

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