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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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The Preference Elite Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:

The Preference Elite System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.

The Preference Elite Pedicle Screw System is a spinal fixation system consisting of a variety of components including screws, various types and sizes of rods, cross-connectors and accessories, as well as implant components from the Preference Pedicle Screw System. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient.

Implant components from the Preference Pedicle Screw System including the curved and straight rods, set-screws, and cross-connectors are compatible with the Preference Elite Pedicle Screw System.

The Preference Elite Pedicle Screw System implants and components are made from titanium alloy (Ti-6A1-4V) per ASTM F136 and Cobalt-28 Chromium-6 Molybdenum Alloy (Co-28Cr-6Mo) per ASTM F1537.

The provided document is a 510(k) Pre-market Notification from the FDA regarding the "Preference Elite Pedicle Screw System." This document is not a study that proves a device meets acceptance criteria in the context of an AI/ML medical device, but rather a regulatory submission for a traditional medical device (a pedicle screw system).

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and AI-specific performance metrics (MRMC, standalone algorithm performance) is not applicable to this document. This document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design, materials, and intended use.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not present acceptance criteria or reported performance in the context of an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Testing and analyses were completed in accordance with the applicable standards" and "The testing results demonstrate that the new system, Preference Elite Pedicle Screw System, is substantially equivalent to the predicates."

The applicable standards mentioned are:

• ASTM F1717 Static Axial Compression Bending
• ASTM F1717 Static Torsion
• ASTM F1717 Dynamic Axial Compression Bending
• ASTM F1798 Static Pull-off

The "acceptance criteria" here would be meeting the established performance requirements set by these ASTM standards for spinal implant systems, which are intended to ensure mechanical integrity and safety. The reported "performance" is that the device did meet these standards and was found substantially equivalent.

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

• Sample size for the test set: Not stated in terms of patient data. The testing mentioned (ASTM standards) refers to mechanical testing of the device components, not human subject data. The "sample size" would relate to the number of devices or components tested, which is not specified in this summary.
• Data provenance: Not applicable in the context of clinical data. The "data" pertains to mechanical test results of the device itself.

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

Not applicable. This is not a study involving human interpretation or ground truth establishment by experts for clinical data.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication for mechanical testing of a medical device like a pedicle screw system.

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/ML device, and no MRMC study was performed or described.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Not applicable in the context of clinical data. For mechanical testing, the "ground truth" is typically defined by the objective physical measurements and established parameters of the ASTM standards themselves.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.

Summary relevant to the document provided:

The document describes a regulatory submission for a pedicle screw system, not an AI/ML device. The "acceptance criteria" and "study" refer to mechanical testing performed according to ASTM standards to demonstrate the device's mechanical integrity and its substantial equivalence to previously cleared predicate devices. The study concludes that the Preference Elite Pedicle Screw System is substantially equivalent based on these tests and comparison of its characteristics.

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Valeo II Interbody Fusion Devices - Cervical are 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 radios. Valeo II Interbody Fusion Devices-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft.

Valeo II Interbody Fusion Devices-Cervical are 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.

Valeo II Interbody Fusion Devices-Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with desenerative disc disease (DD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Valeo II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

The Valeo II Interbody Fusion Devices consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material (autograft or allograft comprised of cancellous and/or corticocancelous bone graft).

The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo II Interbody Fusion Device is manufactured from Si3N4 ceramic material (silicon nitride), and is:

• provided sterile (gamma sterilization)
• single use

The purpose of the subject 510(k) is to add additional sizes to the Lateral Lumbar Interbody Fusion Device - Valeo II LL.

The provided text describes a 510(k) premarket notification for the Valeo II™ Interbody Fusion Device System. It states that "Performance Testing: Failure Effects Analysis was performed to determine if the new sizes created a new worst case with respect to ASTM F2077 and ASTM F2267. No new worst cases were identified with regard to the ASTM standards requirements. No additional testing required."

This means that no new studies were conducted, and the device's acceptance criteria are based on its substantial equivalence to previously approved predicate devices, specifically the Valeo II™ Interbody Fusion Device (K121892) and the Globus PATRIOT® TransContinental® Llif Spacer (K093242) and Valeo II™ Interbody Fusion Device (K143518). The "No additional testing required" comment implies that the device is relying on testing performed for these predicate devices.

Therefore, the information regarding the acceptance criteria, study that proves the device meets the acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set size is not explicitly detailed for this specific 510(k) submission. The submission primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting new clinical study data for acceptance.

However, based on the provided text, we can infer the following:

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):
No specific sample sizes for a new test set are provided for this 510(k) as no additional clinical or in-vitro testing beyond the Failure Effects Analysis was deemed necessary. The device relies on previous testing of its predicate devices.

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, as no new test set requiring expert ground truth establishment for clinical or diagnostic performance is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new test set requiring adjudication is mentioned.

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 interbody fusion device, not a diagnostic AI system requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is an interbody fusion device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this medical device's performance would primarily be related to its mechanical integrity and biocompatibility, as established through engineering standards (like ASTM F2077, ASTM F2267) and chemical/biological testing (like Bacterial Endotoxin Testing). Clinical outcomes are inferred from the predicate devices.

8. The sample size for the training set:
Not applicable, as this is a medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable.

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Valeo® Spacer System and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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.

Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System – Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

The Valeo® Spacer System and Valeo IIIM Interbody Fusion Device System consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material (autograft or allograft). The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo® Spacer System and Valeo II™ Interbody Fusion Device System is manufactured from Si3N4 ceramic material (silicon nitride), and is provided sterile.

The provided text is related to a 510(k) premarket notification for a medical device (Valeo® Spacer System; Valeo II™ Interbody Fusion Device System) and describes its indications for use, technological characteristics, predicate devices, and a summary of the substantial equivalence determination.

However, the document does not contain the kind of information requested in the prompt, which typically relates to performance studies for AI/machine learning devices. The document explicitly states that a "comprehensive, clinical literature review has been provided to investigate the risks and benefits associated with the use of the Valeo® Spacer System - L and Valeo II™ Interbody Fusion Device System - Lumbar devices in lumbar fusion procedures with allograft." This indicates that the device's acceptance was based on a literature review and comparison to predicate devices, not on a new study with specific acceptance criteria, test sets, ground truth establishment, or expert reviews for its own performance.

Therefore, I cannot provide the requested table or detailed information because it is not present in the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance: No such criteria or performance results are listed for the described device.
2. Sample size used for the test set and data provenance: No test set or related data is mentioned.
3. Number of experts and qualifications for ground truth: Not applicable as no new study was conducted.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable as it's not an AI device.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as it's not an AI/ML device.
9. How ground truth for the training set was established: Not applicable.

The submission is for an interbody fusion device, which is a physical implant, and the FDA's review for this type of device typically focuses on material safety, mechanical performance, design equivalence to predicate devices, and clinical literature supporting its intended use. It is not an AI/ML powered device, so the requested information categories (e.g., test set, training set, ground truth by experts, MRMC studies) are not applicable to this type of device submission.

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Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are 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™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are 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™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are 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.

Valeo™ System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

The Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System devices consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material per the indications stated above. The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical is manufactured from MC2 ceramic material (silicon nitride), and is provided sterile.

The purpose of the subject 510(k) was to expand the indications of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels from C2/C3 to C7/T1.

This is a 510(k) premarket notification for a medical device, the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System. This type of document is used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, and thus does not typically contain efficacy studies or performance criteria in the way a pharmaceutical approval or a novel medical device approval might.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, ground truth, expert involvement, adjudication, MRMC studies, standalone performance), and training set information is generally not applicable to this type of regulatory submission.

The document primarily focuses on establishing "substantial equivalence" based on indications for use, design, and performance compared to a predicate device, rather than proving the device meets specific quantitative performance criteria through a dedicated study.

Here's what can be extracted based on the document's content, and where information is not present:

1. Table of acceptance criteria and the reported device performance:

• Not Applicable. This document does not present quantitative acceptance criteria or detailed performance metrics from a study designed to prove such criteria. The "performance" mentioned is in the context of demonstrating similarity to a predicate device.

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

• Not Applicable. No specific test set or study data is presented to evaluate the device against pre-defined performance criteria. The submission relies on a "comprehensive clinical literature review" to assess additional safety concerns for expanded indications, not a direct study of the device.

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. As no specific "test set" with ground truth determination is mentioned, this information is not provided. The review of existing literature would implicitly involve expert knowledge, but not in the structured way of establishing ground truth for a device performance study.

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

• Not Applicable. No test set or direct adjudication process for device performance is described.

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 intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

• Not Applicable. This is a physical medical implant, not an algorithm. Standalone performance as an algorithm is not relevant.

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

• Not Applicable. As no direct study on the device's performance against a ground truth is reported in this 510(k), this information is not available. The submission's argument for substantial equivalence relies on existing knowledge and a literature review.

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithm development.

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

• Not Applicable. This device does not involve a "training set" or "ground truth" establishment in the context of machine learning.

Summary of what the document DOES state:

• Purpose of current 510(k): To expand the indications for use of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels (C2/C3 to C7/T1).
• Predicate Device: ANATOMIC PEEK™ Cervical FUSION SYSTEM (K130177).
• Basis for Substantial Equivalence: The Valeo™ system is similar in design and indicated use to the predicate. A "comprehensive clinical literature review" was conducted to assess any additional safety concerns for the expanded indications (use with allograft and at two contiguous levels). The conclusion was that there were no additional risks, and the device was substantially equivalent.

In essence, this document is a regulatory filing demonstrating equivalence, not a detailed clinical study report with performance metrics against predefined acceptance criteria.

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Valeo II Interbody Fusion Devices - Cervical are 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 radios. Valeo II Interbody Fusion Devices-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Valeo II Interbody Fusion Devices-Cervical are 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.

Valeo II Interbody Fusion Devices-Lumbar are indicated for use with autograft bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems, such as the Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

The Valeo II Interbody Fusion Device consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from to 22mm in height and 14mm to 34mm in length.

This document describes the premarket notification (510(k)) for the Valeo II Interbody Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for a new clinical indication. Therefore, many of the requested categories for AI/ML device studies are not directly applicable.

Here's an analysis based on the provided text, addressing the closest relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present clinical acceptance criteria in terms of accuracy, sensitivity, or specificity for diagnostic or prognostic tasks. Instead, the acceptance criteria are met by demonstrating the device's mechanical and biological equivalence to a legally marketed predicate device.

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

This document describes non-clinical performance and biocompatibility testing for a medical implant device, not a data-driven AI/ML diagnostic or prognostic device.

• Test Set Sample Size: Not applicable in the context of clinical data for AI/ML. The "sample size" for mechanical testing refers to the number of devices or iterations tested per condition (e.g., for static compression, dynamic compression, etc.), and for biocompatibility, it refers to the number of animals or cell cultures used for in vitro/in vivo tests. These specific numbers are not provided in the summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of clinical data. The tests are conducted according to international standards (ASTM, ISO).

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/ML (e.g., expert consensus on medical images) is not relevant for the mechanical and biological safety testing of an interbody fusion device. The "ground truth" here is the established performance requirements of the relevant ASTM and ISO standards for mechanical properties and biocompatibility.

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

Not applicable. Adjudication methods are used in clinical studies involving interpretation (e.g., image reading). The testing performed here (mechanical and biocompatibility) involves objective measurements against established 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 510(k) submission for an interbody fusion device, not an AI/ML diagnostic aid. No MRMC study was conducted or is relevant to this device's regulatory pathway.

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

Not applicable. This is a physical implant device, not a software algorithm.

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

Not applicable for an AI/ML context. The "ground truth" for the device's performance is adherence to:

• Mechanical Standards: ASTM F2077-11 for static and dynamic compression/torsion.
• Biocompatibility Standards: ISO 10993 series (ISO 10993-5, 10993-10, 10993-11, 10993-3).
• Predicate Device Performance: Demonstrating "comparable performance" to the Phantom Plus Ceramic Cage System (K121892).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment in that context.

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The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of nonoperative therapy.

The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.

The Phantom Plus Ceramic Cages-Cervical are 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. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Phantom Plus Ceramic Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 14mm to 45mm in length.

The provided text describes a 510(k) premarket notification for the Phantom Plus® Ceramic Cage System, which is an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as well as details about sample sizes, expert involvement, and ground truth establishment, cannot be directly extracted from the provided text because such a study was not presented.

Instead, the submission relies on demonstrating compliance with recognized performance standards and substantial equivalence to predicate devices.

Here's a summary of what can be gathered, addressing the spirit of the request as much as possible given the available information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence to predicate devices and compliance with existing standards, explicit acceptance criteria for a novel performance study are not defined or reported in the text. Instead, the device's performance is demonstrated by meeting the requirements of recognized ASTM and AAMI standards.

• Adherence to ASTM F2077 (for lumbar intervertebral body fusion devices)
• Adherence to ASTM F1839 (for ceramic materials for surgical implants)
• Adherence to ASTM F1877 (for intervertebral body fusion devices with integrated plate fixation) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Material/Biocompatibility:
• Adherence to AAMI TIR 33 (Guidance for biocompatibility risk management)
• Same or equivalent materials as predicate devices (ceramic) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Design and Function:
• Same or equivalent design and function as predicate devices (e.g., hollow vertebral body spacers, convex, bullet nose design, axial void for bone graft, angular teeth for expulsion resistance) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used." |
  | Indications for Use:
• Equivalent indications for use as predicate devices (e.g., DDD patients with specific conditions, autogenous bone graft, supplemental fixation) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices... and has the same or equivalent indications for use..." |

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

The document does not describe a clinical "test set" in the context of a prospective clinical trial. The "testing and engineering analyses" mentioned likely refer to bench testing and mechanical studies conducted in a laboratory setting, not human clinical trials. Therefore, information about sample size (patients), data provenance, or retrospective/prospective nature is 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, as a clinical test set with human subject data requiring expert ground truth establishment is not discussed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This device is an implant, not an AI-assisted diagnostic tool, and therefore MRMC studies are not relevant.

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 (expert concensus, pathology, outcomes data, etc)

Not applicable, as a clinical study requiring ground truth is not presented. The "ground truth" for this submission is adherence to recognized performance standards and demonstrated mechanical equivalence to predicates.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set. The "engineering analyses" would involve material samples and device prototypes.

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

Not applicable.

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The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.

The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.

The Valeo® Spacer System -AL, -TL, -PL, -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.

The Valeo Spacer System consists of cervical and lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Valeo Spacer System is manufactured from MC2, a ceramic material, and is provided sterile.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way you've outlined. The document is a 510(k) summary for a medical device (Valeo® Spacer System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against detailed acceptance criteria through a specific study with statistical methods.

Here's a breakdown of why I cannot fulfill your request as precisely as you've asked, followed by what information is available in the text:

• No detailed acceptance criteria and reported device performance table: The text states, "Testing performed on this device indicates that the Valeo Spacer System is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met." This is a high-level statement and does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) or the granular performance metrics from a dedicated study.
• No information on sample size, data provenance, number of experts, adjudication, MRMC studies, or standalone algorithm performance: These concepts are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the nature of this 510(k) submission for an intervertebral body fusion device. The testing mentioned refers to mechanical and biocompatibility testing against standards like ASTM F2077.
• No details on ground truth used or training set information: Again, these are relevant for machine learning or diagnostic device studies, which are not described in this document.

What information is available from the provided text regarding performance and testing:

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

   • Acceptance Criteria/Standard: Adherence to ASTM F2077 performance standards.
   • Reported Device Performance: "all applicable requirements were met," and the device was "substantially equivalent to predicate devices."

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to testing against a standard (ASTM F2077), which would involve a specific number of test articles for mechanical and material testing, but this is not detailed in the summary. Data provenance (e.g., country of origin, retrospective/prospective) is not relevant for this type of device submission as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a component of proving substantial equivalence for this type of mechanical device.

4. Adjudication method for the test set: Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not provided. This type of study is for evaluating medical imaging or diagnostic device performance, often involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is relevant for AI/algorithm-based devices.

7. The type of ground truth used: Not applicable/Not provided in the context of diagnostic performance. For an intervertebral body fusion device, "ground truth" might refer to known material properties or biomechanical benchmarks, but this is not specified as "ground truth" in the diagnostic sense.

8. The sample size for the training set: Not applicable/Not provided. This is for AI/machine learning.

9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided text is a 510(k) premarket notification for an intervertebral body fusion device. Its focus is on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through adherence to established performance standards (ASTM F2077) for mechanical and material properties. It does not describe a clinical study in the way one would for a diagnostic device, nor does it provide the detailed performance metrics, ground truth establishment, or expert involvement that your questions imply for a diagnostic or AI-based product.

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The SEEplate Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The SEEplate Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The SEEplate Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The SEEplate Cervical Plate System is manufactured from wrought Ti-6Al-4V in accordance with ISO 5832-3.

The provided text describes a 510(k) premarket notification for the Amedica SEEplate Cervical Plate System. This is a medical device for spinal fixation, and the documentation pertains to its substantial equivalence to a predicate device, not to its performance against specific acceptance criteria in a clinical study as would be seen for AI/ML devices or novel therapies.

Therefore, many of the requested categories are not applicable to this type of device submission. The submission relies on establishing substantial equivalence to a legally marketed predicate device rather than presenting performance data from a clinical study with detailed acceptance criteria.

Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this 510(k) clearance are primarily based on demonstrating "substantial equivalence" to a predicate device (Amedica Valeo Cervical Plate System, K071990) across key attributes: indications for use, design, function, and materials. The document states that "Testing performed indicates the subject device is substantially equivalent to predicate devices," implying that any relevant performance standards (likely mechanical and biocompatibility tests for an implantable device) were met to support this claim, but the specific numerical acceptance criteria or detailed results are not included in this summary.

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

Not applicable. This 510(k) summary does not describe a clinical study with a test set of data. The "testing performed" mentioned refers to non-clinical performance standards to demonstrate equivalence.

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

Not applicable. This is not a study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This type of study is typically done for diagnostic imaging devices or AI tools assisting human interpretation, not for an implantable cervical plate system seeking 510(k) clearance based on substantial equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/ML algorithm or diagnostic tool.

7. Type of Ground Truth Used

Not applicable in the context of data for an AI/ML algorithm. For this device, the "ground truth" equivalent would be established engineering and biocompatibility standards, and clinical outcomes data from the predicate device that inform the safety and effectiveness profile.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm requiring a training set.

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

Not applicable.

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The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation and noncervical nonpedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Valeo™ Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising screws, rods, connectors, and set screws. The system is designed to stabilize the spine during the fusion process. The Valeo Pedicle Screw System is fabricated from wrought Ti-6A1-4V (ISO 5832-3).

The provided text is a 510(k) summary for the Valeo™ Pedicle Screw System. This document primarily focuses on demonstrating substantial equivalence to predicate devices for a mechanical medical implant, not a diagnostic AI device. Therefore, many of the requested categories about acceptance criteria, study design for AI algorithms, and expert involvement are not applicable or cannot be extracted from this type of regulatory filing.

Here's an analysis based on the information available:

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

The document does not explicitly state quantitative acceptance criteria in terms of device performance metrics (e.g., accuracy, sensitivity, specificity) as would be seen for a diagnostic device. Instead, acceptance for this type of device is based on substantial equivalence to legally marketed predicate devices, primarily demonstrated through mechanical testing and material characterization to ensure performance characteristics are similar and meet recognized standards.

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

This information is not applicable and not provided in the document. The "test set" for a mechanical implant typically refers to specimens subjected to mechanical testing, not a dataset for an AI algorithm. Therefore, details about data provenance (country, retrospective/prospective) are not relevant here.

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

This information is not applicable and not provided. "Ground truth" in the context of an AI device usually refers to expert-validated labels for a dataset. For a mechanical implant, "ground truth" relates to the physical and mechanical properties of the device, established through standardized testing procedures, not expert consensus on medical images or diagnoses.

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

This information is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of data for AI algorithms. For a mechanical implant, testing results are typically evaluated against pre-defined engineering standards, not through adjudications of expert opinions.

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

An MRMC study is not applicable and not mentioned. This type of study is specifically designed for assessing the impact of AI on human reader performance in diagnostic tasks. The Valeo™ Pedicle Screw System is a physical implant, not an AI diagnostic tool.

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

A standalone performance study for an algorithm is not applicable and not mentioned. The device is a mechanical implant and does not involve an algorithm with standalone performance.

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

The "ground truth" for this device is based on engineering standards and material specifications. This includes:

• Mechanical testing results: Demonstrating strength, fatigue life, and other mechanical properties meet relevant ASTM or ISO standards for spinal implants.
• Material properties: Confirmation that the Ti-6A1-4V material conforms to ISO 5832-3 standards.
• Design and functional equivalence: Comparison of the device's design and intended function to legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a mechanical implant.

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

This information is not applicable and not provided. As there is no training set for a mechanical implant, the method for establishing its ground truth is irrelevant.

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