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The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

STALIF TTTTT, MIDLINE™/ MIDLINE II-Ti™ are radiolucent intervertebral body fusion cages 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 devices are similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. The STALIF devices are manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The MIDLINE II-Ti™ is identical to this design with a titanium plasma spray coating on the device endplates.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided documents (FDA 510(k) letter and 510(k) Summary) describe a medical device, the Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ intervertebral body fusion devices. Crucially, these documents are for a 510(k) submission, which means the device is being cleared based on substantial equivalence to a predicate device, not on meeting specific, pre-defined acceptance criteria through a de novo clinical trial demonstrating performance metrics.

Therefore, direct "acceptance criteria" in the sense of specific sensitivity, specificity, or similar performance thresholds, and a "study that proves the device meets the acceptance criteria" in that context, are not applicable to this type of FDA submission.

Instead, the "acceptance criteria" here are regulatory requirements for substantial equivalence, and the "study" is the comparison to predicate devices and supporting evidence to demonstrate that equivalence.

Here's a breakdown of the information that is available in the provided text, structured to address your questions as much as possible within the context of a 510(k):

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

As explained above, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) defined in the provided documents for this 510(k) submission. The "acceptance criteria" are the regulatory requirements for showing substantial equivalence.

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

• Test Set Sample Size: Not applicable in the context of a traditional clinical trial with a "test set" for performance metrics. This 510(k) relies on a literature review and comparative analysis to predicate devices.
• Data Provenance:
  • Literature Review: The text mentions a "comprehensive, clinical literature review." The specific countries of origin or whether these studies were retrospective or prospective are not detailed in the provided document.
  • PearlDiver Reimbursement: This refers to a healthcare claims database, which typically contains retrospective data (claims submitted after services are rendered) from the United States.

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

Not applicable. There was no "test set" in the sense of patient data requiring expert ground truth labeling for algorithm performance. The evaluation was a regulatory assessment based on equivalence to predicate devices and a literature review.

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

Not applicable. As there was no test set for performance comparison, no adjudication method was used. The regulatory review process itself involves expert reviewers (FDA staff), but this is not a clinical "test set" 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

Not applicable. This device is an intervertebral body fusion cage, not an AI or imaging diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant to this device's regulatory submission.

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

Not applicable. This is a surgical implant, not a software algorithm.

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

Not applicable directly to a "ground truth" for a performance study. However, the basis for the safety and efficacy assessment for the expanded indication of using allograft relied on:

• Clinical Literature Review: Implies published studies where outcomes were determined by standard clinical endpoints, potentially including expert assessment, imaging, and patient-reported outcomes.
• PearlDiver Reimbursement Data: Provides real-world evidence of healthcare utilization and potentially associated diagnoses/procedures.
• Predicate Device Performance: The "ground truth" for the core device performance (structural integrity, fusion rates, etc.) would have been established through prior studies and regulatory clearances of the predicate devices.

8. The sample size for the training set

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

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

Not applicable. As noted above, this device does not involve a training set.

Summary of the 510(k) Submission's Core Argument:

The 510(k) submission for Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ sought to expand the marketing indications to include the use of allograft (allogenic bone graft) in addition to autograft.

The core "study" proving "acceptance" (i.e., substantial equivalence) was a comparison to legally marketed predicate devices (K141942, K101301, K073109) and a literature review, supported by biomechanical studies (presumably conducted for previous submissions of the predicate devices or the current device under its prior indications).

The argument was that:

• The device design and materials have not changed from the predicate, thus existing mechanical data applies.
• The expanded use of allograft does not introduce new safety or effectiveness concerns compared to autograft in the context of this device, based on existing clinical literature and reimbursement data.
• Therefore, the device with the expanded indication is substantially equivalent to the predicate devices.

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The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIFTM TT system may be used with bone grafting material (autograft only).

The Surgicraft STALIF"M TT is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.

This is a 510(k) premarket notification for the STALIF™ TT Intervertebral Body Fusion System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested data points related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This section is Not Applicable in the traditional sense of a clinical performance study with predefined acceptance criteria and measured device performance against those criteria. For medical devices pursuing 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device.

The study presented here asserts that the STALIF™ TT system meets the "acceptance criteria" of being substantially equivalent to its predicates based on:

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

• Sample Size for Test Set: Not applicable. This submission relies on engineering drawings and non-clinical mechanical testing, not a clinical "test set" of patient data.
• Data Provenance: Not applicable for a clinical test set. The mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04) are international standards. The origin of the actual test samples would likely be from the manufacturer (Surgicraft Limited, UK). The study is not retrospective or prospective in the clinical sense.

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

• This is Not Applicable as no clinical test set with ground truth established by medical experts was used or described. The "ground truth" in 510(k) for mechanical testing is adherence to the specified ASTM standards.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set requiring expert adjudication was used.

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

• Not Applicable. This is a medical device clearance, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is defined by the ASTM standards (ASTM F 2077-03 for static and dynamic tests, and ASTM F 2267-04 for subsidence tests). The device's mechanical performance is compared against the requirements and typical performance characteristics for intervertebral fusion devices as outlined in these standards and generally accepted for substantial equivalence to predicate devices. There is no pathology, outcomes data, or expert consensus used as ground truth in the clinical sense for this submission.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device. The physical device is manufactured based on design specifications and then tested.

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

• Not Applicable. See point 8.

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The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.

The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.

This document is a 510(k) Premarket Notification summary for the STALIF TT™ System, a spinal intervertebral body fixation orthosis. It does not contain information typically found in a study proving a device meets acceptance criteria. A 510(k) submission generally relies on demonstrating substantial equivalence to a predicate device, rather than detailed performance study data against specific acceptance criteria.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as it is not a study report.

The document states: "Performance data were provided" under the "Substantial Equivalence" section, implying that some data was submitted, but the detailed results and methodology are not included in this summary.

Summary of available information:

• Device Name: STALIF TT™ System
• Intended Use: Replacement, partial vertebrectomy, and/or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma, to restore planar alignment, height, and facilitate neural decompression. Designed to restore biomechanical integrity of the spinal column (T9 to L5) for prolonged periods, even without fusion.
• Predicate Devices: DePuy AcroMed Stackable Cage™ System and Interpore Cross International GEO Structure.
• Substantial Equivalence: Claimed based on provided "Performance data." (Details of this data are not in this document).

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The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).

The STALIF ™ TT device is intended for use with supplemental internal fixation.

The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).

The Surgicraft STALIFTM TT is a radiolucent vertebral body replacement device used in conjunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion. Material: PEEK-OPTIMA LT1

This is actually an FDA 510(k) summary for a medical device (STALIF TT™ SYSTEM), not a study analyzing AI performance. Therefore, most of the requested information about acceptance criteria and study design for AI models does not apply.

However, I can extract the relevant information from the provided document regarding device performance and its regulatory approval process, which serves as a form of "acceptance criteria" for medical devices.

Here's a breakdown of the available information:

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

For a medical device like the STALIF TT, "acceptance criteria" are typically based on demonstrating substantial equivalence to a legally marketed predicate device, as well as meeting established performance standards through various testing. The document states "Performance data were submitted." This implies that the device underwent various tests to prove its safety and effectiveness, likely against a set of predetermined criteria based on engineering standards and expected biological response.

However, the specific quantitative acceptance criteria (e.g., minimum compression strength, fatigue life cycles) and the detailed results are not disclosed in this summary. The summary only confirms that performance data was submitted and found acceptable by the FDA for its 510(k) clearance.

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 provided in the 510(k) summary. For medical devices, "test sets" typically refer to mechanical, biocompatibility, and potentially animal studies, not human clinical data in the same way an AI study would. The data provenance would refer to the testing lab and the standard(s) adhered to.

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 is not applicable to a medical device 510(k) submission in the context of expert consensus for ground truth. Ground truth for a device like this would be established through engineering specifications, material properties, and pre-clinical testing protocols.

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

This is not applicable to a medical device 510(k) submission. Adjudication methods are typically for subjective assessments or disagreements in clinical trials or AI validation.

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. The STALIF TT is a physical medical implant, not an AI diagnostic tool that assists human readers.

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

This is not applicable. The STALIF TT is a physical medical implant, not a software algorithm.

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

For this device, the "ground truth" for its performance would be established through a combination of:

• Engineering specifications and standards: Confirming material properties, mechanical strength (e.g., compression, fatigue, subsidence), and dimensional accuracy.
• Biocompatibility testing: In vitro and potentially in vivo (animal study) testing to ensure the material is safe for implantation.
• Pre-clinical (benchtop) testing: Simulated use conditions to verify the device's mechanical performance under expected physiological loads.

8. The sample size for the training set

This is not applicable. The STALIF TT 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

This is not applicable. The STALIF TT is a physical medical implant, not an AI model.

In summary: The provided document is a regulatory notice for a medical device, not a study evaluating an AI system. The "acceptance criteria" here refer to meeting FDA requirements for market clearance through demonstrating substantial equivalence and submitting adequate performance data, rather than specific performance metrics for an AI algorithm.

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