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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 STALIF MIDLINE™ is indicated for use with autogenous 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 MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIF MIDLINE™ system must be used with bone grafting material (autograft only).

The STALIF MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIFTM TT (K073109) to include a modified anti-back out feature and additional sizes.

The provided text describes the STALIF MIDLINE™ intervertebral body fusion device and its substantial equivalence to a predicate device (STALIF™ TT, K073109). The information primarily focuses on the device's indications for use, description, and mechanical performance testing.

Here's an analysis of the requested information based on the provided text:

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

The study that proves the device meets the acceptance criteria is the mechanical testing performed in accordance with ASTM F2077 and ASTM F2267. This testing indicated that the STALIF MIDLINE™ is "mechanically equivalent to predicate devices."

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 provide details on the sample size used for the mechanical tests, the type of data (human or animal), or its provenance. It only states that "Testing performed in accordance with ASTM F2077... and ASTM F2267... indicates the STALIF MIDLINE™ is mechanically equivalent to predicate devices." These ASTM standards refer to in-vitro mechanical testing of intervertebral body fusion devices, not clinical trials with patient data.

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 as the study involves mechanical testing of a medical device, not a performance study that requires expert review of diagnostic images or clinical outcomes.

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

This is not applicable, as there is no human interpretation of data described in the mechanical testing.

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

This is not applicable. The provided document concerns the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on mechanical equivalence, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

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

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

The "ground truth" for the mechanical performance of the STALIF MIDLINE™ device is established by the specifications and performance characteristics defined in the ASTM F2077 and ASTM F2267 standards, and by comparison to the established mechanical performance of the predicate device (STALIF™ TT, K073109).

8. The sample size for the training set

This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm.

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

This is not applicable, as there is no training set for an algorithm. The "ground truth" for the mechanical testing is based on established engineering standards for medical devices and the predicate device's performance.

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