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The STALIF C FLX™ device is 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 with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft 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 non-operative treatment prior to implantation of the cage.

The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine.

The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine.

The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. 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 lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. 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 nonfusion spinal surgery at the treated. These implants may be implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non- fusion spinal surgery at the treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system.

The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.

The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.

The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 nonfusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.

The FLXTM Platform is composed of 8 different interbody fusion implant families:

• STALIF C FLXTM
• STALIF M FLXTM
• STALIF L FLXTM and STALIF Lateral-Oblique FLXTM
• ACTILIF C FLXTM
• ACTILIF M FLXTM
• ACTILIF L FLXTM and ACTILIF Lateral-Oblique FLXTM

The FLX™ Platform is a novel range of interbody fusion implants with a complex randomized lattice. The Implants retain all of the benefits of the STALIF® product family while taking advantage of the benefits of porous, laser sintered Ti6Al4V. With the recent advances in additive manufacturing, titanium implants are printed with a porous scaffold structure which reduces the stiffness of the device to potentially reduce subsidence and facilitate bone growth through and around the implant.

The FLX™ Platform is intended to be implanted between the vertebral bodies into the cleared disc space to help provide stabilization and height restoration and facilitate the interbody fusion process. The device is intended to be used with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The devices are available in a variety of heights, lengths, and widths as well as different lordotic angles to provide surgeons with a wide array of solutions for the highly variable patient population. Surgical instrumentation has been previously developed for the STALIF® Platform and is compatible with the new devices.

In addition, interbody-only versions of the FLX™ devices are available in similar size ranges as the STALIF® versions. These devices are not designed to be used with the current STALIF® ABO screw constructs and are instead to be used with supplemental fixation.

This document is a 510(k) premarket notification for a medical device submitted to the FDA, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them in the context of an AI/human reader performance evaluation.

Instead, this document describes the Centinel Spine FLX™ Platform, a series of intervertebral body fusion devices, and seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "study" mentioned is performance testing focused on mechanical aspects of the implant to ensure it is as safe and effective as existing legally marketed devices.

Here's an breakdown of the information that can be extracted or inferred based on the provided text, and what cannot:

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

The document does not provide a formal table of acceptance criteria with numerical performance metrics in the way one would see for an AI device's diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the mechanical testing standards referenced and the outcome of "substantial equivalence."

The "reported device performance" is a general statement that the testing demonstrated substantial equivalence to predicate devices, meaning it performed comparably to devices already on the market.

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 discusses physical device testing, not clinical data or algorithm testing with a test set of data. Therefore, there is no information about a "test set" in the context of patient data, data provenance, or retrospective/prospective studies. The "test set" refers to the physical devices subjected to mechanical testing. The specific number of physical devices (samples) used for each mechanical test 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)

This is not applicable as the document describes mechanical testing of physical medical devices, not a study involving expert review of data/images to establish ground truth.

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

This is not applicable as the document describes mechanical testing of physical medical devices, not a study involving expert review of data/images.

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

This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool.

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

This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool.

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

For the mechanical testing, the "ground truth" is established by the specified ASTM standards (e.g., F2077-14, F2267-04). These standards define the test methods and performance requirements for intervertebral body fusion devices.

8. The sample size for the training set

This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool that requires a training set.

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

This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool that requires a training set.

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The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CENTINEL SPINE PCT SYSTEM is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centinel Spine PCT System consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, and connecting components (e.g., variable and fixed cross connectors). The hooks and polyaxial screws are intended to be attached to the posterior elements of the cervical and/or upper thoracic spine and serve as bone anchors. The rods are longitudinally secured to the bone anchors with the set screw. The various connecting components serve to both secure the construct and provide additional construct configuration options. All implants are manufactured from titanium alloy, Ti6A14V (ASTM F136 or ISO 5832-3)

This document is a 510(k) summary for the Centinel Spine PCT System, a device intended for spinal immobilization and stabilization. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific clinical acceptance criteria in terms of AI/algorithm efficacy. As such, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable or available in this document.

However, I can extract information related to the device's mechanical performance testing:

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

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

• Test Set Sample Size: Not explicitly stated within this document. The testing refers to "performance testing" and indicates that "published literature" was also used, but does not detail the number of constructs or specimens tested for each mechanical test.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "Performance Testing" conducted according to modified versions of ASTM standards (ASTM F1717 and ASTM F1798), implying laboratory-based mechanical testing rather than clinical data from human subjects. It would be considered an in-vitro study.

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

This information is not applicable. The "ground truth" here is mechanical performance measured against engineering standards, not clinical diagnoses or outcomes requiring expert interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical tests for physical devices typically involve direct measurement against specified engineering limits, not human 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 a spinal 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:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for performance assessment was based on mechanical engineering standards and the performance of predicate devices. Specifically, the "acceptance criteria were defined by predicate device performance."

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would have a training set.

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

Not applicable.

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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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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 MIDLINE II™ / MIDLINE II -Ti™ 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 MIDLINE II™ / 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 MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).

The MIDLINE II™ / MIDLINE II-Ti™ is a radiolucent intervertebral body fusion device manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with three metallic X-ray markers manufactured from unalloyed Tantalum (ASTM F560) and plasma sprayed with optional commercially pure titanium (CPT) per ASTM F1580. The device is secured with titanium (Ti-6A1-4V per ASTM F136) unicortical cancellous bone screws provided and is intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the MIDLINE™ (K133286) to include a titanium coating (ASTM F1580-12) and an additional lordotic option.

The MIDLINE II™ / MIDLINE II-Ti™ is provided in 11-21mm heights, 30-42mm widths, 24-30.2mm lengths, and lordotic angles ranging from 8°-20°. The devices are provided sterile.

The provided text describes a medical device, the MIDLINE II™ / MIDLINE II-Ti™, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. As such, the request for acceptance criteria and a study proving an AI device's performance cannot be fully addressed in the format requested.

However, I can extract information regarding the device's mechanical performance acceptance criteria and the study (testing) that demonstrates it meets these criteria, as detailed in the "Substantial Equivalence" section.

Here's the relevant information paraphrased to fit the spirit of the request, focusing on the device's mechanical performance rather than AI performance.

Acceptance Criteria and Study for MIDLINE II™ / MIDLINE II-Ti™ (Mechanical Performance)

Since the document describes a traditional medical implant (intervertebral body fusion device) and not an AI/ML powered device, the typical AI-specific metrics like AUC, sensitivity, specificity, and MRMC studies are not applicable. Instead, the acceptance criteria and study focus on mechanical integrity and performance of the implant.

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical)

Note: The document explicitly states that the "results demonstrate that the acceptance criteria defined by predicate device performance were met." The specific numerical thresholds for "predicate device performance" are not provided in this summary but would typically be detailed in a full test report.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated in the provided text. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards (e.g., ASTM F2077-11 and F2267-04 mentioned).
• Data Provenance: The data is generated from mechanical testing of the physical device samples, likely performed in a laboratory setting. This is not patient-derived data for AI.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for mechanical testing. Ground truth for device mechanical performance is established by objective physical measurements and adherence to engineering standards and safety margins, not by expert human consensus.

4. Adjudication Method for Test Set

• Not applicable for mechanical testing. Test results are objective measurements (e.g., force, displacement, cycles to failure) compared against predefined engineering thresholds and predicate device performance, not subject to human adjudication in the context of diagnostic interpretation.

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

• Not applicable. This study type is relevant for AI-assisted diagnostic tools involving human readers interpreting medical images. The MIDLINE II™ / MIDLINE II-Ti™ is a physical surgical implant.

6. Standalone Performance (Algorithm Only)

• Not applicable. This term relates to the performance of an AI algorithm without human intervention. The device in question is a physical implant.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The "ground truth" (or acceptance standard) for this device's mechanical performance is defined by compliance with established ASTM standards (F2077-11, F2267-04) and the performance characteristics of previously cleared, substantially equivalent predicate devices (K133286, K101301). This involves objective physical measurements and engineering analyses.

8. Sample Size for Training Set

• Not applicable. This device does not involve an AI algorithm with a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. This device does not involve an AI algorithm with a training set.

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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 from levels C2 to T1 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. STALIF C® and STALIF C® Ti are intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative 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 PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.

The provided text describes a 510(k) submission for the STALIF C® and STALIF C® Ti intervertebral body fusion devices, seeking to expand their indications to include use with allograft. This is a regulatory submission for a medical device, and the content focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance derived from a study, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document. The FDA 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering tests, material compatibility, and sometimes clinical literature reviews, rather than a clinical effectiveness study with defined performance metrics, a test set, and ground truth as might be seen for AI/diagnostic devices.

Here's what can be inferred or stated based on the provided text, and what cannot:

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

• Cannot be provided directly. The document does not specify quantitative acceptance criteria for device performance (e.g., fusion rates, pain reduction scores, range of motion values) or report specific performance metrics from a study related to these criteria. The submission is about expanding indications based on clinical literature for allograft use.

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

• Cannot be provided directly. No "test set" in the context of a performance study (like for an AI algorithm) is mentioned. The submission refers to a "comprehensive, clinical literature review" and "PearlDiver reimbursement data." These are not a single, defined test set with a specific sample size for a device performance study. Details on country of origin or retrospective/prospective nature of the literature reviewed are also 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):

• Cannot be provided directly. Since no specific "test set" requiring ground truth establishment by experts is described, this information is not available. The clinical literature review would involve evaluation of published studies, whose ground truth and expert evaluations would have been established within those individual studies.

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

• Cannot be provided directly. This is not applicable as there is no described test set requiring expert adjudication for ground truth.

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 such study was done. This type of study (MRMC for AI assistance) is not relevant for this device, which is an intervertebral body fusion cage, not an AI diagnostic tool.

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

• No such study was done. This question pertains to AI algorithms. The STALIF C® and STALIF C® Ti are physical medical implants.

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

• Implied ground truth from literature review: The submission relies on "clinical literature review" and "PearlDiver reimbursement data" to suggest the benefits and risks of allograft. For fusion cages, the ultimate 'ground truth' related to effectiveness would typically be radiographic evidence of fusion and patient-reported outcomes (e.g., pain, disability scores) from clinical studies. The document states, "The clinical literature suggests that there is a positive benefit associated with allograft with minimal risk."

8. The sample size for the training set:

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

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

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

Summary of what the document does state regarding demonstrating device appropriateness:

• The submission aims to demonstrate "substantial equivalence" of the STALIF C® and STALIF C® Ti to the predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM.
• The primary purpose of this specific 510(k) was to expand the indications to include use with allograft.
• This expansion was supported by:
  • A "comprehensive, clinical literature review" to investigate risks and benefits associated with using allogenic bone graft with the STALIF C®.
  • "PearlDiver reimbursement data" also provided for the same purpose.
  • No new mechanical tests were performed because there were no design changes to the device itself. The original device would have undergone mechanical testing to demonstrate safety and function.

In conclusion, the document provided is a regulatory clearance letter for a physical medical device (intervertebral body fusion cage) seeking an expanded indication. It does not contain information typically found in a study proving an AI device meets specific performance acceptance criteria.

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The STALIF C® is 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 from levels C2 to T1 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 to facilitate fusion. STALIF C® is intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative 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. STALIF C® is manufactured from PEEK-OPTIMA® LTI with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The purpose of this 510(k) was to include a titanium coating (ASTM F1580) on both endplates.

Acceptance Criteria and Study for STALIF C®

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each mechanical test. It mentions that "Testing performed indicate that the STALIF C® is as mechanically sound as predicate devices," suggesting the tests were performed on the device itself.

The data provenance is from laboratory testing (mechanical testing), not from patient data, and is therefore neither retrospective nor prospective in the clinical sense.

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

Not applicable. The ground truth for this device is based on mechanical engineering standards (ASTM F2077 and F2267) and the device's ability to meet those established criteria, not on expert clinical interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" is determined by whether the device's performance meets the defined mechanical standards, rather than expert consensus on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not conducted as this is a medical device (intervertebral body fusion cage), not an AI algorithm or diagnostic tool that relies on human interpretation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established mechanical engineering standards (ASTM F2077 and F2267) for intervertebral body fusion devices. The device's performance was compared against these universally recognized standards for mechanical soundness.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model, so there is no "training set." The device itself underwent the mechanical tests.

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

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it. The standards (ASTM F2077 and F2267) that define the "ground truth" for mechanical performance were established by industry experts and regulatory bodies.

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

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

The 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 STALIF™ TT and STALIF MIDLINE™ (K101301, K073109) to include modified geometries.

Here's an analysis of the provided text regarding the MIDLIN E™ device, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the device's mechanical performance relative to predicate devices, rather than clinical efficacy. Therefore, the "acceptance criteria" are based on established mechanical testing standards for intervertebral body fusion devices.

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

The document does not specify the exact sample sizes (number of devices) used for each mechanical test. Mechanical tests typically use a small, representative sample of devices.

The data provenance is from laboratory mechanical testing conducted by the manufacturer, Centinel Spine, Inc. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" don't directly apply in the clinical sense. These are engineering/material science tests.

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

This question is not applicable in the context of this submission. The "ground truth" for mechanical performance tests is established by adherence to the specified ASTM standards and the measurements obtained from the testing equipment, not by human expert consensus or clinical assessment of a test set.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are objectively measured against predefined criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a 510(k) for a medical device (intervertebral body fusion device), which typically relies on mechanical and material equivalence to predicate devices, not clinical efficacy studies involving human readers and AI. The document does not mention any AI component or human-in-the-loop performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This refers to mechanical testing of a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is the established mechanical performance characteristics required by the ASTM standards (F2077-11 and F2267-04(2011)) for intervertebral body fusion devices. The device's performance was compared to these standards and to the performance of predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an algorithm, typically in the context of AI or machine learning. This submission is for a physical medical device and its mechanical equivalence, not an algorithm.

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

This question is not applicable, as there is no "training set" in the context of this device's submission.

Summary of the Study:

The study described is a series of bench-top mechanical performance tests comparing the MIDLINE™ device to its predicate devices and against recognized industry standards (ASTM F2077-11 and ASTM F2267-04(2011)). The goal was to demonstrate substantial equivalence in mechanical characteristics. The tests covered various loading conditions relevant to an intervertebral body fusion device, including compression, compression-shear, torsion, subsidence, and expulsion. The conclusion was that the MIDLINE™ device is "as mechanically sound as predicate devices," thereby supporting its substantial equivalence claim for 510(k) clearance.

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The STALIF X™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. 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 lateral approach.

The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF X™ system should be used with bone grafting material (autograft only).

The STALIF XTM is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used with supplemental fixation. The device is manufactured from PEEK Optima LT-1 or Zeniva ZA PEEK per ASTM F2026 and titanium alloy (Ti6Al4V) per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called STALIF XTM. This submission focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and does not involve a study to evaluate AI algorithm performance or establish acceptance criteria related to such algorithms.

Therefore, most of the requested information regarding acceptance criteria for a device's performance (especially AI/software performance), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from the given text.

The document is a regulatory submission for a physical intervertebral body fusion device and outlines its indications for use, device description, and mechanical performance testing against predicate devices.

Here's what can be extracted based on the provided text:

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

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

• This information is not available in the provided text. The text refers to "testing performed" but does not specify sample sizes for mechanical tests or data provenance.

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 available. This is a submission for a physical medical device, not an AI or software device that requires expert ground truth for a test set.

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

• This information is not applicable and not available.

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

• This information is not applicable and not available. This is not an AI-assisted device.

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

• This information is not applicable and not available. This is not an AI algorithm.

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

• The "ground truth" for this device's performance demonstration is based on established mechanical testing standards (ASTM F2077, F2267, and F-04.25.02.02) and comparison to the performance of legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable and not available. This is not an AI/machine learning device that uses a training set.

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

• This information is not applicable and not available.

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The STALIF C® is 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 from levels C2 to T1 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 to facilitate fusion. STALIF C® is intended to be used at one level.

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 sevity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560).

The provided text describes a medical device, the STALIF C®, and its substantial equivalence to predicate devices, but does not contain information regarding an acceptance criteria study for device performance in the context of AI/ML or diagnostic accuracy.

The provided document, K120819, is a 510(k) summary for a medical device (intervertebral body fusion cage) which is primarily concerned with demonstrating substantial equivalence to previously cleared devices through mechanical testing and FEA simulation. This is a premarket notification for a physical medical device, not a software as a medical device (SaMD) or AI-powered diagnostic tool.

Therefore, I cannot fulfill the request as it pertains to AI/ML specific criteria and studies, as this information is not present in the provided text.

The closest relevant information is about the mechanical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The following points cannot be answered from the provided text as they relate to AI/ML or diagnostic performance studies, which are not detailed in this 510(k) submission for a physical implantable device:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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