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The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature paient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the WaveForm™ C Interbody System, the 2,3,4 hole TruProfile spacers and plates, are intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T), and must be used with bone screw fixation and locking covers. The No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-Tl), and must be used with bone screw fixation and locking covers.

When the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interded to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-TI).

The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™ C Interbody System offers spacers in low profile (TruProfile) and no profile versions in various lengths and are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001.

The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) summary for the SeaSpine WaveForm™ C Interbody System, a medical device for spinal fusion. As such, it describes the device's technical specifications and demonstrates its substantial equivalence to existing predicate devices.

However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/machine learning performance. The document focuses on non-clinical testing of the physical device (e.g., mechanical safety) as per ASTM standards for intervertebral body fusion devices, not on the performance of a software algorithm or AI model.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, because this document is not about an AI/ML medical device.

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The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system. the WaveForm™ C Interbody System. which includes the 2.3.4 hole TruProfile plates and 2-hole No-Profile interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-Tl), and must be used with bone screw fixation and locking covers.

When the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™ C Interbody System offers spacers in low profile (TruProfile) and No-Profile versions in various lengths and heights and are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F136 and ASTM F3001.

The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

The provided text describes the submission of a 510(k) premarket notification for the "SeaSpine WaveForm™ C Interbody System," an intervertebral body fusion device.

However, the provided text does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, specifically regarding a device that relies on artificial intelligence or machine learning. The acceptance criteria and performance data mentioned in the document are related to the mechanical and biological safety and effectiveness of the interbody fusion device itself, not an AI or machine learning component.

Therefore, I cannot provide a response that directly addresses your request for:

1. A table of acceptance criteria and reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance (for an AI/ML device).
3. Number of experts used to establish ground truth and their qualifications (for an AI/ML device).
4. Adjudication method (for an AI/ML device).
5. MRMC comparative effectiveness study or effect size (for an AI/ML device).
6. Standalone performance (for an AI/ML device).
7. Type of ground truth used (for an AI/ML device).
8. Sample size for the training set (for an AI/ML device).
9. How ground truth was established for the training set (for an AI/ML device).

The document is purely a 510(k) clearance letter and summary for a physical medical device (an intervertebral body fusion system), not a software or AI/ML-driven device.

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The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the WaveForm™ C Interbody System, including the Low Profile and No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1), and must be used with bone screw fixation and locking covers.

When used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C2-T1).

The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™C Interbody System offers spacers in low profile (TruProfile) and no profile versions and are manufactured from Ti-6Al-4V titanium alloy per ASTM F3001.

The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

The provided text is a 510(k) summary for the SeaSpine WaveForm™ C Interbody System, a medical device used in spinal fusion procedures. This document describes the device, its intended use, and its equivalence to legally marketed predicate devices.

However, the document does not contain any information regarding clinical studies, acceptance criteria for an AI/ML-based medical device, or performance metrics typically associated with such systems. Specifically, it lacks details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or retrospective/prospective study designs.
• The number or qualifications of experts establishing ground truth.
• Adjudication methods for test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Training set sample sizes or ground truth establishment for a training set.

The document focuses on the mechanical and biological performance of the interbody system as a physical implant, not on its performance as an AI/ML-driven diagnostic or prognostic tool. The non-clinical testing mentioned (ASTM F2077, F2267, and F1877) refers to standards for intervertebral body fusion devices, which typically cover mechanical properties, material biocompatibility, and sterilization, not AI algorithm performance.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria or the study that proves an AI/ML device meets those criteria, as no such information is present.

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