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The ALTES™ Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

The ALTES™ Anterior Buttress Plating System consists of plates and screws. The plate is shaped to conform to the anatomy of the anterior spine. The system features two screws which engage the vertebral body and prevent rotation. A unique locking mechanism of the screw prevents the plate and screws from releasing. The plates are available in three sizes: 20mm, 25mm. and 30mm. The screws are available in two diameters: 4.5mm and 5.0mm, and two lengths: 15mm and 20mm. The components of the ALTES™ Anterior Buttress Plating System are manufactured from titanium alloy and have a smooth anodized color-coded finish.

The Altiva ALTES™ Buttress Plating System is a medical device designed for anterior intravertebral body screw fixation/attachment to the L1-S1 spine. The 510(k) submission (K061482) describes the device and its intended use, and indicates that performance data were submitted to characterize the system. However, the provided text does not include specific acceptance criteria or a detailed study description with performance metrics, sample sizes, or ground truth establishment.

The document is a 510(k) summary and the FDA's substantial equivalence letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. This typically means that the device has similar technological characteristics and is as safe and effective as the predicate device(s). While performance data were submitted, the specifics of those data, including the acceptance criteria, study design, and results, are not contained within the provided excerpts.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

Here's how I would present the information based on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Altiva ALTES™ Buttress Plating System states that "Performance data were submitted to characterize the ALTES™ Anterior Buttress Plating System." However, the specific acceptance criteria for this performance data and the detailed results of the study are not included in the provided document. The document primarily focuses on the device description, intended use, and the FDA's determination of substantial equivalence.

Therefore, I am unable to populate the table of acceptance criteria and reported device performance or answer the detailed questions regarding the study.

Information not available in the provided text:

• Specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, screw pull-out force thresholds).
• Reported device performance values against these criteria.
• Detailed study design (e.g., type of tests conducted, methodologies).
• Sample sizes for test sets (e.g., number of implants tested).
• Data provenance (e.g., in-vitro, in-vivo, country of origin).
• Any information regarding expert involvement in ground truth establishment or adjudication.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone performance details.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data), as applicable to a clinical study (which isn't detailed here).
• Sample size for any training set (if an AI/ML component were involved, which is not indicated).
• How ground truth for any training set was established.

General understanding from the document:

The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the new device is as safe and effective as the predicate, often through comparisons of design, materials, and performance data (e.g., mechanical testing, biocompatibility). The FDA's substantial equivalence letter confirms that Altiva Corporation provided sufficient information to meet this requirement for the ALTES™ Buttress Plating System. However, the specifics of that "performance data" are not elaborated in the public summary.

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