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The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis;
• Trauma (i.e. fracture or dislocation);
• Spinal stenosis;
• Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis; and
• Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors and associated surgical instruments. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. RIPLEY SPINAL SCREW SYSTEM BY SAGICO is designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

This FDA 510(k) Premarket Notification document (K232561) for the Ripley Spinal Screw System by SAGICO describes a medical device, not an AI or software-driven diagnostic tool. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic performance, is not applicable in this context.

The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices based on:

1. Indications for Use: The Ripley Spinal Screw System's intended uses are comparable to existing predicate devices.
2. Design and Materials: The system's design (monoaxial, uniplanar, polyaxial screws, rods, hooks, connectors) and material (Ti6A14V alloy) are similar to predicate devices.
3. Performance Data (Non-Clinical): Mechanical testing was performed to ensure the device's physical properties are equivalent or superior to predicate devices.

Here's a breakdown of the relevant information provided for this medical device, which differs significantly from the requested AI-specific information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific clinical acceptance criteria or human-in-the-loop diagnostic performance. Instead, it references performance data generated from mechanical testing standards:

Explanation: For mechanical devices like spinal screws, "acceptance criteria" are typically defined by engineering specifications (e.g., maximum load, fatigue cycles without failure, deformation limits) derived from recognized standards like ASTM. The goal of the testing is to show that the new device performs at least as well as legally marketed predicate devices, thereby establishing substantial equivalence.

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

• Sample Size (Test Set): Not applicable in the context of human data or AI diagnostic test sets. The "test set" here refers to the number of physical device samples used for mechanical testing according to ASTM standards. The exact number of samples tested for each ASTM standard is not specified in the provided summary, but these are typically small numbers of physical prototypes designed to represent the final product.
• Data Provenance: The data is non-clinical, derived from laboratory mechanical testing of physical implants, not from patient data or clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. As this is a mechanical device, there is no "ground truth" to be established by clinical experts in the diagnostic sense. The "truth" is determined by the physical properties and performance measured in a laboratory setting against engineering standards.
• Mechanical testing engineers and quality assurance personnel would be involved in performing and validating these tests, but they are not "experts" establishing clinical ground truth.

4. Adjudication Method:

• Not Applicable. There is no adjudication method described for clinical interpretation or data labeling, as this is non-clinical product testing.

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

• No. This type of study is relevant for evaluating the diagnostic performance of software or AI with human readers. It is not applicable to the mechanical testing of a spinal implant system.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

• Engineering Specifications and Performance Standards (e.g., ASTM F1717, F1798). The "ground truth" or reference for evaluating performance is adherence to established mechanical testing standards and demonstrating comparable performance to predicate devices in those tests.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI model. There is no concept of a "training set" for physical product development in this context. Design and engineering principles guide the development, followed by verification and validation through mechanical testing.

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

• Not Applicable. No training set exists for this type of device.

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The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). 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. The Titus Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titus Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

The Titus Titanium Cervical by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The Titanium Cervical by SAGICO, is intended to be used at one disc level from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Titus Titanium Cervical by SAGICO incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The Titus Titanium Cervical by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The Titus Titanium Cervical by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Titus Titanium Cervical by SAGICO." This document is a regulatory filing for a medical device and describes its intended use, design, and comparison to legally marketed predicate devices to establish substantial equivalence.

**Crucially, this document does not describe:

• A study proving the device meets acceptance criteria.** Instead, it lists non-clinical performance data testing (like ASTM standards for static and dynamic compression, torsion, and pullout tests) that was conducted to support the claim of substantial equivalence. These are engineering and material tests, not clinical studies with patients or image-based diagnostic performance studies.
• Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" discussed implicitly are related to the mechanical and material properties of the implant, ensuring it functions safely and effectively as an intervertebral body fusion device.
• Any human-in-the-loop (MRMC) studies or standalone algorithm performance. This is an implantable medical device, not an AI/ML-based diagnostic software.
• Ground truth establishment for diagnostic purposes or expert review processes.

Therefore, I cannot extract the information requested as it pertains to AI/ML diagnostic device performance studies. The document describes a physical medical device (an intervertebral body fusion device), not an imaging or diagnostic AI. The "K221138" is a 510(k) clearance number for an implant, not for a diagnostic algorithm.

If the request was for a different type of document (e.g., an FDA clearance for an AI-powered diagnostic device), I would be able to provide the requested information, assuming it was present in that document.

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The SAGICO Spinal System - Lucas Expandable Lumbar by SAGICO are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO are to be filled with autogenous bone graft material. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device.

The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). 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. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO must be used with the additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

LUMBAR: The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

CERVICAL: The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device.

MATERIALS: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO, are implants that are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (InvibioTM) per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IJNS R05200, IJNS R05400 according to ASTM F560.

FUNCTION: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.

The provided text describes a 510(k) premarket notification for the "SAGICO Spinal System" and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data. It does not contain information about a study that proves the device meets acceptance criteria related to an AI/ML-based medical device.

The document details:

• Device Type: Intervertebral Body Fusion Device (implants for spinal fusion).
• Purpose of filing: 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Study described: Non-clinical (benchtop) testing to evaluate the mechanical performance of the spinal implants against established ASTM standards. This is done to show the physical device's safety and performance, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance, as the document concerns a physical medical implant and its non-clinical testing for 510(k) clearance.

If you have a different document or context related to an AI/ML medical device, please provide it, and I will do my best to answer your questions.

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