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The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine SupStance VBR System that was the subject of K072537. This device modification has been submitted as a Special 510(k) Premarket Notification because the proposed SupStance VBR System, Line Extension, is identical in intended use and fundamental scientific technology to the parent SupStance VBR System originally described in K072537.

The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available.

The provided document is a 510(k) summary for a medical device: the Creaspine SupStance Vertebral Body Replacement System, Line Extension. This document primarily focuses on establishing substantial equivalence to previously cleared devices through mechanical testing and does not describe a clinical study involving human patients or a software algorithm evaluated with clinical data.

Therefore, many of the requested items regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted based on the provided text, and where certain requested information is N/A:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable for a software algorithm evaluated with clinical data. This submission is for mechanical testing of a physical implant. The document does not specify the number of physical devices or tests performed, only that "Performance testing included the types of mechanical testing recommended..."
• Data provenance: Not applicable. The data is generated from mechanical testing in a lab setting, not from a clinical patient population.

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

• Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is not relevant for this type of device (a physical spinal implant) or the type of data presented (mechanical testing). This study does not involve human readers interpreting clinical cases with or without AI assistance.

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

• Not applicable. This device is a physical spinal implant, not a software algorithm.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established for vertebral body replacement systems, likely based on relevant standards and predicate device performance. The study aims to demonstrate that the new device's mechanical properties meet these established engineering benchmarks and are comparable to predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is mechanical testing of a physical medical device, not a machine learning model. There is no "training set" in this context.

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

• Not applicable. See point 8.

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The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance Small VBR System is optional.

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System consists of the SupStance Small VBR implants and the instrumentation required for implantation of the device. The SupStance Small VBR implant is a cage composed of fused hollow trapezoidal tubes with open sides and integral end caps. The SupStance Small VBR cages are available in three sizes (12mm, and 16mm) and cover a range of heights from 18mm to 50mm.

Like the sides of the cages, the SupStance Small VBR end caps have large openings for introduction of allograft and/or autograft and evenly spaced round serrations for fixation to the vertebral endplates. The end caps have a various (total) sagittal angle of 0°, 5°, and 8° to accommodate spinal anatomy.

The SupStance Small VBR cages are fabricated from poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. The implants are provided non-sterile and may be implanted via an anterior approach or a costo-tranverse approach.

Here's an analysis of the provided text regarding the Creaspine SupStance Small Vertebral Body Replacement System, focusing on acceptance criteria and the supporting study:

The provided text is a 510(k) Summary for a medical device. It does not describe a study involving human or animal subjects, or an AI/algorithm-based device, in the typical sense of testing diagnostic accuracy or clinical effectiveness with patient data.

Instead, this document focuses on mechanical performance testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" and "device performance" are related to mechanical properties, not diagnostic or clinical outcomes in a biological system.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, training set) are not applicable to this type of regulatory submission.

Here's the breakdown based on the provided document:

Description of the Acceptance Criteria and Supporting Study for the Creaspine SupStance Small Vertebral Body Replacement System

1. Table of Acceptance Criteria and Reported Device Performance:

• Static compression testing
• Dynamic compression testing
• Static torsion testing
• Dynamic torsion testing
• Expulsion testing | The document states, "Performance testing included the types of mechanical testing recommended... (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)." While specific quantitative results aren't provided in this summary, the conclusion is that the data confirms comparability. |
  | Intended Use Equivalence: | The device's intended use must be substantially equivalent to that of predicate devices. | The device "share[s] the same intended use... as that of the predicate devices." (Paragraph 2, "Statement of Technological Comparison") |
  | Design Concepts & Materials Equivalence: | The device's basic design concepts and materials must be substantially equivalent to those of predicate devices. | The device "share[s] the same... basic design concepts, and materials as that of the predicate devices." (Paragraph 2, "Statement of Technological Comparison") The material (PEEK with 6% BaSO4) and design (fused hollow trapezoidal tubes with open sides and integral end caps) are described. |
  | Substantial Equivalence to Predicate Devices (Overall): | The device must demonstrate substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness, meaning it is as safe and effective as a legally marketed device that is not subject to premarket approval. | "The information and data collected support a claim of substantial equivalence for the proposed SupStance Small VBR System to the specified predicate devices." This conclusion is affirmed by the FDA's 510(k) clearance letter. |

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

• Sample Size for Test Set: Not explicitly stated. The "test set" in this context refers to the number of physical device units or samples subjected to mechanical testing. The FDA guidance for such devices typically specifies the number of samples per test.
• Data Provenance: The testing was conducted by Creaspine or their contracted laboratories to support the 510(k) submission. The exact country of origin for the testing itself isn't specified, but the applicant company (Creaspine) is based in France. The data is prospective in the sense that the testing was performed specifically for this submission.

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

• Not Applicable. For mechanical performance testing of a physical device, "ground truth" isn't established by human expert consensus or clinical observation. The ground truth is determined by the physical properties measured according to standardized engineering test methods (e.g., ASTM standards or ISO standards for medical devices).

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human readers/experts in clinical or image interpretation studies. For mechanical testing, the results are quantitative measurements, and reconciliation would involve engineering analysis of test setup, measurement precision, and adherence to protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This type of study (MRMC) is relevant for evaluating the performance of diagnostic tools (e.g., AI with radiologists) where human interpretation is a key component. This submission is for a physical implantable device, not a diagnostic algorithm.

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

• Not Applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• Engineering Measurement & Standardized Test Methods: The "ground truth" for mechanical testing is established by objective, verifiable measurements obtained from standardized tests (static/dynamic compression, torsion, expulsion) conducted according to established engineering and regulatory guidelines (e.g., FDA guidance, ASTM/ISO standards). The performance is compared against known characteristics of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not Applicable. (See point 8)

Summary Takeaway:

The provided document details a regulatory submission for a physical medical device (vertebral body replacement system). The "study" referenced is a series of mechanical performance tests designed to demonstrate the device's physical properties are substantially equivalent to already-approved predicate devices, thereby establishing its safety and effectiveness for its intended mechanical function within the human body. The acceptance criteria are largely implicit in the FDA guidance for such devices, requiring performance comparable to established benchmarks or predicate devices under specified test conditions.

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The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system, intended for use as an aid in spinal fusion. The SupStance VBR System consists of the SupStance VBR implant and the associated instrumentation required for implantation of the device. The SupStance VBR implant is a cage constructed of fused hollow cylindrical tubes with integral endcaps and open sides for introduction of bone graft material and bone reconstruction. The SupStance VBR cages are available in three diameters (22mm, 25mm, 28mm) and cover a range of heights from 35mm to 55mm with a total fixed sagittal angle of 5°.

The SupStance VBR cages are fabricated from poly-ether-ether-ketone (PEEK) and include markers made from titanium alloy. The implants are provided non-sterile and will be implanted via an antero-lateral approach.

The provided text describes the 510(k) summary for the Creaspine SupStance Vertebral Body Replacement System. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness related to AI or human-in-the-loop performance.

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is a different type of evaluation.

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document refers to "Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)" and states "The data collected confirms that the mechanical properties of the proposed SupStance VBR System are comparable to those of the predicate devices." However, specific quantitative acceptance criteria or reported performance values are not provided.
2. Sample size used for the test set and data provenance: No test set related to diagnostic or AI performance is mentioned. The mechanical testing details do not include sample sizes in this summary.
3. Number of experts and their qualifications: Not applicable, as there's no diagnostic or AI performance study described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the "ground truth" would be established engineering standards or predicate device performance.
8. Sample size for the training set: Not applicable, as no AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

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