(491 days)
The Aesculap HydroLift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap HydroLift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aescular HydroLift VBR System may be used with bone graft. The Aesculap HydroLiff VBR System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Aesculap HydroLift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The center column of the device can be adjusted to the exact length required by the patients anatomy after implantation. Once it is adjusted to the desired length the column is mechanically locked in place. Primary components are manufactured from titanium alloy (Ti6ANV).
The provided text is a 510(k) Premarket Notification for the Aesculap HydroLift VBR System. However, it does not contain details about acceptance criteria or a specific study proving the device meets those criteria in the way a diagnostic AI device submission would.
Instead, this document describes a spinal implant and its substantial equivalence to existing predicate devices. The "performance data" section states:
"Static and dynamic testing of the Aesculap HydroLift VBR System was performed in accordance with ASTM F1717 as recommended by the FDA Guidance for Spinal System 510(k)'s."
This indicates that the device's performance was evaluated against a recognized standard for spinal implants, but the document does not provide the acceptance criteria (e.g., specific thresholds for fatigue life, displacement, or strength) nor the detailed results of these tests. It merely confirms that the tests were conducted.
Therefore, I cannot fill in the requested table and answer many of the questions, as the information is not present in the provided text.
Here is what can be inferred and explicitly stated from the given text:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Compliance with ASTM F1717 (Standard Specification for Spinal Implant Constructs in a Vertebral Body Replacement Device) as recommended by FDA Guidance. "Static and dynamic testing... was performed in accordance with ASTM F1717." Specific quantitative acceptance criteria (e.g., fatigue limits, displacement thresholds, load-bearing capacity) Not provided in the document. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The testing was done according to a US standard (ASTM F1717) and submitted to the US FDA, implying testing relevant to the US market, but the actual location of testing or origin of data is not stated.
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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 question is not applicable to this type of device submission. The device is a mechanical implant, and its "ground truth" for performance is established through engineering and mechanical testing standards, not expert clinical interpretation of data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable to this type of device. Adjudication methods are relevant for clinical studies involving human interpretation or subjective endpoints, not mechanical testing.
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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 question is not applicable to this type of device. An MRMC study is for diagnostic or AI-assisted devices involving human readers/interpreters. This is a spinal implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to this type of device. This is a physical spinal implant, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this mechanical spinal implant is based on engineering performance standards (specifically ASTM F1717) and the ability to meet the mechanical and functional requirements for a vertebral body replacement device, such as stability, load-bearing capacity, and fatigue resistance. It is not clinical "ground truth" derived from patient data or expert consensus in the typical sense for diagnostic devices.
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The sample size for the training set
- This question is not applicable to this type of device. There is no "training set" in the context of mechanical testing for a spinal implant.
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How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.