(139 days)
The Inion spinal graft containment plate system, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing indications.
INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System plates are bioresorbable anterior thoraco-lumbar fusion devices for graft containment (screws and plates). The plates are made of degradable poly(L-lactide-co-D,L-lactide 80:20). Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years.
INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System devices provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing.
The purpose of this submission is a line extension for new sizes.
The user is asking for information about the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) document for the "Inion Spinal Graft Containment System".
Here's the breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength and Fixation Properties | Inion S-2™ plates' strength and fixation properties were verified. Performance of new plates in Graft push-off, torsion, axial tensile, axial compression, and cyclic compressive bending tests showed results "within the performance range of the predicate device." |
| Functional and Handling | New plates, when fixed with predicate device unmodified screws, and used with accessory instruments, packaging, and Instructions for Use, were verified to be "functioning together as intended, and conform to the defined user needs and intended uses" through functional and handling tests and simulated clinical use tests. |
| Substantial Equivalence to Predicate Device | The data demonstrates that the intended use, material composition, scientific technology, degradation profile, and mechanical properties of new Inion S-2™ line extension plates are substantially equivalent with the predicate device Inion Spinal Graft Containment System (K071810). |
| Biocompatibility | The device is made of degradable poly(L-lactide-co-D,L-lactide 80:20) and bioresorbs within two to four years, consistent with similar bioresorbable implants. (Implied acceptability based on predicate equivalence and material use.) |
| Sterility and Shelf Life | The implants are provided sterile, with a shelf life of 3 years. (Implied acceptability as per predicate and manufacturing control.) |
| Compatibility with Instruments | The new plates are inserted using the predicate device Inion S-2™ system screws unmodified, and same accessory instrumentation. (Implied acceptability as part of functional testing.) |
Study Details
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: The document does not explicitly state numerical sample sizes for the mechanical tests (e.g., number of plates tested for push-off, torsion, etc.). It refers to "mechanical testing" and "functional and handling test and simulated clinical use test" that were performed.
- Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given the nature of mechanical testing for a medical device regulatory submission, it is almost certainly prospective laboratory testing conducted by the manufacturer (Inion Oy, Finland).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a passive mechanical implant (surgical plate) and does not involve AI, image interpretation, or diagnostic analysis where experts establish ground truth. The "ground truth" here is the physical performance of the device against established engineering and material science standards, and comparison to a predicate device.
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Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on objective mechanical measurements and performance against specifications, there is no need for expert adjudication in the context of diagnostic interpretation.
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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:
- No. This is a physical medical implant, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement with AI, or AI assistance is relevant or discussed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical implant, not an AI algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance is based on mechanical test results (e.g., strength, torsion, compression values) and functional verification against established engineering principles and performance of the legally marketed predicate device. The goal was to demonstrate "substantial equivalence" to the predicate in terms of mechanical properties and function.
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The sample size for the training set:
- Not applicable. This is a physical medical implant, not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is a physical medical implant, not an AI algorithm.
§ 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.