Search Results

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

Study Details

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not applicable. This is a physical medical implant, not an AI algorithm that requires a training set.

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

   • Not applicable. This is a physical medical implant, not an AI algorithm.

Ask a specific question about this device

Inion Spinal Graft Containment 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. The device is not intended for load bearing indications.

Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. 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 plates and screws include tantalum spheres for postoperative radiographic imaging. The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.

The provided text is a 510(k) summary for the Inion Spinal Graft Containment System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a de novo study. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment (as would be found in a performance study for a novel device or a device requiring clinical evidence) is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not applicable/provided:

1. Table of acceptance criteria and the reported device performance

• Not applicable/provided. This 510(k) summary is not a report of a performance study against specific acceptance criteria. Its purpose is to demonstrate substantial equivalence to existing devices. The "performance data" mentioned refers to mechanical and degradation characteristics that show it behaves similarly to predicates, not metrics against pre-defined clinical acceptance criteria.

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

• Not applicable/provided. There is no "test set" in the context of a clinical or performance study as usually understood for AI/diagnostic devices. The submission relies on a comparison of material properties and intended use with predicate devices.

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

• Not applicable/provided. Ground truth establishment is not relevant in this type of regulatory submission, as it doesn't involve subjective interpretations (e.g., image-reading by experts).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/provided. Adjudication is not relevant here.

5. 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

• Not applicable/provided. This device is a physical implant, not an AI or diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not applicable/provided. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/provided. Ground truth, in the context of clinical or diagnostic device performance, is not established for this type of submission. The "truth" here relates to material properties and bio-compatibility, which are assessed through engineering and biological testing, not expert consensus or pathology data in a clinical trial.

8. The sample size for the training set

• Not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/provided. Not an AI/machine learning device; thus, no training set or ground truth for it.

Summary based on the provided document:

The 510(k) summary for the Inion Spinal Graft Containment System demonstrates substantial equivalence to legally marketed predicate devices, rather than meeting specific performance acceptance criteria from a novel study. The key arguments for substantial equivalence are based on:

• Intended use: Both the Inion system and predicates are used in spinal fusion procedures to maintain the position of weak bony tissue (allografts or autografts) in conjunction with rigid fixation, and are not intended for load-bearing.
• Material composition and scientific technology: The components are made of degradable polylactic acid copolymers, P(L/DL)LA, similar to the predicate devices.
• Degradation profile: The implants retain most strength for 16 weeks and resorb within 2-4 years, which is compared to predicates.
• Mechanical properties: These are considered equivalent, although specific data points are not included in this summary.
• Radiographic markers: The inclusion of tantalum spheres for post-operative imaging is deemed equivalent to the Biomet Tantalum Beads predicate.

The FDA's decision to clear the device is based on this demonstration of substantial equivalence, with the added limitation that the device's "safety and effectiveness... when used without rigid supplemental internal fixation has not been established. This device is not designed to withstand physiologic loads when used by itself." This limitation highlights a critical aspect of how the device must be used, reinforcing that its performance is tied to its use as an adjunct rather than a standalone load-bearing implant.

Ask a specific question about this device