(28 days)
The Integra Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
The Integra Laminoplasty System consists of titanium alloy plates and screws that are attached to the lamina after a laminoplasty procedure. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage
The provided document is a 510(k) premarket notification for a medical device called the "Integra® Laminoplasty System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study as would be common for AI/software devices.
Therefore, many of the requested categories for AI/software studies are not applicable directly to this submission. However, I can extract the relevant information from the document regarding the device and its testing:
Device Name: Integra® Laminoplasty System
Regulation Name: Spinal interlaminal fixation orthosis (21 CFR 888.3050)
Regulatory Class: Class II
Product Code: NQW
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as the predicate device. For the Integra Laminoplasty System, this was demonstrated through non-clinical testing.
- Reported Device Performance: The device "demonstrated equivalent performance to the predicate systems through static testing per ASTM F2193." This implies that the mechanical properties tested under ASTM F2193 met or exceeded the performance of the predicate device(s). Specific quantitative performance metrics (e.g., tensile strength values, compression resistance values) are not provided in this summary.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated equivalent performance to predicate systems through static testing per ASTM F2193. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes non-clinical testing (static testing per ASTM F2193), not a test set for an algorithm. Therefore, "sample size" here refers to the number of physical samples tested. The document does not specify the number of samples tested under ASTM F2193.
- Data Provenance: Not applicable, as it's non-clinical lab testing of physical components, not patient data.
3. 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)
- Not applicable. This device is a mechanical implant; "ground truth" in the context of expert review for AI algorithms is not relevant here. The ground truth for mechanical performance is established by standardized testing methods (ASTM F2193) and engineering principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies among expert readers in clinical image review or similar tasks for AI evaluations. This document describes mechanical testing of a medical implant.
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
- No. The document explicitly states: "No clinical testing was required to demonstrate equivalence." Therefore, no MRMC study, or any clinical study involving human readers with or without AI assistance, was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The "Integra® Laminoplasty System" is a physical medical device (implants and instruments) for surgery, not an algorithm or AI software. Therefore, there is no "standalone algorithm performance" to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance, in the context of regulatory submission, would be its mechanical properties meeting or exceeding those of the predicate devices as determined by standardized laboratory testing (ASTM F2193). This is a physical, objective "ground truth" based on engineering standards.
8. The sample size for the training set
- Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
Summary of what the document does provide regarding acceptance criteria and performance:
The acceptance criterion for this 510(k) submission was substantial equivalence to predicate devices in areas including intended use/indications for use, technological characteristics, and performance. This equivalence was demonstrated through non-clinical static testing per ASTM F2193, showing "equivalent performance" to the predicate systems. Specific quantitative results from this testing are not included in the public 510(k) summary. No clinical testing or AI-related studies were performed or required for this submission.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.