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510(k) Data Aggregation
(90 days)
The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scollosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.
The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system
The provided text describes a 510(k) summary for the OPTIMA™ Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of design, materials, and intended use, along with basic bench testing to show functional equivalence.
Therefore, the study described is not a clinical study involving human participants or AI for diagnostic purposes. It is a bench test evaluating the mechanical performance of a spinal implant system. As such, many of the requested categories are not applicable or cannot be answered from the provided text.
Here's the breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Equivalence to predicate devices (K020279, K002059, K001319) in accordance with ASTM F1717 standard for static and fatigue testing of spinal implant constructs. | "Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." (Specific quantitative results or detailed criteria are not provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for the bench testing. The ASTM F1717 standard would outline the minimum number of samples required for various tests (e.g., static compression, static torsion, fatigue).
- Data Provenance: Not explicitly stated, but bench testing typically occurs in a controlled laboratory environment. It is not patient data (retrospective or prospective) from a country of origin in the traditional sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For mechanical bench testing of an orthopedic implant, "ground truth" is established by adherence to a recognized international standard (ASTM F1717) and engineering principles, rather than expert clinical consensus.
4. Adjudication method for the test set
- Not applicable. Mechanical tests are objective measurements, not subjective evaluations requiring adjudication.
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. This device is a physical spinal implant, not an AI-powered diagnostic tool requiring human reader performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" for demonstrating performance is adherence to validated mechanical testing standards (ASTM F1717) and demonstrating mechanical equivalence to predicate devices. This indicates that the device can withstand the expected physiological loads without premature failure, similar to existing approved devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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(84 days)
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MN), The AMT Spinal™ System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine (1) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis).
The AMT Spinal™ Svstem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
The AMT Spinal™ System is designed for use as a construct system and consists of set screws, hex nuts, hooks, rods, screws, and cross link assembly (cross link rod and connecting hook) which can be variously assembled to provide immobilization of the thoracic. lumbar, and lumbosacral spine. The system is composed of the following components: right hand set screw, left hand hex nut, pedicle screw, polyaxial screw, rod, cross link assembly (cross link rod and connecting hook). All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136).
The components under review are the Polvaxial screws. Polyaxial upper body head, and concave compression washer. The AMT Polyaxial Pedicle Screw serves as an additional option to the pedicle screw configurations currently offered in the AMT Spinal™ System (K002059). in a construct system. The AMT Polyaxial Pedicle Screw utilizes the same straight forward simple instruments and is identical to the pedicle screws currently offered in the AMT Spinal™ System in the all areas with the exception of the following:
The top loading polyaxial head allowing for greater positioning abilities.
- The rotating head (polyaxial) eliminates the need to bend rods for constructs up to the . three (3) vertebral levels.
- The rotating head (polyaxial) can be rotated allowing the surgeon greater versatility in ● positioning rod and screws to the anatomy.
- Allows anatomical screw placement and easy rod positioning. ●
- This allows the surgeon multi-angle pedicle screw insertion. .
- All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). Materials:
Function: The system functions to assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine.
The provided document does not describe a study involving an AI/Machine Learning device or software. Instead, it's a 510(k) premarket notification for a spinal implant system: the Micron Precision Engineering AMT Spinal™ System, specifically the AMT Polyaxial Pedicle Screw.
Therefore, I cannot provide information about acceptance criteria or studies related to AI performance, as the document details:
- Mechanical testing of a physical medical device. The "study" mentioned is non-clinical performance testing for static and fatigue compression and static torsion of the pedicle screw, performed according to ASTM F1717-96.
- A "substantial equivalence" determination by the FDA, comparing the proposed device to legally marketed predicate devices. This process does not involve clinical trials with human subjects for this type of device, nor does it involve AI performance validation.
Here's what I can extract from the document regarding the device's performance and the basis for its clearance, as per the request, but adapted to the context of a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a physical medical device (spinal implant), the "acceptance criteria" are not reported as specific performance metrics against a predefined threshold like sensitivity, specificity, or AUC for an AI model. Instead, the acceptance criteria are generally met by demonstrating substantial equivalence to predicate devices and verifying mechanical performance through established standards.
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Demonstrate that static and fatigue compression, and static torsion performance are similar to or exceed previously cleared spinal systems and meet the requirements of ASTM F1717-96. The FDA has no specific performance standards for pedicle screw systems, so adherence to this recognized standard is key. | "Static and fatigue compression and static torsion testing of the AMT Polyaxial Pedicle Screw were performed according to ASTM F1717-96. Data regarding the functional performance of the proposed AMT Polyaxial Pedicle Screw has been generated." |
| "Mechanical testing shows the biomechanical performance of the subject device to be similar to the performance of previously cleared spinal systems with similar indications." (Page 1) | ||
| Biocompatibility | Materials used must meet or exceed ASTM standards and have an extensive safe clinical history, being common to orthopedic products. | "The materials used meet or exceed ASTM standards, are common to orthopedic products today, and leave an extensive safe clinical history." (Page 3) |
| Pyrogenicity | Follow USP XXII, NF18 (1995 edition) guidelines, acknowledging that these requirements do not apply to orthopedic products. | "Neither the predicate nor the proposed devices are labeled as non-pyrogenic. Per USP XXII, NF18 (1995 edition). "These requirements do not apply to orthopedic products."" (Page 3) |
| Sterility | Devices are supplied non-sterile and intended for steam sterilization, consistent with predicate devices. | "Both the predicate and the proposed devices will be supplied as a non-sterile implant." |
| "Both the predicate and the proposed devices will be steam sterilized." (Page 3) | ||
| Design, Materials, Function, Intended Use | Demonstrates "substantial equivalence" to predicate devices, meaning no significant differences that would adversely affect use. Design, function, material, and intended use should be similar to legally marketed devices. The proposed device's unique features (e.g., polyaxial head) should not introduce new safety or effectiveness concerns. | No significant differences affecting use were found compared to predicate devices (Spine System Evolution Aesculap, Global Spinal Fixation System Forex, Global Spinal Fixation System U & I Corporation, Spiral Radius 90D - Surgical Dynamics, Trinity Polyaxial Screw Corin Spinal Systems, and the existing AMT Spinal™ System). The polyaxial head offers greater positioning versatility but is considered within the scope of similar intended uses and does not adversely affect safety/effectiveness. (Page 1, 3) |
The following points (2-9) are not applicable as this is not an AI/ML device study:
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the biomechanical samples tested in a lab, not a data set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering standards and physical measurements.
4. Adjudication method for the test set: Not applicable.
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. This is a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used: For mechanical testing, the "ground truth" is derived from established engineering principles, material properties, and the performance requirements of the ASTM F1717-96 standard. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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(143 days)
The FOREX Corporation, OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
The OPTIMATM Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system.
The information provided describes the FOREX Corporation OPTIMA™ Spinal System, a medical device. The document primarily focuses on its 510(k) submission for market clearance, establishing substantial equivalence to predicate devices, and thus does not directly address typical acceptance criteria and performance studies commonly seen in AI/ML device submissions.
Instead, the "acceptance criteria" for this device are met through demonstrating substantial equivalence to already legally marketed predicate devices, and the "study" proving this involves bench testing.
Here's how to frame the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (Bench Testing Result) |
|---|---|
| Equivalence in materials to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
| Equivalence in design to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
| Equivalence in operational principles to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
| Equivalence in indications for use to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
Study Details
-
Sample size used for the test set and the data provenance:
- The document states "Bench testing as listed in Section XII". Section XII is not provided, so the specific sample size for the bench tests is not specified in the given text.
- The data provenance is from bench testing, meaning in-vitro mechanical and material tests, not patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. Bench testing for mechanical properties does not typically involve human expert adjudication for ground truth. The "ground truth" for these tests would be the measured physical properties compared against established engineering standards (ASTM F1717) and the properties of predicate devices.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Bench testing results are typically objectively measured and do not require adjudication by experts in the same way clinical or imaging studies might.
-
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, an MRMC comparative effectiveness study was not done. This is a spinal implant system, not an AI or imaging device that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench testing was established by standardized mechanical testing protocols (ASTM F1717) and engineering specifications. The performance was compared to that of legally marketed predicate devices.
-
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
-
How the ground truth for the training set was established:
- This is not applicable as there is no training set for a physical implant device.
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