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510(k) Data Aggregation
(130 days)
The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix® spinous process fixation plate is intended for use with bone graft material and is not intended for stand-alone use.
The SP-Fix® Spinous Process Fixation Plate System consists of plates, rods, and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix® implants are composed of titanium allov (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).
Here's an analysis of the provided 510(k) summary for the Globus Medical Inc. SP-Fix® Spinous Process Fixation Plate, specifically addressing the requested information about acceptance criteria and the supporting study:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report or a comprehensive technical specification. Therefore, much of the requested information (like specific acceptance criteria values, detailed study designs, and ground truth establishment for AI systems) is not present in this type of document, as it's not typically required for a 510(k) for this type of device (a spinal fixation plate). This submission relies on engineering rationale and mechanical testing, not a clinical effectiveness study with human readers or AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criterion: Substantial equivalence in technological characteristics (design, dimensions, intended use, materials, performance characteristics) compared to predicate devices. | Performance: Mechanical testing (static plate dissociation) was conducted, and an engineering rationale was provided. The results demonstrated substantial equivalence. Additional SP-Fix® implants perform "as well as or better than the predicate device." |
| Criterion: Ability to provide supplemental stabilization of spinal segments to support fusion. | Performance: Indicated for use in achieving supplemental fusion for specified conditions (degenerative disc disease, spondylolisthesis, trauma, tumor). The mechanical testing and engineering rationale support this function in comparison to the predicate device. |
| Criterion: Mechanical strength sufficient for the intended use and to be "as well as or better than the predicate device." | Performance: Static plate dissociation testing was performed. The exact values or specific acceptance thresholds are not provided in this summary, but the conclusion is that the new implants perform "as well as or better than the predicate device." |
Explanation: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented (mechanical testing) supports this determination by showing that the new device's mechanical properties are comparable or superior to the predicate. Specific quantifiable thresholds for "static plate dissociation" are not typically disclosed in a public 510(k) summary, as they are part of the detailed testing protocol submitted to the FDA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a spinal implant. The "test set" here refers to the samples used in mechanical testing, not a clinical dataset for an AI or human reader study. The number of physical units tested for "static plate dissociation" is not specified in this summary.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable. The data is from laboratory mechanical testing, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for a medical device (spinal fixation plate) and relies on mechanical testing and engineering rationale, not expert clinical review (e.g., radiologist consensus) to establish ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This relates to clinical studies with human observers or AI outputs, which is not the basis of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. An MRMC study was not done. This device is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Testing Measurements: The "ground truth" for this device's performance is established through physical measurements and destructive testing in a laboratory setting (e.g., force required for static plate dissociation). This is compared against the known performance characteristics of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. This refers to machine learning algorithms. The device does not involve a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. The device does not involve a "training set" or AI.
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(168 days)
The SP-Fix™ Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.
The SP-Fix™ Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix™ implants are composed of titanium alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).
The provided text is for a 510(k) summary for the SP-Fix™ Spinous Process Fixation Plate, a medical device. It does not describe or include an AI device or a study involving AI. Therefore, I cannot provide information regarding acceptance criteria and studies that prove an AI device meets acceptance criteria.
The information provided pertains to the mechanical testing of a physical medical device to demonstrate its substantial equivalence to predicate devices, which is a standard regulatory pathway for non-AI medical devices.
Here's what I can extract from the provided text about the device and its testing:
| Acceptance Criteria Category | Description from Document | Reported Device Performance |
|---|---|---|
| Device Substantial Equivalence | The purpose of the submission is to add the SP-Fix™ Spinous Process Fixation Plate to the REVERE® Stabilization System. The device must demonstrate substantial equivalence to predicate devices (Medtronic Spire™, LANX Aspen™, NuVasive AFFIX™) in terms of technical characteristics, performance, and intended use to be cleared by the FDA for marketing. | "The SP-Fix™ has been demonstrated to be substantially equivalent to predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s)." This statement implies that the device met the necessary criteria to be considered substantially equivalent to the predicates. |
| Mechanical Performance | Mechanical testing must be conducted to prove the device's functional integrity and safety under various loading conditions, comparable to predicate devices. This includes static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension. The implied acceptance criterion is that the SP-Fix™ performs similarly or better than the predicate devices under these tests. | "Mechanical testing (static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension) was conducted to demonstrate substantial equivalence to the predicate system(s)." The successful clearance by the FDA (K102195) confirms that these tests were sufficient to establish acceptable performance relative to the predicates. |
Regarding the specific questions about AI device studies:
Since this document describes a physical medical device and its mechanical testing for regulatory clearance, the following points are not applicable and cannot be answered based on the provided text:
- Sample size used for the test set and the data provenance: Not relevant for mechanical testing of a physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for mechanical testing.
- Adjudication method for the test set: Not relevant for mechanical testing.
- 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 relevant for a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for mechanical testing. The "ground truth" for mechanical testing is typically engineering specifications and performance benchmarks derived from predicate devices or industry standards.
- The sample size for the training set: Not relevant as there is no AI model being trained.
- How the ground truth for the training set was established: Not relevant as there is no AI model being trained.
The document states that mechanical testing was performed to demonstrate substantial equivalence. This type of testing involves subjecting the device to various physical forces and measuring its response, not analyzing data with an AI algorithm.
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