Search Results
Found 4 results
510(k) Data Aggregation
(300 days)
The coflex-IF is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.
The coflex-IF system is an implant system for interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.
The purpose of this Special 510(k) is to add a notch in the posterior portion of the U-shaped body. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.
Here's a breakdown of the acceptance criteria and study information for the coflex-IF device, based on the provided FDA 510(k) summary:
- Note: This document is a 510(k) summary for a spinal implant (coflex-IF), which is a physical medical device, not a software or AI-based diagnostic device. Therefore, many of the requested categories (like sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) are not applicable to this type of submission. The information provided focuses on engineering and mechanical testing for substantial equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result compared to criteria) |
|---|---|
| Mechanical Stability and Properties (per ASTM F 1717-13): | The "worst case device" was subjected to these tests. The results demonstrated that the acceptance criteria (defined in an unprovided "Design Control Activities Summary") were met, and the performance was equivalent to the predicate device. |
| Static Compression Bending | Achieved equivalence to predicate device. |
| Static Torsion | Achieved equivalence to predicate device. |
| Compression Bending Fatigue | Achieved equivalence to predicate device. |
Study Information (Where applicable, based on a physical medical device)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as "sample size" in the context of human subjects or data, but "The worst case device" was tested. This refers to a manufactured physical device chosen as representative of the most challenging conditions or configurations.
- Data Provenance: Not applicable in the context of human data. The testing is described as mechanical performance testing of the device itself.
-
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's mechanical performance is established through standardized engineering tests (e.g., ASTM F 1717-13) and comparison to the predicate device, not expert consensus on human data.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical testing results are objective measurements of physical properties, not subject to human adjudication in the way clinical diagnostic interpretations would be.
-
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 spinal implant, not an AI software/diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical spinal implant, not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical performance, the "ground truth" is defined by the standards set by ASTM F 1717-13 and the established performance of the predicate device. The goal is substantial equivalence, meaning the new device performs acceptably within the same safety and effectiveness parameters as the legally marketed predicate.
-
The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set of data. Device design and manufacturing parameters are based on engineering principles and material science, not machine learning.
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI training set for this type of device.
Ask a specific question about this device
(429 days)
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system 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)
- spinal tumor
The device is not intended for stand-alone use.
The Integra Spinous Process System consists of an implantable spacer featuring plates of varying lengths with fixed hub diameters and set screws in order to clamp bilaterally to the spinous processes. It is a multicomponent device consisting of two plates coupled by a central hub and locked by a set screw. Each plate contains spikes for fixation to the spinous process to aid in resisting rotation after implantation. The device is available in a range of sizes to accommodate variations in patient pathology and anatomy. It is manufactured from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is single use only. The complete system, including insertion and accessory instrumentation for implantation, is packaged in a tray for transportation, cleaning and sterilization.
The Integra Spinous Process System is a medical device and as such, the concept of "acceptance criteria" and "device performance" as it might apply to an AI/ML model's diagnostic accuracy is not directly applicable.
Instead, the provided text describes the device's substantial equivalence to predicate devices based on technological characteristics and performance testing.
Here's an breakdown of the information that is available, structured to align with your request where possible:
(1) A table of acceptance criteria and the reported device performance
For a medical device like the Integra Spinous Process System, "acceptance criteria" are typically related to meeting established mechanical and material standards and demonstrating equivalence to legally marketed predicate devices. "Device performance" is then evaluated against these established standards and predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Devices | The Integra Spinous Process device has the same technological characteristics as the referenced predicate devices, including: composed of two clamping plates, a locking set screw, various hub diameters, and manufactured from Ti-6AL-4V per ASTM F136. |
| Mechanical Performance Requirements (ASTM F1717 & ASTM F1798) | Performance testing (compression bending and torsion) was conducted in accordance with ASTM F1717 and ASTM F1798 standards. Analysis and interpretation of the test results and device comparisons demonstrate that the Integra device is substantially equivalent to the predicate devices. (Specific quantitative performance metrics are not provided in this summary, but the conclusion is that they meet the acceptance criteria by being equivalent to predicates.) |
(2) Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical medical device (implant) and not an AI/ML diagnostic system. The "test set" here refers to mechanical testing of the device itself, not clinical data or patient samples. The provenance of such mechanical testing is typically the testing lab.
(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)
This information is not applicable. Ground truth, in the context of device performance, would be defined by the technical specifications outlined in the ASTM standards (F1717 and F1798) and the performance of the predicate devices. The "experts" would be the engineers and scientists who conducted and interpreted the mechanical tests.
(4) Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from human expert opinions. For mechanical device testing, the results are typically objectively measured against pre-defined engineering standards.
(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
This information is not applicable. This device is an implantable surgical system, not an AI-assisted diagnostic tool.
(6) If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device.
(7) The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Established mechanical testing standards: Specifically, ASTM F1717 and ASTM F1798, which define methods for evaluating the mechanical properties of spinal implants.
- Performance of legally marketed predicate devices: The Integra Spinous Process System's performance was compared to the performance of predicate devices (Life Spine Interspinous Fixation System, NuVasive® Spinous Process Plate System, Lanx Spinous Process Fusion Plate (SPFP), and Medtronic CD Horizon Spinous Process Plate) to demonstrate substantial equivalence.
(8) The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML model.
(9) How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML model.
Ask a specific question about this device
(122 days)
The VertiFlex® 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 spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.
The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.
The provided text describes the VertiFlex® Spinous Process Fixation Plate, a medical device for spinal fixation. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states, "No clinical testing was conducted to support this submission."
Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics from clinical trials, a test set, ground truth, expert involvement, or AI-related data, is not available in the provided text.
Based on the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific clinical study for device performance. The "acceptance criteria" for regulatory submission seems to be substantial equivalence to predicate devices, based on design, materials, indications, and non-clinical performance.
- Reported Device Performance:
- Non-Clinical Tests: The device demonstrated "substantial equivalence... in terms of performance" to a commercially available predicate through tests conducted in accordance with ASTM F1717-12 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), static pull-off testing in synthetic bone, and static dissociation testing. Specific performance values (e.g., load limits, displacement) are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set data is provided. The non-clinical tests likely used test samples of the device and synthetic bone models.
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. No clinical test set and thus no ground truth established by medical experts for device performance are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set is mentioned.
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. This device is a mechanical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a mechanical implant. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices against which the VertiFlex® plate was compared for substantial equivalence.
8. The sample size for the training set
- Not applicable. No machine learning or AI training set is mentioned as this is a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. No machine learning or AI training set is mentioned.
Ask a specific question about this device
(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.
Ask a specific question about this device
Page 1 of 1