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510(k) Data Aggregation
(133 days)
4-WEB, INC.
The 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation on osteotomies in the foot, such as:
- Opening wedge osteotomies of Hallux Valgus
- Cotton opening wedge osteotomies
- Evans lengthening osteotomies
These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.
The 4Web Osteotomy Bone Wedge is a titanium alloy implant used for correction of small bones in the foot. It is offered in two shapes and multiple sizes for each shape with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4-Web truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
This document describes a 510(k) premarket notification for the 4Web Osteotomy Bone Wedge. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a new, innovative device technology (like AI/ML).
Therefore, many of the requested sections regarding AI/ML-specific performance studies are not applicable or cannot be extracted from the provided text.
Here is the information that can be extracted from the provided documents:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device standards) | Reported Device Performance (4Web Osteotomy Bone Wedge) |
|---|---|
| Static Compression Testing (per ASTM F2077-11) | Indicated substantial equivalence to predicate device and adequacy for intended use. |
| Dynamic Compression Testing (per ASTM F2077-11) | Indicated substantial equivalence to predicate device and adequacy for intended use. |
| Expulsion Testing | Indicated substantial equivalence to predicate device and adequacy for intended use. |
Explanation: The acceptance criteria are implicitly defined by the performance of the predicate device (Biofoam Bone Wedge from Wright Medical, K073535) and the standards applied to that class of device (ASTM F2077-11). The 4Web Osteotomy Bone Wedge aims to meet or exceed these established performance levels to demonstrate substantial equivalence.
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 provided in the document. The document refers to "pre-clinical testing" but does not detail sample sizes for the mechanical tests, nor does it refer to 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)
This information is not applicable/provided. This device is undergoing a 510(k) submission based on substantial equivalence through mechanical testing, not a clinical study involving expert interpretation of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. As above, this is a mechanical device submission, not a clinical study requiring adjudication of expert interpretations.
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/provided. The document does not describe an AI/ML device, nor a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The document does not describe an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the established performance standards (ASTM F2077-11) and the performance characteristics of the predicate device. There is no biological or clinical "ground truth" mentioned as these are pre-clinical mechanical tests.
8. The sample size for the training set
This information is not applicable/provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no mention of a training set or its ground truth establishment.
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(127 days)
4-WEB, INC.
The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. Th DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.
The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in two basic "footprint" sizes, 17mm x 14mm x 11mm. These sizes are available in zero and 7 degree lordosis and each of these in 8 heights ranging from 5mm to 12mm in 1mm increments.
The provided text describes the 510(k) summary for the Cervical Spinal Truss System (STS) Interbody Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than a clinical study evaluating human reader performance with or without AI.
Therefore, many of the requested criteria related to clinical studies, human readers, AI, and ground truth establishment are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Axial Compression (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Static Compression Shear (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Static Torsion (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Dynamic Axial Compression (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Dynamic Compressive Shear (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Dynamic Torsion (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Subsidence (per ASTM F2267-04) | Performed, results indicate substantial equivalence |
| Expulsion Testing (per industry accepted methodology) | Performed, results indicate substantial equivalence |
Note: The document only states that testing was "performed" and that the "minor differences that do exist do not raise any new types of safety or efficacy issues" and "do not adversely impact device performance." Specific numerical acceptance values or detailed performance data are not provided in this 510(k) summary (which is typical for such summaries, as detailed data is usually in the full submission).
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated for each test (e.g., how many devices were tested for static compression). The tests appear to be benchtop mechanical engineering tests, not tests on biological samples or patient data.
- Data provenance: Not applicable in the context of clinical data. These are laboratory-based mechanical performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device's evaluation is based on engineering performance tests against established ASTM standards and an industry-accepted methodology for expulsion testing. It does not involve human expert interpretation of data points in the way a diagnostic AI would.
4. Adjudication method for the test set
- Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for mechanical performance testing against objective 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
- No such study was done. This document is for an interbody fusion device, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to diagnostic AI system performance; the device is a physical implant.
7. The type of ground truth used
- Objective engineering standards and measurements: The "ground truth" for the performance testing is adherence to the specified ASTM standards and an "industry accepted methodology" for expulsion testing. This is based on physical properties and mechanical behavior.
8. The sample size for the training set
- Not applicable. This evaluation does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. This evaluation does not involve machine learning or a training set.
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(125 days)
4-WEB, INC.
The ALIF Spinal Truss Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in 0, 6, 8 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 17mm in 1mm increments.
The provided document describes the 510(k) summary for the ALIF Spinal Truss System® Interbody Fusion Device. It details the device, its indications for use, and a comparison to predicate devices, focusing on mechanical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Static Compression Shear | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Static Torsion | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Dynamic Axial Compression | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Dynamic Compressive Shear | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Subsidence (per ASTM F2267-04) | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Expulsion Testing (per industry accepted methodology) | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
Explanation of "Acceptance Criteria" based on the document:
The acceptance criteria are not quantitatively defined in the provided text. However, the regulatory submission relies on demonstrating substantial equivalence to predicate devices. Therefore, the implicit acceptance criteria for the mechanical performance tests are that the ALIF Spinal Truss System® Interbody Fusion Device performs "equal to or better than" the original design (K083894) or other previously approved predicate devices (DePuy/AcroMed Brantigan Cage and Advanced Medical Technologies Distractable Wave Cage).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size (number of devices or tests performed) for the preclinical mechanical performance testing.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "Preclinical testing performed" by "4-Web Spine, Inc." It is assumed this testing was conducted in a laboratory setting for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of preclinical mechanical performance study. "Ground truth" in this context would typically refer to clinical outcomes or expert diagnoses, which are not part of a mechanical testing submission for substantial equivalence. The "truth" here is the physical performance as measured by ASTM standards and industry-accepted methodologies.
4. Adjudication Method for the Test Set
This is not applicable to preclinical mechanical performance testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or interpretive devices involving human readers, which is not the case for this interbody fusion device's mechanical performance assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is an interbody fusion implant, not an algorithm or software. Its performance is entirely standalone in a mechanical testing environment.
7. The Type of Ground Truth Used
As explained in point 3, the concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic devices is not directly applicable. For this mechanical performance study, the "ground truth" is established by adherence to and measurement against recognized industry standards (ASTM F2077, ASTM F2267-04) and industry-accepted methodologies, with the performance benchmarks being those of legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. The ALIF Spinal Truss System® is a medical implant, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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