Search Results
Found 4 results
510(k) Data Aggregation
(266 days)
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.
The provided documents describe findings for a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) cannot be answered from the provided text.
However, I can extract information related to the device's mechanical performance and the study conducted.
Here is the information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (How the device performed) |
|---|---|
| Static interconnection testing | Met all mechanical test requirements based on worst-case construct testing. |
| Compression bending fatigue | Met all mechanical test requirements based on worst-case construct testing. |
| Dissociation testing | Met all mechanical test requirements based on worst-case construct testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual tests. The text refers to "worst-case construct testing."
- Data Provenance: Not applicable. This refers to mechanical testing, not clinical data provenance.
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 mechanical testing is established by engineering standards and measurements, not expert consensus.
4. Adjudication method for the test set
Not applicable. Mechanical tests have pass/fail criteria based on 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
Not applicable. This device is not an AI/ML diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical spinal fixation system.
7. The type of ground truth used
For mechanical testing, the "ground truth" or reference criterion is based on established engineering standards (ASTM F1717, ASTM F1798) and relevant FDA guidance (FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Ask a specific question about this device
(98 days)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.
Here's a summary of the acceptance criteria and study information for the Polaris Spinal System - Translation Screw, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Static Compression Bending (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. |
| Static Torsion (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. | |
| Dynamic Compression Bending Fatigue (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. | |
| Resistance to cantilever loading or non-axial torque | Ability to resist cantilever loading or non-axial torque comparable to the predicate device. | Testing verified the ability of the subject device to resist cantilever loading or non-axial torque compared to the predicate device. | |
| Substantial Equivalence | Intended Use | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices (K131615, K123549, K090203, K061441). |
| Indications for Use | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Design | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Materials | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Manufacturing Methods | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Sterility | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Fundamental Technology | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Operational Principles | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical testing as the primary method to demonstrate performance. For this, the sample size is not explicitly stated as a number of devices or constructs, but it mentions testing was performed on "worst-case construct testing." There is no information about country of origin or whether the data was retrospective or prospective, as this pertains to physical device testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance data is based on mechanical laboratory testing against established ASTM standards and direct comparison to predicate devices, not on expert assessment of a test set.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is based on objective mechanical testing in a laboratory setting, not on human adjudication of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (spinal fixation system modification). This document focuses on the mechanical substantial equivalence of a medical device, not the interpretive accuracy of human readers with or without AI assistance.
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, not an algorithm or AI system. Its performance is inherent in its mechanical properties and design.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- ASTM F1717 Standard: This standard dictates specific methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model. Compliance with this standard represents a recognized and accepted "ground truth" for mechanical performance in this domain.
- Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate devices (K131615, K123549, K090203, and K061441). The subject device's performance is compared directly to these.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
Ask a specific question about this device
(125 days)
The Solitaire -C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The purpose of this submission is to gain market clearance for the Solitaire-C Cervical Spacer System. The Solitaire -C Cervical Spacer System consists of spacers and bone screws for stand-alone cervical intervertebral body fusion. The Solitaire -C spacer will be available in a variety of sizes, angles and footprints. This cervical spacer has a PEEK main body (PEEK-Optima LT1 per ASTM F-2026) with a titanium faccplate and band (Ti-6Al-4V ELI alloy per ASTM F-136), and tantalum markers (unalloyed tantalum per ASTM F-560). This device accepts titanium bone screws that are available in two diameters and multiple lengths.
The provided text describes a medical device, the Solitaire®-C Cervical Spacer System, and its clearance process. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance.
The document K113796 is a 510(k) summary for a traditional medical device (cervical interbody fusion device), cleared in 2012. The "Performance Data" section details mechanical testing performed on the physical device to ensure its strength and suitability for its intended use, according to ASTM standards. This is standard for orthopedic implants, demonstrating the physical integrity and biocompatibility of the device itself.
There is no mention of an AI/ML component in this device, nor any discussion of diagnostic or prognostic performance metrics that would typically be associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Therefore, the specific information requested about acceptance criteria, reported device performance (in terms of AI metrics), sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the provided document.
To directly answer your request based on the absence of such information in the provided text:
-
A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing to established ASTM standards but does not present acceptance criteria or performance in a table format relevant to AI/ML. Mechanical testing "shows that the mechanical strength of the subject device is sufficient for its intended use," implying it met internal or regulatory mechanical performance criteria, but these are not specified quantitatively.
-
Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples for mechanical testing, not a digital test set for AI/ML.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on physical measurements and compliance with engineering standards, not expert medical interpretation of images or patient data.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
-
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. No AI component is described.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" is compliance with specified ASTM standards for static and dynamic compression, shear, torsion, subsidence, and expulsion, along with evaluation of screw back out, push through, and interconnection, and wear debris analysis.
-
The sample size for the training set: Not applicable. No AI component is described.
-
How the ground truth for the training set was established: Not applicable. No AI component is described.
In summary, the provided document describes the mechanical performance of a physical orthopedic implant and does not contain the type of information requested about AI/ML device performance and validation.
Ask a specific question about this device
(79 days)
The Construx External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.
The Construx External Fixation System consists of a central body, and several other components that can be used to create an external fixation frame. These components include:
- Male Stem Assembly
- Aluminum Ankle Assembly
- Carbon Ankle Assembly
- Carbon Straight Clamp Assembly
- Aluminum Male Straight Clamp
- Aluminum Female Straight Clamp
- Aluminum T-clamp
- Aluminum Angular Hinge Clamp
- Aluminum Ring Adapter
These components can be used with the DFS Bone Screws, and other components of the DFS Standard Fixator, DFS Ring and Vision External Fixation Systems.
The presented document is a 510(k) Summary for the Construx External Fixation System, which is a medical device for bone fixation. The document details the device description, indications for use, and a summary of performance data. However, the available text does not contain the specific acceptance criteria or an in-depth study report that would allow for a detailed answer to all parts of your request regarding AI/algorithm performance.
Here's what can be extracted and inferred from the provided text regarding the device's performance assessment, along with the information that is not present:
Acceptance Criteria and Study for Construx External Fixation System (Non-AI Device)
The Construx External Fixation System is a mechanical device, not an AI/algorithm. Therefore, the questions related to AI performance, such as human reader improvement with AI, standalone algorithm performance, training data, and expert ground truth for AI models, are not applicable to this document. The "Performance Data" section solely discusses mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established by Predicate Devices) | Reported Device Performance |
|---|---|
| Met for Static Testing (Assumed, based on text) | New Construx components met the established acceptance criteria set by the predicate devices. |
| Met for Fatigue Testing (Assumed, based on text) | New Construx components met the established acceptance criteria set by the predicate devices. |
- Note: The specific numerical values or qualitative descriptions of the acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the exact performance results are not detailed in this summary document. The document only states that the new components met the established criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Mechanical testing was performed on the Construx External Fixation System. Static and fatigue testing was performed on the new Construx components assembled as external fixation constructs."
- Sample Size for Test Set: Not specified. The number of constructs or individual components tested is not provided.
- Data Provenance: The nature of mechanical testing generally means the "data" is generated in a lab setting, not typically originating from a country or being retrospective/prospective in the way clinical data would be.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable to mechanical testing of a physical device. Ground truth for mechanical testing is based on engineering specifications and physical measurements, rather than expert clinical consensus.
4. Adjudication Method for the Test Set
- This question is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation or clinical data, not for objective mechanical performance.
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 question is not applicable. The Construx External Fixation System is a physical medical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The Construx External Fixation System is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications and established performance benchmarks derived from the predicate devices. For mechanical testing, this typically involves stress, strain, displacement, and cycle count measurements against pre-defined limits.
8. The Sample Size for the Training Set
- This question is not applicable. Mechanical testing does not typically involve a "training set" in the context of machine learning or algorithms. The "training" for such a device would be the design and manufacturing process, optimized based on engineering principles and prior device data.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reasons as #8. The "ground truth" for the design and manufacturing would be based on biomechanical principles, material science, and regulatory requirements, informed by the performance of predicate devices.
Summary of Missing Information:
The provided 510(k) summary is a high-level overview. For a comprehensive understanding of the acceptance criteria and study, one would typically need access to the full test report, which would detail:
- Specific test methods (e.g., ASTM standards referenced).
- Exact load conditions, displacement limits, and cycle counts for static and fatigue tests.
- The number of samples tested for each configuration.
- The actual measured performance values compared against the criteria.
- Detailed information about the predicate device's performance data that established these criteria.
Ask a specific question about this device
Page 1 of 1