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510(k) Data Aggregation
(82 days)
PLUS PIVOT LINK UNIVERSAL SYSTEM
When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis
- fracture
- spinal stenosis
- deformities (i.e. scoliosis, kyphosis, lordosis)
- tumors
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion.
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 neurologic impairment
- fracture
- dislocation
- scoliosis
- kyphosis
- spinal tumor
- failed previous fusion (pseudoarthrosis)
The PI.US Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and The 11100 Proceed be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
The document is a 510(k) summary for the PLUS™ Pivot Link Universal System for spinal instrumentation. This type of submission is for medical devices, not AI/ML-driven software, and therefore the concepts of acceptance criteria related to algorithmic performance, ground truth, expert adjudication, or MRMC studies do not apply.
The basis of substantial equivalence for this device is primarily through mechanical testing which demonstrates its equivalence in terms of design, material, and intended use to other FDA-cleared spinal instrumentation systems.
Therefore, I cannot provide the requested information as it pertains to an entirely different type of device evaluation than what is described in the provided text.
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(88 days)
PLUS PIVOT LINK UNIVERSAL SYSTEM
When used for anterior screw fixation or as a posterior, non-pedicle system of the nohcervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history . and radiographic studies)
- spondylolisthesis .
- fracture ●
- spinal stenosis ◆
- deformities (i.e. scoliosis, kyphosis, lordosis) ●
- tumors
- failed previous fusion (pseudoarthrosis) .
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- . have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to ● sacrum); and
- . have the device removed after the development of a solid fusion.
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 neurologic impairment
- fracture .
- dislocation ●
- scoliosis
- kyphosis ●
- . spinal tumor
- failed previous fusion (pseudoarthrosis) .
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
This 510(k) premarket notification for the PLUS™ Pivot Link Universal System describes a spinal instrumentation system and seeks to establish its substantial equivalence to previously cleared devices. It does not contain information about an AI device or a study involving an AI algorithm and human readers.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device conformance for an AI device. The document primarily focuses on:
- Device Description: Components (hooks, screws, rods, connectors) and materials (stainless steel, titanium alloy, pure titanium).
- Intended Use/Indications for Use: Various spinal disorders for both anterior/posterior non-pedicle fixation and pedicle screw applications.
- Basis of Substantial Equivalence: Stated as "identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA" and mechanical testing to demonstrate equivalence to currently marketed spinal systems.
There is no mention of an AI component, performance metrics, clinical study design, ground truth establishment, or human reader studies in this document. The "study that proves the device meets the acceptance criteria" refers to mechanical testing in this context, demonstrating the physical properties and performance of the spinal implants, not an AI efficacy study.
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(72 days)
PLUS PIVOT LINK UNIVERSAL SYSTEM
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history and radiographic studies)
- spondylolisthesis .
- fracture ●
- spinal stenosis ●
- deformities (i.e. scoliosis, kyphosis, lordosis) ●
- tumors
- failed previous fusion (pseudoarthrosis) ●
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ●
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 neurologic impairment
- fracture ●
- dislocation .
- scoliosis ●
- . kyphosis
- spinal tumor
- failed previous fusion (pseudoarthrosis) ●
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
This document is a 510(k) summary for the PLUS™ Pivot Link Universal System, a spinal instrumentation system. It's a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study in the way modern AI/ML device submissions might.
Therefore, many of the requested numbered points are not directly applicable or available in this type of document. I will extract what is present and explicitly state when information is not provided.
Device: PLUS™ Pivot Link Universal System (Rod, Hook, and Screw Spinal Instrumentation)
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Key Performance Indicators) | Reported Device Performance |
|---|---|
| Substantial Equivalence: The primary "acceptance criterion" for a 510(k) application is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by comparing design, material, and intended use. | The document explicitly states: "The components of the PLUS Pivot Link Universal System are identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for posterior spinal use." |
| Mechanical Performance: Ensuring the device can withstand physiological loads without failure. | "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." (Specific performance metrics, such as fatigue life, pull-out strength, bending stiffness, or the comparative results, are not provided in this 510(k) summary. The summary only states that testing was performed to demonstrate equivalence.) |
| Biocompatibility: Materials are safe for implantation. | The materials used are specified (stainless steel according to ASTMs F138 and F1586, titanium alloy complying with ASTM-F136, and commercially pure Titanium complying with ASTM F67). Compliance with these standards implies biocompatibility was addressed, but no specific testing results are presented in this summary. |
| Sterilization: The device can be effectively sterilized. | Not explicitly mentioned in this summary, but a standard requirement for implantable devices. |
| Labeling/Indications for Use: Clear and appropriate for the device. | The indications for use are clearly listed for both posterior non-pedicle and pedicle screw applications (see pages 1-2 and 4). These align with predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a submission for a spinal implant, which relies on mechanical testing and material compliance, not clinical data in the sense of patient test sets.
- No "test set" of patient data is described for performance evaluation.
- The "testing" mentioned is mechanical testing of physical device constructs. The sample size for these mechanical tests (e.g., number of constructs tested) is not provided in this summary.
- Data provenance for mechanical testing (e.g., location of a lab) is not specified.
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. There is no patient-data-based "test set" or ground truth requiring expert consensus to establish. This is a physical device approval, not an AI/ML diagnostic or prognostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No patient-data-based "test set" or adjudication method described.
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 not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is typically established through:
- Engineering Standards: Adherence to established ASTM standards for materials (F138, F1586, F136, F67).
- Biomechanical Testing Principles: Ensuring mechanical performance (fatigue, strength) meets or exceeds that of predicate devices, often based on recognized test methods.
- Predicate Device Performance: The primary "ground truth" for a 510(k) is often the demonstrated safety and effectiveness of an already legally marketed, substantially equivalent predicate device.
No medical expert consensus, pathology, or outcomes data is mentioned as a "ground truth" source in this summary for the purpose of device validation.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML algorithm.
Ask a specific question about this device
(84 days)
PLUS PIVOT LINK UNIVERSAL SYSTEM
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis
- fracture
- spinal stenosis
- deformities (i.e. scoliosis, kyphosis, lordosis)
- tumors
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion.
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 neurologic impairment
- fracture
- dislocation
- scoliosis
- kyphosis
- spinal tumor
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
The provided text describes a medical device submission (510(k)) for the PLUS™ Pivot Link Universal System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI algorithm or diagnostic performance.
The document is a regulatory submission for a spinal instrumentation system, focusing on its design, materials, indications for use, and a claim of substantial equivalence to previously cleared devices based on mechanical testing. It's a traditional medical device submission, not one related to an AI/ML powered device.
Therefore, I cannot provide the requested information for the following reasons:
- No AI/ML Component: The device described in the document is a physical spinal instrumentation system (rods, hooks, screws), not an AI algorithm or a diagnostic imaging device. As such, concepts like "acceptance criteria for device performance" in the context of sensitivity, specificity, AUC, human reader improvement, and ground truth establishment (other than for materials testing) are not applicable to this submission.
- No Performance Study as Described: The document mentions "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." This mechanical testing is done to ensure the structural integrity and functionality of the physical components, not to assess diagnostic accuracy or an AI's performance.
If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested information.
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