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510(k) Data Aggregation
(59 days)
OLYMPIC Posterior Spinal Fixation System
The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.
The provided document is a 510(k) premarket notification for the "OLYMPIC Posterior Spinal Fixation System" (K182239) and later references the "PASS LP Spinal System" (K182240). It appears that these are related or the K182240 is meant to be the direct subject of the 510(k) summary. I will answer based on the information provided for K182240, as that is where the performance data is detailed.
The document does not describe an acceptance criteria table with reported device performance for an AI/ML powered device. Instead, it details the substantial equivalence of a spinal fixation system to predicate devices based on biocompatibility and mechanical testing. The questions asked are typically relevant to the evaluation of AI/ML software.
However, I will extract the information that is present concerning performance testing for the spinal fixation system, even though it doesn't align with the AI/ML focus of the prompt's questions.
Here's the closest interpretation of the prompt's questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal "acceptance criteria" table with specific quantitative thresholds. Instead, it states that the performance data "indicate that the products are substantially equivalent as other devices commercially available."
Here's a table based on the types of tests performed and the general conclusions:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993 and G95-1 (Implied: No adverse biological reactions) | Passed Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen Testing. Material conforms to ASTM F136 and ISO 5832-3. |
| Mechanical Testing: Conformance to ASTM F1717-15 (Implied: Mechanical strength equivalent to predicate devices) | Static axial compression, static torsion, and dynamic axial compression tests performed. Products are "substantially equivalent as other devices commercially available." |
2. 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 for either biocompatibility or mechanical testing. Biocompatibility tests are typically performed on material samples, and mechanical tests on a set number of device samples according to the standard.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a spinal fixation system, ground truth (e.g., successful fusion, mechanical integrity) is established through standardized testing (biocompatibility, mechanical tests) rather than expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments, which are not described here.
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-assisted device. The document explicitly states "No clinical studies were performed." and "No animal studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Standardized Material Properties: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy.
- Standardized Biocompatibility Testing: Results of tests (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) against recognized international standards (ISO 10993).
- Standardized Mechanical Testing: Performance against ASTM F1717-15 for static axial compression, static torsion, and dynamic axial compression. The implicit ground truth is that the device should meet or exceed the performance of predicate devices as outlined by these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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(67 days)
OLYMPIC Posterior Spinal Fixation System
The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior Spinal Fixation System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle and non-pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pediatric pedicle and non-pedicle fixation is limited to a posterior approach.
The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled uniplanar screws, hooks, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.
The provided text is a 510(k) summary for the OLYMPIC Posterior Spinal Fixation System. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.
Based on the content of the provided document, here's an analysis regarding acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices through a non-clinical test.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical acceptance criteria. The underlying acceptance is likely to meet or exceed the performance of the predicate devices. | The results of the Dynamic Compression Bending – ASTM F1717 evaluations indicate that the OLYMPIC PSFS is equivalent to predicate devices. |
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a non-clinical test (Dynamic Compression Bending – ASTM F1717) but does not specify a sample size for this test. It also does not mention data provenance as it's a mechanical test, not data from patients.
- 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 is not applicable. The study conducted was a non-clinical mechanical test, not a study requiring expert interpretation or ground truth establishment based on human observation or diagnosis.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. As explained above, the study was a mechanical test, not one involving human interpretation or adjudication.
- 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a spinal fixation system (implants), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. As it was a non-clinical mechanical test, the "ground truth" would be established by the physical properties and mechanical behavior of the materials and device in controlled laboratory settings, against established standards (ASTM F1717) and comparative predicate device performance.
- The sample size for the training set
This is not applicable. There was no training set as this is a physical medical device and not an AI/ML or software device that undergoes a training phase.
- How the ground truth for the training set was established
This is not applicable, as there was no training set.
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(133 days)
OLYMPIC Posterior Spinal Fixation System
The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.
This document is a 510(k) Summary for the OLYMPIC Posterior Spinal Fixation System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices primarily based on non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it lists the types of non-clinical tests performed and states a general conclusion of equivalence to predicate devices. The "acceptance criteria" are implied by the standards cited for each test.
| Test Type | Standard | Reported Device Performance / Outcome |
|---|---|---|
| Finite Element Analysis | (Not a specific ASTM standard listed for FEA) | Determined worst case for testing |
| Static Compression Bending | ASTM F1717 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Dynamic Compression Bending | ASTM F1717 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Static Torsion | ASTM F1717 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Axial grip | ASTM F1798 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Torsional grip | ASTM F1798 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Corrosion testing | ASTM F2129 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the 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)
- Sample Size for Test Set: Not applicable as the study involved non-clinical bench testing rather than human or animal subjects. The "test set" here refers to the physical device components and constructs subjected to mechanical testing. The specific number of samples for each test (e.g., how many constructs were tested for static bending) is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on actual device components. The location where these tests were conducted is not specified, but the applicant (Astura Medical, LLC) is based in Carlsbad, CA, USA.
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. This study is a non-clinical, mechanical performance evaluation of a spinal fixation system. "Ground truth" in the sense of expert clinical consensus or pathology is not relevant for this type of testing. The performance is measured against engineering standards (ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is a non-clinical, mechanical testing study, there is no adjudication of findings by experts. The results are objective measurements against 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
No. This document explicitly states: "No clinical studies were performed." Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical spinal implant, not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests are the established mechanical performance requirements and limits defined by the cited ASTM standards. The device's performance is compared against the performance of predicate devices and the requirements of these standards to demonstrate substantial equivalence, not against clinical expert consensus or pathology data.
8. The sample size for the training set
Not applicable. There is no training set for this device, as it is a physical medical implant and not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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