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510(k) Data Aggregation
(73 days)
The PASS 2 Spinal System includes a pedicle 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
When used as a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS 2 also includes hooks and rods indicated for degenerative disc disease (ddd) 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 stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Medicrea PASS 2 Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDICREA PASS 2 Spinal System:
The provided document, K082069, is a 510(k) summary for a Special 510(k) submission, primarily for a product range extension and additional components of the PASS 2 Spinal System. As such, the performance data provided is focused on mechanical testing rather than clinical or AI-driven performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical soundness equivalent to commercially available devices | Tests performed on additional components according to ASTM F1717 or ASTM F1798 indicate that the products are as mechanically sound as other devices commercially available. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical tests. It mentions "tests performed on the additional components," implying a discreet number of physical units were tested.
- Data Provenance: The tests refer to ASTM standards, which are recognized industry-wide standards for mechanical testing of medical devices. The country of origin for the data is not specified beyond being generated for a French company submitting to the FDA. The testing conducted is inherently prospective in nature, as it involves newly manufactured components undergoing specific mechanical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for mechanical testing of spinal implants is defined by the physical properties and performance characteristics measured against established ASTM standards, not by expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Mechanical testing results are typically quantitative and objective measurements against predetermined pass/fail criteria from the ASTM standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. The PASS 2 Spinal System is a mechanical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone study was not done. This submission is for a mechanical spinal implant, not an algorithm or AI device.
7. The Type of Ground Truth Used
For the mechanical performance, the "ground truth" is based on the specified mechanical properties and performance requirements outlined in the ASTM F1717 and ASTM F1798 standards. The device's components must withstand certain loads, fatigue cycles, and exhibit specific mechanical behaviors to be deemed acceptable.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of mechanical performance testing of a spinal implant. Training sets are typically associated with machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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(72 days)
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps members utilized 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation. scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
As a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The provided text is a 510(k) summary for the PASS 2 Spinal System, which is a pedicle screw spinal system. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical testing, rather than a clinical study involving human patients. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanically sound as other commercially available devices | "Testing performed according to ASTM F1717 indicate that the PASS 2 Spinal System is as mechanically sound as other devices commercially available." |
2. Sample size used for the test set and the data provenance
Sample Size: Not specified for the mechanical testing. The testing was likely conducted on a sufficient number of device components to meet ASTM F1717 requirements.
Data Provenance: The data is from mechanical testing, not clinical data from patients. The specific lab or country where the testing was performed is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a mechanical testing study, not a study requiring expert clinical assessment for ground truth. The "ground truth" was established by the specified ASTM F1717 standard for mechanical integrity.
4. Adjudication method for the test set
Not applicable. This was a mechanical testing study, not a study requiring expert adjudication of clinical findings.
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 a pedicle screw spinal system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating the device's performance was compliance with the ASTM F1717 standard, which outlines mechanical testing procedures for spinal implant constructs.
8. The sample size for the training set
Not applicable. This device is a pedicle screw spinal system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a pedicle screw spinal system, not a machine learning model.
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