(130 days)
The PASSmed 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system PASSmed is indicated for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
It also includes hooks and a sacral plate 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 PASSmed system includes pedicies include polyasial screws in a various lengths and diameters. Standard and offist height seres are available, with the offset used in cases of severe spondylolisticsis. Standard and realignment clamps are used to connect the screw and rods. Rods are Ø6mm in lengths ranging from 50mm. It also includes sacral plates and serens. The sacral plate takes the place of pedicle screw in connecting the rod to the sacrum. The place is attached to the sarum with two serews. The polyasial attachment mechanism to the same as the pedicle screws. The plates come in right and left configuration. The rod-plates are similar to the consist of a short rod segment that has enarged portions at the ends with holes to attach directly to screw with hemispherical nuts rather than connecting to the rod was a clamp. The rods attach to the hooks and can be used for single or multiple level lisations. They have the same rod attachment mechanism as the polyasial serews. The laminar hooks are inserted inferior around the lamina, pediele hooks are inserted inferior and superior around the pedicles.
This is a 510(k) summary for a spinal fixation device, not a diagnostic or AI-driven device. As such, the information typically found in acceptance criteria and efficacy studies for software-driven medical devices (such as sensitivity, specificity, reader studies, ground truth establishment) is not applicable here.
The provided document describes the PASSmed Spinal System, a hardware device used for spinal immobilization and stabilization. The "study" mentioned in the document is a non-clinical mechanical test to demonstrate the device's physical properties, not a clinical study involving human patients or a software algorithm evaluating medical images.
Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" in the context of a mechanical spinal implant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Soundness | Performance according to ASTM F1717 standard. | "PASSmed system is as mechanically sound as other devices commercially available." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the ASTM F1717 testing. For mechanical tests of components, this would typically involve a statistically significant number of samples of each device configuration or critical component.
- Data Provenance: The testing was "performed according to ASTM F1717," indicating it was likely conducted in a controlled laboratory setting. No country of origin for data is specified, but the submitter (Medicrea) is from FRANCE, and the contact person is in the USA. Given it's a mechanical test, the origin of the data isn't tied to patient demographics or retrospective/prospective collection as it would be for a clinical diagnostic study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For a mechanical device, "ground truth" typically refers to the physical properties of the materials and design, evaluated against established engineering standards (like ASTM F1717). There aren't "experts" in the same way as radiologists for image interpretation; rather, there are engineers and technicians who conduct and analyze the mechanical tests according to predefined protocols.
4. Adjudication Method for the Test Set
- Not Applicable. Mechanical testing against an ASTM standard doesn't involve "adjudication" in the sense of resolving disagreements among human reviewers. The results are quantitative and objective measurements of material properties and structural integrity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human readers interpret data. It is not applicable to a mechanical implant device.
6. If a Standalone Performance (i.e. algorithm only without human-in-the-loop performance) was done
- No. This refers to the standalone performance of a software algorithm. The PASSmed Spinal System is a physical implant, not a software algorithm. The "standalone performance" equivalent would be the mechanical performance of the device itself, which was evaluated via ASTM F1717.
7. The Type of Ground Truth Used
- Engineering Standards and Material Specifications. The "ground truth" for a mechanical device is its ability to withstand specified loads, fatigue, and other physical stresses as defined by relevant engineering standards (in this case, ASTM F1717) and the material properties of its components.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no "training set" for this type of device.
Summary of the "Study" Mentioned:
The "study" referenced in the 510(k) summary is identified as:
- "Testing performed according to ASTM F1717."
ASTM F1717 is a standard test method for "Spinal Implant Constructs in a Vertebrectomy Model (Mechanical Testing of Spinal Implants)." This standard specifies the methodology for mechanical characterization of spinal implant assemblies, including pedicle screw systems, under various loading conditions (e.g., static, fatigue).
The purpose of this testing is to demonstrate the mechanical equivalence and safety of the PASSmed system compared to legally marketed predicate devices. The acceptance criterion is that the device is "as mechanically sound as other devices commercially available," which is demonstrated by meeting or exceeding the mechanical performance benchmarks set by the ASTM F1717 standard and comparing favorably to predicate devices that have also undergone similar testing. This is a common approach for demonstrating substantial equivalence for hardware medical devices in 510(k) submissions.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.