(63 days)
The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the ISOLA system. It is intended for use in pediatric and other applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.
The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and rod and it eliminates the "claw hammer" effect associated with other screw designs. The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration. The screw is available in cancellous thread lengths from 25-50 mm, in 5 mm increments.
Here's an analysis of the provided text based on your request:
It's important to note that the provided text is a 510(k) summary for a medical device (AcroMed Pedicle Screw) seeking clearance from the FDA. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial for a diagnostic AI device would.
Therefore, many of your requested points will either be "Not Applicable" (N/A) or have limited information available due to the nature of a 510(k) submission for a mechanical implant.
Acceptance Criteria and Device Performance (Based on available information)
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Perform consistently with previously cleared components (specifically, AcroMed pedicle screws cleared under K951657 and K951116) in static and fatigue testing. | "Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components." |
| Material Conformance | Manufactured from implant grade stainless steel conforming to ASTM F1314 specifications. | "The AcroMed Pedicle Screw is manufactured from implant grade MATERIAL: stainless steel conforming to ASTM F1314 specifications." |
| Indications for Use | For use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft, with the ISOLA Spine System (K944737), and intended to be removed after solid fusion. Also, as a line extension for pediatric and other applications where anatomic considerations limit implant size. | The device's stated indications for use (as described in the "INDICATIONS" section) define its intended application. The "performance data" confirms its mechanical suitability for these applications in comparison to predicate devices. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not explicitly stated in terms of patient numbers or specific measurement counts. The "performance data" refers to "static and fatigue testing," which typically involves a specific number of mechanical test specimens (e.g., screws) tested under laboratory conditions. The exact number of screws tested is not provided.
- Data Provenance: N/A for clinical data. The performance data relates to in vitro mechanical testing, not human patient data. There is no information on the country of origin of this in vitro testing.
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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):
- N/A. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is its physical and mechanical properties measured by engineering tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes. The performance data presented here refers to objective mechanical testing.
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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:
- N/A. This study relates to the mechanical performance of a pedicle screw, not a diagnostic AI system or human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a mechanical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical performance, the "ground truth" is defined by engineering standards and measurements. This includes ASTM F1314 for material composition and internal mechanical testing protocols for static and fatigue strength, with "consistency" to predicate device performance as the benchmark. For indications for use, the ground truth is established by clinical understanding of spinal conditions like spondylolisthesis.
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The sample size for the training set:
- N/A. This device is a mechanical implant, not an AI or machine learning model that requires a "training set."
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How the ground truth for the training set was established:
- N/A. (See point 7).
Summary for K963639 - AcroMed Pedicle Screw (4.75 mm):
This 510(k) summary focuses on demonstrating that the 4.75 mm AcroMed Pedicle Screw is substantially equivalent to previously cleared AcroMed pedicle screws. The "study" described is primarily mechanical performance testing (static and fatigue). The acceptance criteria for this testing is that the new screw performs "consistently with previously cleared components." The sample size for this mechanical testing is not specified, but it would involve a certain number of test specimens. Ground truth is established by engineering standards and comparative mechanical performance metrics. There are no elements related to human readers, AI, or large-scale clinical trials in the provided information.
§ 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.