(189 days)
The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fision for the following indications: degenerative disc disease (defined as back. pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthess: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis: and failed previous fusion.
The Arthro-DIF Acrosspine Pedicle Screw System is an implant device made from an unalloyed titanium and 6Al4V Titanium Alloy. It is to be implanted from the posterior approach. The screws are available in 5.5, 6.5 and 7.5mm diameters and in lengths from 35-60 mm. The screws are available as polyaxial screws. All rods are available in 5.5mm diameter with curved rod in lengths from 40-100 mm, and straight rods from 150-300mm.
This document is a 510(k) summary for the Acrosspine Pedicle Screw System. It provides information about the device's indications for use, description, predicate devices, and performance testing. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for an AI/device performance study (e.g., accuracy, sensitivity, specificity, or human reader improvement).
The document is for a pedicle screw system, which is a physical implant used in spinal surgery, not a software or AI device that generates diagnostic outputs or assists in image interpretation. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.
Instead, the "acceptance criteria" for a physical implant like this typically involve mechanical and material testing to ensure its structural integrity and safety. The "study that proves the device meets the acceptance criteria" refers to the pre-clinical mechanical testing performed against established ASTM standards.
Here's an interpretation based on the provided document, addressing what is relevant and indicating what is not applicable:
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A table of acceptance criteria and the reported device performance
The document lists pre-clinical mechanical tests and the ASTM standards they conform to. The acceptance criteria for these tests are implicitly defined by the ASTM standards themselves, meaning the device must meet the performance requirements (e.g., strength, durability, resistance to specific forces) outlined in those standards. The document doesn't explicitly state quantitative acceptance criteria or raw performance data (e.g., "device withstood X N-m of torque, exceeding the required Y N-m"). Rather, it states that these tests were "performed" and implies successful completion as part of the substantial equivalence claim.
Test ASTM Standard Implied Acceptance Criteria (from ASTM) Reported Device Performance Static Compression Bend F1717-13 Must meet minimum static bending strength requirements for pedicle screw systems. Tests were performed. Implied successful conformance to standard. Dynamic Compression Bend F1717-13 Must meet minimum dynamic bending fatigue life requirements. Tests were performed. Implied successful conformance to standard. Static Torsion F1717-13 Must meet minimum static torsional strength requirements. Tests were performed. Implied successful conformance to standard. Axial Pullout F543-13 Must meet minimum axial pullout strength and securement requirements. Tests were performed. Implied successful conformance to standard. Torque to Failure F543-13 Must characterize the torque required to cause failure (e.g., stripping). Tests were performed. Implied successful conformance to standard. Axial Slip F1798-97 (08) Must demonstrate adequate resistance to axial slippage. Tests were performed. Implied successful conformance to standard. Flexural Grip F1798-97 (08) Must maintain adequate gripping strength under flexural forces. Tests were performed. Implied successful conformance to standard. Torsional Grip F1798-97 (08) Must maintain adequate gripping strength under torsional forces. Tests were performed. Implied successful conformance to standard. -
Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. For mechanical testing, this refers to the number of individual implants or constructs tested for each specific test.
- Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective). This is laboratory mechanical test data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for mechanical testing is defined by the physical properties measured and compared against established ASTM standard specifications, not by expert interpretation of clinical data.
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Adjudication method for the test set
Not applicable. Mechanical testing does not involve adjudication.
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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
Not applicable. This device is a physical pedicle screw system, not an AI software.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical pedicle screw system, not an algorithm.
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The type of ground truth used
The "ground truth" (or basis for evaluation) for this device is the mechanical performance measured against established ASTM standards for spinal implant components.
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The sample size for the training set
Not applicable. This is a physical device, not an AI model.
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How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.