(42 days)
The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior non-cervical, pedicle and nonpedicle fixation for the following indications: 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 ; tumor ; pseudoarthrosis and failed previous fusion.
The cleared range of Sterispine™ PS system includes multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 85mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Sterispine™ PS implants are supplied sterile with a sterile single-use set of surgical instruments supplied in kits. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Here's an analysis of the provided text regarding acceptance criteria and device performance.
Important Note: The provided document is a 510(k) summary for a medical device (Sterispine™ PS) and focuses on demonstrating substantial equivalence to a predicate device. It does not present a study proving an AI device meets acceptance criteria. The document pertains to a traditional orthopedic implant system, not an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements for an AI device (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
The document primarily discusses non-clinical mechanical testing of a physical implant (pedicle screw system).
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions specific non-clinical mechanical tests and states the general outcome. It does not provide a quantitative table of specific acceptance criteria values and corresponding performance results.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength | Meets or exceeds functional requirements and suitability for use. |
| Performs equivalent or better than predicates systems. | |
| Cross-connector & Surgical Instrument Functionality | All tests met the acceptance criteria. |
| Single-use Surgical Instruments Functionality | New added surgical instruments can be assembled with each component of the Sterispine PS instrument/implant kit. |
| No deterioration or blocking observed during functional testing. | |
| Suitable and fulfill requirements for single-use. |
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 specified quantitatively. The tests are mechanical in nature, likely on a set number of implants/components per test (e.g., n=5 or n=10 per ASTM standard).
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. This refers to lab testing of physical devices, not clinical data from patients.
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 document describes mechanical device testing against engineering standards, not clinical diagnosis or AI model evaluation requiring human expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective human interpretations, typically in clinical studies or AI model ground truth establishment. This is mechanical testing.
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 relates to AI-assisted human performance in diagnostic tasks. The device in question is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to the performance of an AI algorithm as a standalone diagnostic tool. The device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is adherence to established mechanical testing standards (e.g., ASTM F1798, ASTM F1717) and functional engineering requirements. It's engineering/mechanical performance standards, not clinical ground truth.
8. The sample size for the training set
- Not applicable. This refers to AI model training data.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI model training data.
Summary regarding the provided document:
The provided K201648 510(k) summary is for a traditional surgical implant (pedicle screw system). The "acceptance criteria" and "study" described are focused on non-clinical mechanical and functional testing to demonstrate the device's physical properties and performance against established engineering standards, and its substantial equivalence to previously cleared predicate devices. It does not involve AI technology or clinical performance studies in the way envisioned by the posed questions.
§ 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.