(87 days)
The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle 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.
SteriSpine™PS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpine™PS system are made of Titanium Ti-6Al-4V ELI according to ASTM F136. The SteriSpine™PS range of products is supplied sterile with a sterile single-use set of surgical instruments.
This document is a 510(k) premarket notification for the SteriSpine™ PS, a pedicle screw spinal system. It describes the device, its indications for use, and the data presented to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them, specifically for an AI/ML device.
Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a spinal implant system). Therefore, the questions related to AI/ML device performance (like multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, training set details) are not applicable to this submission.
The "Performance data" section refers to mechanical testing and packaging/sterilization validation for the physical implant, not AI algorithm performance.
Let's break down what is present and what is not for this specific device submission:
1. A table of acceptance criteria and the reported device performance:
The document states:
- Acceptance Criteria (Implicit via "conforms to special control"): The device "conforms to special control established for Pedicle Screw spinal system." This implies meeting design specifications and performance standards for such systems, primarily mechanical integrity and safety.
- Reported Device Performance: "Mechanical testing was conducted according to ASTM F1717 and ASTM F1798 Standard. Performed mechanical testing includes the following: Static Compression, static torsion, dynamic torsion, static slipping, static bending and static rotation."
- No specific numerical results are provided in this summary, but the "Discussion of Testing" states: "Mechanical testing demonstrates comparable mechanical properties to the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating equivalence to the predicate's performance under these tests.
| Acceptance Criterion (Implicit) | Reported Device Performance/Conclusion |
|---|---|
| Conformance to "special control established for Pedicle Screw spinal system" (e.g., mechanical integrity, safety) | "Mechanical testing was conducted according to ASTM F1717 and ASTM F1798 Standard. Performed mechanical testing includes the following: Static Compression, static torsion, dynamic torsion, static slipping, static bending and static rotation." |
| "Mechanical testing demonstrates comparable mechanical properties to the predicate devices." | |
| "Non clinical performance testing demonstrates that the added devices are substantially equivalent to predicate devices in terms of intended use, materials, design and function." | |
| Packaging Validation | "Packaging validation according to ISO 11607-1 and 11607-2" |
| Sterilization Revalidation | "sterilization revalidation according to ISO 11137-1, 11137-2 and 11137-3." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For mechanical testing of a physical device, "sample size" typically refers to the number of devices or components tested. This specific numerical sample size is not provided in the document.
- Data Provenance: Not explicitly stated, but given the manufacturer is French ("Parc des Bellevues, Eragny sur Oise - FRANCE") and the testing standards are international (ASTM, ISO), the testing would have been conducted in a lab, likely in France or a certified testing facility elsewhere. This is "pre-market" testing, 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:
- N/A. This applies to AI/ML devices where human expert annotations are used to establish ground truth for diagnostic or prognostic tasks. For this physical device, "ground truth" is established by physical measurement against engineering standards.
4. Adjudication method for the test set:
- N/A. This applies to AI/ML devices where inconsistencies in human expert annotations need to be resolved. Not relevant for 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:
- No. This applies to AI/ML devices assessing clinical images/data. This device is a physical implant. The document explicitly states: "No clinical data has been presented."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This applies to AI/ML devices. Not relevant for this physical device.
7. The type of ground truth used:
- For mechanical properties: Engineering standards and physical measurements (e.g., force applied, deformation, yield strength, fatigue life) as defined by ASTM F1717 and ASTM F1798.
- For packaging and sterilization: International standards (ISO 11607-1, 11607-2, 11137-1, 11137-2, 11137-3) for sterility and package integrity.
8. The sample size for the training set:
- N/A. This applies to AI/ML devices. This is a physical device; there is no "training set" in the AI sense.
9. How the ground truth for the training set was established:
- N/A. Applies to AI/ML devices.
In summary: This document is typical for a 510(k) for a physical implant device, focusing on substantial equivalence through material properties, mechanical performance, and manufacturing processes (sterilization, packaging) compared to predicate devices. It explicitly states "No clinical data has been presented," confirming that no human-in-the-loop or clinical efficacy studies were part of this specific submission for clearance. The questions posed in your prompt are primarily geared towards AI/ML medical devices, which this product is not.
§ 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.