(182 days)
- Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
The HAIDER-UCR Spinal System is a pedicle screw system indicated for the . treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-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. - Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
. The HAIDER-UCR Spinal System 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 with objective evidence of neurological ● spondylolisthesis impairment,
- . fracture,
- dislocation, ●
- scoliosis, .
- kyphosis.
- spinal tumor, and ●
- failed previous fusion pseudarthrosis). .
The HAIDER-UCR Spinal System is a pedicle screw system. The system components include Titanium Pedicle screws, Pedicle Screw Components (Set Screw, Washer, Cap, Housing), Screw Sub-Assembly, Crosslink (Cross Link Nut, Cross Link Hook, Cross-link Bar), 5.5 mm Titanium Rods, and Accessories (Hex 3mm Screw Driver, Hex 4mm Screw Driver). The system is made from titanium alloy (6Al, 4V, Ti).
The provided text describes a medical device, the HAIDER-UCR Spinal System, and its regulatory submission (510(k)) to the FDA. It details device characteristics, indications for use, materials, and testing summarized in comparison to a predicate device.
However, the document is a 510(k) Pre-market Notification, which is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission primarily focuses on comparing the new device to an existing one for safety and effectiveness, rather than providing a detailed study proving the new device meets specific, quantitative acceptance criteria through clinical trials or extensive standalone performance studies in the way you might expect for a novel AI/software medical device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, AI efficacy studies, ground truth establishment) are not applicable or not present in this type of regulatory document for this specific device. The HAIDER-UCR Spinal System is a mechanical implant, and its performance is evaluated through material specifications, mechanical testing, and comparison to an established predicate.
Here's an attempt to answer based on the provided text, indicating where information is not available or not relevant to this type of device submission:
Acceptance Criteria and Device Performance Study (HAIDER-UCR Spinal System)
The HAIDER-UCR Spinal System is a pedicle screw spinal system. Its acceptance criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Synergy™ Spinal System, K974749) and compliance with relevant material and mechanical testing standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely defined by demonstrating equivalence to the predicate device and meeting specified engineering standards. The "reported device performance" in this context refers to the results of static and fatigue mechanical testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Static Testing: Compliance with ASTM F-1717-96 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static and Fatigue)". Specifically, performance in compression bending, tension bending, and torsion of a typical system configuration. (Implied acceptance: performance equal to or better than predicate, or meeting established safety limits for such devices). |
Fatigue Testing: Compliance with ASTM F-1717-96. Establishment of an S/N (stress-number of cycles) curve with run-out points. (Implied acceptance: ability to withstand a specified number of load cycles without failure, equivalent to or better than predicate, or meeting established safety limits). | Static Testing: "Static tests of compression bending, tension bending and torsion of a typical system configuration indicated design performance was met. All samples were tested according to ASTM F-1717-96, the pedicle screw spinal system guideline."
Fatigue Testing: "Samples subjected to cyclic fatigue testing also performed according to expectations. Seven constructs were tested and an S/N curve established. At least two run out points exceeded 5,000,000 load cycles." |
| Materials | Compliance with quality and composition standards for Titanium alloy or 6Al, 4V, Ti titanium alloy. (Implied acceptance: meeting ISO or ASTM material specifications, and being the "SAME" material as the predicate). | "The system is made from a well known metallic alloy commonly known as titanium alloy or 6Al, 4V, Ti titanium alloy. This material meets or exceeds the quality and composition standards listed in the table below [table not legible for specific values, but indicates compliance]."
Comparison Table: "Materials: Titanium alloy" and "Synergy™ Spinal System: SAME" (indicating equivalence). |
| Indications for Use | Equivalence in indications for use to the predicate device. | The device "has been determined... substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".
Comparison Table: "Indications for Use: SAME" as Synergy™ Spinal System. |
| Sterility | Supplied "NON-STERILE" with a recommended sterilization process (high-temperature steam) that will achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶. | "The HAIDER-UCR Spinal System is supplied 'NON-STERILE' and must be sterilized prior to use. The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10⁶. The validated cycle is: Method: Steam Cycle: Gravity Temperature: 270°F (125°C) Exposure Time: 15 minutes."
Comparison Table: "Sterile: Supplied Non-sterile Autoclave processed by end user" and "Synergy™ Spinal System: SAME". |
| Design / Components | Equivalence in design (Rod, sacral screw, pedicle screw & cross-link system) and sizes (rods, pedicular screws) to the predicate device. | Comparison Table: "Design: Rod, sacral screw, pedicle screw & cross link system" and "Synergy™ Spinal System: SAME".
"Sizes: Rods: 5.5mm dia. X 40-305mm length Pedicular screws 7.0mm 35mm, 40mm, 45mm" and "Synergy™ Spinal System: EQUIVALENT". |
| Regulatory Compliance | Compliance with general controls and special controls (material standards, mechanical testing standard, biocompatibility standard, specified labeling requirements) for pedicle screw spinal systems. | The FDA's 510(k) clearance indicates compliance: "You may, therefore, market the device, subject to the general control provisions of the Act... If your device is classified... into... class II (Special Controls)... it may be subject to such additional controls." The document lists special controls that apply and states IAME, INC. meets appropriate general controls. |
2. Sample size used for the test set and the data provenance
- Sample size for test set:
- For mechanical testing (ASTM F-1717-96): "Seven constructs were tested" for cyclic fatigue. The number of samples for static tests (compression bending, tension bending, torsion) is not explicitly stated, but it mentions "All samples were tested." In the context of ASTM F1717, typically a minimum of 6 samples per test condition are recommended.
- Data provenance: The data is generated from in vitro mechanical testing performed by the manufacturer, INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. The country of origin for the data is implicitly the USA, where the company and the FDA are located. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission, rather than being collected retrospectively from a pre-existing dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a mechanical implant device. The "ground truth" for its performance is established through adherence to engineering standards (ASTM F-1717-96) measuring physical properties, not by expert interpretation of clinical data or images.
4. Adjudication method for the test set
- Not Applicable. As per point 3, there is no expert interpretation or "ground truth" in the sense of clinical assessment requiring adjudication. The compliance is assessed by comparing measured mechanical properties against standard requirements.
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 is not an AI/software medical device. No human-in-the-loop studies or AI assistance are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/software medical device.
7. The type of ground truth used
- Engineering Standards and Predicate Device Equivalence: The "ground truth" is defined by the requirements of recognized engineering standards (e.g., ASTM F-1717-96) for mechanical performance and the established performance and safety profile of the legally marketed predicate device (Synergy™ Spinal System). For materials, it's compliance with material composition standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/software medical device for which a "training set" in the machine learning sense would be used. The design and manufacturing processes are informed by established engineering principles and prior knowledge from the predicate device and similar implants.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no "training set" in this context. The "truth" for developing such a device relies on decades of biomedical engineering research, material science, surgical experience, and regulatory guidance for spinal implants.
§ 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.