(88 days)
The PASS OCT spinal system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT spinal system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.
The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.
The purpose of this submission is to add Patient Specific, UNiD OCT rods. The Patient Specific Rod is a rod bent before surgery by MEDICREA, following the design defined by the surgeon only specific to a unique patient.
The provided document is a 510(k) summary for a medical device called "PASS OCT Patient Specific Rods." This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing studies to meet specific acceptance criteria in the manner one might find for a novel AI/software product. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert qualifications, and specific study designs (like MRMC or standalone performance) is not applicable or not present in this type of submission.
However, I can extract the information that is present and indicate where the requested details are not provided.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Evaluation: |
- Static Compression
- Dynamic Compression
- Static Torsion
- Dynamic Torsion | Met:
- Mechanically evaluated following ASTM F2706-08.
- Conducted on a justified worst case.
- IMPLICITLY met, as the submission concludes substantial equivalence based on these tests. The document does not provide specific numerical outcomes (e.g., maximum load, cycles to failure) or pass/fail thresholds, but states these tests were performed and support the equivalence claim. |
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 for test set: The document states that "the mechanical test was conducted on a justified worst case." This implies that a limited number of samples (perhaps one or a few representing the worst case) were tested to demonstrate mechanical properties. It does not specify the exact number of samples.
- Data provenance: Not specified in the document.
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/Not provided. This submission is for a physical medical device (spinal rods) and relies on mechanical testing standards, not clinical assessments by experts for "ground truth" in the context of image analysis or diagnostic algorithms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is not relevant for mechanical testing of spinal rods.
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 is a submission for a physical medical implant (spinal rods), not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is not relevant for a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical (mechanical) tests, the "ground truth" is adherence to ASTM F2706-08 standards for static and dynamic compression and torsion. The device's performance is compared against the expected behavior as defined by these engineering standards.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/software product that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/software product that requires a training set or ground truth in that context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and predicate device designs.
Summary of Study (Non-Clinical Test Summary):
- Study Type: Non-clinical mechanical evaluation.
- Purpose: To demonstrate that the PASS OCT Patient Specific Rods are technologically similar and perform comparably to predicate devices in terms of mechanical safety.
- Methods: Static and dynamic compression tests and static and dynamic torsion tests were performed. These tests followed the ASTM F2706-08 standard.
- Test Cases: The tests were conducted on a "justified worst case" configuration of the device.
- Conclusion: Based on these mechanical tests, the components were concluded to be substantially equivalent to legally marketed predicate devices, implying they met the performance expectations outlined in the standard for safety and effectiveness.
- Clinical Data: The document explicitly states that "Published literature was used to demonstrate substantial equivalence," meaning no new clinical studies were conducted for this 510(k) submission.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.