(193 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 junction, the cervical 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 rods 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 provided document is a 510(k) premarket notification for a medical device called the "PASS OCT Spinal System." This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as one might find for novel drug or high-risk device approvals.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment is largely not present in this type of FDA submission. The provided text primarily addresses material specifications, intended use, and comparison to predicate devices, along with some mechanical testing information.
Here's an attempt to answer your questions based only on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for the device itself or reported performance outcomes in terms of clinical efficacy or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the same implicit performance standards.
The only "performance" mentioned is in the "Non-clinical Test Summary":
| Acceptance Criteria (Implicit) | Reported Device Performance (as tested) |
|---|---|
| Mechanical integrity under dynamic compression, conforming to ASTM F2706-08 | "mechanically evaluated in dynamic compression tests following the ASTM F2706-08." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For the non-clinical mechanical testing, the sample size is not specified. The provenance is also not specified, beyond the fact that Medicrea International S.A. is based in France. This was a non-clinical, in-vitro test, not human data.
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)
This is not applicable as the described "study" is a non-clinical mechanical test, not a study involving human subjects or requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the described "study" is a non-clinical mechanical test that does not involve expert adjudication.
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
The document explicitly states: "No reference devices were used in this submission." and later, under "8. Clinical Test Summary": "Published literature was used to demonstrate substantial equivalence." This indicates that neither a clinical trial nor an MRMC study was conducted by the applicant for this submission. The device is a spinal implant, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a spinal implant, not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance requirements outlined in the ASTM F2706-08 standard. It's a pass/fail against established mechanical properties, not a biological or clinical ground truth.
8. The sample size for the training set
This is not applicable. No training set is mentioned as this is a medical device approval and not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable. No training set is mentioned.
Summary of what is available from the document regarding acceptance criteria and studies:
- Acceptance Criteria for Device (Implicit): Substantial equivalence to predicate spinal systems (Vertex Reconstruction System, Virage OCT Spinal Fixation System, and a previous version of the PASS OCT Spinal System). This implies meeting the safety and performance characteristics of those already cleared devices.
- Specific Performance Criterion (Mechanical): Conformity to ASTM F2706-08 for dynamic compression tests.
- Study: A non-clinical, in-vitro mechanical evaluation.
- Sample Size (Mechanical Test): Not specified.
- Clinical Data: No new clinical studies were conducted by the applicant. Substantial equivalence was demonstrated through comparison to legally marketed predicate devices and reliance on published literature (though the specific literature isn't detailed).
§ 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.