(30 days)
The Pallas M Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudarthrosis).
The Pallas M Spinal System consists of rods, screws, revision rod system, lilac rod system, MIS pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:
The provided 510(k) submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance testing. Instead, this submission relies on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested sections (2-9) related to a performance study will be marked as "Not Applicable" or "Not Provided" because such a study was not performed for this specific submission as stated in the document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit performance-based acceptance criteria are presented in this 510(k) summary. The basis for clearance is substantial equivalence to a predicate device, not meeting new performance criteria through testing. | No specific device performance data from testing is reported in this 510(k) summary. The submission states: "No additional testing for this 510(k) submission was performed." The substantial equivalence is based on design, materials, indications, intended use, packaging, and labeling being similar to the predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. No performance testing with a specific test set was conducted for this 510(k) submission.
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. No performance testing with expert-established ground truth was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No performance testing requiring adjudication was conducted for this 510(k) submission.
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 / Not Provided. This device is a pedicle screw spinal system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a pedicle screw spinal system, not an algorithm. No standalone performance evaluation was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. No performance testing requiring ground truth was conducted for this 510(k) submission.
8. The sample size for the training set
- Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm.
Summary of the Study (or lack thereof) to Prove Acceptance:
The Pallas M Spinal System obtained 510(k) clearance by demonstrating substantial equivalence to an existing legally marketed device, the "Pallas M Spinal System (Korea Bone Bank Co., Ltd.; K102574)".
The key points from the submission are:
- No additional testing was performed for this 510(k) submission. The device's safety and effectiveness were concluded by comparing its design, materials, indications for use, intended use, packaging, labeling, and performance to the predicate device.
- The difference between the subject device and the predicate device is limited to the addition of curved rods and new surgical instruments. The submission implies these minor differences do not alter the fundamental safety and effectiveness profile such that new performance testing would be required.
- The FDA's clearance is based on the determination that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the legally marketed device to which it is compared. This is a common pathway for medical device clearances where new performance data specific to the device being submitted is not always required if equivalence to an already cleared device can be sufficiently demonstrated.
§ 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.