(29 days)
The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radio graphic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI PEEK SA ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the surgeon choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use inthe lumbar spine must be used. Supplemental fixation, cleared by the FDA for use inthe lumbosacral spine, must be used with implants ≥ 20°.
The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System consists of PEEK cages, titanium screws, and a titanium cover plate. The KMTI PEEK SA ALIF System cages are intended to be used with the bone screws, the anterior cover plate assembly (cover plate), and do not require supplementary fixation systems unless less than four bone screws are utilized or cage lordosis is ≥20°. The screws protrude through the interbody portion of the cage implant and stabilize the vertebral body while preventing expulsion of the cage implant. The KMTI PEEK SA ALIF System offers hexalobe drive with both fixed and variable angle screw options. The fixed angle screw option provides a tighter fit with the cage than the variable angle screws while the variable angle screw option provides more clearance between the screw than the fixed screw, which allows for a small amount of screw angulation. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. The cover plate assembly and screw are part of the implant construct.
The KMTI PEEK SA ALIF System cages are available in a variety of sizes to suit the individual patient anatomical needs.
The purpose is to offer non-sterile packaging for cage sizes in the PEEK SA ALIF System (formerly S128 ALIF System) previously cleared for sterile packaging only.
The provided text is a 510(k) summary for the Kyocera Medical Technologies, Inc. PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through clinical studies or extensive standalone device performance testing.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given text, because the submission explicitly states:
"Performance testing was not required in this submission for the modifications proposed."
The primary purpose of this submission is to introduce non-sterile packaging for previously cleared cage sizes. The device's substantial equivalence is based on its technological characteristics being identical to the predicate device, not on new performance data demonstrating its effectiveness against predefined metrics.
However, I can extract what is implied regarding the "proof" of the device meeting its intended purpose for substantial equivalence based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission focused on substantial equivalence and minor modifications (non-sterile packaging), the "acceptance criteria" are implied by the features demonstrated to be identical to the predicate device. "Device performance" in this context refers to the demonstration of these identical characteristics.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Identical Indications for Use | Identical to predicate device |
| Identical Principle of Operation | Identical to predicate device |
| Identical Structural Support Mechanism | Identical to predicate device |
| Identical Materials of Manufacture | Identical to predicate device |
| Identical Sizes | Identical to predicate device |
| Sterilization validated for new packaging | Validated according to ISO 17665-1 |
2. Sample sized 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: Not applicable in the context of performance testing for this submission as "Performance testing was not required." The comparison is based on the inherent design and materials of the device being identical to the predicate.
- Data Provenance: Not applicable for performance testing. The "data" pertains to the specifications and design files of the device itself and its predicate.
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. No "ground truth" establishment by experts for a test set was required for this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance test set requiring adjudication was performed.
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 device is a physical intervertebral body fusion system, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical intervertebral body fusion system, not an algorithm. The "standalone" aspect mentioned in the Indications for Use ("The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation") refers to its mechanical functionality as an implant, not standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance data requiring "ground truth" was generated for this submission. The "truth" for substantial equivalence is based on the objective technological characteristics being identical to the predicate.
8. The sample size for the training set
Not applicable. No machine learning or AI model was developed or trained for this submission.
9. How the ground truth for the training set was established
Not applicable. No machine learning or AI model was developed or trained for this submission.
Summary of "Proof" in this 510(k) Submission:
The "proof" in this document is not derived from clinical trials, observational studies, or performance testing against specific acceptance criteria. Instead, the proof that the device "meets the acceptance criteria" (in the context of a 510(k) for substantial equivalence with minor changes) is based on the following:
- Demonstration of Identical Technological Characteristics: The submission explicitly states, "The subject and predicate have identical technological characteristics. There are no differences between the subject and predicate devices that raise questions regarding the safety and effectiveness of the subject device." This is the core "proof."
- Validation for Sterilization Changes: For the minor modification of non-sterile packaging, the submission states, "Changes in sterilization were validated according to ISO 17665-1." This ensures that the new packaging method meets international standards for sterilization processes, thereby addressing any potential safety concerns related to the change.
In essence, the device is considered to "meet acceptance criteria" because it is fundamentally the same device as one already cleared by the FDA (the predicate), with a validated change to its packaging.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.