(119 days)
The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine. All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI). The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 – 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update.
This FDA 510(k) summary for the Endoskeleton® TCS Interbody Fusion Device (K151596) deals with a minor modification to an already cleared device (predicate device K142940). Therefore, the provided text does not contain the detailed information typically found in a new device's acceptance criteria and study report.
Specifically, this document describes a modification to the hex size of the screws used with the device and a slight change in the screw heights. It argues for substantial equivalence to the predicate device without conducting new performance studies for these modifications, relying instead on an "engineering rationale."
Therefore, for this particular submission (K151596), many of the requested sections about acceptance criteria and study details cannot be fully answered. This document provides an engineering rationale for why these minor changes do not impact safety and effectiveness, rather than reporting on new performance studies.
Here's a breakdown based on the provided text, indicating where information is present and where it is explicitly stated as not applicable due to the nature of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or new reported device performance for K151596 because it's a modification to an already cleared device. The manufacturer states that the modifications (hex size and screw height) do not impact the overall function, and thus, no new performance testing was deemed necessary. The "reported device performance" is essentially that the modified device performs equivalently to the predicate device based on engineering rationale.
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. No new test set or data provenance is mentioned for K151596 as no new performance studies were conducted for this specific modification. The submission relies on the prior clearance (K142940) for such information.
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 new test set requiring expert ground truth establishment was created for K151596 since no new performance studies were conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned for K151596 as no new test set needing adjudication was generated.
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 an interbody fusion device, which is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant to this type of medical device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical implant, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for K151596 as no new performance studies were conducted. The substantial equivalence argument rests on the predicate device's prior approval.
8. The sample size for the training set
Not applicable. This is a physical implant, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set or ground truth for a training set for this physical medical device.
§ 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.