The Endius TiTLE 2® Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Endius TiTLE 2° Poly Axial Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Endius TiTLE 2® Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius TiTLE 2® Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

The Endius TiTLE 2® Poly Axial Spinal System can also be linked to the Minit Posterior Cervical and Upper Thoracic Fixation System.

Device Description

The proposed Endius TiTLE 2% Poly Axial Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.

AI/ML Overview

This document is a 510(k) summary for the Endius TiTLE 2® Poly Axial Spinal System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new, unproven device. Therefore, much of the requested information about acceptance criteria and study details for a new device's performance will not be found.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or device performance metrics as would be expected for a novel AI/software device. Instead, the "performance" described is in the context of demonstrating substantial equivalence to an existing predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (Endius TiTLE 2® Poly Axial Spinal System, K072840)	"Documentation, including mechanical test results, has been provided which demonstrate that the proposed Endius TiTLE 2® Poly Axial Spinal System components are substantially equivalent to the existing Endius TiTLE 2® Poly Axial Spinal System, K072840." (Section 5.6)
Materials Compliance	"The system is manufactured from titanium which complies with ASTM F136." (Section 5.5.1)
Intended Use and Indications	The Indications for Use section outlines the specific conditions and spinal regions for which the device is intended, mirroring or being a small extension of the predicate device's indications. The FDA letter confirms the device is equivalent "for the indications for use stated in the enclosure."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The substantial equivalence argument relies on "mechanical test results" and documentation, not on clinical data or a "test set" of patient data in the sense of an AI/software study.

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 information is not applicable/not provided. The assessment is based on mechanical testing and comparison to an existing device, not on expert-adjudicated ground truth for a clinical dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There is no mention of a test set requiring adjudication in the context of human expert review.

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

This information is not applicable/not provided. This is a 510(k) submission for a physical medical device (spinal system), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would have been performed or required for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/not provided. This device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the performance and safety established for the predicate device (Endius TiTLE 2® Poly Axial Spinal System, K072840) and the demonstrated equivalence of the modified device to that predicate through mechanical testing and material compliance. There isn't a "ground truth" derived from patient-specific data, pathology, or outcomes in the way one would describe for a diagnostic or prognostic medical device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

Summary of Device and Evidence:

The Endius TiTLE 2® Poly Axial Spinal System is a physical medical device (spinal fixation system) seeking 510(k) clearance by demonstrating substantial equivalence to a previously cleared device (Endius TiTLE 2® Poly Axial Spinal System, K072840). The primary evidence for this claim comes from:

Mechanical test results: These tests would compare the physical properties and performance (e.g., strength, fatigue life) of the new components to the predicate device to ensure they perform equivalently.
Material compliance: The device is manufactured from titanium that complies with ASTM F136, a standard for implantable materials.
Indications for Use comparison: The indications for the new device are consistent with or a minor modification of those for the predicate device.

The 510(k) process for such a device does not typically involve clinical studies with human participants comparing device performance against "ground truth" established by experts, nor does it involve AI algorithms with training and test sets.

Summary

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Endius, Inc. Endius TiTLE 2 Poly Axial Spinal System December 12, 2007 Section 5 - 510(k) Summary

Premarket Notification: Traditional 510(k)

:上一【】

5.1 Statement

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Endius, Inc. chooses to submit a summary of information respecting safety and effectiveness. According to $513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the modified device, Endius TiTLE 26 Poly Axial Spinal System is provided below.

5.2 Submitter

Endius, Inc. 23 West Bacon Street Plainville, MA. 02762 Establishment Registration #: 1057469

5.3 Company Contact

Regina Wagner Manager, Regulatory Affairs/Quality Assurance (508) 643-0983 x107 Regina.wagner(a)zimmer.com

5.4 Device Name

Proprietary Name: Endius TiTLE 28 Poly Axial Spinal System Common Name: Pedicle Screw System, Non-pedicle spinal fixation system Classification Name: Posterior, Noncervical, Nonpedicle System (KWP) Noncervical, Pedicle System (MNH, MNI, NKB) Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulatory Class: III *

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Endius, Inc. Endius TiTLE 2 Poly Axial Spinal System December 12, 2007 5.5 Predicate Devices

Device Name(s) & 510(k) Number: Endius TiTLE 20 Poly Axial Spinal System, K072840.

Device Description રે રેં. I

5.5.2 Device Indications and Intended Use

The Endius TiTLE 20 Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Endius TiTLE 20 Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius TiTLE 20 Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

5.6 Substantial Equivalence

Documentation, including mechanical test results, has been provided which demonstrate that the proposed Endius TiTLE 2® Poly Axial Spinal System components are substantially equivalent to the existing Endius TiTLE 2® Poly Axial Spinal System, K072840.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 11 2008

Endius, Inc. % Ms. Regina Wagner Manager, Regulatory Affairs/Quality Assurance 23 West Bacon Street Plainville, MA, 02762

Re: K073510

Trade/Device Name: Endius TiTle 2® Polyaxial Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI, KWP Dated: December 12, 2007 Received: December 26, 2007

Dear Ms. Wagner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Regina Wagner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Endius, Inc. Endius TiTLE 2® Poly Axial Spinal System December 12, 2007

Indications for Use

510(k) Number (if known): K07xxxx

Device Name: Endius TiTLE 2® Polyaxial Spinal System

Indications For Use:

The Endius TiTLE 2® Poly Axial Spinal System can also be linked to the Minit Posterior Cervical and Upper Thoracic Fixation System.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Page 1 of 1
	000010

510(k) Number	K073510
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Regulation Number and Section

§ 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.