When used as a pedicle screw fixation system, the Eisertech Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment

1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

The Eisertech Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Eisertech Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies)

1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthrosis
1. Tumor resection and/or
1. Failed previous fusion

Device Description

The Eisertech Spinal System consists of a variety of polyaxial screws, rods, hooks, locking nuts, and rod-to-rod connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. All components are made of titanium allow per ASTM F136.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the "Spinal System" device by Eisertech, LLC. It outlines the regulatory classification, indications for use, and a summary of non-clinical tests conducted to establish substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present acceptance criteria in a tabular format as performance metrics for a diagnostic or AI device. Instead, it details mechanical testing performed on the Spinal System to demonstrate its safety and effectiveness relative to a legally marketed predicate device.

Acceptance Criteria (Implied from Mechanical Testing Standards):

Acceptance Criteria Category	Specific Test / Standard	Acceptance Outcome (Reported Device Performance)
Static Strength - Bending	ASTM F1717 - Static Compression Bending	Device passed, demonstrating substantial equivalence to the predicate.
Static Strength - Torsion	ASTM F1717 - Static Torsion	Device passed, demonstrating substantial equivalence to the predicate.
Dynamic Strength - Bending	ASTM F1717 - Dynamic Compression Bending	Device passed, demonstrating substantial equivalence to the predicate.
Interconnection Strength - Pull-off	(Not a specific ASTM F1717 component, but a custom test for tulip/screw shank)	Device passed, demonstrating substantial equivalence to the predicate.
Interconnection Strength - Static Torsion	(Custom test for tulip/screw shank)	Device passed, demonstrating substantial equivalence to the predicate.
Interconnection Strength - Dynamic Torsion	(Custom test for tulip/screw shank)	Device passed, demonstrating substantial equivalence 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)

The document refers to mechanical testing of a physical device, not a test set of data. Therefore, concepts like sample size for a test set of data, country of origin, or retrospective/prospective data provenance are not applicable in this context. Mechanical testing typically involves a number of physical samples (e.g., individual screws, rods, or assembled constructs) to ensure statistical validity of the results, but the exact number of samples used for each mechanical test is not specified in this summary.

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 question is not applicable. The "ground truth" for a mechanical implant like the Spinal System is established by engineering standards and physical measurements, not by expert consensus on clinical images or data. The "experts" involved would be mechanical engineers and quality control personnel following established test protocols.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving interpretation (e.g., image reading). For mechanical testing, the results are derived from objective measurements against defined pass/fail criteria, not subjective interpretations requiring 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

This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Spinal System is a physical implant, not an AI diagnostic tool, so such a study would not be performed for this device.

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

This question is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention. The Spinal System is a physical medical device, not an algorithm, so this concept does not apply.

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

The "ground truth" for the mechanical performance of the Spinal System is based on:

Established engineering standards: Specifically, ASTM F1717 for static and dynamic testing of spinal implant constructs.
Physical measurements and defined tolerances: The device components and assembled constructs must meet specific strength, stiffness, and fatigue resistance criteria as outlined in the relevant ASTM standards or internal design specifications.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train an AI model. The Spinal System is a physical medical device, and its performance is evaluated through mechanical testing, not by training an algorithm.

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

This question is not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Febraury 26, 2015

Eisertech, LLC Mr. Lukas Eisermann Chief Executive Officer 13795 Blaisdell Place, Suite 102 Poway, California 92064

Re: K142576

Trade/Device Name: Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: January 27, 2015 Received: January 28, 2015

Dear Mr. Eisermann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142576

Device Name Spinal System

Indications for Use (Describe)

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment

1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

Degenerative disc disease (as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies)

1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthrosis
1. Tumor resection and/or
1. Failed previous fusion

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary:
A. Submitted by:
Date Prepared:	January 27, 2015
Company:	Eisertech, LLC13795 Blaisdell Place, Suite 102Poway, California 92064
Contact:	Lukas Eisermannlukas@eisertech.com888-262-2817x101
B. Device Name:
Trade Name:	Spinal System
Common Name:	Pedicle Screw System
Classification Name:	Spinal Pedicle Screw System, Spinal InterlaminalFixation Orthosis, Spinal Intervertebral BodyFixation orthosis.
Classification:	Class III
Regulation Number:	i. 21 CFR 888.3070 - Pedicle screw spinal systemii. 21 CFR 888.3060 - Spinal intervertebral body fixationorthosisiii. 21 CFR 888.3050 - Spinal interlaminal fixation orthosis
Product Code:	NKB, MNI, MNH, KWQ, KWP

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Eisertech, LLC believes that the Eisertech, LLC Spinal System is substantially equivalent to the primary predicate Interpore Cross International Synergy Spinal System (K984578).

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E. Intended Use

When used as a pedicle screw fixation system, the Eisertech Spinal System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Deqenerative spondylolisthesis with objective evidence of neurologic impairment

1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

The Eisertech Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Eisertech Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthrosis
1. Tumor resection and/or
1. Failed previous fusion

F. Comparison to Predicate Devices

The subject device has indications for use identical to those of its predicate, and employs the same principles of operations. TThe primary predicate is K984578.

G. Summary of Non-Clinical Tests

Mechanical testing was presented, including static compression bending, static torsion, and dynamic comprmession bending per ASTM F1717. The following addtional tests were performed to assess the interconnection strength of the tulip and screw shank: pull-off testing, static torsion, and dynamic torsion testing.

H. Conclusion of Non-Clinical Tests

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The mechanical testing demonstrated substantial equivalence to the predicate device.

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.