The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

The subjects of this Special 510(k) submission are the addition of rod-plate components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

The rod-plates are similar to the rods as they consist of a short rod segment that has enlarged portions at the ends with holes to attach directly to the screws with hemispherical nuts rather than connecting the rod to the screw via a clamp. The proximal end is circular is shape with a circular hole, while the distal end is oval in shape with an oval opening that allows vertical variability of the distal screw placement. These components are offered in two versions (two or three holes) for one or two level instrumentation, each being available in two sizes, small and large. Rod-plates are present to match the lumbar lordosis.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

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

Acceptance Criteria	Reported Device Performance
Static compression testing according to ASTM F1717-96	Performed according to ASTM F1717-96
Fatigue compression testing according to ASTM F1717-96	Performed according to ASTM F1717-96

Explanation: The document explicitly states, "The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96." This indicates that the chosen acceptance criteria were specific engineering tests to demonstrate the mechanical integrity of the device, aligned with an established standard for spinal implant testing. The reported performance is simply that these tests were conducted as per the standard. There is no pass/fail metric or numerical result provided in this summary.

2. Sample size 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 specified. The document only mentions "static and fatigue compression testing of the PASS Spinal System," but does not provide details on the number of devices tested.
Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given that this is a 510(k) submission for mechanical components, the "data" would refer to laboratory test results.

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 section is not applicable to this device. This 510(k) pertains to a mechanical medical device (spinal system components), not an AI or diagnostic imaging device that requires interpretation by human experts to establish ground truth from medical images or clinical data. The "ground truth" here is the physical performance of the device under specific mechanical loads.

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

This section is not applicable to this device. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where there might be disagreement among experts. For mechanical testing, the results are typically quantitative measurements that do not require 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 section is not applicable to this device. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices, not for a mechanical spinal implant.

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

This section is not applicable to this device. This is a mechanical implant, not an algorithm.

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

The "ground truth" in this context is the mechanical performance of the device as measured by standardized engineering tests. Specifically, the performance under static and fatigue compression loading conditions, as defined and evaluated by ASTM F1717-96.

8. The sample size for the training set

This section is not applicable to this device. This is a mechanical implant, not an AI or machine learning model that requires a training set.

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

This section is not applicable to this device. As it's not an AI/ML device, there is no training set or ground truth established for one.

Summary

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OCT 2 4 2001

(2)

510(k) Summary of Safety and Effectiveness

(1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Common or usual name:

Encore Orthopedics, Inc. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Joanna Droege September 21, 2001

PASS Spinal System Pedicle screw spinal system Class II

(3) Legally marketed predicate device:
Trade or proprietary device name:

PASS Spinal System (K001024)

(4) Subject device description:
Classification name:

(5) Subject device intended use:

(6) Performance data:

The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96.

(7) Basis for substantial equivalence:

The Additional Components of the PASS Spinal System are equivalent to the other spinal systems commercially available that incorporate pedicle screws, rods, and crosslinking members, including the TTL Isobar Spinal System.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like figure with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Ms. Joanna Droege Regulatory/OA Engineer Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, Texas 78758

Re: K013191

Trade Name: PASS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH Dated: September 21, 2001 Received: September 24, 2001

Dear Ms. Droege:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Joanna Droege

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Milkeran

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __ K

Device Name: Additional Components to PASS Spinal System

Indications For Use:

Additional Components to PASS Spinal System

Indications For Use

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use per 21 CFR 801.109) (Optional Format 1-2-96) Division of General, Restorative and Neurological Devices 510(k) Number_

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.