The PASS LP Spinal System includes a pedicle 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 of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation 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 (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks, rods and sacral/iliac screws indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Device Description

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136

AI/ML Overview

Here's an analysis based on the provided text:

This document is a 510(k) summary for a medical device called the PASS LP Spinal System. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and clinical performance studies of the type described in the prompt. The provided text primarily focuses on comparing the new device to existing legally marketed predicate devices and outlining the mechanical testing performed.

Therefore, the requested information about acceptance criteria and studies demonstrating that the device (i.e., AI/software) meets these criteria cannot be fully extracted from this document, as it pertains to a mechanical spinal implant system, not a software device.

However, I can extract what is available regarding the mechanical aspects of the device and structure it to the best of my ability according to your request, while highlighting the absence of information relevant to software performance studies.

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

Acceptance Criteria (for spinal implant)	Reported Device Performance (from text)
Mechanical soundness, comparable to commercially available devices.	Mechanical tests such as static torsion, static and dynamic compression bending (according to ASTM F1717), static axial sliding, static torsion, and dynamic flexion/extension (according to ASTM F1798) have been performed.
	The purpose of these tests was "to indicate that the products are as mechanically sound as other devices commercially available."
Material conformity	Manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Geometric similarity	The new device and previously cleared PASS LP devices "have the same geometry."

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: Not specified for the mechanical tests.
Data Provenance: Not specified, but generally, mechanical testing is performed in a lab setting, not on patient data.

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. This information is for medical device software performance evaluations involving expert interpretation. The provided document describes mechanical testing of a spinal implant.

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

Not applicable. This information is for medical device software performance evaluations involving expert interpretation. The provided document describes mechanical testing of a spinal implant.

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

No MRMC study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a mechanical spinal implant, not an algorithm.

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

For the mechanical performance, the "ground truth" would be the standards set by ASTM (e.g., F1717, F1798) for mechanical properties and the ASTM F136 standard for titanium alloy material properties. The device's performance is compared against these engineering standards and to the performance of predicate devices.

8. The sample size for the training set

Not applicable. This document describes a mechanical implant, not a machine learning model that requires a training set.

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

Not applicable. As above, this is for a mechanical implant, not a machine learning model.

Summary of Device and Study:

The device is the PASS LP Spinal System, an orthopedic implant designed for spinal fixation. This 510(k) submission is for an "Additional components" to the already cleared system, specifically noting the "PASS MIS" product as having the same material and geometry as existing PASS LP devices, but with restrained indications for use.

The "study" or performance data presented focuses on mechanical testing:

Tests Performed: Static torsion, static and dynamic compression bending (per ASTM F1717), static axial sliding, static torsion, and dynamic flexion/extension (per ASTM F1798).
Purpose of Testing: To demonstrate that the additional components are "as mechanically sound as other devices commercially available."
Material Conformance: The device is manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The document does not contain information related to AI/software performance studies, human reader performance, or clinical efficacy trials beyond the statement that mechanical tests were performed to demonstrate mechanical soundness compared to predicates. The 510(k) clearance (K112493) confirms substantial equivalence to the predicate devices based on the information provided, including the mechanical testing.

Summary

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510(k) SUMMARY

1. GENERAL INFORMATION
Trade Name	PASS LP Spinal System
Common Name	✓ Posterior pedicle screw system✓ Hooks✓ Sacral plate
Classification Name	✓ orthosis, spinal pedicle fixation per MNI 888.3070✓ orthosis, spondylolisthesis spinal fixation per MNH 888.3070✓ appliance, fixation, spinal interlaminal per KWP 888.3050
Class	Class II
Product Code	MNI / MNH / KWP
CFR section	888.3070 / 888.3050
Device panel	Orthopedic
Legally marketed predicate devices	PASS LP Spinal System (MEDICREA) = K062136, K080099, K080822,K082577, K083308, K083810, K100297ISOLA (ACROMED) = K908485SYNERGY VLS (INTERPORE CROSS INTL) = K012871MOSS MIAMI (DEPUY) = K964024
Reason for Special 510(k)	Additional components
Submitter	MEDICREA International14 Porte du Grand Lyon01700 Neyron, France
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-Mail: ortho.medix@sbcglobal.net

2. PREDICATE DEVICE DESCRIPTION

3. DESCRIPTION OF DEVICE MODIFICATION

The purpose of this submission is to submit the new spinal system PASS MIS. This new device and PASS LP devices previously cleared in K062136, K080099, K080822, K082577, K083308, K083810 and K100297 are manufactured in the same material, titanium alloy (Ti-6Al-4V ELI), and have the same geometry. The only devices differences are PASS MIS indications for use restrained than PASS LP devices.

4. INTENDED USE

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sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

5. PERFORMANCE DATA

When applicable, mechanical tests such as static torsion, static and dynamic compression bending, (according to ASTM F1717) static axial sliding, static torsion and dynamic flexion/extension (according to ASTM F1798) have been performed on the additional components to indicate that the products are as mechanically sound as other devices commercially available.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or bird-like figure, with three curved lines forming the body and wings.

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

MEDICREA International % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K112493

Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: October 24, 2011 Received: October 31, 2011

Dear Mr. Webb:

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

NOV 2 1 2011

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Page 2 - Mr. J.D. Webb

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.html

Sincerely yours,

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

Enclosure

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STATEMENT OF Indications for Use

510(k) Number (if known): K112493
Device Name: PASS LP Spinal System

PASS LP Spinal System Indications for Use

Prescription Use > (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices...

KII 244 3 510(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.