The PASS LP Spinal System is a pedicle screw fixation system intended for 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. 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 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "OLYMPIC Posterior Spinal Fixation System" (K182239) and later references the "PASS LP Spinal System" (K182240). It appears that these are related or the K182240 is meant to be the direct subject of the 510(k) summary. I will answer based on the information provided for K182240, as that is where the performance data is detailed.

The document does not describe an acceptance criteria table with reported device performance for an AI/ML powered device. Instead, it details the substantial equivalence of a spinal fixation system to predicate devices based on biocompatibility and mechanical testing. The questions asked are typically relevant to the evaluation of AI/ML software.

However, I will extract the information that is present concerning performance testing for the spinal fixation system, even though it doesn't align with the AI/ML focus of the prompt's questions.

Here's the closest interpretation of the prompt's questions based on the provided text:

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

The document does not provide a formal "acceptance criteria" table with specific quantitative thresholds. Instead, it states that the performance data "indicate that the products are substantially equivalent as other devices commercially available."

Here's a table based on the types of tests performed and the general conclusions:

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility: Conformance to ISO 10993 and G95-1 (Implied: No adverse biological reactions)	Passed Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen Testing. Material conforms to ASTM F136 and ISO 5832-3.
Mechanical Testing: Conformance to ASTM F1717-15 (Implied: Mechanical strength equivalent to predicate devices)	Static axial compression, static torsion, and dynamic axial compression tests performed. Products are "substantially equivalent as other devices commercially available."

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: Not explicitly stated for either biocompatibility or mechanical testing. Biocompatibility tests are typically performed on material samples, and mechanical tests on a set number of device samples according to the standard.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For a spinal fixation system, ground truth (e.g., successful fusion, mechanical integrity) is established through standardized testing (biocompatibility, mechanical tests) rather than expert consensus on a test set.

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

Not applicable. Adjudication methods are typically for subjective assessments, which are not described here.

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 is not an AI-assisted device. The document explicitly states "No clinical studies were performed." and "No animal studies were performed."

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this device's performance is based on:

Standardized Material Properties: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy.
Standardized Biocompatibility Testing: Results of tests (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) against recognized international standards (ISO 10993).
Standardized Mechanical Testing: Performance against ASTM F1717-15 for static axial compression, static torsion, and dynamic axial compression. The implicit ground truth is that the device should meet or exceed the performance of predicate devices as outlined by these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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October 18, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Astura Medical, LLC Mr. Parker Kelch Quality Manager 3186 Lionshead Avenue, Suite 100 Carlsbad, California 92010

Re: K182239

Trade/Device Name: OLYMPIC Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, OLO Dated: August 17, 2018 Received: August 20, 2018

Dear Mr. Kelch:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Colin O'neill -S

for MNM

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) K182240

Device Name PASS LP Spinal System

Indications for Use (Describe)

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)

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K182240 Page 1 of 4

510(K) SUMMARY V.

The Company's 510(k) Summary is provided on the following pages.

DEVICE SUBMITTER a.

MEDICREA® INTERNATIONAL S.A. 5389, route de Strasbourg 69140 RILLIEUX-LA-PAPE - France

Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88

Contact Person: David RYAN VP Product Development and Marketing dryan@medicrea.com

Date Prepared: 08/16/2018

b. DEVICE

Name of Device: PASS LP Spinal System Common or Usual Name: Spinal Fixation System Classification Name:

Thoracolumbosacral pedicle screw system per NKB 888.3070 Regulatory Class: II Product Code: NKB, KWP

PREDICATE DEVICE ﻥ

Xia® 3 Spinal System, K170496 (Primary) EXPEDIUM® Spine System, K102249 (Additional) PASS LP Spinal System, K162786 (Additional)

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DEVICE DESCRIPTION d.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

INDICATIONS FOR USE e.

The PASS LP Spinal System is a pedicle screw fixation system intended for 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Indications For Use statement for the PASS LP Spinal System is identical to the predicate device. Both the subject and predicate device have the same intended use for the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE f. DEVICE

The table below compares the features and characteristics of the PASS LP Spinal System to its predicate device.

Device	StrykerCorporationXia® 3 SpinalSystem	DePuy Spine Inc.EXPEDIUM®Spine System	Medicrea®InternationalPASS LP SpinalSystem	Medicrea®InternationalPASS LP SpinalSystem'Dominoes &Iliac Connectors'
510(k) number	K170496	K102249	K162786	To bedetermined
Intended use	Immobilizationand stabilizationof spinalsegments inskeletally matureor pediatricpatients	Immobilizationand stabilizationof spinalsegments inskeletally matureor pediatricpatients	Immobilizationand stabilizationof spinalsegments inskeletally matureor pediatricpatients	Immobilizationand stabilizationof spinalsegments inskeletally matureor pediatricpatients
Components
Implants	- Dominoes- Iliac Connectors	- Dominoes- Iliac Connectors	- Dominoes- Iliac Connectors	- Dominoes- Iliac Connectors
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI

PERFORMANCE DATA 8.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the PASS LP system was conducted in accordance with the FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
ü Sensitization
ü Irritation
Systemic toxicity
Pyrogen Testing

According to the standard ISO 10993-1, the PASS LP Spinal System is defined as implantable

device in contact with tissue and bone and as a permanent contact with the patient.

For chemical composition, the material conforms toTi-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3.

Mechanical testing

According to the ASTM F1717-15, static axial compression, static torsion and dynamic axial compression tests have been performed on the new components and indicate that the products are substantially equivalent as other devices commercially available.

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K182240 Page 4 of 4

Clinical study

No clinical studies were performed.

Animal study

No animal studies were performed.

h. CONCLUSION

MEDICREA® INTERNATIONAL S.A. PASS LP and its new components are equivalent to its predicate device in terms of indications for use, material and function and substantially equivalent to its predicate device in terms of design.

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.