The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
1. spondylolisthesis,
1. trauma (i.e., fracture or dislocation),
spinal stenosis, 4)
1. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
1. tumor,
1. pseudoarthrosis, and
1. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

Device Description

The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion. It indicates that the submission is for an expansion of a previously cleared system, focusing on adding new non-pedicle components (Hooks and Iliac Connectors). Therefore, the "device" in question refers to these additional components for the existing Firebird Spinal Fixation System.

It's important to note that this is a 510(k) submission, which typically demonstrates substantial equivalence to a predicate device rather than independent proof of safety and effectiveness through a clinical trial with specific performance criteria for AI/software-as-a-medical-device. The "performance data" here refers to mechanical testing for the new components.

Here's an analysis based on the provided text, recognizing the context of a spinal implant device and not an AI/software device:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance Equivalent to Predicate Device	- Static compression bending, static torsion, and dynamic compression bending were conducted. - Results were compared to the predicate Firebird systems when used for the same intended use of iliac fixation.
No New Issues of Safety or Effectiveness	- The mechanical evaluations addressed technical differences. - "These differences do not present any new issues of safety or effectiveness."
Substantial Equivalence to Predicate Devices	- The expanded system has the "same intended use and similar indications, technological characteristics and principles of operation" as its predicate systems. - The device was granted 510(k) clearance due to substantial equivalence (K093926).

Explanation of "Acceptance Criteria" for this device:

For spinal fixation systems like this, acceptance criteria in a 510(k) context are typically demonstrated through:

Mechanical Testing: Showing that the new components meet established standards for strength, durability, and resistance to wear, and perform comparably to legally marketed predicate devices. The document specifically mentions static compression bending, static torsion, and dynamic compression bending.
Biocompatibility: (Though not explicitly detailed in this summary, it's an inherent requirement for implantable devices.)
Design Rationale & Risk Analysis: Demonstrating that the design is appropriate for its intended use and that potential risks have been mitigated.
Demonstration of Substantial Equivalence: The overarching goal of a 510(k) is to prove the device is as safe and effective as a legally marketed predicate device.

2. Sample Size for Test Set and Data Provenance

This document describes mechanical testing of physical implants, not a clinical study involving a "test set" of patients or data in the way an AI/software device would. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission. Mechanical tests would use a certain number of device components but this is not specified as a "sample size" in this document.

3. Number of Experts and Qualifications for Ground Truth

Again, this is a mechanical device submission, not an AI/software device. There were no experts used to establish "ground truth" in the clinical sense for a test set. The "ground truth" for mechanical testing is derived from established engineering standards and comparison to predicate device performance data (often from similar mechanical tests or published data).

4. Adjudication Method

Not applicable. There was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission is for a physical spinal implant, not an AI/software device that would assist human readers in diagnosis or analysis.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device; there is no algorithm or standalone software performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this device's performance demonstration relies on:

Engineering Standards: Established international and national standards for spinal implant mechanical testing.
Predicate Device Performance Data: Mechanical test results from the identified predicate devices (e.g., Firebird Spinal Fixation System Cobalt-Chrome Rods, Blackstone Pedicle Screw System, Synthes Universal Spine System, DePuy Acromed systems). The performance of the new components must demonstrate equivalence to these established predicate devices.

8. Sample Size for the Training Set

Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

{0}------------------------------------------------

K093926, Page 1 of 3

Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion

510(k) SUMMARY

Blackstone Medical, Inc. Expanded Firebird Spinal Fixation System

Date:	7-23-2010	JUL 2 8 2010
Sponsor:	Blackstone Medical, Inc.1211 Hamburg TurnpikeSuite 300Wayne, NJ 07470
Registration Number:	3004606875
Contact Person:	Russell JohnsonRegulatory Affairs
Telephone Number:Fax Number:Email:	214-937-2000800-445-1923russelljohnson@orthofix.com
Submitter:	Martin G. SprunckRegulatory Affairs Manager
Manufacturer:	Orthofix, Inc.1720 Bray Central Dr.McKinney, TX 75069
Registration Number:	2183449
Contract Manufacturers:	Pulse Technologies2000 AM DriveQuakertown, PA 18951Structure Medical, Inc.2975 S. Horseshoe Dr., Suite 400Naples, FL 34104Accellent, Inc.6500 Zane Avenue North, Suite 105

Brooklyn Park, MN 55429

Firebird Spinal Fixation System Additions – 510(k) Summary Page 1 of 3

{1}------------------------------------------------

K093926 Page 2 of 3

Trade Name:	Firebird Spinal Fixation System
Product Code:	NKB - Orthosis, Spinal Pedicle Fixation, for DegenerativeDisc Disease
Subsequent Product Codes:	MNI – Orthosis, Spinal Pedicle FixationMNH - Orthosis, Spondylolisthesis Spinal FixationKWP - Appliance, Fixation, Spinal Interlaminal
Common Name:	Posterior Thoracolumbar/Iliosacral System
Regulatory Classification:	Class III preamendment Device, 888.3070 - Pedicle ScrewSpinal System - *Class III Summary andCertification RequiredClass II – 888.3070 – Pedicle Screw Spinal SystemClass II - 888.3050 - Spinal Interlaminal Fixation Orthosis
Review Panel:	Orthopedic Device Panel
Predicate Devices:	• Firebird Spinal Fixation System, Cobalt-Chrome Rods(K092624 SE 9-25-09)• Blackstone Pedicle Screw System, 4.0 mm Screws(K082797 SE 10-17-08)• Blackstone Pedicle Screw System (K081684 SE 9-15-08)• Blackstone Medical, Inc. Spinal Fixation System (SFS),represented by that system's most recent premarketnotification, K080407 SE 3-13-08• Synthes Universal Spine System Iliosacral/PolyaxialSystem (K082572 SE 11-24-08)• DePuy Acromed Moss Miami Spinal System (K030383SE 2-26-2010)• DePuy Acromed Isola System (K993030 SE 12/29/1999)• DePuy Acromed Monarch Spine System (K024348 SE1/28/2003)

Intended Use / Indications for Use

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
  Firebird Spinal Fixation System Additions – 510(k) Summary Page 2 of 3

{2}------------------------------------------------

Page 3 of 3 K093926

1. spondylolisthesis,
1. trauma (i.e., fracture or dislocation),
spinal stenosis, 4)
1. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
1. tumor,
1. pseudoarthrosis, and
1. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or $2 spinal level.

The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

Technological Characteristics

The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.

Performance Data

Evaluations of the proposed components for addition to the Firebird Spinal Fixation System were conducted and demonstrate that the expanded system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

Static compression bending, static torsion, and dynamic compression bending were conducted and results were compared to the predicate Firebird systems when used for the same intended use of iliac fixation.

Substantial Equivalence

The expanded Firebird Spinal Fixation System and its predicate systems have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the proposed component and their predicates are technical characteristics that have been addressed by mechanical evaluations. These differences do not present any new issues of safety or effectiveness, therefore, the expanded system is substantially equivalent to its predicate systems.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized eagle-like symbol. The text is arranged in a circular fashion around the symbol. The symbol itself is composed of three curved lines that resemble a bird in flight.

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

JUL 2 8 2000

Blackstone Medical, Inc. % Mr. Russell Johnson 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

Re: K093926

Trade/Device Name: Firebird Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: July 07, 2010 Received: July 08, 2010

Dear Mr. Johnson:

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 misJeading.

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

{4}------------------------------------------------

Page 2 - Mr. Russell Johnson

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Raibarg Buclus

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

Enclosure

{5}------------------------------------------------

K093926

Premarket Notification 510(k Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion Confidential

Indications for Use Statement

510(k) Number (if known): ___ K093926

JUL 2 8 2010

System Name: Firebird Spinal Fixation System Device Name: Non-Pedicle Components

Indications for Use:

I) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
1. spondylolisthesis,
1. trauma (i.e., fracture or dislocation),
1. spinal stenosis,
1. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
1. tumor.
1. pseudoarthrosis, and
1. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of of 1

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

K093926 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.