The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

Device Description

The Blackstone™ Spinal Fixation System is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Blackstone™ Spinal Fixution System consists of an assortment of screws, rods, and cross-connectors with are all new implant offerings specific to this system.

AI/ML Overview

This document describes a 510(k) submission for the Blackstone™ Spinal Fixation System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, the information requested in your prompt regarding acceptance criteria, specific studies proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device is not applicable in this context.

Here's why and what the document does provide:

Acceptance Criteria and Reported Device Performance: Not applicable. The submission is based on substantial equivalence. The "performance" is considered equivalent to the predicate device.
Sample Size, Data Provenance: Not applicable. No new clinical studies were conducted to generate performance data for this submission.
Number of Experts, Qualifications: Not applicable. No new ground truth needed to be established for a performance study.
Adjudication Method: Not applicable.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone Performance Study: Not applicable.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires training data.
How Ground Truth for Training Set was Established: Not applicable.

What the document does provide regarding "performance" and "equivalence":

The core of this 510(k) submission is the demonstration of substantial equivalence to existing, legally marketed devices.

Predicate Devices Identified:
- DePuy Moss Miami Spinal System
- Moss Miami Spinal System - 6.0 System
Basis of Substantial Equivalence: "The Blackstone™Spinal Fixation System by its very nature is substantially equivalent to the DePuy Motech Moss Miami Spinal Systems which have been cleared by FDA for certain anterior and pedicle fixation use indications."

This means that Blackstone Medical, Inc. did not need to perform new clinical trials demonstrating the performance of their device against specific acceptance criteria. Instead, they showed that their device is similar enough in terms of intended use, design, materials, and technological characteristics to devices that have already been cleared by the FDA. The FDA, by clearing the 510(k), concurred that the device is substantially equivalent to the predicate.

Summary

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FEB 2 8 2000

K994217

$1000 SUMMARY OF SAFETY AND EFFECTIVENTSS

Blackstone™ Mcdical, Inc. 90 Brookdalc Drive Springfield, MA 01104

Name of Firm:	Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104
510(k) Contact:	Alan LombardoDirector of Engineering
Trade Name:	Blackstone™ Spinal Fixation System
Common Name:	Rod and screw spinal instrumentation
Device Product Code& Classification:	MNH 888.3070 - Spondylolisthesis SpinalFixation Device SystemKWQ 888.3060 - Spinal Intervertebral Body FixationOrthosisMNI 888.3070 - Pedicle Screw Spinal System
SubstantiallyEquivalent Devices:	DePuy Moss Miami Spinal SystemMoss Miami Spinal System - 6.0 System

Device Description:

The Bluckstone™ Spinal Fixation System is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Blackstone™ Spinal Fixution System consists of an assortment of screws, rods, and cross-connectors with are all new implant offerings specific to this system.

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1199 4217

Intended Usc / Indications for Use:

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

a} Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (1,3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.

a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
c) Kyphosis:
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stemosis:
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis:
f) Tumor;
g) Trauma (i.c., fracture or dislocation);
h) Previous failed fusion.

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16994217

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™Spinal Fixation System by its very nature is substantially equivalent to the DePuy Motech Moss Miami Spinal Systems which have been cleared by FDA for certain anterior and pedicle fixation use indications.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight.

FEB 2 8 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Lombardo Director, Engineering Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K994217

Trade Name: BlackstonerM Spinal Fixation System Regulatory Class: II Product Code: KWO, MNH and MNI Dated: December 10, 1999 Received: December 15, 1999

Dear Mr. Lombardo:

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 control provisions of the Act. The general control 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 - Mr. Alan Lombardo

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,

Russell Vayen

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pg 1 of 2

510(k) Number:

Device Name: Blackstone™ Spinal Fixation System

Indications for Use:

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
o) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spiral segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spinc:

a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
Spinal tumor; and টি
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

h) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
a) Spinal stenosis;
b) Spondylolisthesis;
c) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
d) Pseudarthrosis;

Prescription Use J (Per 21 CFR 801.109)

Page (Division Sign-Off)
REDivision of General Restorative Devices
510(k) Number K99417

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c) Tumor;
Trauma (i.e., fracture or dislocation); f)
g) Previous failed fusion.

Concurrence of CDRH, Office of device Evaluation

Prescription Use

(Per 21 CFR801.109

Over-The-Counter Use

Russell Jayne

(Division Sign-Off)
Consion of General Restorative Devices
5 । O(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.