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.

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;
Spinal turnor: and f)
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-podicle 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:
Tumor; 1)
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

Device Description

The Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw 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 Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217, K013558 & K003735). The 4.5mm Multi-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217, K013558 & K003735).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw). It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.

This document focuses on regulatory approval based on substantial equivalence to existing devices, not on a study proving the device meets specific acceptance criteria through performance metrics. There is no performance data, clinical study, or technical acceptance criteria defined within this document. The FDA's 510(k) clearance process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and therefore does not raise new questions of safety and effectiveness.

Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.

Here's an assessment based on the provided text:

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

Not Applicable. This document does not define specific performance acceptance criteria (e.g., tensile strength, fatigue life,
etc.) beyond ensuring the device is substantially equivalent to predicates. No device performance metrics are reported.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. No test set or data provenance is mentioned. The submission is based on demonstrating substantial
equivalence, not on new performance testing 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. No ground truth establishment for a test set is described.

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

Not Applicable. No test set requiring adjudication is described.

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 device is a spinal fixation system, not an AI-assisted diagnostic tool.

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

Not Applicable. This device is a spinal fixation system, not an algorithm.

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

Not Applicable. The concept of "ground truth" as it applies to performance evaluation is not relevant here. The "truth" in this context is the safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable. No training set for an algorithm is mentioned or relevant to this device submission.

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

Not Applicable. No training set for an algorithm is mentioned or relevant.

Summary of what can be extracted from the document related to the "study":

Study Type: This is not a performance study in the traditional sense, but rather a Substantial Equivalence Demonstration as part of a 510(k) premarket notification.
"Acceptance Criteria": The primary "acceptance criterion" for this submission is that the device is substantially equivalent to legally marketed predicate devices.
"Device Performance": The document claims the device's performance is substantially equivalent to the predicates. Specific performance data (e.g., biomechanical testing results) are likely contained in other parts of the 510(k) submission, but not in this summary. The summary only asserts equivalency.
Predicate Devices: DePuy Motech Moss Miami Spinal System (K980477, K982320).
Basis of Substantial Equivalence: The Blackstone™ 4.5mm Multi-Axial Screw is stated to be "by its very nature" substantially equivalent to the predicate, implying similar materials, design principles, and intended use as described.

This document serves as a regulatory summary for a mechanical device, not a report on a clinical or AI performance study.

Summary

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APR 0 3 2002

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4. 5mm Multi-Axial Screw (System Addition)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Firm:	Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104
510(k) Contact:	Alan LombardoDirector of Engineering
Trade Name:	Blackstone™ Spinal Fixation System4.5mm Multi-Axial Screw (System Addition)
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 Motech Moss Miami Spinal System (K980477,K982320).

page 1 of 2

K020674#### Device Description:

Summary

Revision 1

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

page 2 of 2
K 020674

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (System Addition)

Intended Use / 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;
e) Kyphosis;
Spinal turnor: and f)
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-podicle 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:
Tumor; 1)
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ 4.5mm Multi-Axial Screw by its very nature is substantially equivalent to the DePuy Motech Moss Miami Spinal System (K980477, K982320) which has been cleared by FDA for certain anterior and pedicle fixation use indications.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 0 3 2002

Re: K020674

Trade/Device Name: Blackstone Spinal Fixation System 4.5mm Multi-Axial Screw Regulation Number: 21 CFR 888.3060, 21 CFR, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, spondylolisthesis spinal fixation device system, pedicle screw spinal system Regulatory Class: Class II Product Codes: KWO, MNH, MNI Dated: February 26, 2002 Received: March 1, 2002

Dear Mr. Lombardo:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 -- Mr. Alan Lombardo

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millkenen

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

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

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (System Addition)

510(k) Number: K020674

page 1 of 2

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:

Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; a)
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.

a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture:
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
Spinal tumor; and f)
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);

Mark n Mullever
(Division Sign-Off)

Summary

Division of General, Restorative and Neurological Devices

Revision 1

510(k) Number

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

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (System Addition)

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

page 2 of 2

Kodo674

Concurrence of CDRH, Office of device Evaluation

Prescription Use

(Per 21 CFR801.109

Over-The-Counter Use

Mark n Millerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020674

Revision 1

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.