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.

The Blackstone Spinal Fixation System, when used for posterior 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 Posterior Hooks are 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 Blackstone™ Spinal Fixation System consists of an assortment of screws and rods, which have received 510k clearance (K994217 & 003735) (K013558 pending). The Posterior Hooks are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217 & 003735) (K013558 pending).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone™ Spinal Fixation System Posterior Hooks.

Important Note: The provided document is a 510(k) summary for a medical device (spinal fixation system posterior hooks) from 2002. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials or detailed performance studies as might be expected for an AI/software as a medical device (SaMD). Therefore, many of the typical elements requested in your prompt for validating an AI device (like sample size for test sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of filing.

The "acceptance criteria" here refer to the regulatory pathway for demonstrating that the new hooks are as safe and effective as a previously cleared device. The "study" isn't a traditional clinical trial but rather a comparison to an existing product.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Reasoning for Substantial Equivalence)
Safety and Effectiveness comparable to predicate device.	The Blackstone™ Spinal Fixation System Posterior Hooks are "by their very nature substantially equivalent to the Danek CD Horizon Spinal System (K981676)." This implies that the design, materials (titanium alloy), and intended use for spinal fixation are comparable, leading to similar safety and effectiveness profiles.
Material Composition comparable to predicate device.	The hooks are made of "titanium alloy," a commonly used material in spinal implants and presumably similar to the predicate device.
Intended Use/Indications for Use align with predicate device.	The document explicitly lists detailed indications for use, mirroring those typically accepted for such spinal fixation systems and found in the predicate device’s clearances. The new hooks are an "adjunct" and "fully interchangeable" with the existing Blackstone Spinal Fixation System components, which already had 510(k) clearance.
Mechanical/Biomechanical Performance (implied, not detailed).	While not detailed, achieving substantial equivalence suggests that any required mechanical testing (e.g., strength, fatigue) would demonstrate performance comparable to the predicate device. This is often part of the submission but not always summarized in the public 510(k) summary.
Sterilization and Single-Use capability.	Stated as "non-sterile, single use components," which is standard for such devices and would be consistent with the predicate.

Study Details (as applicable to a 510(k) for a device addition)

Sample size used for the test set and the data provenance:
- N/A. This is a 510(k) for an addition to an existing spinal fixation system. Substantial equivalence is demonstrated by comparing the new components (posterior hooks) to a predicate device (Danek CD Horizon Spinal System, K981676) and to the previously cleared Blackstone Spinal Fixation System components (K994217, 003735, K013558). No "test set" in the sense of a patient cohort or image dataset (as for AI) was used or described. The "data" refers to the technical specifications and indications of the predicate and existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth establishment by experts for a specific test set is not part of this type of 510(k) submission. The evaluation is based on regulatory review of technical documentation, materials, and intended use comparison.
Adjudication method for the test set:
- N/A. Not applicable, as there is no "test set" or adjudication process in this context.
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:
- N/A. This is a physical medical implant, not an AI or diagnostic device. MRMC studies are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in a 510(k) submission for a device like this is primarily the established safety and effectiveness of the identified predicate device as determined by its prior FDA clearance. The new device is then compared against this established benchmark. There isn't "pathology" or "outcomes data" specifically collected for the new hooks in this filing.
The sample size for the training set:
- N/A. This is not an AI or machine learning device; therefore, there is no concept of a "training set."
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary of 510(k) Process for this Device:

This 510(k) submission for the Blackstone™ Spinal Fixation System Posterior Hooks relies on demonstrating that the new components are substantially equivalent to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as existing, cleared devices on the market. The "study" in this context is primarily a comparison of technical characteristics, materials, and intended uses rather than a clinical trial or a performance study on a specific data set. The acceptance criteria are met if the FDA agrees that the new hooks do not raise different questions of safety and effectiveness compared to the predicate device.

Summary

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

P'i3 K01385

FEB 01 2002

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

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 SystemPosterior Hooks (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 SystemKWP - 888.3050 - Spinal Interlaminal Fixation Orthosis
SubstantiallyEquivalent Devices:	Danek CD Horizon Spinal System (K981676)

Device Description:

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4/3 C013885

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

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;
1. 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;
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.

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

3/3 K013RRS

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

The Blackstone Spinal Fixation System, when used for posterior 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.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Spinal Fixation System Posterior Hooks by their very nature are substantially equivalent to the Danek CD Horizon Spinal System (K981676), which has been cleared by FDA for certain anterior and pedicle fixation use indications.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in all capital letters and is arranged in a circular fashion to follow the shape of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

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

K013885 Re:

Blackstone™ Spinal Fixation System Posterior Hooks Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3070, 21 CFR 888.3050 Regulatory Class: Class II Product Code: MNI, KWQ, MNH, KWP Dated: November 21, 2001 Received: November 23, 2001

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 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 (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.

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

Page 2 - Mr. Alan Lombardo

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 nredicate 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 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, (Jease 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,

Mark M Milliken

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

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Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

p.i/2

510(k) Number:

K013885

Device Name: Blackstone™ Spinal Fixation System

Mark M. Milken

Division of General, Restorative and Neurological Devices

Indications for Use:

KO13885 510(k) Number

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 (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 ি

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;

{6}------------------------------------------------

10013888

14:

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
Tumor; f)
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

The Blackstone Spinal Fixation System, when used for posterior 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.

Concurrence of CDRH, Office of device Evaluation

Prescription Use

Over-The-Counter Use

(Per 21 CFR801.109

b. Mark N. Mullen

ivision of Gener | Restorative and Neurological J. Ices

510(k) Number K013883

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.