The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to 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 regardless of the intended use:

degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
spondylolisthesis.
trauma (i.e., fracture or dislocation).
spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis, and
failed previous fusion
The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

Device Description

The Blackstone Pedicle Screw System 4.0 mm Diameter Screws consists of an assortment of multiaxial and monoaxial pedicle screws.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the Blackstone Pedicle Screw System, specifically introducing 4.0 mm diameter screws. The submission highlights mechanical testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study involving human subjects or AI-based performance metrics.

Therefore, many of the requested elements are not applicable to this type of submission, as they pertain to clinical studies or AI/software validation.

Here's an analysis based on the provided document:

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

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices (Blackstone Pedicle Screw System K081684)	Mechanical testing demonstrated that the additional 4.0 mm diameter screw components are substantially equivalent to the current Blackstone Pedicle Screw System.

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

The document primarily discusses mechanical testing, not clinical studies or data involving human subjects in a "test set" in the context of AI or diagnostic performance. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) as they relate to human data are not applicable here. The data provenance would be from manufacturing and testing facilities.

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. This is a submission for a mechanical medical device, not a diagnostic or AI device that requires expert-established ground truth from images or clinical assessments. Ground truth for mechanical testing would involve engineering standards, material properties, and physical measurements.

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

Not applicable. Adjudication methods are relevant for clinical assessments or expert reviews, not for mechanical device testing where results are quantifiable through engineering metrics.

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 a mechanical device submission. There is no AI component or human reader involvement described.

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

Not applicable. This is a mechanical device submission.

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

For mechanical testing, the "ground truth" would be established by:

Engineering Standards: Adherence to established ASTM or ISO standards for spinal implants (e.g., fatigue strength, torsional rigidity, pull-out strength).
Predicate Device Performance Data: The performance characteristics of the legally marketed predicate devices (K081684, K052123, K052151) serve as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of AI or machine learning for this mechanical device.

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

Not applicable. There is no "training set" for this mechanical device.

Summary

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

OCT 1 7 2008

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Modification Confidential

510(k) SUMMARY

Blackstone Medical, Inc. Pedicle Screw System – 4.0 mm Diameter Screws

Sponsor:	Blackstone Medical, Inc.1211 Hamburg TurnpikeSuite 300Wayne, NJ 07470
Registration Number:	3004606875
Contact Person:	Whitney G. Törning, Senior Director of Regulatory Affairs& Quality Assurance
Telephone Number:	973.406.2838
Fax Number:	973.406.2938
Email:	wtorning@blackstonemedical.com
Submitter:	Martin G. SprunckRegulatory Affairs Manager
Manufacturer:	Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104
Registration Number:	1225457
Contract Manufacturer:	Pulse Technologies2000 AM DriveQuakertown, PA 18951
System Name:	Blackstone Pedicle Screw System
Trade Name:	4.0 mm Diameter Pedicle Screws
Common Name:	Posterior Thoracolumbar System
Product Code:	NKB - Orthosis, Spinal Pedicle Fixation, for DegenerativeDisc Disease
Subsequent Product Codes:	MNI - Orthosis, Spinal Pedicle FixationMNH - Orthosis, Spondylolisthesis Spinal Fixation

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

14082797

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Modification Confidential

Regulatory Classifications:	Class III Preamendment Device, 888.3070 - Pedicle ScrewSpinal System - *Class III Summary and CertificationRequiredClass II - 888.3070 - Pedicle Screw Spinal System
Review Panel:	Orthopedic Device Panel
Predicate Devices:	Blackstone Medical, Inc. Pedicle Screw System (K081684SE 9/15/08)
	Synthes Pangea Spine System (K052123 SE 9/23/05 &K052151 SE 12-7-05)

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)
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

The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

Technological Characteristics

The Blackstone Pedicle Screw System 4.0 mm Diameter Screws consists of an assortment of multiaxial and monoaxial pedicle screws.

Performance Data

Mechanical testing of the Blackstone Pedicle Screw System 4.0 mm Diameter Screws was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

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

K082797

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Modification Confidential

Basis of Substantial Equivalence

Mechanical testing was conducted to demonstrate that the additional 4.0 mm diameter screw components are substantially equivalent to the current Blackstone Pedicle Screw System, (K081684 SE 9/15/08), which has been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol, with three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs & Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

OCT 1 7 2008

Re: K082797

Trade/Device Name: Blackstone Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system. Regulatory Class: III Product Code: NKB, MNI, MNH Dated: September 22, 2008 Received: September 23, 2008

Dear Ms. Törning:

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.

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

Page 2 - Ms. Whitney G. Törning

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number (if known):_ 1408 2797

System Name: Blackstone Pedicle Screw System Device Name: 4.0 mm Diameter Pedicle Screws

Indications for Use:

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

The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

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

NithRPoshe for nxn

Page 1 of 1

Division Sign-Off Division of General. Restorative. and Neurological Devices

510(k) Number KO 82797

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.