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 consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Blackstone Pedicle Screw System

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (Blackstone Pedicle Screw System)
Substantial Equivalence	Demonstrate substantial equivalence to legally marketed predicate devices in intended use, indications, technological characteristics, and principles of operation. Differences should not raise new safety or effectiveness issues.	- Same intended use as predicate devices. - Similar indications as predicate devices. - Similar technological characteristics and principles of operation as predicate devices. - Mechanical testing addressed technical differences, showing no new safety or effectiveness issues.
Mechanical Performance	Mechanical performance (e.g., strength, durability) must be comparable to predicate devices to ensure safety and effectiveness.	Mechanical testing was conducted which demonstrates that the system is substantially equivalent to predicate devices.

Explanation of Implicit Criteria: The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. Therefore, the explicit acceptance criteria are not stated in terms of specific performance metrics for the device itself but rather its ability to perform at least as well as and be as safe and effective as the predicate devices. The "performance data" section states that mechanical testing was conducted to prove this equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not specify a sample size for a "test set" in the context of clinical data or human evaluation. The performance data section refers to "mechanical testing," which implies laboratory-based tests on device components or finished products.

Sample Size for Test Set: Not applicable/Not specified in the provided document, as the study described is mechanical testing, not a user-based or clinical study.
Data Provenance: Not applicable/Not specified. The tests are laboratory-based mechanical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This information would be relevant for studies involving human interpretation or clinical outcomes. The document discusses mechanical testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used to resolve discrepancies in human assessments, which is not relevant to mechanical testing.

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

No, an MRMC comparative effectiveness study was not done. The document describes mechanical testing for a medical device (pedicle screw system), not an AI-assisted diagnostic or interpretative system that would involve human readers.

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

Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the mechanical integrity and functionality of the physical pedicle screw system itself, which was assessed through mechanical testing.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing would be the performance characteristics of the predicate devices. The Blackstone Pedicle Screw System was deemed acceptable if its mechanical performance was "substantially equivalent" to these known and previously approved devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned for this device, there is no ground truth established for it.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K081684'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable.

SEP 1 5 2008

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

510(k) SUMMARY

Blackstone Medical, Inc. Pedicle Screw System

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:	Marox Corporation373 Whitney AvenueHolyoke, MA 01040-2766Pulse Technologies2000 AM DriveQuakertown, PA 18951Structure Medical, Inc.2975 S. Horseshoe Dr., Suite 400Naples, FL 34104Omni Components, Inc.46 River Rd.Hudson, NH 03051

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K081684

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

Trade Name:	Blackstone Pedicle Screw System
Product Code:	NKB - Orthosis, Spinal Pedicle Fixation, for DegenerativeDisc Disease
Subsequent Product Codes:	MNI - Orthosis, Spinal Pedicle FixationMNH - Orthosis, Spondylolisthesis Spinal Fixation
Common Name:	Posterior Thoracolumbar System
Regulatory Classification:	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. Spinal Fixation System (SFS):· Blackstone SFS (K994217 SE 2-28-00)· Blackstone SFS 4.5mm Multi-Axial Screws(K020674 SE 4-3-02)· Blackstone SFS 4.5mm Mono-Axial Screws(K013558 SE 1-23-02)· Blackstone SFS 2nd Gen. Cross-Connector(K003735 SE 5-8-01)· Blackstone SFS Modified Multi-Axial Screws(K023498 SE 11-13-02)· Blackstone SFS Lateral Offset Components(K030581 SE 6-26-03)· Blackstone SFS Rigid Cross Connector(K030862 SE 4-17-03)· Blackstone SFS Parallel Rod Connectors(K080407 SE 3-13-08)· Synthes Pangea Spine System (K052123 SE 9/23/05& K052151 SE 12-7-05)

Intended Use / Indications for Use

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

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 consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.

Performance Data

Mechanical testing of the Blackstone Pedicle Screw System 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.

Substantial Equivalence

The Blackstone Pedicle Screw System, the Blackstone Medical SFS System (K080407 SE 3/13/08), and the Synthes Pangea Spine System (K052123 SE 9/23/05) have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the Blackstone Pedicle Screw System and its predicates are technical characteristics that have been addressed mechanical verification testing. These differences do not present any new issues of safety or effectiveness, therefore, the Blackstone Pedicle Screw System is substantially equivalent to its predicate devices.

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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 consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2008

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

Re: K081684

Trade/Device Name: Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: June 13, 2008 Received: June 17, 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.

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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 yours,

Mark M. Millman

Mark N. Melkerson 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 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Confidential

Indications for Use Statement

510(k) Number (if known): KO816889

Device Name: Pedicle Screw System

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 (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 1

FOR M. MELKERSON
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number K08/684

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.