When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g .: the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLARTM Spacer System.

The PILLARTM PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARTM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ Spacer System is designed to restore the biomechanical integrity of the anterior. middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.

Device Description

The PILLAR Spacer System components consist of:

A PEEK Spacer
Tantalum Markers

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone Medical, Inc. PILLAR™ Spacer System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K081177) is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. In the context of a 510(k), explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or reader agreement are typically not presented as they would be for a novel device. Instead, the primary "acceptance criterion" is that the device's technological characteristics and performance are sufficiently similar to predicate devices such that it does not raise new questions of safety or effectiveness.

Therefore, the table reflects this approach:

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance (Blackstone PILLAR™ Spacer System)
Mechanical Performance: Should not present new issues of safety or effectiveness compared to predicates.	Mechanical testing was conducted which demonstrates that the system is substantially equivalent to predicate devices. Minor dimensional differences were addressed by mechanical verification testing and do not present new issues of safety or effectiveness.
Intended Use/Indications for Use: Must be the same as or very similar to predicate devices.	Same intended use and similar indications for use as predicate devices: DePuy Acromed Saber™ Lumbar I/F Cage®, Surgical Dynamics, Inc. Ray Threaded Fusion Cage, and Synthes Spine Opal Spacer System.
Technological Characteristics & Principles of Operation: Must be similar to predicate devices.	Similar technological characteristics and principles of operation to predicate devices. Components include a PEEK Spacer and Tantalum Markers.

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

The document does not provide information regarding a specific "test set" in the way one might expect for a diagnostic or AI-driven device. As this is a 510(k) for an implantable medical device, the "test set" primarily refers to the samples used in the mechanical testing.

Sample Size for Test Set: Not explicitly stated for mechanical testing, but the context implies sufficient samples were tested to demonstrate substantial equivalence.
Data Provenance: Not applicable in the sense of patient data. The "study" here is mechanical testing of the device itself, likely conducted in a lab setting.

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

This information is not applicable to this 510(k) submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices that interpret images or other patient data. For an implantable device like the PILLAR™ Spacer System, the "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) submission. Adjudication methods like "2+1" or "3+1" are used to resolve discrepancies among multiple expert readers in diagnostic studies. Mechanical testing does not involve such an adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools (especially those with human-in-the-loop components) and comparing reader performance with and without AI assistance. This document describes an implantable device, not a diagnostic algorithm.

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

No, a standalone algorithm performance study was not done. This document pertains to a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this 510(k) is based on engineering standards and established mechanical testing methodologies. The device's components (PEEK Spacer, Tantalum Markers) and overall system are subjected to tests that simulate the forces and conditions they would experience in vivo, and the results are compared against performance benchmarks established by predicate devices and relevant standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an implantable medical device like this. Training sets are used for machine learning algorithms.

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

This is not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is mechanical testing of the Blackstone Medical, Inc. PILLAR™ Spacer System.

Purpose: To demonstrate that the device is substantially equivalent to legally marketed predicate devices (DePuy Acromed Saber™ Lumbar I/F Cage®, Surgical Dynamics, Inc. Ray Threaded Fusion Cage, Synthes Spine Opal Spacer System) in terms of safety and effectiveness.
Methodology: Mechanical testing was performed on the PILLAR™ Spacer System. The document states that "The only technological differences between the PILLAR Spacer System and its predicates are minor dimensional characteristics and have been addressed mechanical verification testing."
Results: The mechanical testing demonstrated that the PILLAR™ Spacer System is substantially equivalent to the predicate devices. The minor technological differences do not present any new issues of safety or effectiveness.

In essence, the entire 510(k) process is the "study" by which the device's acceptance (i.e., substantial equivalence) is proven, primarily through comparison to established, safe, and effective predicate devices, supported by mechanical performance data.

Summary

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

K081177 (pg. 1 of 3)

JUL 2 3 2008

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PILLAR™ Spacer System Confidential

510(k) SUMMARY

Blackstone Medical, Inc. PILLAR™ Spacer 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 01040-2766
Trade Name(s):	PILLAR AL, PILLAR PL, PILLAR TL Spacers
System Name:	PILLAR™ Spacer System
Product Codes:	MAX - Intervertebral Fusion Device with Bone Graft,LumbarMQP - Spinal Intervertebral Body Fixation Orthosis
Common Name:	Intervertebral body fusion device
Regulatory Classification:	Class II - 888.3080 - Intervertebral body fusion device888.3060 - Spinal Intervertebral Body Fixation Orthosis
Review Panel:	Orthopedic Device Panel

PILLAR™ Spacer System – 510(k) Summary Page 1 of 3

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

K081177 (pg. 2 of 3)

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PILLARTM Spacer System Confidential

DePuy Acromed Saber™ Lumbar I/F Cage®, (P960025) Predicate Devices: Surgical Dynamics, Inc. Ray Threaded Fusion Cage (TFC) (bd20019) Synthes Spine Opal Spacer System (K072791 SE 12-26-07)

Intended Use / Indications for Use

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLARTM Spacer System.

The PILLARTM PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.

The PILLARTM Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.

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

K081177 (pg. 3 of 3)

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PILLARTM Spacer System Confidential

Technological Characteristics

The PILLAR Spacer System components consist of:

A PEEK Spacer
Tantalum Markers

Performance Data

Mechanical testing of the Blackstone Medical, Inc. PILLARTM Spacer 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 PILLAR Spacer System, the DePuy Acromed Saber™ Lumbar I/F Cage®, the Surgical Dynamics, Inc. Ray Threaded Fusion Cage and the Synthes Spine Opal Spacer System (K072791 SE 12-26-07) have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the PILLAR Spacer System and its predicates are minor dimensional characteristics and have been addressed mechanical verification testing. These differences do not present any new issues of safety or effectiveness. therefore, the PILLAR Spacer System is substantially equivalent to its predicate devices.

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

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 2 3 2008

Re: K081177

Trade/Device Name: PILLAR™ Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MAX, MOP Dated: April 23, 2008 Received: April 28, 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 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. 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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Page 1 of 1

Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: PILLARTM Spacer System

Indications for Use:

When used as an intervertebral body fusion device, the PILEAR7M Spacer System is indicated for spinal fusion procedures in skelelally mature patients with degenerative disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s),

The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g.; the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment with the PILLARTM Spacer System.

The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach. The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforaminal approach. The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

Prescription Use (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)

510(k) Number | (66)

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.