(59 days)
When used as an Intervertebral Body Fusion System: The PILLAR™ SA PEEK 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 non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System. When used as a Partial Vertebral Body Replacement (VBR) System: The PILLAR™ SA PEEK 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 PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ SA PEEK 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 PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
The Blackstone Medical, Inc. PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1), as described by ASTM F-2026, with tantalum markers as described by ASTM F-560. The implants are available in multiple footprint sizes, and a variety of heights and angles of lordosis. The implants incorporate integrated anterior screw holes to allow for medial placement of titanium screws that anchor to the vertebrae, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.
The provided text describes a 510(k) premarket notification for the Blackstone PILLAR SA PEEK Spacer System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance in the context of an AI/ML medical device.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable as this submission is for a physical medical implant device, not an AI/ML diagnostic or predictive system.
Here's a breakdown of what can be extracted from the provided text, and where the information is not present:
1. A table of acceptance criteria and the reported device performance
Not Applicable. This submission is for a physical medical implant, not an AI/ML device. The "performance" is demonstrated through substantial equivalence to predicate devices based on mechanical testing and similar design/materials, rather than meeting specific performance metrics against a defined ground truth as would be the case for an AI/ML algorithm.
The basis of substantial equivalence relies on:
- Mechanical performance data: This implies various engineering tests were conducted to ensure the device's structural integrity and functionality are comparable to predicate devices. Specific quantitative acceptance criteria and detailed performance results from these mechanical tests are not provided in this summary document.
- Equivalence in configuration and indications for use: The device's design, materials (PEEK-OPTIMA® LT1 with tantalum markers), and intended uses are similar to cleared predicate devices.
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. As this is a physical medical implant, there is no "test set" of patient data or images in the context of an AI/ML device. The "testing" involved mechanical performance evaluations on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. There is no "ground truth" in the AI/ML sense. The substantial equivalence relies on engineering standards and comparison to previously cleared devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. No human adjudication of a "test set" is described for this physical device submission.
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 not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. The "truth" for this device's safety and effectiveness is established through adherence to material standards (ASTM F-2026, ASTM F-560), mechanical testing results (implied, but not detailed), and a comparison of its design, materials, and intended use to legally marketed predicate devices already cleared by the FDA.
8. The sample size for the training set
Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
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le081849
Premarket Notification Special 510(k) Blackstone Medical, Inc. PILLAR SA PEEK Spacer System System Modification
510(K) SUMMARY
AUG 2 8 2008
| Sponsor: | Blackstone Medical, Inc.1211 Hamburg TurnpikeSuite 300Wayne, NJ 07470 | AUG 28 2008 |
|---|---|---|
| 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 | |
| Trade Name: | Blackstone PILLAR™ SA PEEK Spacer System | |
| Common Names: | Intervertebral Body Fusion DeviceSpinal Partial Vertebral Body Replacement Device | |
| Classification | Class II | |
| Device Product Codes: | MAX - Intervertebral Fusion Device with Bone Graft, LumbaMQP - Spinal Vertebral Body Replacement Device | |
| Regulation Numbers: | 888.3080 - Intervertebral Body Fusion Device888.3060 - Spinal Intervertebral Body Fixation Orthosis |
Substantially Equivalent Devices:
- · Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06)
- · Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05)
- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05)
- · Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08)
- · Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08)
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2081849
Premarket Notification Special 510(k) Blackstone Medical, Inc. PILLAR SA PEEK Spacer System System Modification
Device Description:
The Blackstone Medical, Inc. PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1), as described by ASTM F-2026, with tantalum markers as described by ASTM F-560. The implants are available in multiple footprint sizes, and a variety of heights and angles of lordosis. The implants incorporate integrated anterior screw holes to allow for medial placement of titanium screws that anchor to the vertebrae, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.
Intended Use / Indications for Use:
When used as an Intervertebral Body Fusion System:
The PILLAR™ SA PEEK 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 non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft.
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.
When used as a Partial Vertebral Body Replacement (VBR) System:
The PILLAR™ SA PEEK 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 turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of
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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "Kb81849i". The characters are written in a dark ink on a white background. The handwriting is somewhat messy and difficult to read.
fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft.
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Basis of Substantial Equivalence:
Based on mechanical performance data and equivalence in configuration and indications for use, the Blackstone PILLAR SA PEEK Spacer System is substantially equivalent to the following devices, which have been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine:
- · Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06)
- · Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05)
- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · Surgicraft, Ltd., STALIF TT (K051027 SE 6-29-05 and K041617 SE 9-8-04)
- · Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08)
- · Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08)
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 12 2011
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: K081849
Trade/Device Name: Blackstone PILLAR™ SA PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MQP Dated: July 30, 2008 Received: July 31, 2008
Dear Ms. Törning:
This letter corrects our substantially equivalent letter of August 28, 2008.
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 (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 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
{4}------------------------------------------------
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark M. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Blackstone PILLAR™ SA PEEK Spacer System
Indications for Use:
When used as an Intervertebral Body Fusion System:
The PILLAR™ SA PEEK 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 non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft.
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.
When used as a Partial Vertebral Body Replacement (VBR) System:
The PILLAR™ SA PEEK 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 PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ SA PEEK 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 PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft.
Page 1 of _ 2
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1081849
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Prescription Use _ X AND/OR Over-The-Counter Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 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 2 of 2
Soubare buellin
Division of General, Restorative, and Neurological Devices
510(k) Number K081846
§ 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.