(89 days)
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.
The PILLAR Spacer System components consist of:
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A PEEK Spacer
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Tantalum Markers
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.
§ 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.