(140 days)
The PILLAR SA PTC 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 PTC is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.
The PILLAR SA PTC 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 fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Firebird 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 PILLAR SA PTC.
The PILLAR SA PTC in a standalone intervertebral body implant that is comprised of a PEEK OPTIMA LT1 core material as described by ASTM F-2026, with two integrated porous titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580 or ASTM F136. The PILLAR SA PTC device is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
The PILLAR SA PTC is designed to be used as a standalone device, when implanted with accompanying stabilizing screws. The PILLAR SA PTC spacers are provided sterile.
This document is a 510(k) summary for the PILLAR® SA PTC, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with a test set, ground truth, and expert adjudication as typically described for AI/ML device evaluations.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the performance of PILLAR SA PTC was assessed through various mechanical and material tests. It doesn't present explicit "acceptance criteria" in a numerical sense but rather aims to show that the device performs similarly to predicate devices and meets relevant ASTM standards.
| Test Conducted | Reported Device Performance / Outcome |
|---|---|
| Axial Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate devices. |
| Compression-Shear (ASTM F2077) | Demonstrated substantial equivalence to predicate devices. |
| Expulsion (draft standard 04.25.05.02) | Demonstrated substantial equivalence to predicate devices. |
| Subsidence (ASTM F2267) | Demonstrated substantial equivalence to predicate devices. |
| Tensile Strength (ASTM F1147) | Demonstrated substantial equivalence to predicate devices. |
| Shear (ASTM F1044 & ASTM F1160) | Demonstrated substantial equivalence to predicate devices. |
| Wear (ASTM F1877) | Demonstrated substantial equivalence to predicate devices. |
| TABER Abrasion (ASTM F1978) | Demonstrated substantial equivalence to predicate devices. |
| Characterization of Porous Titanium Endplates & Interface (ASTM F1854) | Performed (details not provided, implying satisfactory results). |
| Bacterial Endotoxin Testing (BET) (ANSI/AAMI ST-72:2011) | Endotoxin limit less than 20EU per device (confirms sterility and safety). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" described are primarily mechanical and material characterization, not clinical studies with patients or data sets in the typical sense of AI/ML evaluation.
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)
This is not applicable as the "ground truth" for mechanical properties would be derived from physical measurements and material specifications, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 medical device for spinal fusion, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The "device" is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical and material tests, the ground truth would be established by:
- ASTM standards: Defined methodologies and acceptance ranges for mechanical properties (e.g., strength, wear).
- Material specifications: Chemical composition, microstructure, and physical properties of the PEEK OPTIMA LT1 and Ti-6Al-4V as described by ASTM F-2026, ASTM F1580, or ASTM F136.
- Sterility standards: Endotoxin limits as per ANSI/AAMI ST-72:2011.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device's evaluation.
9. How the ground truth for the training set was established
Not applicable.
§ 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.