(271 days)
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.
SUSTAIN®-IR Spacers are lumbar intervertebral fusion devices used to provide structural stability in skeletally mature individuals following discectomy and may be inserted using a posterior or transforaminal approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SUSTAIN® IR Spacers are inserted into the disc space and rotated 90° to the final position. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SUSTAIN®-IR Spacers have an axial hole to allow autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the spacer.
SUSTAIN®-IR Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.
The provided document is a 510(k) premarket notification for a medical device called "SUSTAIN® Additional Implants," which are intervertebral body fusion devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust clinical studies with acceptance criteria for device performance as would be seen for a novel device.
Therefore, the document does not contain information on:
- Acceptance criteria for device performance based on clinical outcomes. The "acceptance criteria" discussed are primarily related to mechanical testing standards for intervertebral fusion devices.
- A study proving the device meets clinical acceptance criteria (e.g., diagnostic accuracy, sensitivity, specificity, clinical efficacy endpoints).
- Sample sizes for a test set (clinical data), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies. These are typically associated with performance evaluations of AI/ML-driven devices or devices requiring clinical outcome validation beyond substantial equivalence.
- Training set sample size or how ground truth was established for a training set. This information is also typically for AI/ML devices.
Instead, the document focuses on bench testing (mechanical testing) and a cadaver implantation study to demonstrate substantial equivalence for a physical implant device.
Here's the information that can be extracted or inferred from the document regarding "acceptance criteria" and "study":
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for an implantable device focused on mechanical efficacy, the "acceptance criteria" are implied by adherence to recognized standards for intervertebral fusion devices. The document states that testing was conducted in accordance with these standards. Quantitative performance metrics against specific acceptance thresholds are not provided in this summary.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Static Compression (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267) | Conducted and demonstrated substantial equivalence to predicate devices. |
| Dynamic Compression (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267) | Conducted and demonstrated substantial equivalence to predicate devices. |
| Static Compression-Shear (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267) | Conducted and demonstrated substantial equivalence to predicate devices. |
| Dynamic Compression-Shear (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267) | Conducted and demonstrated substantial equivalence to predicate devices. |
| Subsidence (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267) | Conducted and demonstrated substantial equivalence to predicate devices. |
| Implantation Feasibility & Endplate Damage Assessment (Cadaver Study) | Demonstrated feasibility of device insertion and assessed potential endplate damage. |
| Material Composition (Radiolucent PEEK polymer with titanium alloy or tantalum markers) | Meets specified ASTM standards (F136, F560, F1295, F2026). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for the mechanical or cadaver studies in this summary. For mechanical testing, samples typically refer to a number of devices/constructs. For the cadaver study, the number of cadaveric spines or segments is not mentioned.
- Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting. The cadaver study would be performed in a lab or research institution. Data is prospective in the sense that the testing was conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable in the context of this 510(k) submission for a physical implant. "Ground truth" as expert consensus on medical images or patient outcomes is not relevant here. The "truth" for mechanical testing is based on standard test methods and measurements. For the cadaver study, the assessment of insertion feasibility and endplate damage would be observational by the study team, likely including surgeons or anatomists, but their specific number or qualifications are not provided.
4. Adjudication Method for the Test Set
- Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images), which is not part of this type of device evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
- No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical intervertebral fusion device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No, a standalone algorithm performance study was not done. This is not an AI/ML device but a physical implant.
7. The Type of Ground Truth Used
- Mechanical Testing: The "ground truth" is derived from physical measurements and adherence to specified ASTM and FDA guidance document standards.
- Cadaver Implantation Study: The "ground truth" relates to direct observation of device insertion feasibility and any associated endplate damage in cadaveric tissue.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
§ 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.