(66 days)
RISE™ Spacers are lumbar interbody fusion devices 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 or retrolisthesis at the involved level(s).
RISE™ Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.
RISE™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. RISE™ Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
RISE™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. An internal component is manufactured from radiolucent PEEK polymer, as specified in ASTM F2026.
Here's an analysis of the provided text regarding the acceptance criteria and study for the RISE™ Spacer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance Statement |
|---|---|---|
| Mechanical Performance | Demonstrated substantial equivalence to predicate in: | "Mechanical testing (static and dynamic compression, static and dynamic compression-shear and subsidence) was conducted to demonstrate substantial equivalence to the predicate device." |
| - Static compression | (Implied: Met or exceeded predicate performance) | |
| - Dynamic compression | (Implied: Met or exceeded predicate performance) | |
| - Static compression-shear | (Implied: Met or exceeded predicate performance) | |
| - Dynamic compression-shear | (Implied: Met or exceeded predicate performance) | |
| - Subsidence | (Implied: Met or exceeded predicate performance) | |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate device with respect to: | "The RISE™ Spacer has been found to be substantially equivalent to the predicate with respect to technical characteristics, performance, design, materials, performance, and intended use." |
| - Technical characteristics | (Implied: Met or exceeded predicate characteristics) | |
| - Performance | (Implied: Met or exceeded predicate performance) | |
| - Design | (Implied: Met or exceeded predicate design criteria) | |
| - Materials | (Implied: Met or exceeded predicate material criteria) | |
| - Intended use | (Implied: Met predicate intended use) |
Explanation of "Acceptance Criteria": In this context of a 510(k) submission, the "acceptance criteria" are not explicitly listed numerical thresholds as one might find in a clinical trial. Instead, the primary acceptance criterion is "substantial equivalence" to a predicate device. The performance data provided (mechanical testing) serves to demonstrate that this substantial equivalence is met for critical aspects of device function. The implied acceptance for each specific test (e.g., static compression) is that the RISE™ Spacer performs at least as well as, or within an acceptable margin of, the predicate CALIBER™ Spacer.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the mechanical testing (e.g., number of devices tested for static compression).
- Data Provenance: The mechanical testing was conducted by or on behalf of the manufacturer, Globus Medical Inc. (presumably at their facilities or a contracted lab). The document does not specify a country of origin for this data beyond the company's location in Audubon, PA, USA. This is an engineering/bench test, not patient data, so "retrospective or prospective" does not directly apply in the same way it would to a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a premarket submission for a medical device (510(k)) based on mechanical testing and substantial equivalence to a predicate device. It does not involve a study with a "test set" of patient data or the establishment of "ground truth" by clinical experts in the way a diagnostic AI device would. Therefore, this section is not applicable.
4. Adjudication Method for the Test Set
As there is no "test set" requiring expert ground truth in the clinical sense, an adjudication method is not applicable. The assessment for substantial equivalence is based on the mechanical test results and a comparison to the predicate device's characteristics, likely performed by the manufacturer's engineers and regulatory specialists.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an implantable medical device (intervertebral body fusion device), not a diagnostic AI tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable device, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly defined by the performance characteristics and safety profile of the predicate device, CALIBER™ Spacer (K102293). The RISE™ Spacer aims to demonstrate that its mechanical properties and design fall within acceptable parameters established by the predicate, thus proving it is as safe and effective. The type of data proving this is mechanical test data (static and dynamic compression, compression-shear, and subsidence).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an implantable physical device. The design and manufacturing process are informed by general engineering principles, material science, and prior experience with similar devices, not a digital training dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth to establish for it. The "ground truth" for device design and safety is based on established engineering standards for medical devices and the performance history of predicate devices.
§ 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.