(75 days)
Rampart™-O: Rampart™-O is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Rampart™-O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.
Rampart™-T: Rampart™-T is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Rampart™-T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.
Rampart™-O and Rampart™-T devices are designed for use with autograft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The devices are available in a range of lengths and heights. The devices are provided sterile and non-sterile. The associated instruments are provided non-sterile.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific acceptance criteria or performance metrics reported for the device, as no testing was performed. The 510(k) relies on substantial equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| No specific acceptance criteria were defined or reported in the document. | No performance data was reported as "no testing was performed." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No testing was performed on a test set.
- Data Provenance: Not applicable. No new data was generated or used from a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No test set was used, and thus no ground truth was established by experts for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "No testing was performed."
- Effect Size of Human Reader Improvement with AI vs. Without AI: Not applicable, as no MRMC study or AI component is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No new empirical data requiring a ground truth was generated as "no testing was performed." The submission relies on substantial equivalence to previously cleared devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical medical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. The device is a physical medical implant, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.
Summary of the K132053 510(k) Submission:
This 510(k) application for the Rampart™-O and Rampart™-T intervertebral body fusion devices is a submission to update the indications for use and the ability to provide the products as sterile. Crucially, the application states: "No testing was performed."
Therefore, the submission establishes substantial equivalence based on the intended use, materials, configuration, and performance characteristics of the predicate products (Rampart™ O (K131216) and Rampart™ T (K121129)), rather than through new performance studies or data collection. This means that all questions related to acceptance criteria, device performance studies, test sets, training sets, ground truth establishment, and expert involvement are not applicable to the information provided in this specific 510(k) summary.
§ 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.