(595 days)
The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.
This document is a 510(k) Summary for a medical device called the "Reliance Cervical IBF System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with clinical performance or efficacy studies.
Instead, the "Performance Data and Substantial Equivalence" section refers to engineering and manufacturing performance testing to demonstrate that the new device, which has a material modification (Titanium 6Al-4V ELI) compared to its predicates (PEEK Optima LT1 or PEEK Optima LT1-HA), is still substantially equivalent to the predicates. Therefore, many of the requested categories cannot be filled from this document as they pertain to clinical or diagnostic performance studies, which are not described here.
Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information regarding "acceptance criteria" and "study proving the device meets acceptance criteria" in a clinical performance context is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or clinical success rates). Instead, it refers to compliance with engineering and manufacturing standards. Therefore, a table of clinical acceptance criteria and reported device performance cannot be generated from this text. The performance data mentioned relates to demonstrating substantial equivalence for engineering properties.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Reference to Standards) |
|---|---|
| Mechanical Performance | Compliance with ASTM F2077-18 and F2267-04 (2018) standards |
| Packaging Integrity | Compliance with ASTM D4169, D4332, F88, F1886, F2096 |
| Cleaning Validation | Compliance with ASTM F2459 and F2847 |
| Sterilization Efficacy | Compliance with ANSI/AAMI/ISO 11137-1:2006/A1:2013/A2:2019, ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006, ANSI/AAMI/ISO 11737-2:2009, and ANSI/AAMI/ISO TIR13004:2013 |
| Biocompatibility | Determined to be substantially equivalent to predicate devices |
2. Sample size 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. The performance data described are related to engineering and manufacturing tests, not clinical test sets.
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 information is not provided as there is no description of a clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no description of a clinical test set requiring adjudication.
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
There is no mention of an MRMC study or AI in this document. This device is an intervertebral body fusion system, not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as there is no description of a clinical test set requiring ground truth. The "ground truth" for the engineering tests would be the specifications outlined in the referenced ASTM/ISO standards.
8. The sample size for the training set
This information is not provided as there is no mention of a training set, which is typically associated with AI/machine learning models or studies involving clinical data for training.
9. How the ground truth for the training set was established
This information is not provided as there is no mention of a training set or how its ground truth would be established.
Summary regarding the device and the document:
This 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to existing, legally marketed predicate devices. The modification is primarily a change in material for the intervertebral body fusion spacer, from PEEK to Titanium 6A1-4V ELI.
The "study that proves the device meets the acceptance criteria" in this context refers to a battery of engineering and manufacturing tests (mechanical, packaging, cleaning, sterilization, biocompatibility) conducted according to recognized ASTM and ISO standards. The "acceptance criteria" are implied to be the successful compliance with these standards, demonstrating that the new material does not negatively impact the device's fundamental safety and effectiveness compared to the predicate, making it substantially equivalent.
The document does not describe any clinical trials, performance studies, or efficacy studies involving human subjects or clinical data in the form requested to directly assess performance metrics like sensitivity, specificity, or clinical outcomes. For intervertebral body fusion devices in the 510(k) pathway, such extensive clinical performance studies are often not required if substantial equivalence can be demonstrated through other means (e.g., material testing, biomechanical testing, and comparison of design/indications to predicates).
§ 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.