(90 days)
The Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Falcon Spacer is intended to be used with supplemental fixation.
The Falcon Spacer is a radiolucent, oval-shaped spacer intended to be used as an interbody fusion device in conjunction with supplemental fixation. Pyramidal teeth that assist in further stabilization of the construct are located on the inferior and superior surfaces of the spacer. The Falcon Spacer implant may be used to accommodate varying anatomical requirements and is available in a range of heights, sizes and angles. The open architecture of the device is intended to be packed with autogenous bone (i.e., autograft).
The Falcon Spacer is manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with four (4) tantalum radiopaque pins (ASTM F-560); The markers allow intra-operative radiographic assessment of the position of the implant.
The provided text describes the 510(k) summary for the Falcon Spacer. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state acceptance criteria in terms of specific thresholds or pass/fail conditions for each test. Instead, it lists the types of tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device passed these tests and was deemed substantially equivalent.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Mechanical Performance | Device demonstrates equivalent (or superior) mechanical properties to predicate devices according to FDA Guidance and ASTM F-2077. | Synthes conducted the following bench testing: |
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression Shear
- Subsidence
- Expulsion
Conclusion: Falcon Spacer is substantially equivalent to predicate devices based on contained information. |
| Material Biocompatibility | Manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with tantalum radiopaque pins (ASTM F-560), generally recognized as safe and biocompatible materials for implantable devices. | Materials Used: Invibio® PEEK-Optima® LT-1 (ASTM F2026) for the spacer body, and four (4) tantalum radiopaque pins (ASTM F-560) for markers. |
| Radiopacity | Markers allow intra-operative radiographic assessment of implant position. | Radiopaque Markers: Four (4) tantalum radiopaque pins facilitate intra-operative radiographic assessment of position. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing. For such tests, the "sample size" typically refers to the number of test articles (e.g., spacers) subjected to each specific test. This specific number is not explicitly stated in the provided 510(k) summary.
Data Provenance: The data is generated from bench testing conducted by Synthes Spine. It is not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical studies. It would be an internal lab study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device underwent non-clinical bench testing, not a study requiring expert-established ground truth related to patient data or image interpretation. The "ground truth" for these tests would be the established engineering standards, test methods (e.g., ASTM F-2077), and performance characteristics of the predicate devices.
4. Adjudication method for the test set
Not applicable. As this was non-clinical bench testing, there was no "adjudication method" in the sense of reconciling divergent expert opinions on clinical findings. The results of the mechanical tests are objective measurements.
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. The Falcon Spacer is a physical medical device (interbody fusion spacer), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The Falcon Spacer is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for the non-clinical testing was based on established engineering standards, ASTM F-2077 guidance for spinal implant testing, and the known performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the Falcon Spacer performed mechanically equivalent to these predicates.
8. The sample size for the training set
Not applicable. This product is a physical medical device. It does not involve AI or machine learning, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as #8.
§ 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.