(366 days)
The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic 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) weeks of non-operative treatment.
The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
The Manta Ray TDF Spacer features a cervical interbody cage that engages the entire disc space, including the uncovertebral joints, during the fusion process. This engagement between the lateral wings and the uncovertebral joints is intended to further reduce subsidence by increasing the mating surface area. The interbody spacer is manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) markers for radiographic visualization, and NanoMetalene®, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. Each spacer has a central graft window for receiving autograft and/or allogenic bone graft material and is offered in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy. The Manta Ray TDF Spacer is intended for use with supplemental fixation.
The instruments provided with the Manta Ray TDF Spacer facilitate the placement, adjustment, and removal, if necessary, of the interbody spacer. The spacer is provided sterile packaged, whereas the instruments are provided in system-specific trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
This FDA 510(k) premarket notification for the Manta Ray TDF Spacer does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a diagnostic or AI/ML-driven device.
Instead, this document is for a medical device (an intervertebral body fusion device) where the "acceptance criteria" for clearance are based on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through non-clinical mechanical testing. Clinical trials or studies with performance metrics like sensitivity, specificity, or reader improvement are generally not required for this type of device unless new and different technological characteristics are introduced that raise new questions of safety and effectiveness.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a mechanical implant, there isn't a direct "acceptance criteria" table with performance metrics like accuracy or error rates as would be seen for a diagnostic device. The "acceptance criteria" here implicitly refers to meeting or exceeding the performance established by the predicate devices in various mechanical tests.
| Acceptance Criteria (Implicit from Substantial Equivalence and ASTM Standards) | Reported Device Performance (Manta Ray TDF Spacer) |
|---|---|
| Equivalent mechanical performance to predicate devices in static compression | Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077. |
| Equivalent mechanical performance to predicate devices in dynamic compression | Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077. |
| Equivalent mechanical performance to predicate devices in static torsion | Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077. |
| Equivalent mechanical performance to predicate devices in dynamic torsion | Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077. |
| Equivalent mechanical performance to predicate devices in subsidence | Demonstrated equivalent mechanical performance to predicate devices per ASTM F2267. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of clinical test sets. The "test set" here refers to the specimens used for non-clinical mechanical testing. The exact number of samples for each mechanical test (e.g., number of constructs tested for compression, torsion, subsidence) is not provided in this summary. ASTM standards (F2077, F2267) typically specify minimum sample sizes for such tests.
- Data Provenance: Not applicable in the context of clinical patient data. The tests are laboratory-based mechanical tests.
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)
Not applicable. "Ground truth" in the sense of expert clinical diagnosis is not established for this type of mechanical device submission. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics measured according to established ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for expert review of clinical data, which is not part of this submission.
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. This type of study is not relevant for an interbody fusion device that does not involve AI or human interpretation of diagnostic images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device is a passive implantable medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the clinical sense. The "ground truth" for mechanical testing is adherence to and performance measurements against established ASTM (American Society for Testing and Materials) standards for spinal implants.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.