(105 days)
The Endoskeleton TO® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton TO is comprised of a variety of implant sizes to accommodate various patient's anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Here's a breakdown of the acceptance criteria and the study details for the Endoskeleton TO Interbody Fusion Device, based on the provided 510(k) summary:
This device is not an AI/ML powered device but rather a physical interbody fusion device. Therefore, many of the typical questions for AI/ML devices regarding human-in-the-loop, effect size, training data, and ground truth establishment are not applicable.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Mechanical Stability: | |
| - Static axial compression | Performed, indicating substantial equivalence to predicate devices. |
| - Dynamic axial compression | Performed, indicating substantial equivalence to predicate devices. |
| - Static compression shear | Performed, indicating substantial equivalence to predicate devices. |
| - Dynamic compression shear | Performed, indicating substantial equivalence to predicate devices. |
| - Static torsion | Performed, indicating substantial equivalence to predicate devices. |
| Subsidence: | Tested following ASTM F2267-04, results indicate substantial equivalence. |
| Expulsion Resistance: | Tested following a recognized protocol, results indicate substantial equivalence. |
| Material Composition: | Manufactured from medical grade titanium alloy (Ti6Al4V-ELI). |
| Biologic Fusion Facilitation: | Intended use aligns with predicate devices to facilitate biologic fusion. |
| Indications for Use Alignment: | Indications contain no new language not already in predicate devices. |
| Size/Technological Characteristics Alignment with Predicates: | Very similar in size to predicate devices, and no significant differences in technological characteristics that raise new safety/efficacy issues. |
| Safety and Efficacy: | Bench testing demonstrates that minor differences do not adversely impact device performance, confirming substantial equivalence. |
Study Details
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices. The document mentions "variety of implant sizes" being tested. However, the testing was conducted on the "Endoskeleton TO Interbody Fusion Device," implying representative samples of the device were used.
- Data Provenance: This was pre-clinical bench testing performed in a laboratory setting, not clinical data from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for this type of medical device refers to the physical and mechanical properties of the device as measured against established engineering standards (ASTM standards). There are no human experts "establishing ground truth" in the way it applies to diagnostic or prognostic AI/ML devices. The "experts" would be the engineers and technicians conducting the ASTM standard tests.
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Adjudication method for the test set:
- Not applicable in the context of mechanical bench testing. The "adjudication" is the direct measurement and comparison of the device's performance against the established ASTM standards and the performance of predicate devices.
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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. This device is an interbody fusion implant, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. Bench testing is analogous to "standalone" performance for a physical device, in that its mechanical properties are evaluated independently of patient interaction at this stage.
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The type of ground truth used:
- For this device, the "ground truth" is defined by established engineering standards (ASTM F2077-03, ASTM F2267-04) and the performance characteristics of legally marketed predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.
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The sample size for the training set:
- Not applicable. This device does not use a "training set" in the machine learning sense. The device is designed and manufactured, and then its physical properties are tested.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set." The design and manufacturing processes are guided by engineering principles, material science, and regulatory requirements, not by machine learning training data.
§ 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.