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510(k) Data Aggregation
(39 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
The provided text is a 510(k) Premarket Notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a new device's performance. Therefore, many of the requested categories of information are not present in the document.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device's clinical application. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Criteria Type | Description (from text) | Reported Device Performance (from text) |
|---|---|---|
| Substantial Equivalence | "Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner." | The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. |
| Indications for Use | The device is indicated for promoting fusion of the cervical spine and the thoracic spine (C1-T3) for conditions such as DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors. Hooks and rods also provide stabilization for fracture/dislocation or trauma in C1-T3. Screws are limited to T1-T3. Connectors allow linkage to other Endius spinal systems. | The FDA letter acknowledges the indications for use as stated and grants clearance based on substantial equivalence. |
| Material Composition | Fabricated from medical grade titanium or titanium alloy that complies with ASTM F136. | Implied compliance through substantial equivalence to predicate devices which would also use biocompatible, high-grade materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" in the context of human data. The assessment for substantial equivalence appears to be based on:
- Mechanical Test Results: The document mentions "mechanical test results" were provided to demonstrate substantial equivalence. No sample size for these tests is given, nor is their provenance.
- Comparison to Predicate Device: The primary "data" seems to be a comparison to the predicate device (Endius Minit Posterior Cervical and Upper Thoracic Fixation System, K070282) regarding design, materials, and indications for use.
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. No clinical test set with a "ground truth" established by experts is mentioned. The submission is a 510(k) for a spinal fixation system, not a diagnostic or AI device requiring expert ground truth for performance evaluation in a clinical setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is described.
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. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground for the "proof" of the device is its substantial equivalence to a previously cleared predicate device, based on similar design principles, materials, indications, and mechanical performance.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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