(348 days)
The Spinal Foraminoscope for lumbar access is indicated for endoscopic visualization in the lumbar region. The Spinal Foraminoscope for cervical access is indicated for visual inspection of the cervical spinal nerve roots and surrounding tissue.
The Spinal Foraminoscope for lumbar access is an optical and fiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mm working channel and two 1.5-mm irrigation channels and allowing insertion of 2.8-mm or 3.5-mm hand-held instruments. The Spinal Foraminoscope for cervical access is a fiberoptic-based rigid endoscope which shares the same design. It is provided with a 2.2-mm working and irrigation channel, has a 3.6- mm outer diameter and allows insertion of 2.0-mm hand-held instruments. The Spinal Foraminoscope may be attached to standard fiberoptic light sources and Storz, Olympus, Wolf and ACM cameras and video adapters.
The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding the methodologies for establishing ground truth, subject demographics, or expert qualifications. The document is a 510(k) summary for the "Spinal Foraminoscope" and an FDA clearance letter.
However, based on the Performance Data section of the 510(k) summary, the following can be inferred and stated:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device met "all specified design and performance requirements" to demonstrate substantial equivalence to predicate devices (Yeung Endoscopic Spine System, K973405; Spine Scope, K011454; Pollux Arthroscopes, K953484). | "The Spinal Foraminoscope met all specified design and performance requirements." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes a substantial equivalence determination based on meeting design and performance requirements against predicate devices, rather than a clinical study with a test set of data/patients.
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 establishment is not relevant in this type of substantial equivalence submission, which focuses on device functionality and design rather than clinical diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or human interpretation 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:
- No. An MRMC study was not done as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth is not relevant to this type of device submission. The "ground truth" for the device's performance is its ability to meet the engineering specifications and intended use as an arthroscope, similar to predicate devices.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device requiring a training set.
Summary of Study:
The document states that "Testing was performed to support substantial equivalence to the predicate device." While the specific details of this testing are not provided in the summary, it implies that various engineering and functional tests were conducted to ensure the Spinal Foraminoscope performed as intended and comparably to the identified predicate devices (Yeung Endoscopic Spine System, Richard Wolf Medical Instruments Corp., K973405; Spine Scope, Model 2180, Clarus Medical, LLC., K011454; Pollux Arthroscopes, Pollux Endoscopy, Inc., K953484). The conclusion is that the device "met all specified design and performance requirements" to establish substantial equivalence.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.