(29 days)
The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized.
The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.
The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.
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Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state acceptance criteria in a quantitative or qualitative manner against which the Endius Atavi System's performance is measured. Instead, it refers to "validation testing (performance testing)" as part of a Special 510(k) submission, confirming compliance with design control requirements.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text. The basis for substantial equivalence is primarily rooted in comparison to predicate devices, indications for use, and technological characteristics, rather than specific performance metrics against pre-defined acceptance criteria.
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Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific "test set" with a sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission is a "Special 510(k): Device Modification," which focuses on demonstrating compliance with design control requirements and relevant validation testing for the modification. This type of submission typically doesn't involve clinical studies with test sets in the same way as a de novo or traditional 510(k) for a new device might. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The document does not describe a study involving a "test set" for which ground truth was established by experts. -
Adjudication Method for the Test Set:
Not applicable. The document does not describe a study involving a "test set" that would require an adjudication method. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence based on technological characteristics and indications for use compared to predicate devices, and design control compliance for modifications, not on measuring human reader improvement with or without AI assistance. -
Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
No, a standalone (algorithm only) study was not done. The Endius Atavi System is an endoscopic spinal access system, a physical medical device, not an algorithm or AI. -
Type of Ground Truth Used:
Not applicable. The document does not describe a study that established "ground truth" using expert consensus, pathology, or outcomes data. The submission is a Special 510(k) for a device modification, focusing on verifying that the modified device continues to meet its intended purpose and safety requirements in line with predicate devices. -
Sample Size for the Training Set:
Not applicable. The Endius Atavi System is a physical medical device, not an AI or algorithm that would require a "training set." -
How Ground Truth for the Training Set Was Established:
Not applicable. As the device is not an AI or algorithm, there is no "training set" or "ground truth" establishment process for it in this context.
§ 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.