(45 days)
DTRAX Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
The DTRAX® Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of a facet joint access tool, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and tamp. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
The provided text describes the 510(k) submission for the DTRAX® Spinal System, a set of surgical instruments. The information focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to consensus standards. It does not contain the kind of detailed information about acceptance criteria and clinical study results (like MRMC studies, human reader improvement with AI assistance, ground truth establishment for training and test sets, etc.) that would be present for an AI/ML medical device.
Therefore, many of the requested details cannot be extracted from this document, as it pertains to a mechanical surgical instrument system, not an AI/ML medical device.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Device Performance
The document does not explicitly present acceptance criteria in a table format with reported performance against specific metrics in the way one would see for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Non-clinical testing has demonstrated the DTRAX® Spinal System meets the performance requirements to safely distribute and use in accordance with the Indication for Use."
The performance assessment is described as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to perform posterior cervical fusion in cadavers. | "Simulated use cadaveric testing demonstrated the instruments can be used to perform posterior cervical fusion in patients with cervical degenerative disc disease." |
| Safety and efficacy of instruments; strength/integrity for impaction, insertion, removal, rotational loads. | "The bench testing demonstrated the safety and efficacy of the instruments and the strength and integrity to resist impaction, insertion, removal, and rotational loads to perform the stated intend use." |
| Compliance with specific FDA recognized consensus standards. | "Additionally, the DTRAX® Spinal System demonstrated that it is in compliance with the following FDA consensus standards:" (A list of 9 ISO/ASTM/ANSI standards related to sterilization, packaging, biological evaluation, and material properties is provided.) The implication is that the device met the requirements of these standards. |
Study Details (as inferable from a non-AI/ML device submission)
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical 'sample size' for a test set in the context of clinical images or patient data. The testing involved "simulated use cadaveric testing" and "bench testing." The number of cadavers or test repetitions is not specified.
- Data Provenance: The cadaveric testing implies a source of human cadavers (country of origin not specified). Bench testing is in-laboratory. The studies were non-clinical.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not present. This type of ground truth establishment is typically for AI/ML devices analyzing medical images. For a surgical instrument, performance is assessed through mechanical testing and cadaveric simulations, not through expert reading of results in the same way.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not present. Adjudication methods are relevant for interpretation of medical images or clinical outcomes, not for the mechanical performance of surgical tools.
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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:
- No. An MRMC study is relevant for AI-assisted diagnostic devices. This document describes a surgical instrument, not an AI device, so no such study was conducted or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the cadaveric testing, the "ground truth" was likely the successful completion of the surgical procedure and assessment of bone decortication/fusion preparation.
- For bench testing, the "ground truth" was meeting engineering specifications for strength, integrity, and compliance with recognized standards.
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The sample size for the training set:
- Not applicable / Not present. This document describes a non-AI/ML medical device. "Training set" is a concept for machine learning algorithm development, which is not relevant here.
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How the ground truth for the training set was established:
- Not applicable / Not present. As there is no AI/ML component, there is no training set or associated ground truth establishment process in the context of machine learning.
§ 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.