(146 days)
The E9000 System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Arthroscopic, Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.
The E9000 System is a combination drive system and irrigation console, which consists of an AC powered drive/pump console, a power cord, a footswitch, a sterilizable handpiece cord, various motorized handpieces, associated shavers, blades, burs, bur guards, routers, irrigation tubing sets, and bur tips.
This document is a 510(k) summary for the Linvatec E9000 System, a surgical power tool. It establishes substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the format typically used for AI/software-based medical devices.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a hardware device.
Here's an attempt to answer based on the provided document, addressing the relevant sections and indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" or "reported device performance" in the manner typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity thresholds, AUC). Instead, substantial equivalence for this surgical system is based on similarities in design, function, and intended use with predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "Testing has been done to prove safety and effectiveness of the devices." (No specific metrics provided.) |
| Similar Intended Use | The E9000 System's intended use matches or is comparable to predicate devices for cutting soft tissue and bone in various surgical procedures. (Detailed in Section F and the comparison chart). |
| Similar Design/Function | The E9000 System is a combination drive system and irrigation console, with motorized handpieces, shavers, blades, etc., similar to the predicate devices. (Detailed in Section E and the comparison chart). |
| Predicate Device Equivalence | Found "substantially equivalent" to the Hall E9000 Integrated Drive/Pump System, MicroChoice Universal Drive System, and Hall Sternum Saw. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it is a 510(k) summary for a hardware device, not a clinical study on a diagnostic algorithm. The "testing" mentioned is likely engineering and performance testing (e.g., mechanical, electrical, sterilization) rather than clinical efficacy studies with human subjects.
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)
This information is not provided and is not applicable to a 510(k) submission for a surgical instrument. There is no concept of "ground truth" expert review in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for this type of device submission.
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
An MRMC comparative effectiveness study is not applicable as this is a surgical power tool, not an AI-assisted diagnostic or interpretation device that "improves human readers." Therefore, no effect size is reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable as the E9000 System is a physical surgical power device operated by a human surgeon, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for a surgical device like this would be its ability to perform its intended mechanical function safely and effectively (e.g., cutting bone, oscillating saws) as demonstrated through engineering tests and historical performance of similar devices.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device submission. There is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device submission.
§ 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.