(136 days)
The Xomed XPS StraightShot Microdebrider System is intended for the cutting and removal of soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery.
It is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is needed. These include spinal and small and large joint arthroscopic procedures.
The XPS System remains essentially the same as originally described in K963246. There is a Power Control Unit, a footswitch, reusable handpieces and various interchangeable, disposable burs and blades. The system can operate one or two handpieces (one at a time) with suction and irrigation, depending on the handpiece. Xomed now proposes to market the XPS System for the same intended use in orthopedic surgery, including spinal and small and large joint procedures. In order to best meet the needs of the orthopedic surgeons, we have added to the original system, a larger handpiece and additional blades and burs. Other than the larger motor with additional speed and torque, the principle of operation and Power Control Unit remain essentially the same as described in K963246.
This 510(k) submission (K973499) for the XPS StraightShot Microdebrider System describes the device and its intended use, but does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.
The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically focuses on comparing the new device's design, materials, and intended use to existing devices, rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, for your request, I can only provide the following based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The 510(k) summary describes the device and its intended use, and compares it to predicate devices, but does not specify performance acceptance criteria or report on device performance against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document. No performance study data is presented.
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 available in the provided document. No performance study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document. No performance study data is presented.
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:
This information is not available in the provided document. The device is an electrical surgical shaver/debrider, not an AI-assisted diagnostic tool, so an MRMC study or AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document. No performance study data is presented.
8. The sample size for the training set:
This information is not available in the provided document. No performance study data is presented.
9. How the ground truth for the training set was established:
This information is not available in the provided document. No performance study data is presented.
In summary: The provided 510(k) document focuses on establishing substantial equivalence to predicate devices for the purpose of market clearance. It does not include the detailed performance study data, acceptance criteria, or ground truth establishment requested, as these are typically part of a different type of regulatory submission (e.g., PMA) or internal validation testing. The substantial equivalence argument relies on the safety and effectiveness of the predicate devices.
§ 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.