(67 days)
The Hall®Smart Guard® Irrigator is an accessory to a powered instrument system consisting of drills, saws and associated handpieces to perform the cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngology, plastic/reconstructive and oral/maxillofacial procedures.
The proposed Hall® Smart Guard® Irrigator is also an accessory/attachment to a powered instrument system that provides irrigation at the surgical site. It is an injectionmolded, polypropylene sleeve that fits over the bur guard on the distal tip of the handpiece. A stainless steel, single-lumen tube is insert-molded into the sleeve and can be attached to irrigation tubing to direct fluid to the surgical site. Irrigation inflow is controlled by a pump integral to the console. The proposed attachments will be available as sterile, single use devices. The Hall® Smart Guard® Irrigator will be packaged in a Twek®/poly pouch.
The polypropylene contains a thermochromatic dye that changes color when the internal temperature of the bur guard reaches 135° F and before the external temperature of the Hall® Smart Guard®Irrigator reaches 122°. This feature provides a heat indicator that serves two purposes:
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- The temperature of the bur guard increases when the bearings are worn. It will alert the user that the bur guard should be serviced.
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- It will alert the user that the temperature of the Hall® Smart Guard® Irrigator has increased to the point that could result in potential patient injury.
In addition, the Hall® Smart Guard® Irrigator provides thermal insulation to the patient from heat that may be generated by the bur guard. The sleeve provides insulation to the patient by virtue of the physical barrier between the bur quard and the patient.
The provided text describes a medical device, the Hall® Smart Guard® Irrigator, and its 510(k) submission for substantial equivalence. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document focuses on:
- Description of the device: How it works, its components, and its unique feature (thermochromatic dye for heat indication).
- Intended Use: The medical fields and procedures for which it is designed.
- Substantial Equivalence: Comparing it to legally marketed predicate devices to demonstrate it does not raise new issues of safety and efficacy.
- Regulatory Clearance: The FDA's letter granting 510(k) clearance based on substantial equivalence.
Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:
- Table of acceptance criteria and reported device performance: No specific performance metrics or acceptance criteria are mentioned.
- Sample size used for the test set and data provenance: No test sets or study data are discussed.
- Number of experts used to establish ground truth and qualifications: There is no mention of expert involvement in establishing ground truth for testing.
- Adjudication method: Not applicable as no ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable as no ground truth for testing is described.
- Sample size for the training set: Not applicable as there is no training set for an AI algorithm.
- How ground truth for the training set was established: Not applicable.
The document indicates that "The changes made to the legally marketed devices have been tested to assure that the proposed modifications do not raise any new issues of safety and efficacy," but it does not provide details about these tests, their criteria, or results.
§ 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.