(338 days)
The ITALITE tm Light Wand is indicated for illumination during joint examinations, arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporal-mandibular joint, ankle, and elbow.
The ITALITE tm Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use.
The ITALITE tm is for illumination only and is not indicated for viewing. It is to be used by physicians only.
The ITALITE tm models of Light Wands range in size as follows:
| MODEL | LENGTH | DIAMETER |
|---|---|---|
| 650-3.1 | 650 mm | 3.1 mm |
| 600-3.1 | 600 mm | 3.1 mm |
| 550-3.1 | 550 mm | 3.1 mm |
| 500-3.1 | 500 mm | 3.1 mm |
| 450-2.0 | 450 mm | 2.0 mm |
| 400-2.0 | 400 mm | 2.0 mm |
The ITALITE tm series of Light Wands are semi rigid type devices which are intended for illumination during joint examinations, biopsies, in minimally invasive procedures of the knee, shoulder, temporal mandibular joint, ankle, and elbow.
The device consists of a thin walled stainless steel tube (either 3.1 mm or 2.0 mm) varying in length from 400 to 650 mm depending on the model number as above. 50 micron glass fibers fill the inner diameter of the tube. At the proximal end the fibers are sealed with epoxy and polished. They are terminated in a light pipe connector compatible with off the shelf light sources such as those manufactured by ACMI, Wolff, Stortz, and Olympus. A stainless steel knob at the proximal end facilitates the direction and placement of the Light Wand.
The distal end of the Light Wand has a window perpendicular to the shaft where the fibers terminate. They are epoxied and polished to form a window perpendicular to the shaft. Hence the light is directed perpendicular to the shaft and provides illumination in that direction instead of head on from the end of the Light Wand.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ITALITE™ Light Wand, structured to answer your questions:
Acceptance Criteria and Study for ITALITE™ Light Wand
1. A table of acceptance criteria and the reported device performance
Based on the provided K070021 510(k) summary, formal, quantitative acceptance criteria and specific reported device performance values (e.g., lumens, wavelength, beam uniformity) are not explicitly detailed. The device's performance is primarily validated through demonstrating substantial equivalence to predicate devices and adherence to general safety and quality standards.
The closest stated "acceptance criteria" are implied by the device's design and materials, and adherence to relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Specifications: | Device met all functional specifications. (Statement from "Performance tests designed to ensure that the device met all of its functional specifications.") |
| Safety Compliance: | Device complies with applicable industry and safety standards. (Statement from "Safety tests have been performed to ensure the device complies with applicable industry and safety standards.") |
| Biocompatibility: | Constructed of materials of the same specifications as predicate devices to ensure biocompatibility. (Statement from "The ITALITE™ series of Light Wands are constructed of materials of the same specifications as the predicate devices to ensure biocompatibility.") |
| Sterilization Efficacy: | Ability to sterilize the device has been confirmed by the recommended sterilization validation protocol. (Statement from "The ability to sterilize the device has been confirmed by the recommended sterilization validation protocol.") |
| Adherence to Standards: | Designed to meet applicable portions of IEC60601-2-18 and Manufacturing under an approved Quality System. Conforms to applicable ISO standards. (Statements from "PERFORMANCE STANDARDS" and "The ITALITE™ Light Wands conforms to applicable ISO standards.") |
| Safety and Effectiveness: | Shown to be safe and effective (by meeting functional specifications, safety compliance, and providing clear labeling). (Statement from "It has therefore shown to be safe and effective.") |
| Substantial Equivalence: | Substantially equivalent in safety and efficacy to predicate devices. (Conclusion stated.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set, nor does it provide details on data provenance (country of origin, retrospective or prospective). The submitted information focuses on design characteristics, material equivalence, and adherence to general standards rather than a specific clinical or performance evaluation with a dedicated test set.
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 in the document. As the submission relies on substantial equivalence and compliance with general safety standards, there is no mention of a formal test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as there is no described test set requiring a ground truth adjudication process.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable to this device. The ITALITE™ Light Wand is an illumination device without any AI components or human-in-the-loop performance measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study (algorithm only) was not done and is not applicable to this device, as it does not contain any algorithms or software. The device itself is a physical light wand.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic or AI devices is not directly relevant or mentioned for the ITALITE™ Light Wand. Its validation is based on:
- Material Equivalence: To predicate devices.
- Functional Testing: To ensure it meets its own specifications (not defined in detail).
- Safety Testing: To confirm compliance with standards.
- Sterilization Validation: Confirmation of protocol.
There are no diagnostic claims or parameters that would require a ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable and not provided. The ITALITE™ Light Wand is a passive medical device without any software or AI components that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for this device.
§ 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.