(85 days)
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
The Kelsey Interstitial Laser Therapy system consists of the following:
- One laser probe, a 14 gauge needle, 304 stainless steel with one (1) thermistor attached.
- One temperature probe, a 14 gauge needle, 304 stainless steel with five (5) thermistors attached.
- Thermistor temperature to digital converter.
- Syringe infusion pump capable of accurately infusing a normal saline solution at variable flow rates to 1 cc per minute, continuously adjustable, including bolus function.
- Laser diode source, 1-8 watts, 805 nominal nanometer wavelength.
- Storage cart.
- Personal computer running Windows XP with Service Pack 2, or better, including monitor and keyboard.
The provided text is a 510(k) summary for the Kelsey Interstitial Laser Therapy System. It describes the device, its intended use, and its comparison to predicate devices, focusing on the regulatory approval process rather than detailed performance study results.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available within the provided document. The 510(k) summary states that "Bench and clinical testing demonstrated that the use of the Kelsey ILT device for the ablation of breast fibroadenoma tissue is safe and effective," but it does not provide the specifics of these tests or their results in a format that would allow for the detailed table and answers requested.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not specify quantitative acceptance criteria or provide specific reported device performance metrics in a verifiable way. It only broadly states that testing "demonstrated that the use of the Kelsey ILT device for the ablation of breast fibroadenoma tissue is safe and effective."
2. Sample size used for the test set and the data provenance
Not available. The document mentions "clinical testing" but does not provide details on the sample size of any test set, nor does it specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available. There is no mention of experts establishing ground truth or their qualifications.
4. Adjudication method for the test set
Not available. The document does not describe any adjudication method.
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
Not applicable. The Kelsey Interstitial Laser Therapy System is a surgical instrument using laser therapy, not an AI-assisted diagnostic or imaging device for human readers. Therefore, an MRMC comparative effectiveness study would not be relevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As stated above, this device is a surgical instrument, not an algorithm, so this question is not relevant.
7. The type of ground truth used
Not available. While "ablation of breast fibroadenoma tissue" implies a clinical outcome, the specific type of ground truth (e.g., pathology, clinical follow-up, imaging correlation) used to assess the device's "safety and effectiveness" is not detailed.
8. The sample size for the training set
Not applicable/Not available. As above, this is a surgical instrument, not a device involving machine learning algorithms that would typically have a "training set." If "training set" refers to pre-clinical or bench testing, the sample size is not provided.
9. How the ground truth for the training set was established
Not applicable/Not available. As above, this question is not relevant in the context of the device described.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.