(184 days)
The Ceralas Fiber-Coupled Diode Laser family 980nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
Added Indication for Use:
Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.
Ceralas Fiber-Coupled Diode Laser 980 nm Family
The request implicitly asks for a detailed description of acceptance criteria and the study proving the device meets them, but the provided text (K100726 Biolitec Inc.'s Ceralas Fiber-Coupled Diode Laser 980nm Family) does not contain typical acceptance criteria tables or detailed study results like those found in clinical efficacy trials for AI/ML devices.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices for an additional indication of use (Percutaneous Lumbar Disc Decompression/Diskectomy). The performance "data" discussed is not about numerical accuracy or sensitivity/specificity but about confirming the safety and efficacy of the 980nm laser for a new application, primarily by comparing its technological characteristics to already-cleared devices.
Therefore, many of the requested categories (like sample size, ground truth, experts, MRMC study, standalone performance) are not applicable to the type of submission presented here.
Here's a breakdown of what can be extracted and why other parts are not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Efficacy for Percutaneous Lumbar Disc Decompression/Diskectomy | Substantially Equivalent to predicate devices (Ceralas G15 532nm, Ceralas D1950, Quanta System Polysurge, Quanta System Model 30, INTERmedic 810nm & 980nm families) for this added indication. The 980nm family demonstrates "no significant difference" in performance compared to cleared Ceralas G15 532nm and D1950 lasers for this use. |
| Technological Characteristics | The Ceralas 980nm family has "substantially similar technological characteristics" compared to predicate devices for the intended use and added indications. Minor technological differences are stated to raise "no new issues of safety or effectiveness." |
| General Surgical Applications (incision, excision, ablation, cutting, vaporization, hemostasis, coagulation of soft tissue) | The device is indicated for these uses, presumably based on prior clearances and the substantial equivalence to predicate devices which also have these indications. No specific performance metrics or acceptance criteria for these general uses are provided in this document, as the focus is on the added indication. |
Explanation: The "acceptance criteria" here are implicitly meeting the standards of safety and effectiveness as demonstrated by the predicate devices for the target anatomical location and procedure. "Device performance" is stated as being "substantially equivalent" rather than reporting specific metrics like sensitivity or accuracy.
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for substantial equivalence based on technological characteristics and prior clearances, not a clinical study involving a "test set" of patients or data in the typical sense for AI/ML device evaluations. No patient-specific data or cohorts are mentioned for this particular submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no specific data "test set" requiring ground truth by external experts is detailed in this 510(k) summary, this information is not provided. The assessment of substantial equivalence is done by the manufacturer (Biolitec) and reviewed by the FDA, based on engineering data, technological comparisons, and established principles of laser surgery.
4. Adjudication method for the test set
- Not Applicable. There is no "test set" discussed in the context of clinical data requiring an 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. This device is a laser surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related performance metrics are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this type of 510(k) – substantial equivalence for an added indication for a physical device – "ground truth" as typically defined for diagnostic or AI/ML devices is not explicitly stated or required in this summary. The "truth" is based on the established safety and efficacy of the predicate devices and the technological comparison demonstrating the new device performs similarly for the new indication.
8. The sample size for the training set
- Not Applicable. This is a physical medical device (laser), not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or its ground truth is relevant or discussed for this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) Summary):
The "study" presented in this 510(k) summary is not a traditional clinical trial with patient cohorts and statistical outcomes. Instead, it is a design and performance comparison study demonstrating the Ceralas Fiber-Coupled Diode Laser 980nm Family's substantial equivalence to legally marketed predicate devices for the added indication of Percutaneous Lumbar Disc Decompression/Diskectomy.
Key components of this "study":
- Technological Characteristics Comparison: The submission details that the Ceralas 980nm family has "substantially similar technological characteristics" (e.g., wavelength, power output, delivery accessories, fundamental principle of operation) to several predicate devices already cleared for similar applications, including other Ceralas models (G15 532nm, D1950) and lasers from Quanta System and INTERmedic.
- Performance Data Assessment: The document states that "Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers." While the specifics of this "performance testing" are not detailed in this summary, it would typically involve bench testing (e.g., power output stability, beam profile, tissue ablation rates in ex vivo models, thermal effects) to confirm the new device performs within expected parameters and similarly to the predicates for the intended use.
- Safety and Effectiveness Argument: The core of the submission is the argument that because the technological characteristics are similar and performance testing shows no significant difference, the Ceralas 980nm family is as safe and effective for Percutaneous Lumbar Disc Decompression/Diskectomy as its predicate devices, which are already deemed safe and effective for similar uses. The minor technological differences are argued not to raise new issues of safety or effectiveness.
Conclusion from the document: The FDA's review agreed with this assessment, issuing a letter stating that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. This substantial equivalence determination is the primary "proof" for this type of regulatory submission, rather than a clinical trial report with numerical performance metrics.
§ 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.