(56 days)
The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact mode and are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
The neoLaser Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.
The provided text is a 510(k) summary for the neoLaser Laser Surgery Fibers. It describes a medical device and its substantial equivalence to a predicate device, BeaMed Laser Surgery Fibers (K232769). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch.
Therefore, the document does not outline acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device performance study. Instead, it focuses on demonstrating equivalence through comparison of technical characteristics and performance bench testing.
Here's why the requested information cannot be extracted from this document:
- The device is a physical medical instrument (laser surgery fibers), not an AI/algorithm-based device. The questions about MRMC studies, human reader improvement with AI, standalone algorithm performance, and ground truth establishment for training/test sets are relevant to AI/ML medical devices, not simple surgical tools.
- The 510(k) pathway for this device is based on "substantial equivalence" to a predicate device. This means the manufacturer proves the new device is as safe and effective as an already cleared device through comparison of specifications, materials, and bench testing, not through new clinical performance studies against defined acceptance criteria for a novel technology.
- The document explicitly states: "Animal or clinical studies: None." This confirms that performance studies in the way you've outlined for AI/ML models (with test sets, ground truth, expert readers, etc.) were not conducted or required for this 510(k) submission.
However, I can extract information regarding the device's characteristics and the types of "performance" assessments that were deemed sufficient for this 510(k) clearance, even though they don't align with the typical AI/ML study framework you've described.
Based on the provided document, here's an attempt to address the prompt's points, reinterpreting them for a physical medical device clearance based on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) submission for a physical device like this are primarily demonstrated through substantially equivalent technical specifications and material properties to a predicate device, along with successful bench testing to ensure safety and functionality. The document presents a comparative table rather than an acceptance criteria table.
| Specification | Subject Device (neoLaser Laser Surgery Fibers) | Predicate Device (BeaMed Laser Surgery Fibers) | "Performance" / Outcome (Demonstrated Equivalence) |
|---|---|---|---|
| Indications for Use | General surgical applications (incision, vaporization, ablation, hemostasis, coagulation of soft tissue, endoscopic applications, etc.). Wavelength: 450nm-2100nm. Contact/non-contact mode. Used in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT, endovenous occlusion, laser assisted lipolysis. SMA 905 connector. | Identical wording for Indications for Use. | Met: Substantially equivalent indications for use. |
| Fiber core material | Silica quartz glass | Silica quartz glass | Met: Identical material. |
| Fiber cladding material | silica quartz glass cladding and/or Hardclad | silica quartz glass cladding and/or Hardclad | Met: Identical material. |
| Buffer | silicone buffer | silicone buffer | Met: Identical material. |
| Jacket material | silicone / ETFE /polymide /nylon / acrylate / PVDF/ PU (with color additives) | silicone / ETFE /polymide /nylon / acrylate / PVDF/ PU (with color additives) | Met: Identical materials. |
| Maximal temperature | Nylon jacket: 176°F (80°C); ETFE jacket: 302°F (150°C) | Nylon jacket: 176°F (80°C); ETFE jacket: 302°F (150°C) | Met: Identical temperature tolerances. |
| Minimal bend radius | 51 x core diameter (short term); 121 x core diameter (long term) | 51 x core diameter (short term); 121 x core diameter (long term) | Met: Identical bend radius specifications. |
| Maximal laser power | Suitable for laser power up to 100W | Suitable for laser power up to 100W | Met: Identical power handling. |
| Shelf life | 5 years | 5 years | Met: Identical shelf life. |
| Numerical aperture range | 0.37 (for quartz/hardclad fibers); 0.22 (for quartz/quartz) | 0.37 (for quartz/hardclad fibers); 0.22 (for quartz/quartz) | Met: Identical numerical aperture range. |
| Core diameter range | 200 µm to 1000 µm | 200 µm to 1000 µm | Met: Identical core diameter range. |
| Outer diameter range | 240 µm to 1800 µm typically | 240 µm to 1800 µm typically | Met: Identical outer diameter range. |
| Distal fiber tip types | Flat, conical, ball, spherical or bended bare fibers, round or conical caps | Flat, conical, ball, spherical or bended bare fibers, round or conical caps | Met: Identical tip configurations. |
| Fiber tip outer diameter range | 1.0mm to 1.8mm | 1.0mm to 1.8mm | Met: Identical tip diameter range. |
| Length range | 6.5 feet (2 meters) to 9.9 feet (3 meters) | 6.5 feet (2 meters) to 9.9 feet (3 meters) | Met: Identical length range. |
| Emission angle range | Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial 360° | Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial emission of 360° | Met: Identical emission patterns. |
| Single/multiple use | Single use | Single use | Met: Identical use designation. |
| Sterility | Sterile by EO | Sterile by EO | Met: Identical sterilization method. |
| Packaging | Sterile, double pouched | Sterile, double pouched | Met: Identical packaging. |
| Proximal end | SMA 905 connector | SMA 905 connector | Met: Identical connector type. |
Performance Bench Testing included in the submission (serving as "proof"):
- Packaging seal strength
- Dye penetration test
- Packaging microbial barrier
- Shelf-life validation summary
- Sterilization process validation plan
- Sterilization process validation protocol
- Sterilization process validation report
- Sterility Assurance Level (SAL)
- EO-ECH residuals report
- LAL Endotoxin test
- Bioburden bare fibers test / Bioburden capped fibers tests
- Biocompatibility tests protocols & reports
- Thermal safety validation
The success of these tests (implicitly, meeting pre-defined thresholds for each) serves as the "reported device performance" that proves the device's safety and functionality for a 510(k) submission based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is for a physical device, and the submission explicitly states "Animal or clinical studies: None." The "tests" mentioned are bench tests on the device itself or its packaging/materials, not performance studies with human data. Therefore, concepts like sample size for a test set of patient data or data provenance (country, retrospective/prospective) are not relevant here.
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)
Not applicable. No "ground truth" was established in the context of an AI/ML algorithm's performance against human expert interpretations or pathology. The evaluation is based on engineering and material specifications, and physical bench testing results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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 not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's clearance is its conformity to engineering specifications, material standards, and successful completion of bench tests (e.g., sterilization efficacy, biocompatibility).
8. The sample size for the training set
Not applicable. There is no AI/ML training set for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set or associated ground truth.
§ 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.