(90 days)
The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, ureteroscopes, bronchoscopes, cystoscopes, gastroscopes, arthroscopes, colonoscopes, or for open surgery in contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Wave Form Manufacturing PGS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT Surgery, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General and Vascular Surgery.
The Wave Form Manufacturing Prolase General Shaped (PGS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the PGS fiber may be used for a wide variety of surgical procedures.
The provided text does not contain detailed information about acceptance criteria and a study proving the device meets these criteria in the typical format one would expect for a medical device. Instead, it describes a 510(k) submission for a laser surgical instrument accessory, the Wave Form Manufacturing Prolase General Shaped Fiber.
The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove performance against specific acceptance criteria through a comprehensive clinical study. The document states: "Bench testing was performed to demonstrate that the device will perform as intended." This implies that the device's performance was evaluated against its design intent, likely comparing it to the predicate devices, rather than against explicit, quantified, and publicly reported acceptance criteria.
Without a more detailed report of the bench testing, I cannot create the requested tables and information. However, I can infer some aspects based on common 510(k) practices and the provided limited text.
Here's an attempt to address your request based on the available information, with significant limitations due to the nature of the provided text:
Inferred Acceptance Criteria and Performance (Based on "Bench Testing" and "Substantial Equivalence")
Since the provided document is a 510(k) summary, formal "acceptance criteria" and a detailed "study" demonstrating performance against those criteria, as you might find for a PMA (Premarket Approval) or later-stage clinical trials, are not explicitly presented. The core of a 510(k) is demonstrating substantial equivalence to predicate devices. The "bench testing" mentioned was likely conducted to show that the device performed similarly to its predicate devices in relevant functional and safety aspects.
1. Table of Acceptance Criteria and Reported Device Performance
Given the lack of explicit criteria and performance data in the provided text, this table is based on inferences about what would typically be tested for a laser fiber and what "performed as intended" (bench testing) and "substantial equivalence" might imply.
| Acceptance Criteria Category (Inferred) | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from "Bench Testing was performed to demonstrate that the device will perform as intended" and 510(k) clearance) |
|---|---|---|
| Laser Delivery Efficiency | Efficient transmission of laser energy from laser source to the distal tip. | Demonstrated to be comparable to predicate devices. (Pass) |
| Mechanical Integrity/Durability | Ability to withstand bending, tension, and handling without breakage or damage affecting performance. | Demonstrated to be acceptable for intended surgical use. (Pass) |
| Biocompatibility | Materials are non-toxic and do not cause adverse reactions in the body. | Materials are standard for such devices or have established biocompatibility. (Implied Pass based on clearance) |
| Sterility (where applicable) | Device maintains sterility until use. | Packaging and sterilization methods deemed adequate. (Implied Pass based on clearance) |
| Thermal Performance at Tip | Controlled and predictable energy delivery at the working end. | Demonstrated to be comparable to predicate devices for vaporization, cutting, ablation, and coagulation. (Pass) |
| Tip Integrity/Shaping Maintenance | The shaped tip maintains its form during use for consistent energy delivery. | Demonstrated to be effective. (Pass) |
| Compatibility with Laser Systems | Ability to connect and function safely with appropriate laser systems. | Demonstrated compatibility with relevant laser platforms. (Pass) |
| Reflectance/Backscatter Protection | Effectiveness of the internal proprietary quartz sleeve reflector in protecting the laser focusing lens. | Demonstrated to protect the focusing lens from back splatter. (Pass) |
| Secondary Cladding Functionality | Ability of the optical secondary memory cladding to guide a steerable endoscope. | Demonstrated to aid in guiding a steerable endoscope. (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. "Bench testing" typically involves a controlled number of units, perhaps a small batch from production or engineering prototypes, rather than a large statistical sample like in clinical trials.
- Data Provenance: Not specified, but "bench testing" implies data was generated in a lab setting by the manufacturer (Wave Form Manufacturing, Inc.). This would be prospective data generated specifically for the 510(k) submission. There is no mention of country of origin of data beyond the manufacturer's location in Oregon, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For "bench testing" of device performance attributes (like laser delivery, mechanical integrity, etc.), ground truth isn't typically established by clinical experts in the same way it would be for diagnostic accuracy studies involving medical images or patient outcomes. The "ground truth" would be the engineering specifications and performance expectations derived from the predicate devices and general knowledge of fiber optics and laser physics.
- If any expert review was involved, it would likely be internal engineering or quality control personnel.
4. Adjudication Method for the Test Set
- None Specified/Not Applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where subjective interpretation (e.g., image reading) requires consensus. For bench testing of physical device properties, results are typically objective measurements against engineering specifications, not subject to variable interpretation that would require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., reading medical images). The Wave Form Manufacturing Prolase General Shaped Fiber is a surgical instrument accessory; its effectiveness is evaluated through its functional performance, not human interpretative accuracy. Therefore, this type of study would not be applicable or expected for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This question relates to AI/ML algorithms. The Wave Form Manufacturing Prolase General Shaped Fiber is a physical medical device (laser fiber), not an AI algorithm. Therefore, "standalone" performance in this context is not relevant. The device operates inherently without human-in-the-loop for its basic functional aspects, but it is a tool used by a human surgeon.
7. The Type of Ground Truth Used
- For bench testing, the "ground truth" would be engineering specifications, established performance parameters of the predicate devices, and industry standards for laser surgical fibers. For example, a certain laser power output at the tip would be expected, or the fiber would be expected to withstand a certain bend radius without breaking.
8. The Sample Size for the Training Set
- Not Applicable. This question is also relevant for AI/ML algorithms. For a physical medical device like a laser fiber, there is no "training set" in the computational sense. The device is designed and manufactured based on engineering principles and predicate device characteristics, not "trained" on data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not applicable.
Summary Limitations:
The provided text only briefly mentions "Bench testing was performed to demonstrate that the device will perform as intended" as part of the "Technological Characteristics and Performance Data" and confirms the device's clearance via 510(k) due to "substantial equivalence" to predicate devices. Without access to the actual bench test report or the detailed 510(k) submission, specific acceptance criteria and detailed quantitative performance data cannot be extracted. The strength of the 510(k) process is demonstrating equivalence to existing safe and effective devices, which often relies on non-clinical (bench or animal) testing rather than extensive human clinical trials for many Class II devices.
§ 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.