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510(k) Data Aggregation
(82 days)
LGO-Surgical Laser Fibers
LGO-Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified laser with operational wavelengths between 500 nm - 2200 nm equipped with SMA 905 standard or freestanding ferrule connector, as per the indications of the laser device used with.
LGO-Surgical Laser Fibers are a group of single use or reusable with up to 10 total uses EtO sterilized laser powered surgical instruments. They are intended for use in healthcare facilities or hospitals by physicians being familiar with the handling of medical laser devices, and with the therapeutic application of sterile medical optical fibers.
There are two primary product subgroups: Bare Fiber and Side Fire Fiber. Each subgroup encompasses various models on the market, which primarily vary in their distal end design, jacket materials, diameter, length, and usage (single use or 10x reusable). All variations of the LGO-Surgical Laser Fibers feature an SMA-905 connector or a custom special connector at the proximal end for compatibility with appropriate medical laser devices.
The provided FDA 510(k) summary for the LGO-Surgical Laser Fibers describes a medical device (laser fibers), not an AI/Software as a Medical Device (SaMD). Therefore, the document does not contain the information requested regarding acceptance criteria, study details, human reader studies, or ground truth establishment for AI/SaMD.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This includes product code, indications for use, core diameter, material composition, operating wavelength, usage, sterilization, and proximal end connector.
- Non-clinical performance data: This section lists various tests performed on the device to ensure its safety and performance (e.g., biocompatibility, sterilization validation, shelf-life validation, light transmission, functional tests).
- A statement that no clinical testing was performed or deemed necessary.
In summary, none of the requested information regarding acceptance criteria and study proving an AI/software device meets these criteria can be extracted from this document, as it pertains to a physical medical device (laser fibers) and not AI/SaMD.
Therefore, I cannot populate the table or provide answers to the questions based on the provided text.
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(28 days)
OmniGuide RFID Surgical Laser Fibers
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters
Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this 510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)].
The provided text describes the OmniGuide RFID Surgical Laser Fibers and seeks to establish substantial equivalence to a predicate device, the OmniGuide LISA Laser Family of Surgical Laser Fibers (K220189). The document outlines various performance tests and compliance with recognized standards.
However, it's crucial to understand that this document describes a 510(k) submission, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This is different from a typical clinical study with a detailed description of acceptance criteria, statistical analysis, and ground truth establishment you might expect for a novel AI device.
Let's break down the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria in the traditional sense of numerical thresholds for a specific clinical outcome for the new device itself. Instead, it outlines a comparison between the subject device (OmniGuide Prima Surgical Laser Fibers) and the predicate device (OmniGuide LISA Laser Surgical Fibers) to demonstrate substantial equivalence. The "acceptance criteria" here are essentially that the new device performs as well as or similarly to the predicate device across various technical and safety characteristics.
| Characteristic | Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (Subject Device - OmniGuide Prima Surgical Laser Fibers) |
|---|---|---|
| Indications for Use | Same as predicate, covering all surgical specialties with compatible laser systems (500nm - 2200nm) and use with SMA 905/906 or manufacturer-specific connectors. | Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters. (Same/Equivalent) |
| Intended Use | Same as predicate. | Provision of high quality surgical laser fiber optic delivery systems for laser surgery, including ablation, coagulation, incision, excision, or vaporizing in any soft/hard-tissue application. (Same/Equivalent) |
| Regulatory Information | Product Code (GEX), Regulation Number (21 CFR 878.4810), Regulation Name (Laser surgical instrument for use in general and plastic surgery and in dermatology) must be the same. | GEX, 21 CFR 878.4810, Laser surgical instrument for use in general and plastic surgery and in dermatology. (Same/Equivalent) |
| Technological Characteristics | Components, Wavelength Compatibility (High OH or Low OH silica material w/low attenuation between 532nm - 2100nm), Numerical Aperture (between 0.22 - 0.48), Fiber Distal Tip configurations, compatibility with attachments (core diameters suitable to user needs), Connectors, Fiber Construction, Peak/Continuous Wavelengths, Power Ranges, Diameter, Compatibility with surgical laser systems must be the same/equivalent. | Components (Connector configurations suitable to multiple laser platforms), High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm - 2100nm, Fiber having a Numerical Aperture (NA) between 0.22 - 0.48, Multiple configurations of distal tips offered, Core diameters are offered in a range of sizes suitable to user needs, SMA 905/906/manufacturer specific connectors, Fiber Construction (Core - Fused Silica, Clad - Fused Silica or Fluoropolymer Hard Cladding, Buffer - Fluoropolymer Hard Cladding or Silicone Acrylate, Jacket - Nylon, Polyimide, or Teflon), Peak and Continuous Wave lengths (500nm-2200nm), Power Ranges (1-300 Watts), Diameter (Core diameters offered in a range of sizes), Fiber Distal Tip (Multiple configurations), Compatibility with surgical laser systems (Fibers compatible with any cleared laser system with appropriate connection system). (All listed as Same/Equivalent) |
| Sterilization Technique | Same as predicate (EtO). | EtO (Ethylene Oxide). (Same/Equivalent) |
| Performance Characteristics | Demonstrate comparable performance (e.g., Power & Energy input/output, homogeneity of output light, high-power testing, bend radius, pull testing). | Bench testing (Section 21) included: Power & Energy input versus output, Homogeneity of output light (spot check, beam profile), High-power testing, Bend radius testing, Pull testing. Feature-specific testing conducted to demonstrate equivalence, including safety, performance, integrity, stability, transport, and label integrity. Specific tests mentioned: Performance test of Prima 150/1000/Sidefire laser fiber on RevoLix HTL; Test of mechanical stability of Prima 150/1000/550 micron laser fiber. Additional feature testing referenced from predicate K220189: Scatter Free Fiber, Expanded transmission of laser wavelength/energy, distal tip configuration, Nav Tip ability to traverse deflected endoscope. (Results indicated device performs in accordance with requirements and specifications, in similarity to predicate, not raising new safety or efficacy risks/questions). |
| Biocompatibility & Other Safety | Demonstrate biocompatibility and compliance with relevant safety standards (e.g., ISO 10993 series, ISO 14971). | Compliance with ISO 10993-1, 10993-5, 10993-7, 10993-10, 10993-11, ISO 14971, ASTM F56-13, ASTM F619-14. (All standards listed as complied with.) |
| Packaging & Shelf-Life | Demonstrate comparable packaging integrity and shelf-life through testing (e.g., ISO 11607-1, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07, ISTA Project 2A). | Compliance with ISO 11607-1, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07, ISTA Project 2A. (All standards listed as complied with.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "bench testing" and "performance testing" rather than a clinical test set with human subjects.
- Sample Size: The exact sample size for each specific bench test (e.g., how many fibers were subjected to pull testing) is not explicitly stated in the provided text. It generally refers to "the subject device" and "the predicate device."
- Data Provenance: The testing appears to be retrospective in the sense that it's evaluating a product against established benchmarks and a predicate device. The testing was conducted by or for Omni-Guide Holdings, Inc. (the device manufacturer) and its contract manufacturer, LightGuide Optics International Ltd. No specific country of origin for the data is mentioned beyond this, but given the company's address is in Massachusetts, USA, and the FDA submission, the testing would generally align with US regulatory context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable in the context of this 510(k) submission. For devices like laser fibers, "ground truth" is typically established through engineering specifications, material science properties, and performance standards, not through expert clinical consensus as would be the case for an AI diagnostic tool.
4. Adjudication Method for the Test Set:
This is not applicable. The evaluation of laser fiber performance is based on physical measurements, technical specifications, and adherence to engineering standards, not on subjective interpretations requiring an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers in tasks like image interpretation. This document describes a medical device (laser fibers), not an AI diagnostic or assistance tool. The study focuses on the physical and performance equivalence of the laser fibers themselves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical surgical tool (laser fiber), not an algorithm or software. It requires a human operator (surgeon) to use it with a laser system.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating these laser fibers is based on engineering specifications, material science properties, and compliance with recognized industry standards. This includes:
- Documented chemical and physical properties of materials (silica, fluoropolymer, etc.).
- Performance measures like power output, beam homogeneity, bend radius tolerance, and pull strength, measured against design specifications.
- Compliance with various ISO and ASTM standards for sterilization, packaging, biocompatibility, and risk management.
- Comparison data from the predicate device (OmniGuide LISA Laser Surgical Fibers, K220189), which serves as a benchmark for "safe and effective" performance.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This device development does not involve machine learning or AI models that require training data.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as point 8.
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(26 days)
Surgical laser fibers
Surgical Laser fibers are intended to be used to deliver the target tissue when used with any cleared/ certified surgical laser with operational wavelengths between 500mm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact mode during surgical procedures including via endoscopes and cystoscopes.
The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber. These devices are typically jacketed with ETFE, but some models are characterized by the presence of Nylon coating. The devices are 3.0 meters (9.8 ft) or 5.0 meters (16.4 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and several core diameter sizes (from 200 to 1000 microns) are offered.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The document is a 510(k) premarket notification for "Surgical Laser Fibers," which are physical medical devices, not AI/ML software.
The document discusses:
- Device Description: Surgical Laser Fibers, their materials, lengths, connectors, and core diameters.
- Modifications: Addition of 5.0-meter long fibers and nylon-jacketed fibers.
- Performance Data: Mentions biocompatibility testing, reprocessing validation testing, and initial EtO validation testing against ISO standards.
- Comparison with Predicate Devices: States that the device is substantially equivalent to previously cleared predicate devices (K160513 and K170366).
- Indications for Use: Describes how the laser fibers are intended to be used with surgical lasers.
None of the requested information (acceptance criteria for AI/ML performance, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is applicable or present in this regulatory submission for surgical laser fibers.
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(26 days)
Surgical Laser fibers
Surgical Laser Fibers are intended to be used in conjunction with cleared surgical lasers equipped with SMA 905 or SMA 906 or compatible connector.
Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, haemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application).
Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Surgical Laser Fibers are 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 with an approved compatible laser marketed for use in the desired application.
Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.
Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue. The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations (flat and ball shaped) and several core diameter sizes (from 200 to 1000 microns) are offered.
The provided text is a 510(k) premarket notification for "Surgical Laser Fibers" (K180158). This document primarily focuses on establishing substantial equivalence to a predicate device and does not describe a study proving the device meets specific acceptance criteria in the way a diagnostic algorithm or predictive model would.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present quantitative acceptance criteria or device performance data in the typical sense of a diagnostic or predictive device. Instead, it relies on demonstrating compliance with recognized consensus standards and "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterilization | Complies with EN 556-1:2006, ISO 11135-1:2007, ISO 11138-2:2006, EN ISO 17665:2006 (for moist heat sterilization). |
| Biocompatibility | Complies with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010. Materials are unchanged from predicate, assumed biocompatible. |
| Packaging & Labeling | Complies with ISO 15223-1:2012, EN 1041:2008, ISO 11607-1:2006, ISO 11607-2:2006. |
| Risk Management | Complies with ISO 14971:2007. |
| Microbiological Methods | Complies with ISO 11737-1:2006. |
| Fiber Optic Connectors | Complies with IEC 61754-22:2005. |
| Intended Use & Technological Characteristics | Stated as having the "same intended use and the same technological characteristics" as the predicate device (K160513). |
2. Sample Size for Test Set and Data Provenance
Not applicable. This device is a surgical tool, not a diagnostic or AI-driven system that would typically have a "test set" in the context of algorithm performance. The "testing" involved compliance with established medical device standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for this type of device submission. Compliance with standards is typically assessed by engineers and regulatory experts.
4. Adjudication Method
Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is a surgical laser fiber, not an AI-assisted diagnostic tool. Therefore, there's no concept of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for medical device safety, performance, sterilization, biocompatibility, and packaging. The claim of "substantial equivalence" to a predicate device (K160513) also serves as a form of "ground truth" regarding its safety and effectiveness profile.
8. Sample Size for Training Set
Not applicable. This is not an AI/ML device trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study/Evidence Provided:
The "study" or evidence provided in this 510(k) submission is primarily a declarative statement of compliance with consensus standards and a comparison to a legally marketed predicate device. The manufacturer asserts that the modified device (K180158) is "substantially equivalent" to its predicate (K160513) because:
- It has the same intended use.
- It has the same technological characteristics.
- Any minor labeling differences do not raise new questions of safety or effectiveness.
- The device (both predicate and subject) complies with a comprehensive list of recognized international and European standards covering aspects like sterility, biocompatibility, packaging, risk management, and fiber optic connector specifications.
Therefore, the "proof" the device meets acceptance criteria lies in its adherence to these established standards and its demonstrated equivalence to a previously cleared device. There are no clinical trials, diagnostic performance metrics, or expert consensus reviews detailed in this document for this specific device.
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(23 days)
Quanta System Surgical Laser fibers
Quanta System Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector.
Quanta System Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are 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 with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 mm to 2100 om, with pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
The Quanta System Surgical Laser Fibers are a family of medical devices. The Quanta System Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes.
The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 550, 600, 800 and 1000 microns) are offered.
The provided document is a 510(k) summary for Quanta System Surgical Laser Fibers, which details a submission for modifications to an already cleared device (K131473). The key aspect of this submission is a change to the labeling information regarding reprocessing instructions.
Therefore, the primary study conducted and the acceptance criteria are related to the validation of these new reprocessing instructions to ensure the modified device remains safe and effective, similar to the original device. The document states: "In addition to the performance data provided for the unmodified device (K131473), the modified device reprocessing instructions have been validated."
Since this is a modification to reprocessing instructions for a physical laser fiber, the "acceptance criteria" discussed are likely performance metrics for the fiber after reprocessing, rather than, for example, diagnostic algorithm performance metrics (like sensitivity/specificity) which would be relevant for an AI-powered diagnostic device.
Based on the provided text, a detailed table of acceptance criteria and reported device performance from a specific study directly addressing the modified reprocessing instructions is not explicitly provided in a quantifiable format. However, we can infer the nature of the evaluation.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided document for some points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred for Reprocessing Validation) | Reported Device Performance (Inferred from "Validated") |
|---|---|
| Sterility/Cleanliness: Fibers must be sterile or effectively clean after reprocessing according to manufacturer's instructions. | Reprocessing instructions have been "validated," implying that post-reprocessing fibers meet sterility and cleanliness requirements. Specific quantitative outcomes (e.g., bioburden reduction, endotoxin levels) are not provided in this summary. |
| Functional Integrity: Fibers must maintain their structural and functional integrity (e.g., optical transmission, mechanical strength) after multiple reprocessing cycles. | Reprocessing instructions have been "validated," implying that fibers remain functional and structurally sound after reprocessing. Specific quantitative outcomes (e.g., optical power loss, tensile strength, number of reprocessing cycles tested) are not provided. |
| Material Compatibility: Materials must not degrade or leach harmful substances due to reprocessing agents or methods. | Reprocessing instructions have been "validated," implying material compatibility is maintained. No specific details on material degradation or leaching. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used to validate the reprocessing instructions.
- Sample Size: Not specified.
- Data Provenance: Not specified. This would typically be from laboratory testing and potentially in-house or third-party validation studies. It's prospective in the sense that the new instructions are tested.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is generally not applicable for the validation of reprocessing instructions of a physical device. Ground truth for reprocessing validation typically involves laboratory measurements and established sterility/cleanliness standards rather than expert clinical consensus or interpretation.
4. Adjudication Method
Not applicable for reprocessing validation. Adjudication methods like 2+1 or 3+1 are used for expert review of images or clinical cases, not for laboratory testing of device reprocessing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of data. The Quanta System Surgical Laser Fibers are a physical surgical tool; their reprocessing instructions do not involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a physical surgical fiber, not an algorithm, and does not have standalone algorithmic performance.
7. Type of Ground Truth Used
The ground truth for reprocessing validation would be based on:
- Established Performance Standards: Industry standards (e.g., ISO, AAMI) for sterility, bioburden reduction, cleaning efficacy, and material compatibility.
- Laboratory Measurements: Direct quantifiable measurements of microbial load, optical transmission, mechanical properties, and material integrity after reprocessing.
8. Sample Size for the Training Set
Not applicable. Reprocessing validation does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set. The "ground truth" for validation would be established through adherence to scientific principles of sterilization/disinfection and performance testing protocols.
Summary of Study:
The "study" referenced in this 510(k) summary is the validation of the modified device reprocessing instructions. While specific details of the validation study (e.g., protocols, sample sizes, quantitative results) are not provided in this summary document, the FDA's clearance implies that such a study was performed and demonstrated "substantial equivalence" of the modified device to the predicate (K131473). This validation would have focused on ensuring that the new reprocessing steps maintain the device's original performance, safety, and effectiveness, particularly concerning sterility, functional integrity, and material compatibility over its intended lifespan. The phrase "the modified device reprocessing instructions have been validated" serves as the key statement indicating that the necessary tests were conducted and met the required performance standards.
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(155 days)
(QUANTA SYSTEM) SURGICAL LASER FIBERS
Quanta Systems Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta system equipped with SMA 905 connector.
Quanta Systems Surgical Laser Fibers are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery. ENT/ololaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are 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 with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical specially or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 800 and 1000 microns) are offered.
The Quanta System Surgical Laser Fibers are single-use sterile medical devices, supplied sterilized by Ethylene Oxide (EtO).
The provided text describes the 510(k) summary for Quanta System Surgical Laser Fibers, focusing on their substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.
However, I can extract information related to the performance and safety testing conducted to support the device's substantial equivalence.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance that would typically be found in studies for diagnostic or AI devices (e.g., sensitivity, specificity thresholds). Instead, it refers to a "full plan of non-clinical performance tests" to demonstrate safety and effectiveness. The acceptance criteria for these tests would be compliance with the referenced standards and internal methods.
| Acceptance Criteria (based on compliance with standards/methods) | Reported Device Performance (demonstrated by testing) |
|---|---|
| Compliance with ISO 14971:2009 (Risk Management) | Full plan of non-clinical performance tests conducted |
| Compliance with ISO 10993-1:2008 & FDA Blue Book Memo G95-1 (Biocompatibility) | Biocompatibility testing performed |
| Compliance with ISO 11135-1:2007 & FDA Sterility Review Guidance K90 (EtO Sterilization) | First EtO sterilization validation performed |
| Compliance with ISO 11607-1:2009 & FDA Sterility Review Guidance K90 (Packaging) | Packaging validation performed |
| Compliance with ISO 17664:2004 & FDA MDUFMA Validation Data in 510(k) for Reprocessed single-use medical device (Reprocessing) | Re-processing validation performed |
| Visual, mechanical, and functional (optical) requirements per internal methods | Visual, mechanical and functional (optical) tests performed |
| Equivalence to predicate devices in components and technological characteristics | Fiber core/cladding made from silica (same as predicates), jacketed with ETFE (same as predicates), no technological differences compared to predicates, same intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a "test set" of clinical data in the context of an AI or diagnostic device. The performance evaluation is based on non-clinical engineering and biological tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is established by compliance with recognized engineering, sterilization, and biocompatibility standards, not by expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. There is no clinical "test set" or adjudication process described.
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 surgical laser fiber, not an AI or diagnostic tool 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 a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" is defined by:
- International Standards: ISO 14971:2009, ISO 10993-1:2008, ISO 11135-1:2007, ISO 11607-1.2009, ISO 17664:2004.
- FDA Guidance Documents: FDA Blue Book Memo G95-1, FDA Sterility Review Guidance K90, FDA MDUFMA Validation Data in 510(k) for Reprocessed single-use medical device.
- Internal Methods: Visual, mechanical, and functional (optical) tests were conducted according to internal methods.
The overall "ground truth" for the 510(k) submission is that the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device with a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned.
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