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510(k) Data Aggregation
(461 days)
Used for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho:Y AG laser system comprised of any standard SMA-type comector and an output power of up to 100 watts, for the indications for which the system has been cleared.
The Cook Holmium Laser Fibers are supplied sterile in peel-open packages. The multiuse fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in sizes, and will be sold in boxes of three.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Cook Holmium Laser Fiber":
The document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for AI-based systems. As such, the information provided relates to engineering and performance testing for a medical device, not an AI or software-as-a-medical device (SaMD). Therefore, many of the requested points regarding AI/algorithm performance, ground truth, experts, and MRMC studies are not applicable.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile Testing | The tensile force during proper clinical use should not fracture the materials and/or bonds. | Testing shows the tensile force during proper clinical use should not fracture the materials and/or bonds. (Implies criteria met) |
| Bend Radius Testing | Fibers must meet minimum bend radius requirements. | Testing shows that the fibers met the minimum bend radius requirements. (Implies criteria met) |
| Energy Transmission Testing | Fibers must transmit laser energy with not more than 20% loss from laser output to fiber output. | Testing shows that fibers transmit laser energy with not more than 20% loss from laser output to fiber output. (Implies criteria met) |
| Accelerated Aged Testing | Devices accelerated-aged to the equivalent of three years must meet performance requirements for tensile, bend radius, and energy transmission testing. | Testing shows that devices accelerated-aged to the equivalent of three years meet performance requirements for tensile, bend radius, and energy transmission testing. (Implies criteria met) |
| Biocompatibility Testing (ISO 10993-1) | The device must be biocompatible in conformance with ISO 10993-1. | Testing, in conformance with ISO 10993-1, shows the device is biocompatible. (Implies criteria met) |
| Laser System Compatibility Testing | The Cook Holmium Laser Fiber must be compatible with other cleared Ho:YAG laser systems. | Testing shows that the Cook Holmium Laser Fiber is compatible with other cleared Ho:YAG laser systems. (Implies criteria met) |
| Steam Sterilization Validation | The Cook Holmium Laser Fiber must be compatible with recommended autoclave cycles for sterility and functionality. | Testing shows that the Cook Holmium Laser Fiber is compatible with recommended autoclave cycles for sterility and functionality. (Implies criteria met) |
| Sterrad Sterilization Validation | The fiber must be compatible with recommended Sterrad cycles for sterility and functionality. | Testing shows that the fiber is compatible with recommended Sterrad cycles for sterility and functionality. (Implies criteria met) |
| Cleaning Validation | The fiber must be compatible with recommended cleaning procedures. | Testing shows that the fiber is compatible with recommended cleaning procedures. (Implies criteria met) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for any of the individual tests. The document only mentions "testing shows" without detailing the number of units tested.
- Data Provenance: Not applicable in the context of device performance testing. These are laboratory/bench tests, not clinical data from patients.
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. This is for a physical medical device, not an AI or diagnostic algorithm requiring expert ground truth in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for a physical medical device, not an AI or diagnostic algorithm requiring adjudication of clinical results.
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 is for a physical medical device (laser fiber), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a physical medical device, not an AI algorithm. The device's performance is standalone in the sense that it functions physically, but it requires a human operator and a laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" for these engineering tests would be established engineering standards, material properties, and measurement results, not clinical diagnoses or outcomes. For example, for "Energy Transmission Testing," the ground truth is simply the measured laser energy loss.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
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(185 days)
The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared.
The Cook Holmium Laser Fiber is intended for incision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared. The devices are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in six sizes, and will be sold in boxes of three.
The provided text describes a 510(k) submission for the Cook Holmium Laser Fiber. This type of submission is for medical devices, not AI/ML algorithms, so many of the requested fields are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Bend Radius Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Energy Loss Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Accelerated Aged Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Biocompatibility Testing | Results provide reasonable assurance of design and conformance to intended use. |
Note: The document states "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria and detailed performance metrics are not provided in this summary document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The tests listed are for verifying the physical and functional properties of the laser fiber itself, not for assessing performance on a dataset of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a laser fiber and it does not use a ground truth established by experts in the context of medical image analysis or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing 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
This information is not applicable as the device is a medical instrument (laser fiber), not an AI/ML diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The "ground truth" for a physical device like a laser fiber typically involves engineering specifications and performance standards rather than clinical diagnostic ground truth.
8. The sample size for the training set
This information is not applicable as there is no training set for a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved in the development or clearance of this type of medical device.
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