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510(k) Data Aggregation
(86 days)
These devices are reprocessed laser probes from various original equipment manufacturers (OEMs). Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment.
Laser probes are an accessory used as part of a laser delivery system. They consist of a probe handpiece, strain relief, fiber optic cable, and connector. A laser light pipe may or may not be part of the probe. The probes must be connected to a laser console in order to deliver energy. The laser probe delivers the energy to the treatment site through an opening at the probe tip. Note, this submission is only in regard to the laser probe itself. It does not pertain to any other part of a laser delivery system such as the console.
The provided text describes a 510(k) premarket notification for SterilMed's Reprocessed Laser Probes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel medical device. Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, ground truth details, training set information) are not explicitly detailed in the provided summary.
Here's a breakdown of the information that can be extracted and a note on what is not available from the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstration of substantial equivalence to predicate device(s) in terms of functional design, indications for use, and principles of operation. | "SterilMed's reprocessed laser probes are substantially equivalent to HGM Inc.'s Fleischman-Swartz Endo-Ocular Probe (K840590), and to the counterpart devices from the original manufacturers." |
| Reprocessed probes must maintain appropriate functional characteristics after reprocessing. | "Representative samples of reprocessed laser probes underwent bench testing to demonstrate appropriate functional characteristics." |
| Reprocessing procedures (cleaning and sterilization) must be validated. | "Process validation testing was done to validate the cleaning and sterilization procedures..." |
| Device packaging must be validated. | "...as well as the device packaging." |
| Manufacturing process must include visual and functional testing of all produced products. | "In addition, the manufacturing process includes visual and functional testing of all products produced." |
| Intended Use remains consistent with predicate: Part of a laser delivery system, used in ophthalmic procedures where laser energy is the mode of treatment. | Confirmed as the intended use for the reprocessed probes. |
| Device Description remains consistent with predicate: Consists of probe handpiece, strain relief, fiber optic cable, and connector. May or may not have a laser light pipe. Connects to a laser console. | Confirmed as the device description for the reprocessed probes. |
2. Sample size used for the test set and the data provenance
The document mentions "Representative samples of reprocessed laser probes" were used for bench testing and process validation. It does not provide specific sample sizes for these tests. Data provenance is not specified (e.g., country of origin) and the study is for device reprocessing validation, not an AI/diagnostic study, so retrospective/prospective does not apply in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a 510(k) submission for a reprocessed medical device, not a study involving expert-established ground truth for diagnostic accuracy. The testing involves functional and sterilization validation.
4. Adjudication method for the test set
N/A. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.
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
N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is not an algorithm-based device. The "standalone" performance refers to the reprocessed device's inherent functional characteristics, as determined by bench and validation testing.
7. The type of ground truth used
For the functional and safety testing, the "ground truth" would be established engineering specifications and performance standards for laser probes. For cleaning and sterilization, it would be established microbiological and chemical validation standards.
8. The sample size for the training set
N/A. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
N/A. No training set for this device.
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