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The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartidge is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.

BL-Cart™ IOL Delivery Cartridge (Model: Type D) is an intraocular lens (IOL) delivery cartridge solution capable of supplying the ophthalmologist surgeon with a cartridge pre-coated with lubricious coating for use during a typical cataract surgery. The BL-Cart™ cartridge is used to deliver an approved IOL lens. The BL-Cart™ IOL Delivery Cartridge and referenced predicate device, Monarch® III D cartridge, utilize the same lens folding system design in which IOLs are folded and/or delivered from an injector system and the resulting optical and physical properties of the IOL remain unchanged as a result of folding/delivery. The BL-Cart™ IOL Delivery Cartridge comes with one pre-coated cartridge, packaged in a Tyvek pouch, placed in a 10 unit box as intended for marketing, and sterilized by ethylene oxide (EtO). The BL-Cart™ IOL Delivery Cartridge and the referenced legally marketed predicate device share the same principal method to implant an intraocular lens into the eye.

The provided document is a 510(k) Premarket Notification for the BL-Cart™ IOL Delivery Cartridge. This device is classified as a Class I medical device (Intraocular Lens Guide). Class I devices generally have lower regulatory burden and often rely on substantial equivalence to a predicate device rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and supporting study information:

Acceptance Criteria and Reported Device Performance

Given the nature of a Class I device and the 510(k) submission, explicit "acceptance criteria" for performance metrics like sensitivity or specificity are not typically defined or required in the same way as for higher-risk devices or software. Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate, often through shared technological characteristics, intended use, and performance testing that confirms it meets established standards or does not raise new safety/effectiveness concerns.

For this device, the primary performance goals are related to its ability to deliver an IOL without damage to the IOL or the cartridge, and to maintain the IOL's properties.

Study Information

1. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not explicitly state a numerical "sample size" for the non-clinical tests in terms of how many IOLs were tested or how many cartridges were used. It states, "All lenses were delivered through the BL-Cart™ IOL Delivery Cartridge," and that testing involved "Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device." This implies a sufficient number of tests to cover the range of intended use.
• Data Provenance: The data is from non-clinical (bench) testing performed by the manufacturer, AST Products, Inc. There is no mention of country of origin for the data beyond being conducted by the submitting company in the USA. The data is prospective in the sense that it was generated specifically for this submission to demonstrate substantial equivalence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is an IOL delivery cartridge, not a diagnostic or AI-driven device requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for its performance is determined by established engineering and material science standards (e.g., ISO 11979-3 for IOL properties, ISO 10993 for biocompatibility) and direct physical observation/measurement (e.g., micro-inspection for damage, dimensional checks). No human experts are described as establishing "ground truth" for the test set observations.

3. Adjudication method for the test set:

• Not applicable. As there are no human-interpreted "cases" or "ground truth" to adjudicate, no adjudication method is mentioned or required. Performance is determined by objective measurements and adherence to standards.

4. 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:

• No. An MRMC study is relevant for diagnostic AI devices where multiple readers interpret cases with and without AI assistance. This device is a manual surgical tool (cartridge) and does not involve AI or human readers for diagnostic purposes.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is purely mechanical/physical and does not involve any algorithms or AI components.

6. The type of ground truth used:

• The "ground truth" for this device's performance is based on International Standards (e.g., ISO 11979-3 for IOL mechanical properties, ISO 10993 for biocompatibility), engineering specifications (dimensional, optical properties of IOLs post-delivery), and physical observation (absence of damage to IOL or cartridge). The performance is assessed against these objective benchmarks rather than a clinical outcome or expert consensus on clinical findings.

7. The sample size for the training set:

• Not applicable. As this device does not involve AI or machine learning algorithms, there is no "training set."

8. How the ground truth for the training set was established:

• Not applicable. No training set exists for this type of device.

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