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The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.

The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

The bioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The bioli™ IOL Delivery System is intended for use during cataract surgery.

The bioli™ IOL Delivery System is composed of two parts:

• (1) a cartridge that holds the intraocular lens in position in preparation for loading and folding, and
• (2) a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag

The cartridge incorporates a smooth, internal geometry that progressively folds the lens for delivery through conventional nozzle geometry. A coating is applied to the cartridge including the inner surfaces to increase lubricity.

The cartridge is loaded by positioning the intraocular lens into the cartridge, folding the trailing haptic onto the anterior side of the optic, and finally pushing the optic edge of the lens to position it as far into the cartridge as the forceps will permit. After the cartridge is attached onto the injector, the system is now ready for the advancement of the plunger to deliver the lens.

The document provided is a 510(k) summary for the bioli™ IOL Delivery System. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a legally marketed predicate device.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a formal table of acceptance criteria alongside reported device performance for all tests. However, it states that various tests "met the defined acceptance criteria and requirements," or "showed passing results," or "demonstrated that the device can successfully deliver" or "was able to."

Here's a summary of the performance claims, with acceptance criteria implied by the "passing" or "successful delivery" statements:

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 for Test Set: The document does not specify exact sample sizes (number of IOLs or devices) used for the non-clinical tests. It generally refers to "All lenses" being delivered and evaluated.
• Data Provenance: The document does not specify the country of origin of the data, nor whether the non-clinical tests were conducted retrospectively or prospectively. The tests are described as "simulated surgical manipulation" and "performed," suggesting prospective testing in a laboratory setting.

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)

This is a medical device submission, not an AI/algorithm-based diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of diagnostic interpretation is not directly applicable. The "ground truth" for this device's performance relies on objective measurements and established engineering and biocompatibility standards. For instance, IOL damage/scratches were assessed using a "10x microscope," and optical/dimensional properties were assessed against ISO standards. The expertise would be in the technicians and engineers conducting these standardized tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI diagnostic device requiring expert adjudication of interpretations. The tests involve objective measurements against predefined criteria and standards.

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. The bioli™ IOL Delivery System is a physical medical device (an intraocular lens injector), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

Not applicable. This is not an AI algorithm. The performance described is of the physical device in laboratory simulations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bioli™ IOL Delivery System's performance is based on:

• Objective measurements against established industry standards: Such as ISO 11979-3:2012 for IOL properties, ISO 10993 series for biocompatibility, ASTM standards for packaging and transport.
• Visual inspection under magnification: For damage or scratches to IOLs and the device.
• Functional tests: Ensuring successful delivery of IOLs "without affecting the functionality of the lens."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in this context.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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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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The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraccular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the Lenstec Softee I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on the IOL approved labeling.

The set consists of a single-use, sterile svringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.

Note: LubriMATRIX™ is a proprietary treatment composed of a hydrophilic polymer and a lubricious polymer engrafted onto the surface of the cartridge via a chemical polymerization process. Refer to MAF-1963 for further information.

The provided document is a 510(k) summary for the pioli™ IOL Delivery System. It describes the device, its intended use, and its equivalence to a predicate device. The document details performance data from non-clinical tests to demonstrate that the device meets its acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for the IOLs and cartridges tested in the non-clinical performance study. It mentions "All lenses were delivered..." and "All delivered lenses showed no damages..." and "all cartridges showed no damages...", which implies that a set of lenses and cartridges were tested, but the specific number is not provided.

• Sample Size: Not explicitly stated (referred to as "All lenses" and "all cartridges").
• Data Provenance: The study was a "simulated surgical manipulation" non-clinical test conducted by the device manufacturer (AST Products, Inc.). The country of origin of the data is not specified, but the manufacturer is based in Billerica, MA, USA. It is a prospective non-clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document does not mention the use of experts to establish ground truth for the non-clinical performance tests. The evaluation of IOL damage/scratches, dimensional specifications, and cartridge damage appears to be based on objective inspection and adherence to ISO standards, rather than expert interpretation of a 'ground truth' per se.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The non-clinical tests described involve objective measurements and observations against pre-defined criteria (e.g., ISO standards, presence of damage, dimensional specifications). It does not involve subjective assessment requiring adjudication.

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

• No, a TRMC comparative effectiveness study was not done. The device is an IOL delivery system, not an AI-assisted diagnostic or interpretive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. The pioli™ IOL Delivery System is a physical medical device (an IOL delivery system), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical performance study was based on objective measurements and observations per established standards and specifications. This includes:
  • ISO standards: ISO 11979-2 (Optical properties and test methods) and ISO 11979-3 (Mechanical properties and test methods) for IOL evaluation.
  • Visual inspection: For damages, scratches, and homogeneity of IOLs and cartridges.
  • Dimensional specifications: For IOLs after delivery.
  • Functional assessment: The ability to successfully deliver IOLs without affecting their functionality.
  • Packaging tests: Appearance inspection, peeling strength, and adhesion tests.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The "training" for such a device involves engineering design, material selection, and manufacturing processes validation.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the context of an IOL delivery system as described.

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The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.

The provided document describes the lioli™ IOL Delivery System and its substantial equivalence to a predicate device, but it does not contain detailed acceptance criteria or a comprehensive study report that directly proves the device meets specific performance metric acceptance criteria in a structured format.

The document discusses performance data in a general sense, focusing on non-clinical tests to demonstrate the device's functionality and safety by showing that the delivered IOLs were undamaged and within specifications.

Here's an attempt to extract and synthesize the requested information based on the provided text, noting where specific details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Implied/Deduced" Criteria: The document describes the results of the tests ("all delivered lenses showed no damages"), from which we can infer the unstated acceptance criteria (e.g., "no damages or scratches on IOLs post-delivery").

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "All lenses were delivered..." and "Each lioli™ IOL Delivery System were also evaluated...", which implies a sample was used but the exact number for IOLs or delivery systems is not provided.
• Data Provenance: Retrospective, as these are pre-market notification tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is AST Products, Inc., located in Billerica, MA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Experts: Not applicable. The "ground truth" for the performance tests (e.g., integrity checks, dimensional specifications, optical properties) was established through objective measurements and standardized test methods (ISO standards), not through expert consensus or interpretation of subjective data.
• Qualifications: Not applicable for establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests performed are objective measurements and observations (e.g., microscope inspection for damage, dimensional checks), rather than subjective assessments requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable. This device is an IOL delivery system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is a mechanical delivery system for IOLs, not an algorithm. Its "performance" is its ability to successfully deliver an IOL without damage, which was assessed in non-clinical tests.

7. The Type of Ground Truth Used

• Ground Truth: Objective measurements against predefined specifications and visual inspection. For example:
  • IOL optical properties: Measured in accordance with ISO 11979-2.
  • IOL mechanical properties (including sagitta): Measured in accordance with ISO 11979-3.
  • Damages/scratches: Visually inspected using a microscope.
  • Biocompatibility: Tested against known safety standards for materials.
  • Dimensional specifications: Compared against manufacturing specifications.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a mechanical medical device, not a machine learning model, and therefore did not require a "training set."

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable, as there was no training set.

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