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The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

The provided text describes the EyeGility™ Inserter for Preloaded enVista® IOLs and its non-clinical testing to demonstrate substantial equivalence.

Here's the information broken down as requested:

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 sample sizes for each specific test. It broadly mentions "functional testing" and "nonclinical testing." The data provenance is not mentioned, but given it's a premarket notification for the US market (FDA), such tests are typically conducted by the manufacturer in a controlled laboratory setting. The study is prospective in the sense that the device was designed and then tested against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is an inserter for Intraocular Lenses (IOLs) and the testing performed is non-clinical, focusing on the physical performance, biocompatibility, and sterility of the device against established standards (e.g., ISO standards). Ground truth, in the context of expert review, is typically relevant for interpretative devices (e.g., AI for medical imaging diagnosis), which is not the case here.

4. Adjudication Method for the Test Set
Not applicable, as this is a non-clinical device that is tested against objective, measurable performance standards rather than expert 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. The provided text explicitly states: "No clinical testing was completed in support of the subject device." This implies no human readers or AI assistance was involved in a clinical comparative effectiveness study for this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (an inserter) and does not involve an algorithm or AI.

7. The type of ground truth used
The "ground truth" for the non-clinical testing of this device is defined by the acceptance criteria established by international standards (e.g., ISO, ANSI/AAMI, ASTM) for medical devices and IOLs. These standards dictate acceptable performance for parameters like folding and recovery, optical quality, dimensions, biocompatibility, sterilization, and packaging integrity.

8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.

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The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye.

The Medicel ACCUJECT™ REFRA Injector System, Model AR2900 is to be used by an ophthalmic surgeon and is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye. The ACCUJECTTM REFRA is a single use device designed specifically to deliver the STAAR Surgical Implantable Collamer® Lenses.

The provided text describes a 510(k) premarket notification for a medical device called the ACCUJECT™ REFRA Injector. This type of submission establishes substantial equivalence to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information you've requested about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based diagnostic or prognostic devices, is largely not applicable to this 510(k) submission.

This submission focuses on demonstrating that the new injector device (ACCUJECT™ REFRA Injector) is as safe and effective as a previously cleared predicate device (Visian nanoPOINT™ 2.0 Injector) for the same intended use by comparing their technical characteristics and performing non-clinical (laboratory/bench) tests.

Here's a breakdown based on the information available:

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

   Acceptance Criteria	Reported Device Performance
   Functional Performance (in accordance with ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods, Section 5: Recovery of Properties following simulated surgical manipulation)	Result: Intraocular lenses recovered to specifications after being folded and deformed by the Injector.

Conclusion: "The change in injector design does not impact the performance characteristics of the injector cartridge or lens." (Implies meeting the recovery specifications, which are the acceptance criteria from ISO 11979-3). |
| Biocompatibility (in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Result: "The biocompatibility tests performed on the modified injector met all acceptance criteria." (Implies meeting the acceptance criteria defined by applying ISO 10993-1, which would involve various tests like cytotoxicity, sensitization, irritation depending on body contact and duration). |
| Particulate Testing | Result: "The particulate testing performed on the modified injector met all acceptance criteria." (Implies meeting acceptance criteria for particulate matter release, likely defined internally or by relevant standards to prevent complications in the eye). |
| Substantial Equivalence to Predicate Device (K101134) | Conclusion: "The ACCUJECT™ REFRA Injector is substantially equivalent to the predicate device." This is the overarching "performance" reported from the comparative analysis and non-clinical testing, meaning it performs as safely and effectively as the predicate for its intended use, despite minor technological differences (e.g., changes in materials, absence of a spring, presence of a silicone buffer, operating principle including twisting). |

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

   • The document does not explicitly state "sample size" in terms of number of devices or number of lenses tested for each functional, biocompatibility, or particulate test.
   • The study is a non-clinical (bench/laboratory) study, not a clinical study involving human patients or real-world data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the typical sense. The testing was conducted in a controlled laboratory environment.

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

   • This is not applicable. The ground truth is established by objective measurements and standardized test methods (e.g., ISO standards) for mechanical performance, biocompatibility, and particulate matter. There isn't a "ground truth" established by human experts in the context of interpreting images or clinical outcomes for this type of device submission.

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

   • This is not applicable. Adjudication methods are relevant for subjective human assessments, especially in clinical trials or studies involving expert consensus on diagnostic interpretations. This submission relies on objective, quantifiable non-clinical testing.

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 is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic devices in a clinical setting with human readers. The ACCUJECT™ REFRA Injector is a surgical instrument for delivering an intraocular lens, not an AI diagnostic device. There is no AI component or human reader interaction with AI.

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

   • This is not applicable. As explained above, this product is a mechanical medical device, not an AI algorithm.

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

   • The "ground truth" for the non-clinical tests is established by:
     • Standardized specifications: For functional recovery, the specifications would likely be derived from the requirements of ISO 11979-3.
     • Standardized biological safety criteria: For biocompatibility, the criteria are defined by ISO 10993-1 and related sub-parts.
     • Pre-defined acceptance limits: For particulate matter, specific limits for particle size and count would be established, often based on internal specifications, industry standards, or regulatory guidance for sterile medical devices.

8. The sample size for the training set:

   • This is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

   • This is not applicable. As there is no training set.

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The RxSight® Insertion Device (Model 63002) is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling.

The RxSight Insertion Device (Model 63002) is a sterile, single-use device to be used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of:

• A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge
• A single-use, disposable, sterile haptic puller.

The provided text describes the 510(k) summary for the RxSight® Insertion Device (Model 63002). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, information regarding AI-specific acceptance criteria, test set details (sample size, provenance, expert adjudication, MRMC studies), ground truth establishment for training and test sets, and separate standalone algorithm performance is not present in this submission.

The device in question, an intraocular lens insertion device, does not appear to be an AI/ML product. The performance testing is described as non-clinical and pertains to the physical manipulation and integrity of the intraocular lenses after insertion, following ISO standards.

Here's a breakdown of the available information based on your request, with N/A for criteria not addressed in the provided document, as it is not an AI/ML device submission:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance testing. The "acceptance criteria" are implied by adherence to ISO standards for IOLs, indicating that the device should not adversely affect the IOL's mechanical dimensions, sagitta, optical properties, or homogeneity.

Study Details (as applicable for a non-AI/ML device submission)

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

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for specific tests, but general non-clinical performance testing was conducted.
   • Data Provenance: Not specified, but generally, non-clinical lab testing data.
   • Retrospective or Prospective: N/A (for non-clinical lab testing).

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 non-clinical device; "ground truth" as you'd define it for AI/ML diagnostics (e.g., disease presence as determined by experts) does not apply. Performance is measured against physical and optical standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Not relevant for this type of non-clinical device testing.

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/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context refers to the defined specifications and standards for IOLs (e.g., mechanical dimensions, optical properties, homogeneity) as outlined in ISO 11979-2:2014 and ISO 11979-3:2012.

8. The sample size for the training set: N/A. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established: N/A. Not an AI/ML device.

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The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.

The provided text is a 510(k) summary for the RxSight® Insertion Device. This document evaluates the device's substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, novel acceptance criteria through a new clinical study.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular document. The device is a Class I medical device (Intraocular Lens Guide), which typically relies on demonstrating equivalence to existing devices rather than extensive new clinical trials for market approval.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of quantitative acceptance criteria and corresponding performance metrics for a new study. Instead, it demonstrates substantial equivalence to a predicate device. This means the "acceptance criteria" are implicitly that the proposed device performs comparably to the predicate device for its intended use, without raising new questions of safety or effectiveness.

The document states:

• "The descriptive characteristics are well-defined and adequate to ensure substantial equivalence of the RxSight Insertion Device with the predicate device."
• "The RxSight Insertion Device has the same intended use as the legally marketed predicate devices identified in this 510(k) premarket notification and other IOL injectors regulated under 21 CFR 886.4300."
• "This device continues to meet all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device."

The comparison table provided in the document highlights the identical characteristics between the proposed device and its predicate (K192926):

The "performance" documented here is the sameness or equivalence across all these characteristics, leading to the conclusion that the device performs as expected based on its predicate.

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

This information is not applicable and not provided in the document. This is not a study that involved a "test set" in the context of clinical or algorithmic performance evaluation. The submission relies on comparing the technical characteristics and intended use to a previously cleared device.

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

This information is not applicable and not provided. Ground truth establishment by experts is typically relevant for studies evaluating diagnostic accuracy, image interpretation, or treatment outcomes, which is not the nature of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods are used in studies involving multiple readers or complex endpoints, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this device (an IOL insertion tool).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a manual surgical tool, not an AI algorithm.

7. The Type of Ground Truth Used:

Ground truth, in the sense of expert consensus, pathology, or outcomes data, was not used for this 510(k) submission. The "truth" being established is the substantial equivalence of the proposed device to its predicate, based on its identical design, materials, manufacturing, indications for use, and operating principle. The ground truth, in a broader sense, is the already established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. There is no "training set" as this is not an AI or machine learning device.

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

This information is not applicable and not provided.

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The EndoSerter® PL is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.0 mm in diameter and 100 microns in central thickness into the anterior chamber through a minimum 4.0 mm incision during endothelial keratoplasty procedures and for loading and storage of donor transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 48 hours.

The EndoSerter®-PL is a sterile, single use, handheld, manual ophthalmic surgical instrument. It is used to preload a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon is performed by trained technician at the eye bank.

This device, the EndoSerter®-PL, is a medical instrument used for inserting corneal endothelial allograft tissue. The provided document is a 510(k) Premarket Notification from the FDA, which determines substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than meeting specific performance metrics with associated thresholds. The "study" refers to the pre-clinical performance data provided to support this claim of substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a PMA or de novo submission requiring clinical trials with specific endpoints, the "acceptance criteria" are implied by the aspects of safety and effectiveness that need to be comparable to predicate devices. The performance data provided addresses these aspects.

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

The document describes pre-clinical engineering and biological testing. It does not mention a test set in the context of patient data or clinical performance. The "samples" would relate to the number of devices or tissue samples used in each specific test:

• Biocompatibility: Not specified, but typically involves multiple samples of each material or component tested.
• Tissue Handling and Stability Testing: Not explicitly stated, but implies a number of donor allograft tissues were loaded, stored, transported, and delivered. The exact count is not provided.
• Sterilization Validation: Not specified, but validation studies involve multiple sterility tests.
• Shelf Life and Transportation Testing: Not specified, but multiple devices would be subjected to leak tests, accelerated aging, etc.
• Aseptic Handling Testing: Not specified, but multiple samples would be tested to demonstrate the process's ability to prevent contamination.
• Dimensional, Functional, and Mechanical Testing: Not specified, but typically involves a representative sample size of manufactured devices.

Data Provenance: All data appears to be pre-clinical laboratory testing conducted by or on behalf of CorneaGen, Inc. There is no indication of country of origin for test data in the provided text, nor is there information about retrospective or prospective patient data, as no human clinical trials are described.

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

This question is not applicable to this 510(k) submission.

• There is no "test set" in the context of patient data requiring expert ground truth establishment.
• The studies described are pre-clinical performance evaluations (e.g., biocompatibility, mechanical testing) where "ground truth" is established through standardized test methods (e.g., ISO 10993-1, USP ).
• The tissue handling and stability study quantitatively determined endothelial cell damage, likely using a laboratory method rather than expert consensus on images.

4. Adjudication Method for the Test Set

This question is not applicable as there is no "test set" from patient data and no human interpretation to adjudicate.

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 question is not applicable. The EndoSerter®-PL is a manual surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

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

This question is not applicable. The EndoSerter®-PL is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

As this is a pre-clinical performance evaluation of a medical device, the "ground truth" for the studies described would be:

• Standardized Test Methods and Scientific Principles: For biocompatibility (ISO 10993-1), sterility (SAL 10^-6), shelf life, and mechanical testing, the "ground truth" is defined by the requirements of the specific international standards and validated test procedures used.
• Quantitative Measurements: For tissue handling, the "ground truth" for damage would be based on quantitative measurements of endothelial cell loss through established laboratory techniques (e.g., cell counting, viability assays).
• Absence of Contamination: For aseptic handling, the "ground truth" for success is the absence of microbial contamination as determined by microbiological testing.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The studies described are pre-clinical performance validations.

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

This question is not applicable as there is no "training set."

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The CLAREON MONARCH IV IOL Delivery System is for implantation of qualified Alcon foldable IOLs. No unqualified lenses should be used with the CLAREON MONARCH IV IOL Delivery System.

The CLAREON MONARCH IV IOL Delivery System consists of two parts. An autoclavable, reusable, titanium handpiece and a sterile, single-use cartridge are used for implanting foldable intraocular lenses into the eye following removal of the natural crystalline lens.

The system provides a controlled means to reliably place Alcon qualified intraocular lenses (IOLs) into the capsular bag when a qualified combination of handpiece, cartridge, Alcon foldable IOL, and ophthalmic viscosurgical device (OVD) is used.

The cartridge is loaded by inserting the IOL into the opening in the back of cartridge after OVD is applied to the inner lumen of the cartridge. The loaded cartridge is installed into the handpiece and the IOL is delivered through the cartridge nozzle.

The provided text describes a 510(k) summary for the CLAREON MONARCH IV IOL Delivery System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI/software device would.

The information given relates to a hardware medical device (an intraocular lens delivery system), not an AI-powered diagnostic or predictive tool. Therefore, many of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," or "ground truth for training set") are not applicable to this type of device and are not present in the provided text.

However, I can extract the relevant information regarding performance testing and acceptance criteria as described for this hardware device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards and characteristics tested to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these standards and demonstrating equivalence.

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

The document does not specify exact sample sizes for each test mentioned (e.g., how many IOLs were delivered, how many sterilization cycles were performed for specific tests). It only lists the types of tests conducted. "Data provenance" as in country of origin or retrospective/prospective is not specified, as these are typically bench and lab tests for a physical device, not an imaging or diagnostic study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The testing described involves engineering, material, and biological compatibility assessments against established standards, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This is not applicable and not provided as it's not a study involving human interpretation of data for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is compared. The described device is a physical delivery system.

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

No, a standalone algorithm performance study was not done. This is a hardware device; thus, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established international standards (ISO, IEC) and FDA guidance documents for medical device performance, biocompatibility, reprocessing, and human factors. For example:

• IOL Delivery Performance: Compliance with ISO 11979-3-12.
• Biocompatibility: Conformance to ISO 10993-18-20 and ISO 10993-5-09.
• Reprocessing and Sterilization: Adherence to ISO 17664-17, ISO 17665-1-06, and ISO 14937-09.
• Human Factors: Conformance to IEC 62366-1-20 and FDA guidance.

8. The Sample Size for the Training Set

No training set is applicable or mentioned. This is a physical device, not a machine learning model.

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

Not applicable.

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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 RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.

This document is a 510(k) premarket notification for a medical device called the "RxSight Insertion Device." It outlines the device's characteristics, intended use, and demonstrates substantial equivalence to a previously cleared predicate device.

Let's break down the information relevant to acceptance criteria and study proof for this specific device.

Analysis of the Provided Text:

The provided text describes a medical device, the "RxSight Insertion Device," which is an Intraocular Lens (IOL) injector. The FDA document clears this device based on its substantial equivalence to a predicate device.

However, the nature of this particular device (an IOL insertion tool) and the detailed information provided in the 510(k) summary do not involve the kind of AI-driven diagnostic or image analysis performance that would typically have acceptance criteria presented as sensitivity, specificity, or AUC, nor "ground truth" derived from expert consensus on images.

Instead, the "performance" here relates to the mechanical function of the device and its biological safety (e.g., impact on endothelial cell density).

Therefore, I cannot directly fill in a table for AI performance metrics like sensitivity, specificity, etc., or answer questions about multi-reader multi-case studies, training sets, or expert adjudicated ground truth in the way one would for an AI diagnostic algorithm.

Based on the provided text, here’s how we can infer relevant "acceptance criteria" for this mechanical device and the study proving it meets them:

1. Acceptance Criteria and Reported Device Performance (Inferred):

Since this is a mechanical insertion device, the acceptance criteria are not in terms of diagnostic accuracy, but rather in terms of its ability to safely and effectively deliver an IOL without causing significant harm to the eye.

2. Sample Size and Data Provenance (for clinical safety study):

• Sample Size: The document states "post-operative endothelial cell density (ECD) data was collected in a prospective clinical study." It doesn't specify the exact number of patients or eyes.
• Data Provenance: "prospective clinical study." No country of origin is specified, but typically for FDA submissions, studies are conducted in a way that aligns with US clinical study requirements (e.g., IRB approval).

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable in the typical sense of AI ground truth. For this device, "ground truth" for the mechanical tests would be derived from precisely measured physical properties (e.g., using calipers, optical instruments) and analytical chemistry tests (e.g., particulate analysis).
• For the clinical safety study (ECD), the "ground truth" is measured physiological data (endothelial cell count and density) obtained via clinical instruments, not subjective expert assessment of images.

4. Adjudication Method for the Test Set:

• Not applicable in the typical AI sense. For mechanical tests, the results are objective measurements. For the ECD clinical study, the outcome is quantitative physiological data, not requiring multiple human adjudicators for "ground truth."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not specified or relevant for this type of device. MRMC studies are typically for diagnostic imaging AI tools comparing human reader performance with and without AI assistance. This device is a surgical insertion tool, not a diagnostic aid.

6. Standalone (Algorithm only) Performance:

• Not applicable. This device is a mechanical tool. There is no "algorithm only" performance separate from its mechanical function.

7. Type of Ground Truth Used:

• Quantitative Measurements and Clinical Outcomes: For mechanical aspects, the ground truth was based on:
  • Precise measurements of IOL dimensions and sagitta before and after insertion (ISO 11979-3:2012).
  • Evaluation of optical properties (ISO 11979-2:2014).
  • Particulate analysis.
• For clinical safety, the "ground truth" was endothelial cell density (ECD) measurements, which are objective physiological data.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set for model development. The mechanical tests and clinical safety study are for device validation, not for training a model.

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

• Not applicable. As above, no training set for an AI model.

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The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile, single-use device used to fold and insert an intraocular lens (MX60PL) through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

The provided text is a 510(k) summary for the Bausch + Lomb PreVue Inserter for enVista Preloaded. It describes the device, its intended use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.

However, the request asks about acceptance criteria and a study that proves a device meets those criteria. The provided document concerns a medical device accessory (an inserter for intraocular lenses), not an AI/algorithm-based diagnostic device where terms like "ground truth," "expert consensus," "MRMC study," "training set," or "test set" are typically relevant. The document focuses on showing the physical device's functional performance, biocompatibility, sterilization, and packaging validation, primarily through bench tests and laboratory evaluations.

Therefore, many of the requested points in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to the type of device and testing described in this 510(k) summary. The "study" proving the device meets acceptance criteria refers to the non-clinical functional and safety testing performed.

Here's an analysis based on the information available in the provided text, addressing the applicable points and explaining why others are not relevant:

Device: Bausch + Lomb PreVue Inserter for enVista Preloaded
Type of Device: Intraocular Lens (IOL) Inserter (Medical Device Accessory)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test, indicating the device met the standards/requirements. Specific quantitative thresholds for "Pass" are not detailed in this summary but would be found in the full test reports.

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

• Sample Size: Not explicitly stated in the summary. For non-clinical bench testing of medical devices, sample sizes are typically determined by statistical rationale for validation, often involving multiple units per lot and multiple lots. The summary mentions "functional performance testing," but the exact number of devices or number of insertions is not provided.
• Data Provenance: The data originates from internal Bausch & Lomb laboratory and bench testing. There is no mention of specific country of origin for the data beyond the company's location in St. Louis, MO, USA. The testing is prospective as it's performed for regulatory submission of a new device.

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

• Not Applicable. This is a physical medical device accessory, not an AI or diagnostic algorithm requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to meeting predefined engineering and biological safety specifications through physical and chemical testing. The "experts" involved would be engineers, chemists, and quality assurance personnel performing and verifying the tests, but their number and specific qualifications are not detailed as they would be for a clinical AI study.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, this is not an AI/diagnostic algorithm study using human readers. "Adjudication" usually refers to resolving disagreements among multiple human experts. For non-clinical bench testing, results are typically objective (e.g., pass/fail based on measurements) and verified by quality control procedures.

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. MRMC studies are relevant for evaluating diagnostic accuracy or reader performance with AI assistance, which is not pertinent to an IOL inserter. No human readers or AI assistance are involved in the functional testing of this device.

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

• Not Applicable. This is a physical mechanical device, not an algorithm. Therefore, "standalone" algorithm performance is irrelevant.

7. The type of ground truth used:

• Engineering Specifications / ISO Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, relevant ISO standards (e.g., ISO 11979-3 for IOLs and inserters, ISO 10993 for biocompatibility), and internal quality requirements. For example, "Fold and recovery test" and "Lens Dimensions Post Delivery" imply that the true "ground truth" is whether the IOL is inserted without damage and retains its proper form and function after insertion.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a "training set." The device is manufactured based on design specifications and then tested.

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

• Not Applicable. (See point 8).

Summary Rationale from the Document:
The document explicitly states: "No clinical testing was performed on the subject device." and "Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Pre Vue Inserter for enVista Preloaded. No animal or clinical testing was required for this submission." This reinforces that the "study" proving the device met acceptance criteria was entirely non-clinical, focusing on functional performance, material safety, and manufacturing quality. The conclusion emphasizes that "Device functional performance testing all passed and demonstrates equivalence to predicate device." and that all results support "substantial equivalence to the predicate devices."

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The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.

The provided document describes the UNFOLDER Vitan™ Inserter, Model DK9000, which is an intraocular lens (IOL) inserter. It is a Class I device used to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, in combination with the SmartLOAD™ Delivery Technology. The document does not describe an AI/ML device per se but a medical device in general. Therefore, some of the requested information, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and specifics about AI/ML algorithm training, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table detailing numerical acceptance criteria and reported device performance for specific metrics. Instead, it generally states that the device "complies with applicable standards" and "passed all acceptance criteria" during functional testing.

• Post-delivery dioptric power
• Image quality
• Overall diameter
• Sagitta
• Surface and bulk homogeneity |
  | Overall Safety and Effectiveness | Demonstrated substantial equivalence to predicate devices. Functional requirements and product specifications will be met prior to commercial release. |

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

• Sample Size for Test Set:
  • Reprocessing Study: The study involved processing a sufficient number of UNFOLDER Vitan™ Inserters to verify that they can withstand 500 clinical reprocessing cycles. The exact number of inserters tested is not specified but it states "the inserters" implying multiple units.
  • Functional Delivery Testing: "All tested IOLs" were evaluated. The exact number of IOLs tested is not specified, but the phrase implies a representative sample.
• Data Provenance: The studies were non-clinical tests conducted by Johnson & Johnson Surgical Vision, Inc. There is no information about the country of origin of the data as it's not patient-specific data, but rather device performance data. The studies are described as verification and validation testing, which are typically prospective in nature to assess product performance against design specifications.

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

This information is not applicable as the described tests are non-clinical device performance tests. Ground truth in the context of expert consensus is typically associated with clinical studies or AI/ML evaluations where human experts label or interpret data. For device performance testing, "ground truth" is typically defined by engineering specifications and objective measurements against those specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations when there's a need for consensus among multiple human readers/experts to establish a definitive "ground truth" for ambiguous cases. For device performance testing, results are typically determined by objective measurements and passing/failing predefined specification limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, often with and without AI assistance, which is not relevant for a standalone medical device like an IOL inserter that doesn't involve interpretation by human readers in the same way.

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

This information is not applicable. The device described is a physical instrument (IOL inserter), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

• Engineering Specifications and Functional Requirements: For the reprocessing study, the ground truth was the device's ability to maintain its "functional properties," remain "intact," and "successfully deliver IOLs per the Directions for Use," ultimately meeting its predefined design and performance specifications.
• Established ISO Standards (ISO 11979-3: 2012): For functional delivery testing, the "ground truth" was defined by the acceptance criteria mentioned in Section 5 of ISO 11979-3: 2012, specifically for post-delivery dioptric power, image quality, overall diameter, sagitta, and surface and bulk homogeneity. These standards provide objective, measurable criteria for IOL delivery performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

This information is not applicable (as explained in point 8).

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