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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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