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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 Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.

The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye. This device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33º bevel down cartridge tip and a loading block.

This submission describes a medical device, the Visian® nanoPOINT™ 2.0 Injector System, and its substantial equivalence to a previously cleared device. Therefore, a traditional acceptance criteria and study section as seen with AI/ML devices or novel technologies is not fully applicable. However, I can extract the relevant information from the provided text to structure an answer that addresses your requested categories based on the nature of this 510(k) submission.

Nature of the Device and Submission:

The Visian® nanoPOINT™ 2.0 Injector System is an intraocular lens injector system, a Class I medical device. This 510(k) submission (K101134) is a declaration of substantial equivalence to a predicate device (K092023, Naviject Sub2-1P Injector Set) rather than a novel device requiring extensive de novo clinical trials to prove efficacy against specific acceptance criteria. The key argument for substantial equivalence is that the new device is identical to the predicate device in its technological characteristics, design, materials, and operating principle, with only a modification to the indications for use to specifically name the lens model it is intended for.

Given this, the "acceptance criteria" and "study" are framed around demonstrating that the new device is as safe and effective as the predicate device because it is essentially the same device.

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

The "acceptance criteria" for the Visian® nanoPOINT™ 2.0 Injector System were met by demonstrating its substantial equivalence to the predicate device (K092023, Naviject Sub2-1P IOL Injector Set). The performance reported is that the device is identical to the predicate device in all critical aspects.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or performance test set. The submission relies on the established performance and safety of the legally marketed predicate device (K092023).
• Data Provenance: The "data" primarily comes from the regulatory clearance of the predicate device (K092023) and an earlier device (K070669) from which the biocompatibility data was carried forward. This is retrospective in nature, drawing from previous approvals and pre-existing validation reports. The country of origin for the earlier validation studies is not specified in this document, but Medicel AG is based in Switzerland.

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

Not applicable. The ground truth for this type of submission is based on regulatory precedent and the established safety and effectiveness of a predicate device, as determined by the FDA. It does not involve expert consensus on new data for this specific submission, beyond the FDA's regulatory review process itself.

4. Adjudication method for the test set

Not applicable. There was no "test set" in the context of clinical or performance testing requiring adjudication. The adjudication was the FDA's regulatory review process determining substantial equivalence.

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. This device is not an AI/ML diagnostic tool, nor does it involve "human readers" or "AI assistance." It is a mechanical device for implanting intraocular lenses.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this substantial equivalence determination is regulatory precedent and established safety/effectiveness data of the predicate device. Specifically:

• The Visian® nanoPOINT™ 2.0 Injector System is declared "identical" to the K092023 Naviject Sub2-1P IOL Injector Set.
• Biocompatibility data was inherited from the previously cleared K070669 IOL injector, which was deemed substantially equivalent to K092023.
• Mechanical safety was validated for the specific lens model, building on validations done for the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

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The Naviject Sub2-1P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

The Naviject Sub2-1P IOL Injector and Cartridge Set is a sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the human eye.

The provided document describes a 510(k) premarket notification for the Naviject™ Sub2-1P IOL Injector Set. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data in the traditional sense of a clinical trial for a novel AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI assistance effect size, standalone performance, training set details) are not applicable to this type of submission.

The "acceptance criteria" in this context are the demonstration of substantial equivalence to a legally marketed predicate device, as outlined in the comparison table, rather than quantifiable performance metrics against a predefined threshold. The "study" proving acceptance criteria is the comparison analysis itself.

Here's the information that can be extracted or inferred from the provided text:

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

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

• Not Applicable. This submission is based on a comparison analysis to a predicate device, not a performance study involving a patient or clinical test set. The validation for mechanical safety (mentioned in the table) would involve testing the device with the specific IOLs, but no details on sample size or provenance are provided in this regulatory document.

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

• Not Applicable. No ground truth established by experts for a test set is discussed. The "ground truth" for this type of submission is the legally marketed status and characteristics of the predicate device.

4. Adjudication method for the test set:

• Not Applicable. No test set or adjudication method described.

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. This is not an AI device, and no MRMC study was conducted.

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

• Not Applicable. This is not an AI device.

7. The type of ground truth used:

• Primarily comparison to a legally marketed predicate device's characteristics and intended use. The mechanical safety aspects would have involved bench testing against defined specifications, but the specifics of that "ground truth" are not detailed here beyond "Validated for STAAR Surgical phakic Visian ICL intraocular lenses."

8. The sample size for the training set:

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile. The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.

The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Medicel A.G. IOL Injector Set. This submission is for a traditional medical device, not an AI/ML-enabled device. Therefore, the questions regarding acceptance criteria, study details, and performance metrics related to AI/ML are not directly applicable to this document.

However, I can extract the information relevant to the device's performance testing as described in the document.

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the device was tested for biocompatibility and compatibility with recommended intraocular lenses.

Regarding the other questions, they are not applicable or cannot be answered from the provided document as it concerns a traditional medical device, not an AI/ML product.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this traditional medical device. The document mentions "The device was tested with each of the recommended intraocular lenses" but does not specify a sample size for these tests or data provenance.

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)
Not applicable. This is not an AI/ML device relying on expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The performance is based on physical testing and comparison to predicate devices, not medical ground truth.

8. The sample size for the training set
Not applicable. There is no training set for a non-AI/ML device.

9. How the ground truth for the training set was established
Not applicable.

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The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn JI 3A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.

The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses " Inc. Medicer Manason Mysetting when used in conjunction with the MicroGlide cartridge.

The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular Jenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The injector is reusable and can be autoclaved. The cartridge is single-use and is provided sterile. Two types of injectors are provided: a syringe type and a screw type. The MultiJect is designed to be used with the Pharmacia Tecnis Z9000 lenses and the Pharmacia CeeOn 913A lenses.

The device has two components: a reusable injector and a disposable cartridge, sold sterile. The injector is made of titanium. The injector can be autoclaved. The cartridge is made of lubricated polypropylene.

The provided text describes a 510(k) submission for the Medicel MultiJect Reusable Injector for Intraocular Lenses. However, it does not contain specific acceptance criteria, performance data from clinical or non-clinical tests that show how the device meets those criteria, or details regarding study design elements such as sample sizes, ground truth establishment, or expert qualifications.

The document explicitly states: "(2) Clinical tests Not required" and presents the following conclusion: "The MultiJect injector and MicroGlide cartridge are equivalent in safety and efficacy to the legally marketed predicate devices." This indicates that the device's clearance was based on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than meeting specific, pre-defined acceptance criteria through a standalone performance study.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission and substantial equivalence, not on a detailed study proving the device meets specific acceptance criteria in the manner usually associated with a performance evaluation study.

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