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The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.

The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.

The provided text describes a 510(k) premarket notification for a medical device called the "MicroSTAAR Injector System Cartridge, Model CQ." This submission is a "Special 510(k) Notification" for a design modification of an already cleared predicate device (K101782). The key modification is in the polypropylene formulation composing the device.

Therefore, the studies and acceptance criteria presented focus on demonstrating that this material change does not negatively impact the device's performance, safety, and effectiveness compared to the predicate.

Here's an analysis of the acceptance criteria and the studies, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

* N/A here means these were claimed as "same" or design specifications rather than performance metrics requiring specific numeric acceptance criteria and measurement after the material change. The primary focus of the studies was to confirm the material change did not alter the existing performance.

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

The document does not explicitly state the exact sample sizes (number of cartridges or IOLs) used for each non-clinical test (Recovery of Properties, Biocompatibility, Shelf-Life). It only mentions "validation testing" and "tests performed."

Regarding data provenance:

• The studies were non-clinical (laboratory/bench testing).
• There is no mention of country of origin of data or whether it was retrospective or prospective in the context of human data, as these are bench tests. For the shelf-life study, it states it was "initiated and on-going" for "real time and accelerated conditions," indicating a prospective study design for that specific test.

3. 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 intraocular lens injector cartridge, and the studies described are non-clinical (bench testing) to verify material performance, shelf-life, and biocompatibility. There is no "ground truth" established by human experts in the way it would be for diagnostic AI/CADe devices. The "ground truth" is based on established ISO standards and performance specifications for the mechanical and biological properties of the device and lens interaction.

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies are non-clinical, involving physical and chemical testing against established standards. There is no human adjudication process involved.

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 a physical medical device (an injector cartridge), not an AI/CADe system designed for image analysis or diagnosis. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for these non-clinical studies is defined by:

• Performance Specifications: The intraocular lenses must recover to their intended specifications after being folded and deformed by the cartridge, as mandated by Section 5 of ISO 11979-3:2012.
• Standard Requirements: The modified material must meet the biocompatibility requirements laid out in ISO 10993-1:2009 and relevant FDA Guidance.
• Stability Standards: The device must demonstrate stability over its stated shelf-life according to ISO 11979-6:2014.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.

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

Not applicable. See point 8.

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The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.

The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.

The provided document is a 510(k) summary for the MicroSTAAR® Injector System Cartridges, specifically concerning a change in the polypropylene material used for manufacturing. The document describes several performance tests conducted to demonstrate that the device, with the new material, is substantially equivalent to its predicate device.

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

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 individual test (biocompatibility, feasibility, shelf-life, sterilization).
• Data Provenance: The biocompatibility study was performed by "Namsa Laboratory." No country of origin is explicitly mentioned for the data, but the company (STAAR Surgical) is based in the USA, and the material supplier is in Japan. The study is retrospective in the sense that these tests were performed on a device with a modified material to demonstrate equivalence.

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

• This information is not applicable to the type of device and studies described. The tests performed are engineering and laboratory-based assessments (e.g., cytotoxicity, material analysis, mechanical function, sterility), not clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes. Therefore, "ground truth" in the sense of expert consensus on clinical data is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. As the tests are objective laboratory and functional evaluations, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.

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 an intraocular lens injector cartridge, a mechanical device used in surgery, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For biocompatibility, the ground truth is established by standard biological assays and the absence of cytotoxic, sensitizing, or irritating effects as per ISO 10993 standards.
• For feasibility, the ground truth is successful delivery of the lenses without damage, as determined by visual inspection and functional assessment.
• For FTIR, the ground truth is the chemical fingerprint of polypropylene copolymer.
• For shelf-life, the ground truth is the continued functional performance and integrity of the cartridge after accelerated aging, meeting manufacturer's specifications.
• For sterilization, the ground truth is the achievement of the specified Sterility Assurance Level (SAL), demonstrated by biological indicators.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set. The "training" in this context refers to the development and manufacturing processes that establish the device's characteristics.

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

• Not applicable. See point 8. The "ground truth" for the device design and manufacturing is established through engineering specifications, material science principles, and adherence to quality system regulations (e.g., 21 CFR 820). The studies described here are verification and validation activities against those established specifications.

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The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.

The single use, disposable Epiphany Injector System is a delivery system for intraocular lenses (IOLs) for surgical placement in the human eye. The two main materials used in the manufacturer of this injector system will be polycarbonate and polypropylene. All product is also supplied "STERILE."

The provided text describes the Epiphany Injector System, a disposable intraocular lens injector. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the way requested by the prompt.

Instead, the document serves as a 510(k) summary for regulatory submission, primarily focusing on demonstrating substantial equivalence to predicate devices. It references "test results" for "Mechanical Safety" but does not elaborate on these results or the acceptance criteria used.

Therefore, I cannot fulfill many of the requested sections as the information is not present in the provided text. I will indicate where information is missing.

Epiphany Injector System

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific performance acceptance criteria for the Epiphany Injector System. It largely relies on a comparison to predicate devices to establish substantial equivalence.

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

The document states, "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration." This indicates that no clinical test set was used. The brief mention of "Mechanical Safety: See test results" implies some form of engineering or bench testing, but the sample size and data provenance are not provided.

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

Not applicable. No clinical studies or human expert-based test sets are described.

4. Adjudication method for the test set

Not applicable. No clinical studies or human expert-based test sets are 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 device is a mechanical injector system, not an AI or imaging device that would typically involve MRMC studies with human readers.

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

Not applicable. This device is a mechanical injector system, not an algorithm. Bench testing would be analogous to "standalone" performance for a mechanical device, but details are not provided.

7. The type of ground truth used

The primary "ground truth" for this submission appears to be the established performance and safety of legally marketed predicate devices, against which the Epiphany Injector System demonstrated "substantial equivalence." For "Mechanical Safety," internal test results are referenced, implying engineering specifications or performance benchmarks as ground truth, but these are not detailed.

8. The sample size for the training set

Not applicable. This device is a mechanical injector system, not an AI system requiring a training set in the conventional sense.

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

Not applicable.

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The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "MicroSTAAR™ Indigo Injector Foam Tip System." This letter grants market clearance based on a finding of "substantial equivalence" to legally marketed predicate devices, not on the results of a clinical study demonstrating the device meets specific acceptance criteria in the manner that an AI/ML device would be evaluated.

Therefore, the information requested in your prompt (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this document.

This document is for a Class I medical device (intraocular lens guide) and focuses on regulatory clearance rather than a detailed performance study as would be required for a novel AI/ML diagnostic or prognostic device. The 510(k) process for this type of device typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.

In summary, this document does not contain the information necessary to answer your request regarding acceptance criteria and a study proving a device meets those criteria, as it pertains to AI/ML device evaluation.

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The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.

Not Found

This document is a 510(k) clearance letter from the FDA for the MicroSTAAR™ MSI Injector Foam Tip System, a device intended to fold and insert intraocular lenses.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls provisions. It does not include performance data, study design, or ground truth establishment relevant to the questions asked.

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The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.

The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.

The provided document is a 510(k) summary for the STAAR Surgical Collamer 3 Piece Injector, and it describes a medical device (injector), not an AI/ML powered device, therefore most of the requested information (like acceptance criteria for an AI model, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the information relevant to the device's performance based on the provided text, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's the relevant information:

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 is not a study assessing an AI/ML algorithm's performance on a dataset. The testing described is non-clinical mechanical performance testing of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.

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. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" in this context would be the objective measurements and observations of the physical device's mechanical performance and behavior, compared to a predicate device and safety standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The study described is a non-clinical test to demonstrate the substantial equivalence of the Collamer 3 Piece Injector to its predicate device, the MS1-P Elastic Lens Injector (K861085). The study focused on validating the mechanical performance and mechanical behavior of the new injector.

The device meets the (implicit) acceptance criteria because the non-clinical tests showed that it performs equivalently to the predicate device in terms of mechanical performance and behavior, and it was designed and tested in accordance with applicable safety standards. The FDA's clearance letter (K032412) confirms that the device is substantially equivalent, allowing it to be marketed.

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The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line.

The Surge-free Aspiration Adapter is a filter protected flow restriction device intended to be placed between the handpiece and aspiration tubing used during phacoemulsification surgery. The Surge-free Aspiration Adapter prevents/neutralizes vacuum surges in the aspiration line resulting from the sudden clearing of occlusions.

The provided text is a 510(k) premarket notification for a medical device called the "Surge-free Aspiration Adapter." This document focuses on demonstrating the substantial equivalence of the new device to existing legally marketed predicate devices, rather than detailed performance study results against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be fully extracted from the provided text. The document primarily describes the device, its intended use, and compares its technological characteristics to predicate devices. It does not contain information about a performance study with acceptance criteria.

However, I can provide the partially available information:

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

The document does not provide specific acceptance criteria or quantitative performance data. It describes the effect of the device: "Reduction in vacuum surges resulting from release of aspiration tubing occlusions."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the document.

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 information is not present in the document.

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

This information is not present in the document.

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 information is not present in the document. This device is not an AI-assisted diagnostic tool; it's a mechanical adapter for surgical equipment.

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

This information is not present in the document. This device is not an algorithm.

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

This information is not present in the document.

8. The sample size for the training set

This information is not present in the document.

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

This information is not present in the document.

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The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.

The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Premarket Notification [510(K)] Summary for the Disposable MicroSTAAR™ Injector System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Functional Testing:
  • Sample Size: Thirty (30) sterile Disposable MicroSTAAR™ Injectors (Model MSI-P1).
  • Data Provenance: Not explicitly stated but implies laboratory testing done by the manufacturer (STAAR Surgical Company) as part of their validation. It is a prospective test, as it's a validation performed for the device.
• Accelerated Aging Study:
  • Sample Size: "Baseline (zero time) and one year accelerated samples" were used. The exact number of samples for each specific test (Microbial Challenge, Dye Penetration, Peel Strength, Burst) is not explicitly stated, but it would have been a subset of the manufactured devices.
  • Data Provenance: Similar to functional testing, this was likely a prospective laboratory study conducted by the manufacturer.

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

This type of information is generally not applicable to mechanical device testing like an IOL injector. The "ground truth" here is objective physical measurements and performance thresholds (e.g., absence of tears, resolution measurements, integrity assessments). No human experts were used to establish a ground truth in the sense of image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretations requiring adjudication.

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

Not applicable. This device is a mechanical injector, not an AI-assisted diagnostic tool.

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

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

7. The Type of Ground Truth Used

The ground truth used for these tests was based on objective, measurable physical characteristics and performance criteria for the device and its packaging. This includes:

• Absence of physical damage: Lens tears.
• Performance metrics: Optical resolution post-ejection.
• Sterility integrity: Microbial challenge results, dye penetration, peel strength, burst strength.
• Statistical similarity: For aging studies, comparing mechanical properties of new vs. aged samples.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a mechanical device.

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The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.

STAAR Surgical Company's Foam Tip™ Injector is used to fold and insert STAAR Surgical UV-ELASTIC™ silicone intraocular lenses for surgical placement into the human eye. The new Foam Tip™ Injector utilizes the same design principles (i.e. a plunger pushing or threaded mechanism) to push the IOL through a cartridge for injection into the eye as the existing MicroSTAART™ injectors. The new injector system differs from the MicroSTAART™ injector in that it contains a disposable Foam Tip™ plunger insert which may be attached to the sterilized injector body prior to lens loading. This attachable Foam Tip™ plunger insert is encapsulated inside a holder that protects the sponge from damage. The holder acts to guide the plunger as it slides into the injector body and performs as a wrench to remove the plunger from the injector once the lens has been implanted. Once the sponge portion of the foam plunger insert is hydrated, it enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the Foam Tip™ Injector System (K980696):

Acceptance Criteria and Device Performance for Foam Tip™ Injector System (K980696)

1. Table of Acceptance Criteria and Reported Device Performance

Additional Acceptance Criteria and Performance (Accelerated Aging Studies)

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

• Sample Size: 40 functional ejection tests were conducted for the functional testing.
• Data Provenance: The text does not explicitly state the country of origin or whether the study was retrospective or prospective. It describes laboratory or in-house testing performed by or for STAAR Surgical Company.

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

The document does not specify the use of "experts" to establish ground truth in the traditional sense of clinical opinion or image interpretation. The ground truth for functional performance (lens tears, haptic damage, resolution efficiency, particulates) was established through direct observation and measurement in a controlled testing environment, likely by trained technicians or engineers.

4. Adjudication Method for the Test Set

Not applicable. The criteria for functional testing were objective and directly observable/measurable (e.g., presence/absence of tears, adherence to resolution requirements). There was no "adjudication" between multiple expert opinions.

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

No. This document describes non-clinical functional and accelerated aging tests of the device itself, not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This device is a mechanical injector system, not an algorithm or AI. The tests performed are standalone in the sense that they evaluate the physical device's performance directly.

7. The Type of Ground Truth Used

The ground truth was established through objective physical measurements and observations within a controlled laboratory setting (e.g., visual inspection for tears/damage, resolution testing, particulate analysis, microbial challenge results, chemical analysis).

8. The Sample Size for the Training Set

Not applicable. This is a non-AI/algorithm device. The concept of a "training set" does not apply to the development and testing of a mechanical injector system in this context.

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

Not applicable, as no training set was used.

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