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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 RxSight Contact Lens is indication and treatment in the anterior segment of the eye.

The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye.

The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.

The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.

The provided document is a 510(k) summary for the RxSight Contact Lens, which seeks to establish substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria based on performance metrics that would typically be described with sensitivity, specificity, or similar statistical measures. Instead, the "acceptance criteria" here refer to conformance with regulatory requirements and equivalence to a predicate device, demonstrated through a comparison of physical characteristics and specific types of testing.

Therefore, many of the requested fields are not applicable because this is not a performance study in the traditional sense of evaluating an algorithm or diagnostic tool against a ground truth.

Here's the information that can be extracted and synthesized based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study with a "test set" for accuracy metrics like sensitivity/specificity. The testing performed was for biocompatibility, sterilization, and general finished product performance, not a diagnostic accuracy study. The document does not specify the number of individual devices or materials tested for these purposes.
• Data Provenance: Not applicable. The testing described is laboratory-based (biocompatibility, sterilization, physical performance) rather than clinical data from human subjects from a specific country or collected retrospectively/prospectively.

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

• Not applicable. "Ground truth" in the sense of expert-established diagnostic labels is not relevant for this type of device (a diagnostic contact lens) and the types of testing described (biocompatibility, sterilization, physical characteristics).

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication of diagnoses.

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 diagnostic contact lens, not an AI-powered diagnostic system. No MRMC study was conducted.

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

• Not applicable. This device is a physical diagnostic contact lens, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For biocompatibility and sterilization, the "ground truth" would be established by the relevant ISO standards (ISO 10993-1, ISO10993-5, ISO10993-10, ISO 10993-7) and their specified testing methodologies and acceptance limits. For physical characteristics and intended use, the "ground truth" is typically defined by engineering specifications and direct comparison to the predicate device's established characteristics. It is not an expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no training set in that context.

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

• Not applicable. 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 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 only for 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the RxSight Insertion Device:

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

The provided text does not explicitly list "acceptance criteria" with specific pass/fail thresholds. Instead, it describes the types of performance tests conducted and states that the device "meets all product design requirements and applicable standards."

Based on the summary, we can infer the following performance evaluations:

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

• Sample Size for Test Set: The document mentions "two IOLs" for the pre- and post-injection evaluation of mechanical and optical properties. This is an extremely small sample size for a performance test. It does not provide sample sizes for other tests like biocompatibility or sterilization.
• Data Provenance: Not explicitly stated. These appear to be bench tests conducted by the manufacturer, but the location or specific context (e.g., in vivo, ex vivo, in vitro) is not detailed. There is no information about retrospective or prospective data collection from human subjects.

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

Not applicable. The tests described are bench tests involving mechanical and optical measurements against ISO standards. There is no mention of expert-established ground truth or human readers involved in these performance tests.

4. Adjudication method for the test set

Not applicable. There is no mention of clinical endpoints or the need for adjudication as the tests are objective bench measurements.

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 IOL insertion device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. This device is a medical instrument, not an algorithm. Its performance is evaluated through its physical function and interaction with the IOL, not through an algorithm's output.

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

The "ground truth" for the performance tests appears to be defined by international standards (ISO 11979-2:2014, ISO 11979-3:2012, ANSI/AAMI/ISO 11135). The device's performance (e.g., maintaining IOL dimensions, sagitta, optical properties) is compared against requirements or expected values specified by these standards for pre- and post-injection conditions.

8. The sample size for the training set

Not applicable. This device is a mechanical instrument 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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