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The Boston KPro is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

The Boston KPro, Type I Lucia is an artificial corneal device that can be used in patients with severe corneal opacity. The device consists of two components: a front plate constructed of clear polymethyl methacrylate (PMMA) plastic, and a back plate constructed of titanium that locks the device in place around a corneal donor graft. The Boston KPro, Type I Lucia is supplied with an assembly tool/pin to assist in device assembly.

The provided document describes a 510(k) submission for the Boston Keratoprosthesis, Type I Lucia (Boston KPro), which is an artificial corneal device. This is primarily a submission seeking to modify the manufacturing method of the back plate and make related minor changes to the front plate and assembly tool. The document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish new clinical performance acceptance criteria.

Therefore, the information regarding specific acceptance criteria for clinical efficacy studies, sample sizes, expert involvement, and ground truth for clinical performance is not directly provided in the context of a new clinical study with new acceptance criteria. Instead, the focus is on non-clinical testing to confirm that the modified device maintains the performance of the predicate device.

However, I can extract the relevant non-clinical acceptance criteria and the testing performed to demonstrate that the modified device meets these.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study for establishing performance metrics. The testing performed is non-clinical, verification and validation testing of the device's physical and material properties, and manufacturing process. Therefore, sample sizes would be per the requirements of the specific engineering and material tests (e.g., number of devices tested for assembly force, number of samples for chemical analysis, etc.), which are not detailed here.
• Data Provenance: Not applicable in the context of clinical patient data, as no clinical studies were performed. The non-clinical testing data would originate from the manufacturing and testing facilities of MEEI and its subcontractors (e.g., Tecomet, Inc.).

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 in the clinical diagnosis sense was established, as no clinical studies were conducted for this 510(k) submission. Non-clinical tests rely on established scientific methods and standards.

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

• Not applicable, as no human-based clinical performance assessment or diagnostic study was performed that would require 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 MRMC study was done, as this is a physical medical device (corneal implant), not an AI-assisted diagnostic tool.

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

• Not applicable, as this is a physical medical device.

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

• The "ground truth" for the non-clinical testing is based on predefined engineering specifications, material standards (e.g., ASTM, ISO), and regulatory limits. For example, the ground truth for sterilization efficacy is conformance to ISO 11135, and for material biocompatibility, it's conformance to ISO 10993.

8. The sample size for the training set

• Not applicable. No training set in the machine learning sense was used. This is a physical device modification submission.

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

• Not applicable.

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The Boston Keratoprosthesis is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

The Boston Keratoprosthesis is an artificial corneal device that can be used in patients with severe corneal opacity. The Boston Keratoprosthesis is used after standard corneal transplant has failed or when such a transplant would be unlikely to succeed. Thus, keratoprosthesis implantation is a procedure designed to help patients whose conditions are the most difficult to treat. This 510(k) seeks to modify the back plate material from PMMA to titanium. In doing so, the modified implant eliminates the need for a titanium retaining ring which was employed in the predecessors to hold the PMMA back plate in position following implantation. This also simplifies the assembly. It is available in two types. The Type I keratoprosthesis is implanted through and fixed only to the cornea and is used for corneal blindness when the eyelids, blink mechanism and tear film are intact. The Type II keratoprosthesis has an anterior extension to enable implantation through an opening in the closed eyelids. The Type II device is used in eyes with severe dry eye, mucosal keratinization and obliteration of the normal conjunctival fornices, such as after severe chemical injuries or Stevens Johnson syndrome or mucous membrane pemphigoid. Both devices are identical in terms of assembly.

Here's a breakdown of the acceptance criteria and study information for the Boston Keratoprosthesis, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., visual acuity targets, failure rates, etc.). Instead, the primary acceptance criterion is substantial equivalence in safety and effectiveness compared to the predicate device.

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

• Sample Size (Clinical Performance Data):
  • Modified Titanium Back Plate Device: 86 eyes in 86 subjects
  • Predicate PMMA Device: 55 eyes in 50 subjects
• Data Provenance: The document does not explicitly state the country of origin. Given the sponsor is "Massachusetts Eye & Ear Infirmary," it is highly probable the data is from the United States. The study is described as having a "mean follow-up of 14.8 months with a maximum follow-up of 38 months," indicating a prospective collection of follow-up data post-implantation for these cohorts, although the specific start date relative to the device modification isn't given.

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

The document does not mention experts being used to establish "ground truth" in the way one would for an AI diagnostic device (e.g., image interpretation). This device is a surgical implant; its performance is assessed through clinical outcomes and physical properties. Therefore, there's no "ground truth" derived from expert image interpretation in this context.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI diagnostic device and there's no expert "ground truth" to adjudicate for a test set of data points, there is no mention of an adjudication method. Clinical outcomes would typically be recorded by treating physicians.

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

No. This is not an AI diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant or reported.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm. It's a physical medical device (an implant). Therefore, a standalone performance study in the context of an algorithm is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through clinical outcomes data (e.g., safety profiles, effectiveness in providing a transparent optical pathway, long-term follow-up results) and non-clinical engineering testing (e.g., biocompatibility, assembly strength, sterility, shelf life). The key is demonstrating that the modified device's performance is "as safe and effective" as the predicate device.

8. Sample Size for the Training Set

Not applicable. This is not an AI algorithm, 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.

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Adult patients with corneal opacity not suitable for standard penetrating keratoplasty with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated.

The AlphaCor artificial cornea is made of flexible hydrogel PHEMA and comprises an optically clear core surrounded by a peripheral opaque sponge rim, which allows tissue ingrowth. The core allows transmission of light and provides refractive power, while the sponge skirt allows fibrovascular ingrowht for long term securing of the device into place. The AlphaCor device is implanted in a two stage surgical process using a modified intrastromal lamellar technique that places the posterior surface of the optic in direct communication with the anterior chamber. covers the anterior surface of the optic with the anterior corneal lamella and, usually, a conjunctival flap, and places the skirt within the lamellar pocket. The second stage of the surgical process consists of opening the anterior covering layers about 12 weeks post-implant, which exposes the anterior surface of the AlphaCor optic and allows light transmission into the eye. The AlphaCor is available in two different powers: AlphaCor-A™ for aphakic eyes and AlphaCor-P™ for phakic and pseudophakic eyes. AlphaCor-A™ delivers additional positive power to compensate for the absence of a lens in the aphakic eye.

The provided text is a 510(k) summary for the AlphaCor artificial cornea and the FDA's decision letter. It establishes substantial equivalence by comparing the device to a predicate device and outlines its intended use and description. However, it does not include a study that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or any of the other detailed information requested in the prompt.

Therefore, I cannot extract the information to populate the table and answer the questions. The document pertains to regulatory approval based on substantial equivalence rather than a detailed performance study with quantifiable acceptance criteria.

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