(93 days)
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
| Feature/Test | Acceptance Criteria | Reported Device Performance (Modified Device) |
|---|---|---|
| Assembly Force Specifications | 5.5 kg force for disassembly | Testing of the Boston KPro, Type I Lucia has demonstrated that the back plate manufacturing change... as well as other minor changes... do not modify product performance. The product has been found to fulfill prospectively defined performance criteria. (Implicitly met, "Same" as predicate means the criterion is met) |
| EO Sterilization Validation | Per ANSI/AAMI/ISO 11135:2014 and AAMI TIR28:2009/(R2013) | Performed. Confirmed modified device meets functional and performance requirements. |
| EO Residuals Testing | Per AAMI/ANSI/ISO 10993–7:2008(R)2012; EO: (2017); Initial Alert Limit: ≥ 28.0 CFUs/device; Initial Action Limit: ≥ 119 CFUs/device (for Aerobic, Aerobic spores, Anaerobic, Fungal) | Performed. Confirmed modified device meets functional and performance requirements. |
| Endotoxin (LAL) Testing | Per ANSI/AAMI ST72:2011/R2016, USP (2017) and USP (2017); ≤0.2 EU/device | Performed. Confirmed modified device meets functional and performance requirements. |
| Cytotoxicity Testing | Per ISO 10993-5:2009 and FDA GLP regulations (21 CFR 58) | Performed. Confirmed modified device meets functional and performance requirements. |
| MR Safety Testing (Magnetic Field Interactions) | Translational attraction/deflection angle per ASTM F2052-15; Torque per ASTM F2213-06 (R2011) | Performed. Confirmed modified device meets functional and performance requirements. |
| MR Safety Testing (MRI-related heating) | Per ASTM F2182-11a | Performed. Confirmed modified device meets functional and performance requirements. |
| MR Safety Testing (Image Artifacts) | Per ASTM F2119-07 (R2013) | Performed. Confirmed modified device meets functional and performance requirements. |
| Manufacturing Inspection Criteria | 100% inspection for dimensions, burrs/cracks, sharp edge, shadow graph visual, actual back focal length in air | Performing. (Implied to be met, "Same" as predicate means the criterion is applied) |
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.
§ 886.3400 Keratoprosthesis.
(a)
Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Guidance on 510(k) Submissions for Keratoprostheses.”