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510(k) Data Aggregation
(28 days)
Bausch + Lomb Injector System
The Bausch + Lomb Injector System is indicated for the folding and insertion of Bausch + Lomb intraocular lenses cleared or approved for use with this IOL Injector system.
The Bausch + Lomb Injector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.
This document is an FDA 510(k) premarket notification for a medical device (Bausch + Lomb Injector System) and does not contain the detailed information necessary to answer the request.
The request asks for specific details about acceptance criteria, study design (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), and performance metrics (reported and a comparative effectiveness study with AI assistance). This type of information is typically found in study reports, clinical trial summaries, or detailed technical documentation that usually accompanies a 510(k) submission, but is not present in the summary provided.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which usually involves comparing design, materials, and intended use, rather than presenting new detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The text only states:
- "Performance bench testing was completed on the Bausch + Lomb Injector System and results show the system to be in conformance with the requirements set forth in respective standards." (Section 5, page 4)
This statement indicates that testing was done and standards were met, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study with AI (the device appears to be a physical injector system, not an AI-assisted diagnostic tool).
- Standalone algorithm performance (again, not applicable to this type of device).
- Type of ground truth (not explicitly stated beyond "respective standards").
- Training set sample size (not applicable as this is not an AI/ML model being trained).
- How ground truth for the training set was established (not applicable).
To answer your request, you would need access to the actual "performance bench testing" report and "respective standards" referenced in the document.
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(196 days)
BAUSCH & LOMB INJECTOR SYSTEM
The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.
The Bausch + Lomb Iniector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.
Acceptance Criteria and Device Performance for Bausch + Lomb Injector System
This document describes the acceptance criteria and the study that demonstrates the Bausch + Lomb Injector System (BLIS) meets these criteria, based on the provided FDA 510(k) summary (K131958).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes various tests performed to ensure the device's safety and effectiveness. The "acceptance criteria" are implied to be successful completion and conformity to relevant standards and established good practices for medical devices of this type. The "reported device performance" is the successful outcome of these tests.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Manual and automated cleaning processes must be effective in preparing the handpiece for sterilization. | Cleaning validation covered the manual and automated cleaning processes described in the labeling for the Bausch + Lomb Injector System Handpiece. (Implies successful validation). |
| Sterilization Validation | Autoclave methods for handpiece and ethylene oxide (EtO) process for cartridge must achieve sterility. | Sterilization validation included the autoclave methods described in the labeling for the Bausch + Lomb Injector System Handpiece and the ethylene oxide process for the Bausch + Lomb Injector System Cartridge. (Implies successful validation). |
| Sterilization Residual Testing | Ethylene oxide residuals must be within acceptable limits for patient safety. | Ethylene oxide residual testing for a device equivalent to the Bausch + Lomb Injector System Cartridge was included in the 510(k). (Implies compliance with limits). |
| Shipping and Handling Validation | Device integrity and functionality must be maintained after exposure to typical shipping and handling conditions. | Shipping and handling validations were performed on both the Bausch + Lomb Injector System Handpiece and Cartridge. (Implies successful validation). |
| Stability Testing | The cartridge must maintain its integrity and functionality over its specified shelf life. | Stability testing validated the Bausch + Lomb Injector System Cartridge over the shelf life of the device. (Implies successful validation). |
| Biocompatibility | Device components in contact with the patient (handpiece and cartridge) must be biocompatible, showing no adverse biological reactions. | Biocompatibility testing was performed on the Bausch + Lomb Injector System Handpiece and cartridge, and both were found to be biocompatible. |
| Mechanical Properties (Bench Testing) | Device components must meet the mechanical requirements outlined in ISO 11979-3. | Bench testing was performed on both components of the Bausch + Lomb Injector System to demonstrate compliance with ISO 11979-3, Mechanical Properties. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify numerical sample sizes for the test sets used in cleaning, sterilization, shipping, stability, biocompatibility, or bench testing. It indicates that these tests "were performed" or "were included," implying sufficient samples for validation.
The data provenance is internal to the manufacturing and testing processes of Bausch + Lomb. The tests were non-clinical (bench-top and laboratory-based) rather than involving human subjects. Therefore, specific country of origin or retrospective/prospective distinctions as would apply to clinical data are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This device is an injector system, not an AI or diagnostic device that requires expert ground truth for interpretation of output. The ground truth for its performance is derived from standardized testing methodologies and compliance with industry standards (e.g., ISO 11979-3).
4. Adjudication Method
N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or diagnosis, such as those evaluating AI for medical imaging. This device's testing is focused on physical and biological properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not applicable to an intraocular lens injector system. These studies are typically performed for diagnostic devices where human readers interpret medical data (e.g., images) and the impact of AI assistance on their performance is measured. The BLIS is a surgical tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was Done
Yes, in a conceptual sense. All the tests described (cleaning, sterilization, shipping, stability, biocompatibility, bench testing) assess the device's inherent properties and functionality without human intervention in the performance of the core mechanical/biological tests. The device's operation, however, does require a human operator to physically use it. The tests evaluate the "algorithm" of the device's design and materials.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests is objective physical measurements and biological assays that conform to established industry standards and regulatory requirements. This includes:
- Sterility assurance levels
- Residual levels of sterilants
- Material properties (strength, durability, etc.) as defined by ISO 11979-3
- Biocompatibility endpoints as per relevant ISO standards (e.g., ISO 10993 series).
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for an algorithm, this question is not applicable.
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