(67 days)
The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile, single-use device used to fold and insert an intraocular lens (MX60PL) through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
The provided text is a 510(k) summary for the Bausch + Lomb PreVue Inserter for enVista Preloaded. It describes the device, its intended use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.
However, the request asks about acceptance criteria and a study that proves a device meets those criteria. The provided document concerns a medical device accessory (an inserter for intraocular lenses), not an AI/algorithm-based diagnostic device where terms like "ground truth," "expert consensus," "MRMC study," "training set," or "test set" are typically relevant. The document focuses on showing the physical device's functional performance, biocompatibility, sterilization, and packaging validation, primarily through bench tests and laboratory evaluations.
Therefore, many of the requested points in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to the type of device and testing described in this 510(k) summary. The "study" proving the device meets acceptance criteria refers to the non-clinical functional and safety testing performed.
Here's an analysis based on the information available in the provided text, addressing the applicable points and explaining why others are not relevant:
Device: Bausch + Lomb PreVue Inserter for enVista Preloaded
Type of Device: Intraocular Lens (IOL) Inserter (Medical Device Accessory)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Pass" result for each test, indicating the device met the standards/requirements. Specific quantitative thresholds for "Pass" are not detailed in this summary but would be found in the full test reports.
| Test Category / Type | Specific Test Performed | Standard / Guideline | Acceptance Criteria (Implied) | Reported Performance (Result) |
|---|---|---|---|---|
| Delivery Verification | Fold and recovery test | ISO 11979-3: 2012 | Met standard requirements | Pass |
| Dioptric Power and Image quality Post delivery | ISO 11979-2: 2012 | Met standard requirements | Pass | |
| Lens Dimensions Post Delivery | ISO 11979-3: 2012 | Met standard requirements | Pass | |
| Surface and Bulk Homogeneity | ISO 11979-3: 2012 | Met standard requirements | Pass | |
| PreVue Inserter Cosmetic Inspection | N/A (Internal Specification) | Met internal specifications | Pass | |
| Coating transfer study | ISO 10993-1 | No cytotoxic/irritant transfer | Pass | |
| Particle counting study | ISO 10993-1 | Particle limits met | Pass | |
| Biocompatibility & Stability | Biocompatibility and Baseline Stability | ISO 10993-1 | Biologically safe | Pass |
| Leachable Extractions | ISO 10993-18 | Acceptable levels of leachables | Pass | |
| Chemical Evaluation | Evaluation and rationale for inclusion in “family grouping” of similar devices | ANSI/AAMI/ISO 11135 | Consistent with family grouping | Pass |
| Sterilization Validation | Product Adoption Analysis | EN ISO 11135:2014 | Validated sterilization process | Pass |
| EO Residuals | ETO/ECH Transfer Engineering Study | ISO 10993-7: 2008 | Residual limits met | Pass |
| Bacterial Endotoxin | Bacterial Endotoxin test | ANSI/AAMI ST72:2011/(R)2016 | Endotoxin limits met | Pass |
| Packaging Verification | Injector Sealing Validation Report | ASTM F88-09 and ASTM F1929 | Packaging integrity maintained | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary. For non-clinical bench testing of medical devices, sample sizes are typically determined by statistical rationale for validation, often involving multiple units per lot and multiple lots. The summary mentions "functional performance testing," but the exact number of devices or number of insertions is not provided.
- Data Provenance: The data originates from internal Bausch & Lomb laboratory and bench testing. There is no mention of specific country of origin for the data beyond the company's location in St. Louis, MO, USA. The testing is prospective as it's performed for regulatory submission of a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device accessory, not an AI or diagnostic algorithm requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to meeting predefined engineering and biological safety specifications through physical and chemical testing. The "experts" involved would be engineers, chemists, and quality assurance personnel performing and verifying the tests, but their number and specific qualifications are not detailed as they would be for a clinical AI study.
4. Adjudication method for the test set:
- Not Applicable. As per point 3, this is not an AI/diagnostic algorithm study using human readers. "Adjudication" usually refers to resolving disagreements among multiple human experts. For non-clinical bench testing, results are typically objective (e.g., pass/fail based on measurements) and verified by quality control procedures.
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. MRMC studies are relevant for evaluating diagnostic accuracy or reader performance with AI assistance, which is not pertinent to an IOL inserter. No human readers or AI assistance are involved in the functional testing of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical mechanical device, not an algorithm. Therefore, "standalone" algorithm performance is irrelevant.
7. The type of ground truth used:
- Engineering Specifications / ISO Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, relevant ISO standards (e.g., ISO 11979-3 for IOLs and inserters, ISO 10993 for biocompatibility), and internal quality requirements. For example, "Fold and recovery test" and "Lens Dimensions Post Delivery" imply that the true "ground truth" is whether the IOL is inserted without damage and retains its proper form and function after insertion.
8. The sample size for the training set:
- Not Applicable. This is not an AI device that requires a "training set." The device is manufactured based on design specifications and then tested.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
Summary Rationale from the Document:
The document explicitly states: "No clinical testing was performed on the subject device." and "Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Pre Vue Inserter for enVista Preloaded. No animal or clinical testing was required for this submission." This reinforces that the "study" proving the device met acceptance criteria was entirely non-clinical, focusing on functional performance, material safety, and manufacturing quality. The conclusion emphasizes that "Device functional performance testing all passed and demonstrates equivalence to predicate device." and that all results support "substantial equivalence to the predicate devices."
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.