Search Results
Found 1 results
510(k) Data Aggregation
(100 days)
The BOSTON XO2 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.
The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The lens is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lens material is a fluoro silicone acrylate copolymer rigid gas permeable contact lens material. The material is available in blue, ice blue, green, or violet, yellow and red tint. The lenses may contain an ultraviolet light absorber, Uvinul D-49 or MHB. The blue and ice blue tinted lenses contain the color additive D&C Green No. 6; the green tinted lenses contain the color additives D&C Green No. 6 and C.I. Solvent Yellow No. 18; the violet tinted lenses contain the color additive D&C Violet No. 2. the red tinted lenses contain the color additive D&C Red No. 17; and the yellow lenses contain the color additive C.I. Solvent Yellow No.18. All of those color additives are listed in the Code of Federal Regulations (21 CFR 74.3206).
The provided document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, many of the requested categories in the prompt, such as "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," or "Ground truth for training set," are not applicable. I will extract the information that is relevant to the acceptance criteria and the study proving the device meets those criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome Desired | Reported Device Performance (Boston XO2) |
|---|---|---|
| Lens Material Compatibility | No significant changes to lens parameters after 30 cycles with various care regimens. | No significant changes to lens parameters after 30 complete cycles. |
| Total Extractable Substances (ISO 10340:1995(E)) | Total extractable amount should be less than or comparable to the predicate device (Boston XO). | Total amount of material extracted was less than that extracted from Boston XO. |
| Extractable Color Additives and UV Blockers (ISO 10340:1995(E)) | Results should be similar to those obtained from the predicate device (Boston XO). | Results are similar to those obtained when extracting Boston XO. |
| Cytotoxicity (ISO 10993-5) | Material should not induce cytotoxicity. | Material did not induce cytotoxicity (in-vitro assay using L-929 cell monolayer). |
| Ocular Irritation (ISO 10993-10) | Material should be considered a non-irritant. | Material is considered to be a non-irritant (in rabbit ocular tissue). |
| Systemic Toxicity (ISO 10993-11) | Test samples should meet test requirements (e.g., normal observations). | All observations of the mice were normal; test samples meet test requirements. |
| Bioburden and Shelf-Life (ISO 11987:1997) | Average bioburden levels should be within acceptable limits (< 100 cfu/lens) after 30 days. | Average bioburden levels were within the acceptable limit of < 100 cfu/lens after 30 days. |
| Clinical Safety (Adverse Events) | No major complications or adverse events. | No adverse events related to the BOSTON XO2 product; no major complications; no test eyes required medical treatment; no slit lamp findings greater than grade 2. |
| Clinical Efficacy (Vision) | Vision provided should be comparable to the predicate device (Boston XO). | Vision provided by BOSTON XO2 is the same as vision with BOSTON XO. |
| Clinical Efficacy (Lens Tolerance/Symptoms) | Ratings for comfort, end of day comfort, burning/stinging, irritation, itching, dryness, and redness should be at least as good as the predicate device (Boston XO). | BOSTON XO2 was at least as good as BOSTON XO overall and at all follow-up visits for these attributes. |
| Overall Clinical Performance | Satisfactory vision quality and clinical performance meeting expectations. | Investigators were satisfied with vision quality and clinical performance; subjects were successful wearing the lenses. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the clinical study. It mentions a "controlled, multi-center clinical study."
- Data Provenance: The clinical investigation was conducted in accordance with the United States FDA regulations (21 CFR Parts 50, 54, 56 and 812), ICH Good Clinical Practices, ISO 14155-2 and the Declaration of Helsinki. This suggests the data was collected clinically, likely within the United States or countries adhering to these standards. The study compared BOSTON XO2 (test device) to BOSTON XO (predicate device). It explicitly states it included "adapted GP contact lens wearers." It is a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided. The clinical study involved "investigators" who assessed patient outcomes, but their specific qualifications or the number involved are not detailed. Given the nature of a contact lens study, the assessment of safety and efficacy would typically be performed by ophthalmologists or optometrists.
4. Adjudication method
Not applicable for this type of device and study. Clinical endpoints were likely assessed by the treating/evaluating clinician.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For non-clinical tests, the "ground truth" was established by objective laboratory measurements and adherence to ISO standards (e.g., extractable substances, cytotoxicity, irritation, systemic toxicity, bioburden).
For the clinical study, the "ground truth" for safety and efficacy was based on:
- Clinical assessments: Observations by "investigators" (likely ophthalmologists/optometrists) regarding adverse events, slit lamp findings, and overall clinical performance.
- Patient-reported outcomes/symptoms: Ratings for vision, comfort, irritation, dryness, etc., reported by the "adapted GP contact lens wearers."
- Comparison to predicate device: The performance of BOSTON XO2 was compared against the known and accepted performance of the predicate device, BOSTON XO.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The non-clinical tests involved specific lens samples and animal subjects as described. The clinical study involved human subjects, but this is a test set, not a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Ask a specific question about this device
Page 1 of 1