(74 days)
BOSTON XO (hexafocon A) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and nresbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer. The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A name has been adopted by the United States Adopted Names Council (USAN).
The provided text describes the BOSTON XO (hexafocon A) Contact Lens Material, and its submission for 510(k) clearance, asserting substantial equivalence to the predicate device, BOSTON ES (enflufocon A). The document focuses on preclinical and clinical studies conducted to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the clinical study in the format of a target value to be met. Instead, it concludes equivalence to the predicate device. The preclinical tests had requirements that were met.
| Test Category | Acceptance Criteria/Requirement | Reported Device Performance |
|---|---|---|
| Preclinical Testing | ||
| In-Vitro Cytotoxicity | Meets requirements of USP XXII for Agar Diffusion Test | "The test article meets the requirements of the Agar Diffusion Test." |
| Acute Ocular Irritation | No ocular irritation produced | "produced no ocular irritation." |
| Systemic Injection | Meets requirements of Systemic Injection Test; considered non-toxic | "The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic." |
| Shelf Life | Not required for clearance (due to <1% water content and dry shipping) | "shelf-life studies are not required for clearance of this material." |
| Solution Compatibility | No significant changes to lens parameters after 30 cycles of cleaning and conditioning | "There were no significant changes to lens parameters after 30 complete cycles." |
| Clinical Testing | ||
| Overall Safety & Efficacy | Equivalent to predicate device (Boston ES) | "The sponsor concludes that BOSTON XO (hexafocon A) contact lens material is equivalent in safety and efficacy to the predicate device, Boston ES (enflufocon A)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study):
- Enrolled: 128 eyes (64 patients)
- Completed Study: 102 eyes (51 patients)
- Data Provenance: The document does not explicitly state the country of origin. It does state that "3 Investigators" were involved, which often implies a multi-site study, but specific locations are not provided. The study was prospective, as patients were "entered into the study" and followed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for the clinical study in the way one might assess an AI diagnostic device. Instead, the "safety and efficacy measures" were assessed by the clinical investigators. The document mentions "3 Investigators" who entered patients into the study. Their specific qualifications are not detailed beyond "Investigators."
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the clinical study's safety and efficacy measures. The results are presented as conclusions from the study, without mentioning independent adjudication or consensus review of specific findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the evaluation of a contact lens material, not an AI-assisted diagnostic system. Therefore, assessing how much human readers improve with AI vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study
No, a standalone performance study in the context of an "algorithm only" or AI system was not conducted. This document describes the evaluation of a contact lens material, which does not involve an algorithm or AI.
7. Type of Ground Truth Used
For the preclinical tests, the "ground truth" was based on established standard testing methodologies (e.g., USP XXII, Systemic Injection Test requirements) and observable physical changes.
For the clinical study, the "ground truth" for safety and efficacy was established through clinical observations and measurements by the investigators. These included:
- Adverse Events (self-reported and observed)
- Positive Slit Lamp Findings
- Symptoms/Complaints (patient-reported)
- Keratometry Changes (objective measurement)
- Refractive Changes (objective measurement)
- Lens Visual Acuity (objective measurement)
- Lens VA Line Changes (objective measurement)
- Lens Deposits (objective observation/grading)
- Lens Wettability (objective observation/grading)
This constitutes a form of expert assessment and objective measurement in a clinical setting.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a medical device (contact lens material) and its evaluation methods do not involve AI training. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI system, this question is not applicable.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.