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The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. Also, the lenses 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 lenses may be disinfected using a chemical disinfection system only.

The BOSTON ES (enflufocon A) and BOSTON EO (enflufocon B) are rigid gas permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorher.

BOSTON XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.

The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lenses may also be supplied clear (no tint).

The provided text describes information for the "BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON XO® (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES". However, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way a clinical trial would for a novel medical device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size) are not applicable or not provided in this type of document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail sense against pre-defined thresholds. Instead, it reports the physical/optical properties of the lenses, which are implicitly accepted given their substantial equivalence claim. The reported properties are presented below:

• gas to gas method
• polarographic method (ISO/Fatt)
• ***(x 10⁻¹¹ (cm³ O₂ • cm)/ (cm² • sec • mmHg) @ 35° C}

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission based on substantial equivalence to existing predicate devices, not a clinical trial with a "test set" in the context of AI/software performance. The safety and efficacy were previously demonstrated in earlier 510(k) clearances.

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 510(k) submission.

4. Adjudication method for the test set

Not applicable. This is a 510(k) submission.

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 a contact lens device, not an AI-based diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a contact lens device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document supports the safety and effectiveness of the device by demonstrating its physical/optical properties and clinical indications are substantially equivalent to previously cleared predicate devices. The "ground truth" here is regulatory acceptance based on comparisons to established, safe, and effective devices, as well as adherence to recognized material property standards.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical device, not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This is a 510(k) submission for a physical device, not an AI algorithm.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The document itself is the "study" in the context of a 510(k). It states:

• "The safety and efficacy of BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses was demonstrated in 510(k) Premarket Notifications as follows: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively. The most recent Premarket Notification for all three materials (Boston ES, EO, and XO) was 510(k) K013762, cleared April 3, 2002, for a new indication for keratoconus."
• "BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplastv."

This means the "study" is a historical chain of prior 510(k) clearances and the demonstration that the current devices' physical properties and indications are substantially equivalent to those already cleared. There is no new clinical trial data presented in this specific 510(k) summary (K053124) to validate performance against novel acceptance criteria. Instead, the "acceptance criteria" are effectively met by demonstrating that the device is the same or very similar to already approved predicate devices.

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