(98 days)
The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription.
DPCF is available for users with prism in their eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro.
DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e., baseup, base-down, base-in, base-out), per eye.
The Digital Prism Correction Feature (DPCF) is intended to provide a high quality visual experience in Apple Vision Pro spatial computing applications for users with a prism prescription. Specifically, the DPCF is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription, in the horizontal and/or vertical dimensions. DPCF fulfills the prism part of an eyeglass prescription. When an eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), DPCF fulfills the prism part of the prescription, while prescription optical inserts fulfill the other parts of the prescription.
The DPCF achieves its intended use by converting a user's prism prescription into digital image adjustment parameters that are utilized by the spatial computing image system to automatically provide digital image adjustments in horizontal and/or vertical dimensions in accordance with a user's prism prescription. At this time, DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e. base-down, base-in, base-out), per eye.
The provided document, a 510(k) summary for Apple's Digital Prism Correction Feature (DPCF), outlines the acceptance criteria and the study conducted to prove the device meets these criteria.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (How the device performed) |
|---|---|
| Provide prismatic adjustments in accordance with a prism prescription. | The bench validation testing demonstrated that the DPCF provides prismatic adjustments in accordance with a prism prescription. |
| Meet the prism tolerance requirements specified in ISO 8980-1:2017. | The results validate that the digital image adjustments provided by DPCF meet the prism tolerance requirements specified in ISO 8980-1:2017. |
| Provide reliable and acceptable prism adjustments for the available prism adjustment range (up to 7.75 Prism Diopters (PD) in horizontal and/or vertical dimensions, per eye). | The results demonstrate that the DPCF provides reliable and acceptable prism adjustments for the available prism adjustment range. (Maximum supported range is 7.75 PD horizontal and/or vertical, per eye). |
| Perform as intended with and without optical inserts. | The results demonstrate that the DPCF performs as intended with and without optical inserts. |
| The general purpose spatial computing platform (Apple Vision Pro) and its "other functions" do not adversely affect DPCF's ability to meet standardized prism tolerances. | The impact of the general purpose spatial computing platform on DPCF was assessed as part of the feature's risk management, verification, and validation activities, and determined to be acceptable. (This implies it does not adversely affect performance). |
| Software appropriately designed, verified, and validated (based on FDA guidance "Content of Premarket Submissions for Device Software Functions"). | Software verification and validation was conducted in accordance with Apple's robust quality system and documented to address the recommendations in FDA's "Content of Premarket Submissions for Device Software Functions" guidance document. DPCF was determined to be a Basic Documentation Level. Apple's good software engineering practices, as demonstrated by the 510(k) submission's documentation, supports a conclusion that DPCF was appropriately designed, verified, and validated. |
Summary of the Study Proving Device Meets Acceptance Criteria:
The study conducted was Non-Clinical Testing, specifically focusing on Bench Validation Testing and Software Verification and Validation. No clinical testing was performed or submitted.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state a sample size for the bench validation testing. It mentions "results" from the testing but doesn't quantify the number of instances or measurements taken.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It implies the testing was conducted by Apple Inc., an American company, but no further details are given. The nature of "bench validation testing" suggests prospective testing conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts to establish ground truth for the bench validation testing. The ground truth was established by standardized prism tolerance requirements (ISO 8980-1:2017), which are technical and objective metrics, not requiring expert human adjudication in the typical sense for medical imaging AI.
4. Adjudication Method for the Test Set:
- None. As the ground truth was established by objective technical standards (ISO 8980-1:2017), there was no need for human adjudication (e.g., 2+1, 3+1). The testing involved measuring the device's output against these predefined technical tolerances.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was NOT done. The document explicitly states: "No clinical testing data has been submitted." The device is a "software-only" device that modifies digital images based on a user's prism prescription, and its performance was evaluated against technical standards, not by human readers comparing performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Yes, in essence. The "Bench Validation Testing" evaluated the DPCF's ability to meet "standardized prism tolerance requirements" as an independent function. While the DPCF operates within the Apple Vision Pro, the testing focused on the device's algorithmic output (digital image adjustments) against an objective standard, rather than its effect on human performance. The assessment that the "general purpose spatial computing platform... do not adversely affect the DPCF's ability to meet standardized prism tolerances" further supports this standalone assessment of the DPCF's core function.
7. The Type of Ground Truth Used:
- The ground truth used was objective technical standards/specifications, specifically the prism tolerance requirements specified in ISO 8980-1:2017. This is a well-established international standard for ophthalmic optics.
8. The Sample Size for the Training Set:
- The document does not specify a training set sample size. The DPCF is described as software that converts a user's prism prescription into digital image adjustment parameters. This implies a rule-based or calculative approach based on optical principles rather than a machine learning model that would typically require a large training dataset. The "software engineering practices" and "bench validation testing" validate the implementation of these optical principles.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable in the typical sense for machine learning training sets. Given the nature of the device (applying prism corrections based on a prescription), the "ground truth" for its function is rooted in established optical principles and formulas for prism correction in optics. The software's "design" (as mentioned in "design controls") would incorporate these principles. The validation then confirms that the software's output aligns with these physical optical truths as defined by ISO standards.
§ 886.1655 Ophthalmic Fresnel prism.
(a)
Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.