(252 days)
An AccuTip Cover is applied over the tip of a handheld tonometer prior to performing tonometry. The tip cover is used for protection of the patient's eye and the instrument tip.
The AccuTip Cover is intended to be used in conjunction with a handheld tonometer by trained individuals experienced in taking intraocular pressure measurements.
The AccuTip Cover is a non-sterile, sanitized, single use latex disposable. It is used to cover the tip of a handheld tonometer.
Here's a breakdown of the acceptance criteria and the studies mentioned for the AccuTip Cover, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Verification Testing | Product meets all proposed design inputs and outputs. | "The AccuTip cover design met all of the proposed design inputs and outputs." |
| Comparison Testing | Tonometer readings with AccuTip Cover are within proposed acceptance criteria compared to predicate. | "Readings with the AccuTip cover as compared to readings with the predicate were within the proposed acceptance criteria." |
| Validation Testing | All features are fully functional and meet specified intended use and method of application. | "All features were fully functional and met the specified intended use and method of application." |
| High Level Disinfection | Samples meet pre-determined acceptance criteria for bioburden and sterility assurance level. | "The samples met the pre-determined acceptance criteria." (Specific numerical criteria for bioburden or sterility assurance level are not detailed in the provided document, but it confirms the criteria were met). |
| Aging Testing | Aged samples meet pre-determined acceptance criteria for integrity and other possible defects. | "The aged samples met the pre-determined acceptance criteria." (Specific integrity or defect criteria are not detailed, but the document confirms the criteria were met after a 1-year accelerated aging study). |
| Biocompatibility | Compliance with EN/ISO 10993 and FDA G95-1 guidelines. | "EN/ISO 10993 - Biological Evaluation of Medical Devices Compliance per Toxicon reports 13-01358-G1, 13-01358-G2, and 13-01358-G3." "FDA G95-1, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995" (Implies compliance was achieved). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the test set in any of the studies (Verification, Comparison, Validation, Disinfection, or Aging testing).
The document does not explicitly state the country of origin of the data. Given Accutome, Inc. is located in Malvern, PA, USA, and the FDA correspondence, it's highly probable the studies were conducted in the USA.
The studies described are prospective in nature, as they involve testing the AccuTip Cover under various conditions to demonstrate its performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not mention the use of external experts or the establishment of "ground truth" in the context of expert consensus for any of the studies. The evaluation criteria appear to be based on internal design specifications, historical predicate device performance, and established standards.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluations appear to be straightforward comparisons against predetermined criteria.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices or AI-assisted systems, which the AccuTip Cover, a physical tonometer tip cover, is not. The document does not discuss AI or human reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone study was not done. The AccuTip Cover is a passive physical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for the studies performed for the AccuTip Cover is derived from different sources depending on the test:
- Verification Testing: Internal design inputs and outputs.
- Comparison Test: Performance of the legally marketed predicate device (Ocu-Lab Ocu-Film Tip Cover).
- Validation Testing: Specified intended use and method of application.
- High Level Disinfection Validation: Pre-determined acceptance criteria for bioburden and sterility assurance level, likely based on established microbiological standards.
- Aging Testing: Pre-determined acceptance criteria for integrity and defects, likely based on material science and device longevity standards.
- Biocompatibility: Compliance with established international (EN/ISO 10993) and national (FDA G95-1) biocompatibility standards.
In essence, the "ground truth" is a combination of engineering specifications, performance relative to a predicate, and compliance with recognized industry standards.
8. The Sample Size for the Training Set:
There is no mention of a "training set" in the document. This concept is applicable to machine learning or AI models, which are not relevant to the AccuTip Cover.
9. How the Ground Truth for the Training Set was Established:
As there is no training set, this question is not applicable.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.