(94 days)
The Ocular Force Gauge is indicated for applying measured force to the surface of the eye.
The Ocular Force Gauge is a non-sterile, reusable, precision spring-scale manual instrument designed and manufactured to apply measured force to the surface of the eye. The hand held device has a smooth "foot" similar to the "foot" of an opthalmodynamometer, an instrument used to apply and measure force on the ocular surface. The Ocular Force Gauge "foot" is the surface of the device that contacts the ocular surface.
Here's an analysis of the provided text regarding the Ocular Force Gauge, addressing the requested information:
Acceptance Criteria and Study Details for the Ocular Force Gauge
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a "Traditional 510(k) Submission" for the Ocular Force Gauge, seeking substantial equivalence to a predicate device. In this context, specific numerical "acceptance criteria" are not explicitly stated in a tabular format as they would be for a novel device with defined performance thresholds. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate, the Ophthalmodynamometer, and compliance with relevant standards.
The device performance is primarily reported as meeting pre-determined specifications and demonstrating substantial equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|
| Functional Equivalence: Ability to apply measured force to the surface of the eye. | "The Ocular Force Gauge was shown to be substantially equivalent in intended use, principle of operation, and technological characteristics to the legally marketed predicate device, the Ophthalmodynamometer." |
| "The test samples [Ocular Force Gauge and Ophthalmodynamometer] were loaded one at a time into the lower jaws of an Instron and depressed into the anvil at a rate of 1.0 Inch/Minute. When the load cell reached a force of 1.0 ounce the test ended. The maximum load and extension were recorded..." | |
| Foot Surface Quality: Smooth surface with no defects or debris. | "The foot of each instrument [Ocular Force Gauge and Ophthalmodynamometer] was visually inspected to ensure a smooth surface with no defect or debris in between repetitions of the force testing. All samples met pre-determined specifications for both the foot surface and compressive force." |
| Biocompatibility: Non-cytotoxic. | "Ocular Therapeutix completed with passing results a confirmatory cytotoxicty test on the Ocular Force Gauge per ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity." |
| Sterilization Efficacy: Ability to be sterilized to a Sterility Assurance Level (SAL) of 1 x 10^-6. | "A cleaning and sterilization was performed on the Ocular Force Gauge demonstrating the device is able to be sterilized by gravity steam sterilization (autoclave) to a sterility assurance level (SAL) of 1 x 10to." (Note: "1 x 10to" likely a typo for 1 x 10^-6, a common SAL target). |
| Compliance with relevant voluntary standards (e.g., ISO for sterilization, biocompatibility). | The device meets ISO 17665-1:2006, ISO 10993-1:2009 & Cor 1:2010, ISO 10993-5:2009, and ISTA 1A 2001. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states, "Two bench top tests were used to evaluate and compare the foot surface and the ability to apply force for each device." It then mentions "The test samples were loaded one at a time..." This indicates that multiple units of both the Ocular Force Gauge and the Ophthalmodynamometer were tested, but the exact number of samples (units) of each device tested is not specified.
- Data Provenance: The tests were "In vitro preclinical tests" and "bench top tests" performed by Ocular Therapeutix, Inc. This implies the data is retrospective (in the sense that it's prior testing data submitted for regulatory review) and performed in a controlled laboratory setting (likely in the USA, given the submitter's address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable or not specified. This study did not involve human interpretation or subjective assessment that would require expert consensus for ground truth. It relied on objective measurements and visual inspections against "pre-determined specifications" and standard regulatory tests (e.g., cytotoxicity).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As mentioned above, the study involved objective bench testing and compliance with standards, not subjective assessments requiring adjudication. The "visual inspection" of the foot surface would likely have been against a clear specification, rather than requiring expert consensus or adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a manual instrument for applying measured force, not an AI or imaging diagnostic device that would typically involve an MRMC study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Was a standalone study done? This is not an AI algorithm. The device is a physical, manual instrument. Therefore, the concept of a "standalone algorithm" performance study doesn't apply. The performance data presented (bench tests, biocompatibility, sterilization) represents the "standalone" performance of the physical device.
7. Type of Ground Truth Used
- The ground truth for the functional and safety aspects of the device was established through:
- Objective physical measurements: Using an Instron machine to measure maximum load and extension for compressive force.
- Visual inspection: For the foot surface quality, against "pre-determined specifications."
- Standardized laboratory tests: ISO 10993-5 for cytotoxicity testing.
- Validated sterilization methods: Gravity steam sterilization demonstrating a specific SAL.
- Compliance with Predicate Device characteristics: Substantial equivalence in "intended use, principle of operation, and technological characteristics" to the Ophthalmodynamometer.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical instrument, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
§ 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.