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The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers.

The Sensor Medical Single Use Tonometer Prism is used as the optical image doubling prism for Goldmann applanation style tonometers. The prism is a precise optical replacement for the current glass Goldmann tonometer. The Sensor Medical Single Use Tonometer Prism is made from PMMA. The corneal contact diameter is 6.6 +/-0.1mm. The total length of the prism is 30.0 +/- 0.1mm. The prism weighs 1.8 +/- 0.1 g.

Acceptance Criteria and Device Performance for Sensor Medical Single Use Tonometer Prism

This document summarizes the acceptance criteria and device performance for the Sensor Medical Single Use Tonometer Prism based on the provided FDA 510(k) summary. It's important to note that this submission did not include performance data to prove the device met specific criteria, but rather demonstrated substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

The provided document describes a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than conducting new clinical performance studies to prove specific acceptance criteria are met. Therefore, many of the requested details about a study are not applicable in this context.

Crucially, the document explicitly states: "No performance data is provided since no new questions of safety and effectiveness are raised." This means there was no new study conducted to generate performance data for this specific device.

Based on this, here is an explanation for the requested study information:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not Applicable. No new test set data was generated for the Sensor Medical Single Use Tonometer Prism. The device's performance was not measured in a study; instead, its characteristics were compared to a predicate device.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not Applicable. No test set was created, and therefore, no experts were used to establish ground truth for a new performance study.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not Applicable. No test set was created or adjudicated.

• 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 device is a tonometer prism, a physical ophthalmological instrument, not an AI software. No MRMC study was conducted.

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

  • Not Applicable. This is a physical medical device, not an algorithm.

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

  • Not Applicable. No new ground truth was established for the device's performance in a study. The "ground truth" for substantial equivalence was the previously cleared predicate device and its known characteristics.

• 8. The sample size for the training set

  • Not Applicable. This device is a physical instrument, not a learning algorithm, so there is no concept of a "training set."

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

  • Not Applicable. As there is no training set, this question is not relevant.

In summary: The Sensor Medical Single Use Tonometer Prism gained clearance through demonstrating substantial equivalence to an existing predicate device (Luneau Tonometer Separation Prisms, K023838). This pathway does not typically involve new clinical performance studies or the generation of new performance data against specific acceptance criteria for the new device, but rather a direct comparison of its attributes (intended use, technological characteristics, materials, size, weight, sterility, principles of operation) to the cleared predicate. The "study" here is essentially the comparison itself, showing that the new device is functionally identical to one already deemed safe and effective.

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The Sensor Medical Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and retinal structures during vitrectomy surgery.

The Sensor Medical Family of Vitrectomy Lenses and Products includes single-use, disposable, sterile devices for use during vitrectomy surgery. The following devices are included in the family: Plano Lens, Magnifier Lens, Bi-Concave Lens, 20 degree Prism Lens, 30 degree Prism Lens, Osher 78 D Lens, Suture Ring, Silicone Ring, and Lens Forceps.

The Sensor Medical Family of Vitrectomy Lenses and Products is designed around the classic Goldmann contact lens. Each style of lens is of similar design, with slight variations in the posterior surface shape to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with an operating microscope, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.

The lenses typically consist of a PMMA (acrylic) optical element that is applied for a short period of time directly on the globe or cornea of the eye.

Here's a breakdown of the acceptance criteria and the "study" (or lack thereof) based on the provided text, structured according to your request:

Acceptance Criteria and Device Performance

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, there are no explicit acceptance criteria for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy metrics).

The "acceptance criteria" here are implied by the demonstration of substantial equivalence to the predicate device. The performance is deemed acceptable if the new device is as safe and effective as the predicate.

Study Information (or lack thereof)

This submission relies on a demonstration of substantial equivalence to a predicate device (Ocular Instruments Disposable Vitrectomy Lens Kit, K012096), rather than a new clinical or performance study of the Sensor Medical devices themselves. The document explicitly states: "No performance data is provided since no new questions of safety and effectiveness are raised."

Given this, many of your requested points are not applicable.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set was used for a performance study. Comparison was based on design specifications and intended use against a cleared predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No ground truth establishment for a test set was performed.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.
4. 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 device is an optical lens for direct visualization during surgery, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, to which the new device is being compared.
7. The sample size for the training set: Not applicable. No training set was used.
8. How the ground truth for the training set was established: Not applicable. No training set was used.

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The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.

The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic contact lenses use for eve examination and therapy of intraocular abnormalities. The Family consists of 14 lenses - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mirror Lens, 3 Mirror Lens, Iridotomy Lens, Capsulotomy Lens, Retina 90 Lens, Retina 165 Lens, Retina 180 Lens, Indirect Lenses: 90 D, 78 D, 60 D, 28 D and 20 D.
The Family of Ophthalmic Lenses is designed around the classic Goldmann contact lens. Each model lens is of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with a slit lamp, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.
The lenses are provided sterile for single use.

The provided documentation describes a 510(k) premarket notification for the "Sensor Medical Technology LLC Family of Disposable Lenses." This submission primarily focuses on establishing substantial equivalence to a predicate device (Sensor Family of Ophthalmic Lenses, K102371) that was previously 510(k) exempt. The main difference between the new device and the predicate is that the new lenses are provided sterile for single use, whereas the predicate devices were reusable.

Therefore, the performance data presented is focused on demonstrating that the disposable, sterile versions are as safe and effective as the reusable predicate, particularly regarding sterility and shelf life. This is not a study to demonstrate AI/algorithm performance in the typical sense of a diagnostic or predictive device with metrics like sensitivity, specificity, or AUC. Instead, it's a demonstration of product safety and efficacy through engineering and biological testing.

Here's an analysis based on the provided text, highlighting the information (or lack thereof) for each requested point:

Acceptance Criteria and Study for Sensor Medical Technology LLC Family of Disposable Lenses

This submission is for a family of disposable ophthalmic lenses, not an AI or algorithm-based device. The "acceptance criteria" and "device performance" are therefore related to the physical and biological characteristics of the lenses, particularly regarding sterility and shelf life, rather than diagnostic accuracy or clinical effectiveness in the AI context.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the sterility validation or shelf-life testing. These tests are typically performed on a statistically relevant number of product units from manufacturing lots, but the exact numbers are not reported in this summary. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as these are technical validation studies performed by the manufacturer or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable. The "ground truth" for sterility is determined by microbiological testing and for shelf life by accelerated or real-time aging studies and subsequent performance testing, not by expert human interpretation in a clinical context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., reading medical images). Here, the testing involves laboratory procedures for sterility and product stability, where "adjudication" in the human-reader sense does not apply.

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

No. This is not an AI-assisted device. An MRMC study was not performed. The device is a physical ophthalmic lens.

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

No. This is not an AI algorithm.

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

The "ground truth" for this device's performance validation is:

• Sterility Validation: Microbiological test results (e.g., sterility test, bioburden, endotoxin testing) according to recognized standards (e.g., ISO 11135 or ISO 11137 for sterilization, ISO 11737 for bioburden).
• Shelf Life Testing: Physical and functional integrity of the device and its packaging over time, confirmed by various tests (e.g., visual inspection, package integrity, functional performance, and sterility at different time points) after accelerated or real-time aging.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable as there is no training set.

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