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510(k) Data Aggregation
(66 days)
HNC
Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
A single use ophthalmic device designed to retract the eyelids.
This document describes the acceptance criteria and the study conducted for the Stephens Disposable Speculum (K022836).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Retraction of eyelids in various ophthalmic procedures (must be equivalent to predicate devices). | Performance Test: Comparison to Predicate Devices. |
| Conclusion: Intended Use is "Retraction of eyelids in various ophthalmic procedures," which is the same as the predicate devices (Katena Ophthalmic Speculum, Storz Ophthalmic Speculum, Rhein Ophthalmic Speculum, Stephens Ophthalmic Speculum). This indicates the device meets the intended use criteria. | ||
| Performance | Device must perform comparably to predicate devices in terms of retraction tension and holding ability. | Performance Test: Retraction Tension Tests. |
| Conclusion: "The mechanism and holding ability of the Stephens speculum was found to perform as well as the predicate devices." This indicates the device meets the performance criteria. | ||
| Dimensional Equivalency | Blade measurements of the speculum must be substantially equivalent to predicate devices. | Performance Test: Dimensional Equivalency Test. |
| Conclusion: "The blade measurements of the speculum were substantially equivalent to the measurements of the predicate devices listed above." This indicates the device meets the dimensional equivalency criteria. | ||
| Material | Compatibility with existing materials used in predicate devices for ophthalmic speculums. | Performance Test: Material composition comparison. |
| Conclusion: The device uses 420 Stainless Steel & Polystyrene, while the predicate devices use 420 Stainless Steel. The document implies that this combination is compatible and does not negatively impact performance, aligning with substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not indicate any clinical trials or tests involving human subjects or patient data for the Stephens Disposable Speculum. Therefore, there is no "test set" in the context of clinical data for this device. The evaluations were based on engineering performance tests and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set requiring expert ground truth establishment was conducted. The evaluation was primarily based on objective engineering measurements and comparison to existing devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This device is a Class I ophthalmic speculum, and the submitted information focuses on substantial equivalence based on physical and mechanical performance compared to predicate devices, not on a clinical effectiveness study involving human readers or AI.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not conducted. The Stephens Disposable Speculum is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used:
For the performance tests conducted (Dimensional Equivalency and Retraction Tension Tests), the "ground truth" was established by objective engineering measurements and comparisons to the specifications and performance characteristics of the legally marketed predicate devices. There was no pathology, outcomes data, or expert consensus on clinical data used as ground truth.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device, and the submission did not involve machine learning or AI, and therefore no "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
Ask a specific question about this device
(103 days)
HNC
Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.
The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.
The provided text is a 510(k) summary for the Oculostat, an ophthalmic speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing device performance.
This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with performance metrics against acceptance criteria. For devices like the Oculostat (Class I ophthalmic speculum), a detailed clinical study with performance endpoints and defined acceptance criteria is typically not required for 510(k) clearance.
Therefore, I cannot populate the requested table or provide information on the study details because the provided document does not contain this information.
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(50 days)
HNC
The Eye Fixation Speculum, by eyeFix™, Inc. is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and is disposable for single use only.
The Eye Fixation Speculum, by eyeFix, Inc., consists of a low profile scleral vacuum ring attached to a medical quality plastic ophthalmic speculum using a six-degrees of freedom resistance joint. After retracting the eyelids, and securing the speculum, the vacuum ring is attached to the sclera by locating the medical quality concentric elastomer-ring to the cornea. Vacuum is applied by way of the attached spring-loaded syringe. When vacuum is applied, the flexible elastomer portion of the ring sucks down on the scleral region of the eye securing the ring to the eye. The frictional forces within the resistance joint of the attaching arm of the speculum, together with the vacuum ring, hold the eye steady against the tendency of the eye muscles to the move the globe. Although this resistance is high enough to prevent the eye from moving, the force is not so high that the physician is prevented from conveniently moving the ring within the range of motion that the joint allows. Luminescent plastic on the upper portion of the ring helps in visualization of the eye under low examination lighting.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for an ophthalmic speculum, focusing on its description, indications for use, and substantial equivalence to legally marketed devices. It does not include any performance data, clinical study results, or predefined acceptance criteria.
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