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510(k) Data Aggregation
(274 days)
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.
The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
Here's the analysis of the provided text regarding the acceptance criteria and supporting study for the VeraPlug™ Punctal Plug:
This document is a 510(k) premarket notification for a medical device called the VeraPlug™ Punctal Plug. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo acceptance criteria for a novel device. Therefore, the "acceptance criteria" discussed relate to demonstrating this equivalence rather than setting performance thresholds for a new technological concept.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (VeraPlug™ Punctal Plug) |
|---|---|---|
| Intended Use | "For use in patients with dry eye syndromes," consistent with the predicate device which treats "dry eye" syndrome to enhance tear contact time and make eye drops more effective. | The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes. (Matches predicate) |
| Material | Medical Grade Silicone | Medical Grade Silicone (Matches predicate) |
| Sterility | Device must be sterile. | Yes (Matches predicate); Sterility testing completed via validated ETO sterilization cycle. |
| Design (Shape) | Similar design shape with a conical shaped nose (distal end), a shaft, and a dome-shaped proximal end, comparable to the predicate. | Has a similar design shape with a conical shaped nose (distal end), a shaft, and a dome shaped proximal end. (Comparable to predicate) |
| Design (Nose Diameter) | Within cleared nose diameter ranges of the predicate device (Small: 0.75mm, Medium: 0.88mm, Large: 1.01mm). | Small: 0.76mm, Medium: 0.89mm, Large: 1.02mm (All within ~0.01mm of predicate, deemed "within cleared nose diameter ranges") |
| Design (Overall Length) | Within cleared overall length ranges of the predicate device (Small: 1.63mm, Medium: 1.80mm, Large: 1.93mm). | Small: 1.65mm, Medium: 1.83mm, Large: 2.00mm (All within ~0.02-0.07mm of predicate, deemed "within cleared overall length ranges") |
| Mechanical Performance | Must pass a simulated implantation stretch test, similar to the predicate device. | Passed (Matches predicate) |
| Biocompatibility | Must be biocompatible for its intended use. | Biocompatibility testing was deemed unnecessary as the material (medical grade silicone) has a long-standing history of biocompatibility for punctal occluders. |
| ETO Residuals | Ethylene Oxide residuals must meet safety standards. | Testing performed and demonstrated safety. |
| Microorganisms | The product must meet standards for the population of microorganisms (bioburden). | Testing performed and demonstrated safety. |
| Packaging Validation | Post-accelerated aging packaging must maintain integrity and sterility (e.g., Bubble Test, Dye Penetration). | Testing performed and demonstrated safety. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical "test set" in the sense of patient data being collected for evaluation of the device. The non-clinical tests involved laboratory and bench testing of the device itself and its manufacturing processes.
- Sample Size: Not specified for individual tests, but implicitly refers to a sufficient number of devices for bench and lab testing (e.g., for sterility, stretch tests, and packaging validation).
- Data Provenance: The data is generated from non-clinical bench and laboratory testing of the manufacturing processes and device properties. It is not derived from human subjects or patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM) and internal validation protocols for manufacturing processes (e.g., ETO sterilization validation). There is no "test set" that requires human expert adjudication for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Since there is no "test set" involving human interpretation or subjective evaluation, no adjudication method is described or required.
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, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (a punctal plug), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established industry standards and regulations: Adherence to ISO and ASTM standards for sterilization, biocompatibility, and packaging.
- Laboratory test results: Objective measurements demonstrating physical and biological properties (e.g., passing a stretch test, meeting ETO residual limits, adequate bioburden reduction, package integrity).
- Substantial equivalence: The comparative data with the legally marketed predicate device regarding materials, dimensions, and intended use serves as a form of "ground truth" for demonstrating safety and effectiveness based on equivalence.
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" in this context. The manufacturing processes are validated, and devices are tested, but not in the sense of training a model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
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(66 days)
STEPHENS INSTRUMENTS
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.
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(66 days)
STEPHENS INSTRUMENTS
The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.
A single use ophthalmic device designed to retract eye muscles.
The Stephens Disposable Hooks are Class I ophthalmic devices intended for single-use retraction of eye muscles in various ophthalmic procedures. The device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices, namely Katena Ophthalmic Hooks, Storz Ophthalmic Hooks, Rhein Ophthalmic Hooks, and previous Stephens Ophthalmic Hooks. The summary outlines performance tests conducted to prove this equivalence.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1.0 Dimensional Equivalency | Hook measurements were substantially equivalent to the predicate devices. |
| 2.0 Retraction Tension | The mechanism and holding ability performed as well as the predicate devices. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified in the provided text. The document only states that "the instrument's" measurements were compared and "the Stephens hooks" were tested, implying a single sample or a small, unspecified number used for performance evaluation against predicates.
- Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer. No indication of country of origin is given. The data would be considered retrospective in the sense that it's a comparison to existing devices.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The study did not involve establishing ground truth from expert consensus in a clinical setting. It was a physical performance and dimensional comparison.
4. Adjudication Method for Test Set
- Not applicable. This was not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. No MRMC study was conducted as this device is a surgical instrument and not an AI or imaging diagnostic tool.
6. Standalone Algorithm Performance
- Not applicable. This device is a manual surgical instrument, not an algorithm or software.
7. Type of Ground Truth Used
- Dimensional measurements and performance characteristics (retraction tension) of legally marketed predicate devices. The ground truth for the "Dimensional Equivalency Test" was the measurements of the predicate devices. For the "Retraction Tension Tests," the ground truth was the performance of the predicate devices.
8. Sample Size for Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set was Established
- Not applicable. This device is not an AI/ML algorithm.
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(66 days)
STEPHENS INSTRUMENTS
Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.
A single use ophthalmic device designed to manipulate eye tissues or muscles.
The provided text describes a 510(k) premarket notification for the Stephens Disposable Forceps, a Class I ophthalmic device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a complex AI-driven system. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | The teeth measurements of the forceps were substantially equivalent to the measurements of the predicate devices. |
| Manipulation (Mechanism & Holding Ability) | The mechanism and holding ability of the Stephens forceps were found to perform as well as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or data analysis. The performance tests ("Dimensional Equivalency Test" and "Manipulation Tests") likely involved a sample of the manufactured forceps.
- Data Provenance: Not applicable in the traditional sense of patient data. The tests were likely conducted in a laboratory setting on prototypes or production samples of the device and predicate devices. No country of origin for specific "data" is mentioned other than the company's location (Lexington, KY, USA). The studies are not considered "retrospective" or "prospective" as they are performance tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance tests described (dimensional and manipulation) would be assessed against engineering specifications or by direct comparison to the physical characteristics and function of the predicate devices, not by expert clinical consensus for "ground truth."
4. Adjudication method for the test set
Not applicable. There's no mention of a formal adjudication process for interpreting test results, as these are objective engineering and performance comparisons.
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 physical ophthalmic forceps, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For dimensional equivalency, the ground truth would be the measurements of the predicate devices' teeth. For manipulation tests, the ground truth would be the observed performance (mechanism and holding ability) of the predicate devices. Neither is "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
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(66 days)
STEPHENS INSTRUMENTS
Scissors made for single use in the cutting of tissue in various ophthalmic procedures.
A single use ophthalmic device designed for cutting tissues.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Stephens Disposable Scissors:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | "The blade measurements of the scissors were substantially equivalent to the measurements of the predicate devices listed above." |
| Sharpness - Number of Cuts | "It was found that Stephens scissors perform as well as the predicate devices." |
| Sharpness - Initial Cutting Sharpness | "It was found that Stephens scissors perform as well as the predicate devices." |
Explanation of Criteria:
- Dimensional Equivalency: This implies that the critical dimensions (like blade length, width, angle) of the Stephens Disposable Scissors had to be sufficiently close to those of the predicate devices to ensure similar function and safety.
- Sharpness (Number of Cuts & Initial Cutting Sharpness): The device needed to demonstrate comparable cutting ability to the predicate devices, both in terms of how many cuts it could perform effectively and its initial sharpness. This is crucial for an ophthalmic scissor to ensure precise and efficient tissue cutting.
2. Sample Size and Data Provenance for Test Set:
- Sample Size: The document does not specify the exact sample size used for the Dimensional Equivalency Test or the Sharpness Tests. It only states that the tests were "performed."
- Data Provenance: The documents do not provide information on the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of performance bench testing, it would inherently be prospective, but the location is unknown.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not applicable. These tests are objective bench tests, not involving expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set:
- Adjudication Method: Not applicable. These were objective physical performance tests, not requiring human adjudication of results in the traditional sense of clinical imaging or diagnostic studies. The results would be quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not performed.
- Effect Size: Not applicable, as no such study was conducted. This device is a surgical instrument and its performance is evaluated by physical characteristics rather than diagnostic accuracy involving human readers.
6. Standalone Performance Study:
- Standalone Performance Study: Yes, standalone performance tests were conducted. The "Dimensional Equivalency Test" and "Sharpness Tests" (both number of cuts and initial cutting sharpness) evaluate the device's inherent physical characteristics and performance independently. There is no human-in-the-loop component for these specific tests.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for these performance tests was based on objective physical measurements and comparisons to predicate devices. For dimensional equivalency, it would be measured dimensions against predicate device specifications. For sharpness, it would be quantitative sharpness metrics (e.g., force required to cut, number of cuts on a standardized material) compared to the performance of predicate devices.
8. Sample Size for Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The device is a physical surgical instrument.
9. How Ground Truth for Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
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(66 days)
STEPHENS INSTRUMENTS
Trephine made for single use and for the extraction of the cornea.
A single use ophthalmic device designed to extract the cornea.
The Gayheart™ Corncal Excision Device (K022843) is an ophthalmic trephine, a single-use device designed for corneal extraction. Its acceptance criteria and performance were assessed through non-clinical tests demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | Measurements of the Gayheart™ Corneal Excision Device (trephines) were substantially equivalent to the measurements of the predicate devices (Katena, Storz, Rhein, Stephens Ophthalmic Trephines). |
| Sharpness | Sharpness tests (number of cuts and initial cutting sharpness) showed that Stephens trephines perform as well as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set. The tests involved "measurements of the trephines" and "sharpness tests" on the Gayheart™ Corneal Excision Device and a comparison to predicate devices, implying a sufficient number of devices were tested to draw a comparison. The data provenance is not explicitly stated but is implicitly from an internal test by Stephens Instruments as part of their 510(k) submission. This is considered retrospective data from the manufacturer's testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No direct mention of experts or their qualifications for establishing ground truth is provided. The performance tests (dimensional equivalency and sharpness) appear to be objective measurements, likely conducted in a lab setting by technical personnel rather than clinical experts.
4. Adjudication Method for the Test Set
No adjudication method is described. The tests were objective measurements (dimensions, sharpness), not subjective interpretations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is a Class I ophthalmic trephine, and the submission does not mention any clinical studies or human reader involvement in its evaluation for this 510(k).
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Gayheart™ Corneal Excision Device is a physical surgical instrument, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims was based on:
- Objective Measurements: Directly measured dimensions, number of cuts, and initial cutting sharpness of the devices.
- Comparison to Predicate Devices: The performance was assessed against established predicate devices, implying that the performance of these legally marketed devices served as the benchmark or "ground truth" for acceptable performance for this type of device.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical surgical instrument and does not involve any artificial intelligence or machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
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