(14 days)
As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.
- General: The handpiece uses a piezoelectric transduction method to longitudinally oscillate a cutting tip (not included with the device) at a resonant frequency of 28 kHz. The device has integral colinear irrigation and coaxial aspiration fluidic pathways.
- Host Phacofragmentation System: The device is intended as a replacement for the phacofragmentation handpiece used on the Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles. These systems has been commercially available in the U.S. for approximately 10 years. To insure compatibility with the host system, the Envoy handpiece is designed to be equivalent to the original handpiece used on the previously mentioned systems.
The provided text describes the 510(k) summary for the Benjamin ENVOY Phaco Handpiece. This document primarily focuses on establishing substantial equivalence to a predicate device, not on validating performance against detailed acceptance criteria through a clinical study in the typical sense of AI/ML device validation.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not directly applicable to this type of submission. The document relies on comparative data and established technical specifications rather than human reader studies or large-scale outcome data.
Here's an attempt to populate the table and answer the questions based only on the provided text, highlighting where information is not available due to the nature of the submission:
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Benjamin ENVOY) |
|---|---|---|
| Intended Use | Phacofragmentation (Storz Premiere™) | Phacofragmentation (Same) |
| Design | Piezoelectric Transduction (Storz Premiere™) | Piezoelectric Transduction (Same) |
| Materials | Titanium, Silicone, Stainless steel (Storz Premiere™) | Titanium, Silicone, Stainless steel (Same) |
| Operating frequency | 28 kHz (Storz Premiere™) | 28 kHz (Same) |
| Qty. piezocrystals | 2 (Storz Premiere™) | 2 (Same) |
| Sterilization method | Steam only (Storz Premiere™) | Steam only (Same) |
| Host system | Premiere™ and Protégé™ (Storz Premiere™) | Premiere™ and Protégé™ (Same) |
| Biocompatibility | Meets ISO 10993-1 (Storz Premiere™) | Meets ISO 10993-1 (Same) |
| Patient contact | Indirect (fluids) (Storz Premiere™) | Indirect (fluids) (Same) |
| Device setup | Connect tubing, Tip installation, System connection (Storz Premiere™) | Connect tubing, Tip installation, System connection (Same) |
Study Information Pertaining to Device Acceptance (Based on 510(k) Submission)
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical test set as described for AI/ML devices. The "test" here is a technical comparison to a predicate device.
- Data Provenance: The data is a comparison of technical specifications and design features against a legally marketed predicate device (Storz Premiere™). It's not "data provenance" in the sense of clinical study data.
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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. Ground truth in this context refers to the established specifications and performance of the predicate device, which is a regulatory and engineering assessment rather than expert clinical consensus on a test set.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical adjudication for a test set. The comparison is based on engineering design and performance characteristics.
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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 MRMC study was done. This device is a surgical handpiece, not an AI/ML diagnostic aid.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical/electronic surgical instrument, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence is the established performance, design, materials, and intended use of the legally marketed predicate device (Storz Premiere™ Microsurgical System, K946227). This is an engineering and regulatory "truth" rather than a clinical one.
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8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm was used.
Summary of the Study Proving Acceptance Criteria:
The "study" presented here is a comparison to a predicate device to demonstrate substantial equivalence, which is the basis for 510(k) clearance.
The Benjamin ENVOY Phaco Handpiece is described as being equivalent in design, materials, operating frequency, sterilization method, and compatibility with host systems to the Storz Premiere™ Microsurgical System handheld phacofragmentation device (K946227). The manufacturer states that the Envoy handpiece is designed to be "equivalent to the original handpiece used on the previously mentioned systems" (Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles).
Specifically, the device meets acceptance by:
- Sharing the exact same intended use (phacofragmentation for cataract surgery).
- Utilizing the same piezoelectric transduction design.
- Being constructed of the same materials (Titanium, Silicone, Stainless steel).
- Operating at the same frequency (28 kHz) with the same number of piezocrystals (2).
- Requiring the same sterilization method (Steam only).
- Being compatible with the same host systems (Premiere™ and Protégé™).
- Meeting biocompatibility standards (ISO 10993-1), identical to the predicate.
- Having the same type of patient contact (indirect via fluids).
- Requiring similar device setup procedures.
The FDA's letter (K022833) confirms that based on this comparison, the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market. There are no clinical trial data, human reader studies, or AI/ML algorithm performance metrics provided or required for this type of submission for this specific medical device.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.