(79 days)
Eye Spheres: To occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: To maintain the shape of the eye and prevent closure or adhesion during the healing process.
Eye Spheres: Eye spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: Conformers are temporary devices that maintain the shape of the eye and prevent closure or adhesion during the healing process.
This 510(k) submission, K972661, for the Gulden Ophthalmics Eye Sphere and Conformer, is a traditional submission, not a submission for an AI/ML powered device. As such, it does not include information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications for ground truth establishment, or comparative effectiveness studies (e.g., MRMC studies) typically found in AI/ML device submissions.
The submission focuses on establishing substantial equivalence to predicate devices based on design, materials, sterilization methods, and intended use.
Here's a breakdown of the information provided, tailored to the questions where applicable, and noting where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
This information is not applicable and not provided in the 510(k) summary because this is a traditional medical device submission, not an AI/ML powered device. The "performance" assessment is based on demonstrating substantial equivalence to legally marketed predicate devices, not on quantitative performance metrics against pre-defined acceptance criteria. The key assessment here is that:
- The "sterile" eye spheres and conformers are identical to the "non-sterile" versions already sold by Gulden Ophthalmics.
- The "sterile" versions are sterilized by methods (EtO and Gamma) that are considered safe and effective and are used for similar predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The submission does not involve a "test set" in the context of evaluating an algorithm's performance on data. The assessment is based on the device's physical characteristics, materials, and manufacturing processes, and its equivalence to predicate devices.
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 information is not applicable and not provided. "Ground truth" in the context of expert consensus on a test set is not relevant for this type of device submission. The assessment relies on established medical device regulations and industry standards for manufacturing, materials, and sterilization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on ground truth, which is not part of this submission.
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
This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic performance, often for AI-assisted systems, which is not the nature of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical medical implant/conformer, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The concept of "ground truth" as used in AI/ML evaluation does not apply to this device. The basis for substantial equivalence is primarily historical use and accepted safety profiles of the materials (PMMA) and the predicate devices, along with validated sterilization methods. The submission explicitly states: "Not applicable. These products have been in commercial distribution since before July 1976 and are generally regarded as safe." This indicates reliance on long-standing clinical experience and regulatory classification rather than a formal ground truth evaluation.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for this physical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "ground truth for the training set" for this physical device.
Summary of Acceptance Criteria and Study for K972661:
Since this is not an AI/ML device, the "acceptance criteria" discussed are largely based on demonstrating substantial equivalence to already legally marketed predicate devices and adherence to established manufacturing and sterilization standards.
Acceptance Criteria & Reported Device Performance (as inferred from the 510(k) submission):
| Acceptance Criteria (Inferred) | Reported Device Performance / Justification |
|---|---|
| Material Equivalence: Material must be the same as predicate device. | Meets Criteria: Device is made of Polymethylmethacrylate (PMMA), which is the same material as the predicate devices (Gulden Ophthalmics "non-sterile" Eye Spheres/Conformers and Storz Instruments "sterile" Eye Spheres/Conformers). PMMA is "Generally Regarded as Safe" (GRAS). |
| Design Equivalence: Device design (size range, shape) must be the same as predicate device. | Meets Criteria: Eye Spheres have size range 8-22 mm, Conformers have Small, Medium, Large, identical to predicate devices. The physical dimensions and form are stated to be "exactly the same" as Gulden's "non-sterile" versions, which are supplied to Storz as predicate. |
| Intended Use Equivalence: Intended use must be same as predicate device. | Meets Criteria: Intended Use for Eye Spheres (occupy eye cavity after enucleation/evisceration) and Conformers (maintain eye shape, prevent closure/adhesion during healing) is identical to predicate devices. |
| Sterilization Efficacy & Safety: Sterilization methods must be validated to ensure sterility and not compromise device safety/function. | Meets Criteria: Sterilization is performed using Ethylene Oxide (EtO) and Gamma Radiation. Both methods are validated: |
- EtO: Process parameters (temperature, humidity, EO concentration, time, aeration) are specified and align with accepted practices.
- Gamma Radiation: Bioburden studies (per ANSI/AAMI/ISO 11737-1-1995) are conducted, and each lot is validated by bioburden studies. Predicate device (Storz) uses EtO for sterilization. |
| Biocompatibility: Device materials must be biocompatible. | Meets Criteria: PMMA is "Generally Regarded as Safe." This indicates prior successful use in medical devices and established biocompatibility. |
Study to Prove Acceptance Criteria:
The "study" in this context is not a clinical trial or an AI algorithm validation study. Instead, it's a demonstration of substantial equivalence based primarily on:
- Direct Comparison to Predicate Devices: The submission explicitly states the new sterile devices are "exactly the same" as the "non-sterile" versions already marketed by Gulden, which are themselves predicates for the sterile versions (via Storz Instruments). This includes material, size, and intended use.
- Regulatory History and Accepted Practice: The devices (Eye Spheres and Conformers made of PMMA) have been in "commercial distribution since before July 1976 and are generally regarded as safe." This demonstrates a long history of safe and effective use.
- Sterilization Validation: The sterilization processes (EtO and Gamma Radiation) are validated according to recognized standards (e.g., ANSI/AAMI/ISO 11737-1-1995 for bioburden studies for gamma sterilization). These validations ensure that the sterilization effectively renders the device sterile without adversely affecting its material properties or safety.
In essence, the "study" is a technical and regulatory justification of equivalence to devices with a well-established history of safety and effectiveness, coupled with validated manufacturing processes for sterility.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.