(341 days)
The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma.
The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed.
This document is a 510(k) summary for a medical device (Zeiss CPC Probe Laser Probe) submitted in 1997. It describes the device's function, its intended use, and its substantial equivalence to a predicate device.
However, the provided text does NOT contain any information about acceptance criteria or a study demonstrating that the device meets those criteria.
The 510(k) process in 1997 for a device like this primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance statistics in the manner often seen for more novel or higher-risk devices today or for AI/ML-based devices.
Therefore, I cannot fulfill your request for the comprehensive table and study details as they are not present in the provided input.
Based only on the provided text, I can infer the following about what is missing from the prompt's request:
- Acceptance Criteria and Reported Device Performance: Not mentioned. The submission focuses on substantial equivalence to a predicate device, not on specific performance metrics or thresholds.
- Sample size for the test set and data provenance: Not mentioned. No specific "test set" or clinical study data is described.
- Number of experts and qualifications for ground truth: Not mentioned. No ground truth establishment is described for a performance study.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a laser probe, not an AI/ML diagnostic tool, so such a study would be highly unlikely and irrelevant.
- Standalone (algorithm-only) performance: Not applicable. This is a hardware device.
- Type of ground truth used: Not applicable for a performance study.
- Sample size for the training set: Not applicable. This is a hardware device, not an AI/ML model.
- How ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary for the Zeiss CPC Probe Laser Probe does not contain the type of information typically associated with acceptance criteria and a detailed performance study as requested in your prompt, particularly concerning AI/ML device evaluation.
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510-k Summary
MAR 1 7 1997
Pursuant to 21 CFR 807.92 the following summary is submitted.
- Submitter's name-Carl Zeiss, Inc. 1 Zeiss Drive Thornwood, NY 10594 (914) 681-7761 Contact Person-Kenneth M. Nicoll April 4, 1996
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- Zeiss CPC Probe Laser Probe
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We are claiming substantial equivalence to the Iris Medical G-Probe, K 915236.
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The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed.
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This device will be used in the same manner as the device mentioned above and will permit the Zeiss Visulas Diode II to be further utilized as a therapeutic ophthalmic laser. It incorporates the same intended uses as the Iris Medical G Probe and specifically is recommended for treating the following eye disease: Glaucoma.
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The Zeiss CPC Probe is substantially equivalent to the Iris Medical G Probe in that both are used to permit the individual companies laser to deliver impulses that photocoagulate the ciliary body of the eye in patients that are diagnosed with Glaucoma, thereby reducing the patient's intraocular pressure which slows the progress of the disease. The only differences between the two delivery units are: The approximate amount of times the contact tips can be sterilized, the material the tips are made of and slight differences in the power range.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.