(179 days)
These instruments are manually operated surgical devices intended to for use in plastic-aesthetic operations of the orbital region, including bleparoplasty procedures.
The Karl Storz De la Plaza Blepharoplasty Set are manually operated orbital retractors. The body contact portions of the KSEA De la Plaza Blepharoplasty Set are composed of surgical grade stainless steel and Polyamide.
The provided text is a 510(k) summary for the Karl Storz De la Plaza Blepharoplasty Set, which is a set of manually operated orbital retractors. This type of device falls under a classification that typically relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or extensive device performance testing with a large sample size.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's why and what can be extracted from the provided text:
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Focus on Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate that the Karl Storz De la Plaza Blepharoplasty Set is "substantially equivalent" to already legally marketed predicate devices (orbital retractors by Padgett Instruments Inc. and Snowden Pencer). This means the FDA determines if the new device has the same intended use and technological characteristics, or if differences don't raise new questions of safety and effectiveness.
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Lack of Performance Study Details: Because the approval pathway is substantial equivalence, there is no mention of a formal study with acceptance criteria, sample sizes, ground truth, or expert evaluations as would be expected for novel devices or those with more complex performance claims (e.g., AI-powered diagnostic tools).
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Device Type: This is a manual surgical instrument (retractors). Its performance is inherently linked to its physical properties (materials, dimensions, design) and fitness for purpose, not algorithmic accuracy.
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Date: The submission date is 1999. Regulatory requirements and the types of studies expected for medical devices, particularly those involving AI or complex software, have evolved significantly since then.
Information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to Predicate Devices | The device is substantially equivalent to the predicate devices. |
| Same/Similar Intended Use | Intended use matches or is similar to predicates: plastic-aesthetic operations of the orbital region, including blepharoplasty procedures. |
| Same/Similar Technological Characteristics (Materials, Dimensions) | Materials (surgical grade stainless steel and Polyamide) and dimensions are the same or similar. Minor material difference (unidentified insulation material in predicate vs. Polyamide) found not to raise new issues of safety and effectiveness. |
| No New Issues of Safety and Effectiveness | Device deemed to raise no new issues of safety and effectiveness. |
| Manual Operation | It is a manually operated device. |
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is a physical device seeking substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts for a test set is not part of this substantial equivalence demonstration for a manual surgical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is a manual surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. There is no training set mentioned.
9. How the ground truth for the training set was established: Not applicable.
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.