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The Laparosopes and accessories are intended for use in providing access to and visualization of organs, and canals to perform various diagnostic and therapeutic surgical procedures.

The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.

The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.

The Hans Hermann Laparoscopes and accessories consists of

• uls Hermann Daparoped surgical instruments with and without monopolar high frequency connection
• bipolar electrodes and accessories -
• monopolar electrodes and accessories -
• monopolar cicchrodos and accessories, Verres needles and suction-/irrigation systems,
• several Endoscopes (Laparoscope, Arthroscope, Cystoscope) -
• and a light cable -

The body contact portions of the Laparoscopes and accessories are composed of The body comace stainless steel, PTFE, PEEK, several coatings, silicon and brass surgical grade stamicss stock, in medical devices for a wide range of chiromutin placer which is commonly of biocompatibility for human use at short term contact.

The provided document is a 510(k) summary for Laparoscopes and accessories (K051610) from Hermann Medizintechnik GmbH, submitted to the FDA in 2005.

Based on the provided text, the device relies on substantial equivalence to predicate devices rather than a direct performance study against specific acceptance criteria. This means the manufacturer is asserting that their device is as safe and effective as other legally marketed devices and does not present new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria, performance data from a specific study, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly available in this 510(k) submission.

Here's a breakdown of what can be inferred or stated as explicitly absent from the provided text, in response to your questions:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable (N/A) – No specific performance study with a test set is detailed in the document.
• Data provenance: N/A – No specific clinical data from a prospective or retrospective study is presented. The conformity to IEC and EEC directives implies compliance with standards, not necessarily clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A – No specific performance study with a ground truth established by experts is detailed.

4. Adjudication method for the test set

• N/A – No specific performance study with adjudication is detailed.

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 reported. This device is a surgical instrument (laparoscope), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No, a standalone algorithm performance study was not reported. This device is a physical surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• N/A – The concept of "ground truth" as typically used in AI/diagnostic device studies does not directly apply to this 510(k) for a surgical instrument that relies on substantial equivalence for regulatory clearance. Compliance with safety standards (IEC, EEC) serves as the "truth" for device manufacturing and basic function.

8. The sample size for the training set

• N/A – No specific training set for an algorithm is mentioned or applicable.

9. How the ground truth for the training set was established

• N/A – No specific training set for an algorithm is mentioned or applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The document does not describe a clinical study in the traditional sense with specific acceptance criteria related to a performance metric. Instead, the "study" proving the device meets the (implied) acceptance criteria of safety and effectiveness for substantial equivalence consists of:

• Comparison to Predicate Devices: The manufacturer asserts that "Hermann Medizintechnik GmbH Laparoscopes and accessories are substantial equivalent to the predicate and others [devices], since the basic features, design and intended uses are the same. The major assessments of safety and effectiveness... raise no new questions as function or intended use of the devices." This is the primary "proof" for substantial equivalence.
• Compliance with Standards: The manufacturer states, "The devices conform to IEC 60601-2-2 and to the relevant provisions of European Device Directive 93/42/EEC." This indicates that the device has met established international and European safety and performance standards for medical electrical equipment.

In essence, for this 510(k), the "acceptance criteria" are implied to be fulfilled by demonstrating substantial equivalence to already cleared devices and by showing compliance with recognized safety and quality standards, rather than through a dedicated clinical performance study with predefined metrics.

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The Hermann Titanium (Mini/Micro/Medium) plating systems are intended for maxillo-facial surgery.

The various sizes are designed to accommodate osteosynthesis requirements in pediatric and adult patients.

Medical Indications

Fractures in maxillo-facial bones -

The Titanium Miniplating System H12-10104 - H19-30302
The Titanium Microplating System H22-01990 - H29-30302
The Titanium Mediumplating System H32-06104 - H39-30302

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a "Titanium Miniplating System," indicating its substantial equivalence to a predicate device.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study, sample sizes for test or training sets, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the given input.

Ask a specific question about this device