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510(k) Data Aggregation
(72 days)
N-TECH ENDOSCOPY, INC.
Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any of the detailed study parameters requested (sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, ground truth type, or training set details).
The document is an FDA 510(k) clearance letter for an "N" Tech Double Puncture Laparoscope/"N" Tech Operating Laparoscope (Autoclavable). It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it is subject to. It also includes the intended "Indications for Use" for the laparoscopes.
There is no scientific study or performance data described within this document.
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(70 days)
N-TECH ENDOSCOPY, INC.
Our Cystoscopes are used when Operative and/or Diagnostic Cystoscopy is medically indicated. Cystoscopes are used for 2 tasks: Providing an excellent visual image and good illumination of the operating area.
We intend to manufacture our Cystoscopes under strict GMP Guidelines: From incoming material registration and testing to detailed manufacturing instructions and device master and history filing including complaint reporting.
The provided text "Exhibit 6 'N' Tech Cystoscopes 510(k)" is a 510(k) summary for "N" Tech Cystoscopes, dated April 28, 1998. It details the company's claim of substantial equivalence to older equipment.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| As safe and effective as other devices earlier and currently on the market. | "Our Cystoscopes are as safe and effective as all other devices earlier and currently on the market." |
| Designs, lens-systems, materials, glues, and epoxies commonly used by the endoscope industry. | "Our designs, lens-systems, materials, glues and epoxies are commonly used by the endoscope industry." |
| Substantial equivalence in all significant details compared to R. Wolf devices. | "We compared our manufacturing drawings with corresponding devices from R.Wolf. We found substantial equivalence in all significant details." |
| Manufactured under strict GMP Guidelines, including incoming material registration and testing, manufacturing instructions, device master and history filing, and complaint reporting. | "We intend to manufacture our Cystoscopes under strict GMP Guidelines: From incoming material registration and testing to detailed manufacturing instructions and device master and history filing including complaint reporting." |
| Assure safe and long-term use through mechanical and thermic stress testing. | "Our Prototypes underwent extensive mechanical and thermic stress testing to asure safe and long term use." |
| No adverse health effects compared to already marketed devices. | "We are not able to determine any adverse health effects compared to the already marketed devices and can not imagine any possibility of this kind." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical or performance data. The performance testing mentioned ("extensive mechanical and thermic stress testing") refers to prototypes, but no specific number of prototypes or test cases (e.g., number of procedures or patients) is given. Similarly, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for a test set in the context of clinical or performance data. The comparison drawn is primarily against "older equipment, manufactured by R. Wolf and other Manufacturers" and "corresponding devices from R.Wolf" based on manufacturing drawings.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as there is no described test set involving human assessment or interpretation of clinical outcomes for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on device equivalence based on design and mechanical/thermic performance, not on direct comparison of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This device is a physical medical instrument (Cystoscope), not an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Design and Manufacturing Equivalence: Comparison of manufacturing drawings and general industry practices for designs, lens-systems, materials, glues, and epoxies with predicate devices (R. Wolf).
- Mechanical and Thermic Stress Testing: This implies engineering standards or internal specifications for durability and safety, rather than clinical outcomes or pathology.
- Absence of Adverse Health Effects: A claim based on comparison with existing devices and lack of foreseeable issues, rather than empirical data from a study.
8. Sample Size for the Training Set
Not applicable. The device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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(57 days)
N-TECH ENDOSCOPY, INC.
Operative and Diagnostic Arthroscopy for visual imiging and light transmission to the operative area.
The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "N" Tech Arthroscopes. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to an AI/ML-based device. It primarily confirms the substantial equivalence of the arthroscopes to a legally marketed predicate device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the input provided.
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