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The Photonics Coldlightsource PL3000 is indicated for use to provide illumination through light-conducting devices such as fiberoptic cables.

The Photonics Coldlightsource PL3000 is a lightsource for fiberoptic cables, with a 230/240 volt version which conforms to ENEC 11, EN60601, EN55011, and UL 2601. The 120 volt version is manufactured to the same requirements of these standards, and has been submitted for approval. Approval is anticipated in the immediate future.

This device is a light source for fiberoptic cables, specifically the Photonics Coldlightsource PL3000. The provided document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission generally focuses on comparisons of technical specifications and performance to an existing device rather than a comprehensive "study" in the sense of clinical trials or extensive performance testing found with novel devices or AI/ML-based systems.

Therefore, many of the requested fields, such as sample sizes for test sets, expert ground truth, MRMC studies, or training sets, are not applicable to this type of device and submission. The "study" here is essentially a comparison table to a predicate device and a statement of compliance with relevant standards.

Here's the breakdown based on the provided text:

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

The acceptance criteria are implicitly that the Photonics Model PL3000 performs comparably to or within acceptable limits of the predicate device (Luxtec Model 3150S) for the listed features. The reported device performance is presented as a direct comparison in the table.

The "study" demonstrating this involves a comparison of technical specifications and functional capabilities against a legally marketed predicate device (Luxtec Model 3150S, K890716). The conclusion drawn is that the Model PL3000 is "substantially equivalent" to the predicate device. Additionally, the 230/240 volt version conforms to ENEC 11, EN60601, EN55011, and UL 2601, and the 120-volt version is manufactured to similar requirements.

The following questions are not applicable or cannot be determined from the provided 510(k) summary for this type of medical device (a light source). This summary focuses on establishing substantial equivalence based on technical specifications and indications for use, not on a clinical performance study with patient data or AI/ML algorithms.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is a hardware device comparison based on specifications, not a test set of data.

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)

• Not Applicable. No ground truth in the context of diagnostic interpretation is established here. The "ground truth" is essentially the documented specifications and performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No expert adjudication of a test set is involved.

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 basic medical device (light source), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a hardware device, not an algorithm.

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

• Not Applicable. The "ground truth" is effectively the established performance and specifications of the predicate device and compliance with international standards mentioned (ENEC 11, EN60601, EN55011, UL 2601).

8. The sample size for the training set

• Not Applicable. This is a hardware device, not a machine learning model.

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

• Not Applicable. This is a hardware device, not a machine learning model.

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The Schoelly Uretero-Renoscopes are indicated for the transurethral examination and treatment of the upper urinmary tract, including the uterer and kidney, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Schoelly Uretero-Renoscopes

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Schoelly Uretero-Renoscopes." This document primarily addresses the substantial equivalence determination for the device and its intended use. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more detailed device submission.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This FDA letter is a regulatory approval document based on the device's substantial equivalence to a predicate device, not a detailed technical or clinical study report.

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The Schoelly Laparoscope is indicated for examination of body cavities, holow organs, and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures,

Not Found

This document is a 510(k) clearance letter from the FDA for Schoelly Laparoscopes, dated September 14, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain the detailed study information requested in your prompt. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance data like premarket approval (PMA) applications might.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance
2. Sample sizes or data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance data
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document confirms the device's regulatory clearance but does not include the detailed performance study data you're looking for.

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The Schoelly Flexilux II Arthroscopes are indicated to permit a physician or surgeon to view the operative site during an arthroscopic procedure on the knee, shoulder, jaw, wrist, ankle, and elbow.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Scholly Flexilix II Arthroscopic and Accessories". It does not contain information about the acceptance criteria, specific studies, or performance data for the device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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The Naso-Laryngo-Pharyngoscope is indicated for visualization of the pharynx and larynx.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a device called "Naso-Laryngo-Pharyngoscope". It confirms that the device is substantially equivalent to previously marketed devices and lists its indications for use.

Crucially, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, data provenance, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets. These details are typically found in a clinical study report or a technical summary, which is not provided here.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.

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