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The KSEA DCI Endoscope is indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

These instruments are manually operated surgical devices intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text for K9935539 does not contain any information regarding specific acceptance criteria, device performance metrics, or study details. This document is a 510(k) summary for a neuroendoscope, which primarily focuses on demonstrating substantial equivalence to predicate devices and outlines the device's description and intended use.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
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: This is a medical device, not an AI-assisted diagnostic tool, so this type of study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a physical device, not an algorithm.
7. The type of ground truth used: Not applicable for a neuroendoscope's substantial equivalence review.
8. The sample size for the training set: Not applicable for this physical device.
9. How the ground truth for the training set was established: Not applicable for this physical device.

The document states that "The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This indicates that the regulatory approval relies on the similarity to previously approved devices, rather than a separate clinical study with specific performance metrics against acceptance criteria.

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The KSEA DCI Endoscope is indicated for use during endoscopic plastic, reconstructive and aesthetic procedures.

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use,

The provided text is a 510(k) summary for the Karl Storz DCI Endoscope, which is a traditional medical device (an endoscope) rather than a software-based AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML performance metrics are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Here's how the information provided relates to a traditional device clearance, rather than an AI/ML study:

• Acceptance Criteria and Reported Device Performance: For a traditional medical device like an endoscope, acceptance criteria would typically relate to physical characteristics, material biocompatibility, sterilization efficacy, and functional performance (e.g., image clarity, field of view, illumination, mechanical integrity). This document does not report specific performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, it states that "The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This is the core claim for substantial equivalence.

• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These detailed questions are designed for AI/ML performance evaluation studies. They are not relevant to the 510(k) submission for this endoscope. The 510(k) pathway for this type of device typically relies on design comparisons, materials testing, and functional testing to established standards, rather than clinical efficacy trials involving "ground truth" established by experts on a dataset in the way a diagnostic AI would require.

In summary, based on the provided text, it is not possible to answer the questions you posed because the document describes a 510(k) submission for a non-AI/ML medical device where the primary goal is demonstrating substantial equivalence, not reporting AI performance metrics from a dedicated study.

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This instrument is indicated for use during endoscopic urologic procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) summary for the Karl Storz DCI Endoscope. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary primarily focuses on regulatory approval based on substantial equivalence to existing devices, rather than on new performance studies with specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this regulatory submission.

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The KSEA DCI Endoscope is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

• unexplained pelvic pain (acute, chronic)
• infertility work-up
• tubal sterilization
• unexplained primary or secondary amenorthea
• diagnosis and/or treatment of ectopic pregnancy
• evaluation, diagnosis and/or treatment of small pelvic tumors, including myomata
• evaluation of congenital anomalies of the pelvic organs
• retrieval of foreign bodies
• determination of the presence and extent of pelvic endometriosis
• determination of the presence and extent of pelvic inflammatory disease
• laparoscopic assisted vaginal hysterectomy
• visualization, diagnosis and/or treatment of perforate abdominal organs

The KSEA DCI Endoscope is comprised of a rigid, panoramic tolescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria for the Karl Storz Direct Coupled Interface (DCI) Endoscope.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a device already legally marketed. It typically does not involve independent studies with specific performance metrics against acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, I cannot fulfill the request for the following sections as the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states "minor differences...raise no new issues of safety and effectiveness" because "these design differences have no affect on the performance, function or intended use of the devices," implying that performance is considered equivalent to the predicate without specifying new performance metrics.
2. Sample sizes used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth is described.
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 device is an endoscope, 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 device is an endoscope, not an algorithm.
7. The type of ground truth used: Not applicable as no ground truth is described.
8. The sample size for the training set: Not applicable as no training set is described.
9. How the ground truth for the training set was established: Not applicable as no training set is described.

Summary of what is available from the text:

• Device Name: Karl Storz Direct Coupled Interface (DCI) Endoscope
• Intended Use/Indications for Use: For use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Specific indications include unexplained pelvic pain, infertility work-up, tubal sterilization, amenorrhea, ectopic pregnancy, small pelvic tumors (myomata), congenital anomalies, foreign body retrieval, pelvic endometriosis, pelvic inflammatory disease, laparoscopic assisted vaginal hysterectomy, and visualization/diagnosis/treatment of perforate abdominal organs.
• Regulatory Pathway: 510(k) Premarket Notification, asserting substantial equivalence to predicate devices.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

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This instrument is indicated for use to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the K.SEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) Summary of Safety and Effectiveness for the KSEA DCI Endoscope. This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key takeaway: This is not a study proving device performance against acceptance criteria in the way one would describe an AI/ML device study.

Instead, this document asserts substantial equivalence based on the device's design, materials, and intended use being similar to existing, legally marketed devices. It does not contain information about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics for an AI/ML algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions asked are typically relevant for demonstrating the performance of novel AI-driven medical devices, which this endoscope is not.

To directly answer your request based on the provided text, many fields will be "Not Applicable" or "Not Provided," as the document focuses on regulatory equivalence rather than performance metrics from a controlled study.

Here's how I would answer if I were forced to interpret the spirit of your questions within the context of a 510(k) for a non-AI device:

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

2. Sample size 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 traditional medical device (endoscope), not a machine learning algorithm that requires a "test set" in the sense of a dataset for performance evaluation. Substantial equivalence is based on comparison to existing device designs and materials, not clinical performance data from a specific "test set."

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. See above. "Ground truth" in this context refers to regulatory assessment by the FDA, based on engineering, materials science, and clinical equivalence, rather than expert annotation of data.

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

• Not Applicable. See above.

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 not an AI-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• Implicit "Ground Truth": Regulatory standards and the characteristics of legally marketed predicate devices. The "ground truth" for substantial equivalence is that the device's design, materials, and intended use align with established devices and accepted medical practices/safety standards.

8. The sample size for the training set

• Not Applicable. This is not a machine learning device.

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

• Not Applicable. This is not a machine learning device.

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This instrument is indicated for use during general endoscopic and laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) summary for the Karl Storz DCI Endoscope. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, performance data, or details of a study to prove the device meets such criteria.

The 510(k) summary states:

• Substantial Equivalence: "The KSEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices."

This means the submission relies on the established safety and effectiveness of previously cleared, similar devices (predicate devices) rather than presenting new, detailed performance studies against specific acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission claims substantial equivalence, implying the device performs similarly to predicate devices, but no specific performance metrics or acceptance thresholds are given.
2. Sample size used for the test set and the data provenance: Not applicable, as no specific performance test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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 document pertains to an endoscope, 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 not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed performance studies are not described.
8. The sample size for the training set: Not applicable for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on presenting novel performance study data against specific acceptance criteria for a new, unique device.

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This instrument is indicated for arthroscopic procedures of the shoulder, knee and also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

This document is a 510(k) summary for a medical device (endoscope), not a study evaluating a device's performance against acceptance criteria using AI. Therefore, I cannot extract the requested information regarding AI device performance.

The provided text describes:

• A 510(k) submission for the Karl Storz DCI Endoscope.
• The device's identification, indication for use, and description.
• A statement of substantial equivalence to predicate devices.
• The FDA's decision letter confirming substantial equivalence and allowing the device to be marketed.

None of the information you requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details for AI devices is present in this regulatory submission for a conventional endoscope.

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