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The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-ileum using during diagnostic and therapeutic upper GI endoscopy and enteroscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

The device described in this 510(k) consists of a modified sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower GI tract.

The provided 510(k) summary document focuses on establishing substantial equivalence for the Spirus Medical, Inc. Endo-Ease Endoscopic Overtube based on a clinical study and physical comparison to a predicate device.

Here's an analysis of the requested information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds for device approval. Instead, it relies on a clinical study to "demonstrate the device's effectiveness." The primary effectiveness metric reported is the ability to reach the ileum.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 101 patients
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, although the phrasing "In a study involving the treatment of 101 patients" suggests a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical study. The "user" successfully reaching the ileum implies a determination made by the endoscopist performing the procedure.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The outcome simply reports what the "user" (presumably the treating physician) achieved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No information about a multi-reader multi-case (MRMC) comparative effectiveness study is present in the document. The study described is a single-arm study focused on the performance of the device itself, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an endoscopic overtube, a mechanical medical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. Type of Ground Truth Used

The ground truth used appears to be clinical observation/outcome as determined by the endoscopist during the procedure (i.e., whether the ileum or mid-ileum was successfully reached).

8. Sample Size for the Training Set

This device is a physical medical device, not a machine learning model. Therefore, the concept of a "training set" is not applicable in this context. The 101 patients mentioned are part of the clinical study to demonstrate effectiveness for regulatory submission, not for training an algorithm.

9. How Ground Truth for the Training Set Was Established

As this is not an AI/ML device, there is no training set and thus no ground truth establishment for a training set.

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Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

The Spirus Medical Lubricant is a water-based lubricant intended for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device.

The provided text describes a 510(k) premarket notification for the Spirus Medical Lubricant, a Class I patient lubricant. The information given is limited and focuses on the regulatory aspects rather than detailed study results to prove acceptance criteria.

Based on the provided text, here's an analysis of the requested information:

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)

The document does not specify a sample size for any test set or the data provenance. It mentions "biocompatibility testing" and "comparison of the chemical formula" but provides no details on the studies themselves.

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)

This information is not available in the provided document. The submission relies on chemical comparison and biocompatibility testing, not on expert-driven "ground truth" establishment in a diagnostic sense.

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

This information is not available in the provided document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, which is not described here.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to a patient lubricant. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists analyzing medical images with and without AI assistance).

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

This concept is not applicable to a medical lubricant. A lubricant does not involve an algorithm or "standalone" performance in the way a diagnostic AI would.

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

For biocompatibility testing, the "ground truth" would be established by the biological response of cells/tissues to the lubricant, as defined by the ISO 10993 standards. For substantial equivalence, the ground truth is the chemical formula of the predicate devices. There is no mention of expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not available in the provided document. The device is a lubricant, not a machine learning model, so typical "training set" concepts do not apply.

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

This information is not available and not applicable.

Summary of Device Acceptance:

The Spirus Medical Lubricant "meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness." The study that proves this is based on:

• Chemical Comparison: Substantial equivalence was established by comparing the chemical formula of the proposed device to that of predicate devices (K-Y Lubricating Jelly and Probe Personal Lubricant). This comparison is the primary method for demonstrating effectiveness in terms of physical properties expected of a lubricant.
• Biocompatibility Testing: The device underwent testing in accordance with ISO 10993 standards to ensure safety for patient contact.

The document explicitly states: "The Spirus Medical Lubricant meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Spirus Lubricant is substantially equivalent to the predicate devices." This concise statement confirms that the studies performed (chemical comparison and biocompatibility) were deemed sufficient to meet the regulatory requirements for a Class I patient lubricant seeking 510(k) clearance. Specific data, sample sizes, and detailed methodology of these tests are not provided in this summary.

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The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.

The device described in this 510(k) consists of a a modified sterile, single use, flexible over ube designed for use with currently marketed flexible endoscopes in the lower GI tract.

The provided text is related to a 510(k) submission for a medical device called "Endo-Ease Endoscopic Overtube." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, the input does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The text explicitly states it's a "Special 510(k): Device Modification" and relies on compliance with design control requirements and verification/validation testing of the modifications, implying that extensive clinical studies with new performance metrics were not required for this specific submission.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on device modification and equivalence to a predicate, not new performance metrics from a clinical study.
2. Sample sized used for the test set and the data provenance: Not applicable as a clinical performance study with a test set is not described. The text mentions "verification and validation testing methods and results" but does not detail the sample sizes or data provenance for these engineering/design tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is typically for diagnostic devices or those requiring expert interpretation, which is not the primary focus of this overtube device's submission.
4. Adjudication method for the test set: Not applicable as a clinical performance study with expert adjudication is not 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 endoscopic overtube, 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: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance studies requiring ground truth are not outlined. The "safety and performance" claim refers to demonstrated equivalence and successful engineering/design verification.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a device modification, emphasizing substantial equivalence and design control compliance, rather than presenting clinical study data with specific acceptance criteria as you would find for a de novo device or a device requiring new clinical evidence.

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The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the upper GI tract.

The provided text describes a 510(k) summary for a medical device called "Endo-Ease™ Endoscopic Overtube." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a clinical study report that would typically include detailed acceptance criteria and performance data as requested.

Therefore, the specific information about acceptance criteria, a study proving performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided text.

The document focuses on:

• Device Description: A sterile, single-use, flexible overtube for use with endoscopes in the upper GI tract.
• Indications for Use: To aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy.
• Safety and Performance: Stated as being based on "design characteristics and comparison to legally marketed predicate devices."
• Conclusion: The device has been shown to be safe and effective based on indications for use, technological characteristics, performance testing, and predicate device comparison.

No specific acceptance criteria or study results are detailed in this 510(k) summary. The approval is based on substantial equivalence, implying that its performance is expected to be similar to the predicate devices and that any performance testing conducted would have been to support this equivalence, but the details of such testing are not provided.

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The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.

The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower & I tract.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria using performance metrics. This document is a 510(k) Premarket Notification summary for the Endo-Ease Endoscopic Overtube.

The document states that substantial equivalence was based on:

1. design characteristics
2. comparison to legally marketed predicate devices
3. performance testing which "consisted of destructive tensile testing of the helix and collars."

This 510(k) summary focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in efficacy studies.

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

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The provided text describes a regulatory submission for a medical device (Endoscopic Overtube) and its clearance, which primarily relies on demonstrating equivalence to existing devices through design and specific engineering performance tests (destructive tensile testing), not clinical or diagnostic accuracy studies.

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