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These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for billary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The subject devices consist of the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed quidewire lumen, and the subject devices consist of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added.

The subject Single Use Preloaded Sphincterotome V(Distal Wireguided) has a preloaded guidewire, and the subject Single Use Sphincterotome V(Distal Wireguided) does not have a preloaded guidewire. The preloaded guidewire of the subject device is a minor modification of the product from Terumo Corporation that has been cleared via premarket notification, K091417.

The provided document is a 510(k) summary for a medical device (Single Use Preloaded Sphincterotome V and Single Use Sphincterotome V). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI or diagnostic performance. Therefore, many of the requested items related to AI device performance, sample sizes for training/test sets, expert ground truth, and MRMC studies cannot be extracted from this document.

However, I can extract information regarding non-clinical performance and the general approach to demonstrating safety and effectiveness.

Here's an attempt to answer based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-2
• IEC 60601-2-18
• ISO 10993-1
• ISO 10993-5
• ISO 10993-10
• ISO 10993-11
• ISO 11135-1
• ISO 14971
• ASTM F-1980-07 |
  | Comparison to Predicate Device | No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate device. Minor modification of the guidewire does not affect safety and effectiveness. |

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

• Sample Size for Test Set: Not specified. The document refers to "Performance testing" but does not detail the number of devices tested or the specific test parameters.
• Data Provenance: Not applicable in the context of diagnostic data. The testing mentioned is engineering/performance testing of the physical medical device.

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

• Not Applicable: This document describes a physical medical device (sphincterotome) and its engineering performance and safety, not an AI or diagnostic device that requires expert-established ground truth for a test set.

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

• Not Applicable: This pertains to clinical or diagnostic studies, not the engineering performance testing 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

• Not Applicable: This document is for a physical surgical accessory, not an AI-assisted diagnostic device.

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

• Not Applicable: This document is for a physical surgical accessory, not an algorithm.

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

• For the non-clinical performance testing, the "ground truth" would be established engineering specifications, performance standards as defined in ISO and IEC documents, and the functional characteristics of the predicate device. It's not a diagnostic "ground truth" like pathology or expert consensus.

8. The sample size for the training set

• Not Applicable: This document does not describe a machine learning or AI device that requires a training set.

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

• Not Applicable: This document does not describe a machine learning or AI device that requires a training set.

In summary: The provided 510(k) notification focuses on the manufacturing, design, and non-clinical performance (e.g., electrical safety, biocompatibility, sterilization, functional testing) of a physical medical device to demonstrate substantial equivalence to a legally marketed predicate. It does not contain information relevant to AI/ML device acceptance criteria or studies involving diagnostic performance, expert ground truth, or statistical measures like sample size for AI training/test sets.

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These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The subject sphincterotome consists of sphincterotome and preloaded guidewire. It is used in combination with endoscope and electrosurgical unit for papillotomy. The subject sphincterotome is composed of handle section and insertion tube. The preloaded guidewire is used for insertion and exchange of endotherapy accessories including the subject sphincterotome.

The provided text is a 510(k) summary for a medical device (Single Use Preloaded Sphincterotome V) seeking substantial equivalence to predicate devices. It describes the device, its intended use, technological characteristics, and non-clinical testing performed.

However, the document does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in a way that aligns with the requested format (e.g., sensitivity, specificity, accuracy, or similar quantitative performance outcomes compared against expert-established ground truth).

The "Summary of Non-clinical Testing" section states that:

• "Performance testing was conducted to demonstrate the initial performance of the subject device and confirmed that the subject device works as intended."
• "Basic safety and performance testing was performed in accordance with !EC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2 and IEC 60601-2-18. In addition, verification was conducted to evaluate the mechanical and functional performance."
• "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."

This language indicates that internal testing was done against established acceptance criteria, but it does not provide the specifics of those criteria or the results in a quantifiable, comparative manner (e.g., a table of acceptance criteria vs. device performance with specific metrics).

The document is primarily focused on demonstrating substantial equivalence based on technological characteristics and compliance with recognized safety and performance standards for an electrosurgical accessory, rather than reporting on a clinical or AI-driven performance study with detailed metrics against a ground truth.

Therefore, it is not possible to fill out the requested table and provide the specific details about a study proving the device meets acceptance criteria as typically found in submissions for AI/ML-driven devices. The provided text describes compliance with general safety and performance standards and risk analysis-driven design verification, not a study evaluating diagnostic performance against a ground truth.

Ask a specific question about this device