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The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.

The Applied Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowing ease of access and visibility during placement. Differences include a change of indicated use and a selection of different lengths.

This document is a 510(k) summary for the Applied Medical Laparoscopic Guidewire, submitted in 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not provide the information requested in the prompt regarding acceptance criteria and study details related to device performance in an AI/software context.

The information requested, such as sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment, is typically associated with the evaluation of AI-powered medical devices or diagnostic software. The Applied Medical Laparoscopic Guidewire is a physical medical instrument, and its approval process outlined here focuses on mechanical, biocompatibility, and substantial equivalence to existing predicate devices.

Therefore, I cannot extract the requested information from the provided text because it is not relevant to this type of medical device submission.

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NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters: Outside Diameter: .014" - . 045" Length: 20 cm - 500 cm Tip: Straight, Shapable or Preshaped Flexibility: Soft through Stiff Coil Length: 2 cm - 30 cm NOTE: None of these guidewires are for PTCA use.

The provided text describes comparative testing for guidewires, focusing on their substantial equivalence to predicate devices and biocompatibility. However, it does not describe a device that uses an AI algorithm or a study that utilizes features like experts, ground truth, or MRMC studies typically associated with AI/ML medical devices.

Therefore, the following information cannot be extracted from the given text:

• 1. A table of acceptance criteria and the reported device performance: While various tests were performed, specific acceptance criteria values are not provided, only that "All test results were within prescribed specification limits."
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "For each test, there were 30 samples selected" for comparative testing, and "at least two hundred (200) samples of each size (600+ total samples)" were produced. Data provenance (country of origin, retrospective/prospective) is not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device study.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The ground truth for the physical tests would be the measurement results against engineering specifications.
• 8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
• 9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted from the provided text regarding the closest equivalent to acceptance criteria and study findings:

The document describes product qualification tests and biocompatibility tests performed to demonstrate substantial equivalence of new guidewires (with NiTi core and platinum coil) to predicate guidewires (Flexmedics products).

Acceptance Criteria and Device Performance (Summary based on text):

Study Information:

• Study Purpose: To demonstrate substantial equivalence of guidewires with NiTi core and platinum coil to predicate Flexmedics guidewires and assess biocompatibility.
• Test Set Description:
  • Comparative Test Data: LRM guidewires (produced following current manufacturing processes) and Flexmedics guidewires (purchased complete in packaging). Both were sterilized prior to testing.
  • Biocompatibility Testing: Samples of the new guidewire type.
• Sample Size for Test Set:
  • Comparative Test Data: "at least two hundred (200) samples of each size (600+ total samples)" were produced. For each specific test, "30 samples selected."
  • Biocompatibility Testing: Not explicitly stated, but implies sufficient samples for each of the listed tests.
• Data Provenance (Comparative Test Data): LRM samples were manufactured, and Flexmedics products were purchased. No country of origin or explicit retrospective/prospective status stated, but based on the context of premarket notification, it is prospective testing for regulatory submission.
• Type of Ground Truth Used (Comparative Test Data): Engineering specifications/design criteria and comparison to predicate device performance.
• Type of Ground Truth Used (Biocompatibility): Standardized biological evaluation methods (ISO-10993) and established criteria for biological responses (e.g., Grade 0 for cytotoxicity, no hemolysis, etc.).

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