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The disposable accessory Laparoscopic Scissor Tips and Handle are used for electrical and nonelectrosurgical procedures intended for providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.

The Laparoscopic Scissor Tips are accessory disposable components that attach to the reusable Laparoscopic Surgical Handle. Laparoscopic Scissor Tips are assembled from medical grade stainless steel and sterilized for single use with the reusable surgical handle that must be cleaned and sterile before use. The Edge System is used with a standard electrosurgical generator and is a monopolar system. The handle is a standard insulated monopolar type with an insulated shaft.

The provided text describes a 510(k) submission for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation.

Therefore, the requested information elements related to specific performance metrics, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this document because it's a regulatory submission emphasizing design and functional equivalence to an existing device, not a novel device requiring extensive de novo performance validation.

However, I can extract the relevant information pertaining to the "acceptance criteria" as implied by a 510(k) submission and how the device "meets" them, based on the principle of substantial equivalence and compliance with relevant standards.

Here's the closest interpretation of an "acceptance criteria" table and study information based on the provided text:

Acceptance Criteria and Device Performance (Interpreted from 510(k) Submission)

• Same tip materials.
• Same type handle construction.
• The scissor tips are sterilized and packaged for single use.
• Handle is reusable per product instructions.
• The design analysis and predicate comparison confirm the functional characteristics are the same.
  Device Description: "Laparoscopic Scissor Tips are assembled from medical grade stainless steel... The Edge System is used with a standard electrosurgical generator and is a monopolar system. The handle is a standard insulated monopolar type with an insulated shaft." |
  | Performance Standards Compliance | Must comply with relevant mandatory and voluntary standards to ensure safety and effectiveness. | Compliance with the following standards has been made:
• IEC60601-1 (Safety for medical electrical equipment)
• IEC60601-1-2 (Electromagnetic compatibility)
• IEC60601-2-2 (Particular requirements for the safety of high frequency surgical equipment)
• EN550 (Sterilization of Tips)
• GMP/ISO13485 (Quality System Certification) |
  | Functional Performance (Verification) | Specific functional aspects (e.g., retention, grasping, insulation, cutting) must meet established specifications. | "Inspection verification procedures assure retention of tips, grasping, insulation performance with analyzer and cutting performance are compliant to Flexbar specifications." (Specific quantitative "Flexbar specifications" are not detailed in this document but implied to be met). |
  | Safety and Effectiveness | The device must not raise new questions of safety and effectiveness compared to the predicate device. | "The control activity shows that there are no new questions of safety and effectiveness for the Laparoscopic Scissor Tips and Handle made by Flexbar. The design analysis and predicate comparison confirm the functional characteristics are the same to the predicate device and raise no other safety or effectiveness issues." |
  | Sterilization & Reusability Procedures | Clear procedures for sterilization of disposable components and cleaning/sterilization of reusable components must be established and validated. | "Laparoscopic Scissor Tips are... sterilized for single use... The handle is reusable per product instructions."
  "EN550 Sterilization of Tips by contract sterilizer." |

Study Information (as derived from the 510(k) submission):

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

   • No specific "test set" in the context of clinical or performance data is mentioned. The submission relies on design control activities and verification procedures for the manufactured device. The "sample size" would refer to the units tested during manufacturing quality control and design verification, but no numbers are provided.
   • Data Provenance: Not specified as clinical data is not the primary basis of this submission for substantial equivalence. It's an internal validation of manufacturing and design.

2. 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. This is not a study requiring expert-established ground truth for diagnostic or clinical performance. "Ground truth" in this context refers to engineering specifications and regulatory standards.

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

   • Not applicable. No clinical or diagnostic test set requiring adjudication is mentioned.

4. 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 surgical instrument, not an AI-driven diagnostic or assistive device.

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

   • Not applicable. This is a surgical instrument, not an algorithm.

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

   • The "ground truth" implicitly used is compliance with established engineering specifications, recognized industry standards (IEC, EN, ISO), and the functional and material characteristics of the legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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