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The device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate or retract organs and tissues to provide better access as well as visualisation of surgical sites.

Pretzelflex Surgical Retractor

I'm sorry, but your request cannot be fulfilled. The document provided does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets those criteria. Specifically, it is a 510(k) clearance letter for a surgical retractor, which focuses on regulatory approval based on substantial equivalence to a predicate device.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number of experts, adjudication methods, or MRMC studies.
3. Information on standalone algorithm performance or the type of ground truth used.
4. Information about training set size or how its ground truth was established.

Therefore, I cannot extract the requested information from the provided text.

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This device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate organs and tissues to provide better access as well as visualization and stabilization of surgical sites.

The Surgical Retractor is a Reusable device intended for mobilizing and maneuvering organ and tissue within the cavity during laparoscopic Surgical procedures.

The provided text describes a 510(k) premarket notification for a "Surgical Retractor." This device is a reusable surgical instrument, not an AI/ML-driven device or a diagnostic tool that would typically have performance metrics like sensitivity, specificity, or accuracy, or require studies involving ground truth, expert readers, or training sets in the way the prompt describes.

Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable to this type of device and is not present in the provided documentation.

However, I can extract the relevant information from the document:

Device Type: Surgical Retractor (a physical, reusable surgical instrument).

Acceptance Criteria and Reported Device Performance:

Since this is a physical surgical instrument, the "acceptance criteria" are related to its functional and safety performance, implied by its "substantial equivalence" to predicate devices. The document does not provide specific numerical performance metrics for acceptance criteria and reported device performance. Instead, the device is deemed acceptable because it is substantially equivalent to legally marketed predicate devices.

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

  • Not applicable. The document does not describe a "test set" in the context of clinical data for performance evaluation in the way an AI/ML device would. Substantial equivalence for this type of device relies on comparisons to predicate devices and adherence to general controls, likely supported by engineering testing rather than clinical study data.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. "Ground truth" in the diagnostic/AI sense is not established for this type of device.

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

  • Not applicable.

• 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 a surgical instrument, not an AI-assisted diagnostic tool.

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

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

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

  • Not applicable.

• The sample size for the training set:

  • Not applicable. This is a physical surgical instrument, not an AI/ML model requiring a training set.

• How the ground truth for the training set was established:

  • Not applicable.

Summary of the study/submission for this device:

The "study" or justification for market clearance is based on the concept of substantial equivalence to legally marketed predicate devices. The submission (K112659) details that the "Surgical Retractor" is "substantially equivalent" to:

• Laparoscopic Retractors (Diamond-Flex) (K092684) - Cardinal Health
• Nathanson Liver Retractor (K942002) - Automated Medical Products
• Endo-Retract (K914190) - Covidien

This substantial equivalence argument implies that the device performs as safely and effectively as these predicates for its intended use, and therefore meets the necessary regulatory "acceptance criteria" for a Class II medical device under 21 CFR 876.1500 (Endoscope and accessories, Product Code GCJ). The document does not detail specific performance studies beyond this declaration of equivalence.

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The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.

Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories

This is an FDA 510(k) clearance letter for the "Logic Laparoscopic Instrument System". It states that the device is substantially equivalent to legally marketed predicate devices. The letter itself does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory clearance letter, not a detailed study report.

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Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.

The LogiFlex Laparoscopic Band Positioning Device is a sterile, single-use, laparoscopic, blunt dissection instrument. It comprises a shaft with a distal articulating tip incorporating a slot that forms a hook for capturing suture threads and tubing. The LogiFlex Laparoscopic Band Positioning Device is designed to be connected to and used with the reusable, ratchet handle of the Logic Monopolar Laparoscopic Scissors in order to effect articulation of the distal tip. The LogiFlex Laparoscopic Band Positioning Device is not designed to be used with an electrocautery connection.

The provided text describes nonclinical bench testing for the LogiFlex Laparoscopic Band Positioning Device. There is no information about clinical studies with human participants, thus questions related to expert ratings, MRMC studies, or multi-reader performance cannot be answered.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Distal Tip Pull Testing: "13 samples" for production standard product. The provenance of the data is not specified (e.g., country of origin, retrospective/prospective), but it is implied to be laboratory bench testing.
• Lifecycle Testing: "All 10 specimens". The provenance of the data is not specified.
• Shelf Life (Accelerated Ageing): "Thirty test samples at each time point". The provenance of the data is not specified.
• Other tests do not explicitly state sample sizes but generally refer to "the LogiFlex laparoscopic band positioning device," implying testing on representative samples.

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

• Not applicable. The reported studies are nonclinical bench tests, not involving expert review for diagnostic purposes.

4. Adjudication method for the test set

• Not applicable. The reported studies are nonclinical bench tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. The provided text describes nonclinical bench tests.

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

• Not applicable. The device is a physical laparoscopic instrument, not an AI algorithm.

7. The type of ground truth used

• Ground truth was based on pre-defined engineering and safety specifications, as documented in technical notes and industry standards (e.g., ASTM, ISO). For example:
  • Mechanical strength (tensile load, sideway force, pull out force).
  • Articulation angles (-5° to 0°, ≥ 90°).
  • Absence of mechanical defects.
  • Maintenance of sterility and package integrity.
  • Biocompatibility based on established biological response criteria (cytotoxicity, sensitization, irritation).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model.

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

• Not applicable. This is a physical medical device, not a machine learning model.

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Surgical Innovations Resposable Laparoscopic Scissors are designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular gynaecological and thoracic surgical procedures.

Surgical Innovations Resposable Laparoscopic Scissors are designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular gynaecological and thoracic surgical procedures. The Logic Resposable Laparoscopic Scissors consist of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilised for monopolar cautery when attached to standard monopolar cautery cables and their generators.

The disposable shaft consists of an aluminium outer shaft housing a stainless steel actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissors will be available in working lengths of 24cm, 32cm and 42cm.

The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and resterilised.

Here's a breakdown of the acceptance criteria and the study information for the Surgical Innovations Laparoscopic Monopolar Scissors, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing for performance evaluation. Specific sample sizes for each test are not explicitly stated within the summary itself. For example, for the cutting life test, it mentions "a life of 2,400 cuts into latex rubber," but not how many scissors were subjected to this test or how many instances of the 2,400 cuts were performed.

The data provenance is from bench tests conducted by the manufacturer, Surgical Innovations Group plc, a UK-based company (Leeds, UK). The tests are retrospective in the sense that they were performed on manufactured devices as part of the validation process.

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

This information is not applicable as the studies described are bench tests of physical device properties, not clinical studies involving interpretation of data by human experts. The "ground truth" for these tests is based on established engineering standards and physical measurements.

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

This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the context of clinical expert consensus.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI component, in this 510(k) summary. This device is a surgical instrument (laparoscopic scissors), not an AI-assisted diagnostic or imaging device.

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

This information is not applicable as the device is a physical surgical instrument and does not involve an algorithm.

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

The ground truth for the performance evaluations described (biocompatibility, sterility, cutting performance, electrical safety, temperature performance) is based on:

• Established industry standards: ISO 10993, AAMI TIR No 12-1994, ASTM F1079-87 (1993), EN60601-2-2, EN60601-2-18.
• Physical measurements and laboratory testing: Measuring direct characteristics like sterility assurance levels, number of cuts, electrical parameters, and temperature profiles.
• Manufacturer's internal test protocols: These protocols are based on relevant standards and scientific principles to assess the device's functional attributes.

8. The sample size for the training set

This information is not applicable as the device is a physical surgical instrument and does not involve an AI algorithm that requires a "training set."

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

This information is not applicable for the same reasons as #8.

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Not Found

The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. Due to the increased demand for minimally invasive surgery, trocars have become an essential part of laparoscopic procedures. By providing the surgeon with a fully reusable instrument with replaceable tip such as the PortLand Trocars, SI have optimized the economy of a re-usable instrument, with the advantages of the disposable instrument, in the provision of the replaceable tip concept. The materials used in the construction of the PortLand Trocars are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland. Also, the means of sterilization (autoclaving) has long been used by hospitals for the sterilization of surgical instruments.

This document (K962193) is a 510(k) notification for the PortLand Trocars, a surgical device. The information provided is insufficient to answer the request about acceptance criteria and a study proving device performance against those criteria.

Here's why and what information is missing based on the prompt's requirements:

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

• Missing. The document states "The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent..." and "this instrument is as effective as other competitive product and does not increase the risk to the patient." However, it does not provide specific, measurable acceptance criteria (e.g., force required for insertion, durability, sealing characteristics) nor any data on how the PortLand Trocars performed against such criteria.

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

• Missing. There is no mention of any specific test set, sample size, or data provenance.

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 / Missing. This question is typically relevant for AI/ML-driven diagnostic devices where expert ground truth is established. For a mechanical surgical instrument like a trocar, "ground truth" would be performance specifications, and experts would be engineers or surgeons evaluating usability and safety. This document provides no such details.

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

• Not applicable / Missing. Similar to point 3, this is relevant for diagnostic performance evaluation, not for the type of device 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 pertains to AI-assisted diagnostic tools and is not relevant for a surgical trocar.

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

• Not applicable. This pertains to AI/ML algorithms and is not relevant for a surgical trocar.

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

• Missing (and applies differently to this device type). For a trocar, "ground truth" would relate to its physical properties, safety, and functional performance. The document only mentions similarity to other devices and materials.

8. The sample size for the training set:

• Not applicable / Missing. This is typically for AI/ML and is not mentioned for this device.

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

• Not applicable / Missing. This is typically for AI/ML and is not mentioned for this device.

Summary of Document K962193 in relation to the prompt:

This 510(k) notification focuses on demonstrating substantial equivalence to predicate devices. It largely relies on:

• Similar intended use: Both the PortLand Trocars and existing trocars are for laparoscopic procedures.
• Similar technological characteristics: "very similar to all other trocar devices," "materials used... are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland."
• Similar principles of operation: Functionally, it's a trocar.
• Safety and Effectiveness claims: "as effective as other competitive product and does not increase the risk to the patient."

The document does NOT provide:

• Specific, quantified acceptance criteria.
• Results from a formal study (clinical or performance bench testing) with defined methodologies, sample sizes, or outcome measures to prove performance against those criteria.
• Any details related to AI/ML performance, ground truth, or expert evaluations in the context of diagnostic accuracy.

To answer your prompt fully, a different type of document, such as a detailed test report, clinical study protocol, or specific sections within a more comprehensive regulatory submission, would be required. The provided 510(k) summary is high-level and focused on equivalence rather than detailed performance data or AI/ML evaluation.

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