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For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

The K&W 2-Piece Take-Apart Instrumentation are endoscopic instruments which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle.

The provided text is a 510(k) summary for the K&W 2-Piece Take-Apart Instruments. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, study design, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

The document is primarily focused on establishing substantial equivalence to a predicate device (Karl Storz Endoscopy America, Inc., K952149) based on similar intended use and technological characteristics, rather than presenting a performance study with defined acceptance criteria.

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The Dexterity® Pneumo Sleeve is intended to provide abdominal access for the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery.

The Protector® Retractor is intended to provide incision retraction and to protect it against wound contamination during both laparoscopic and open surgery.

This device allows the surgeon to use his hand while performing corrective surgery in the abdominal cavity under pneumoperitoneum.

The Dexterity® Pneumo Sleeve is a sterile, disposable device. It prevents leakage of CO2 and provides an extension of the pneumoperitoneum. It has an adhesive flange at one end that is placed over the inoision and adhered to the patient's abdomen. A velcro strap at the other end is used to tighten the Sleeve around the surgeon's arm.

The Protector® Retractor is a sterile, disposable device. The Retractor consists of an open-ended cylinder with a flexible ring at each end. One ring is inserted through the incision into the peritoneal cavity while the other remains outside the incision. The Retractor holds the incision open and protects it against wound contamination.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request.

It's important to note that the provided 510(k) summary (K962147 for the Dexterity® Pneumo Sleeve and Protector® Retractor) describes a medical device for surgical access, not an AI/ML powered device. As such, many of your requested criteria, which are highly specific to AI/ML device validation (e.g., sample size for test set/training set, expert grounding, MRMC studies, standalone performance, data provenance for AI), are not applicable to this traditional medical device submission. I will answer those questions with "Not Applicable" and explain why.

K962147: Dexterity® Pneumo Sleeve and Protector® Retractor

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative "acceptance criteria" in the way one might for an AI algorithm (e.g., target specificity, sensitivity, or AUC). Instead, the "acceptance criteria" for this traditional medical device are defined by its ability to demonstrate safety and effectiveness for its intended use, typically by being substantially equivalent to a predicate device and showing favorable outcomes in a clinical setting against established surgical practices.

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

• Sample Size for Test Set:
  • Pilot Study: 10 surgeons and 40 patients.
  • Pivotal Clinical Study: Not explicitly stated, but was a "prospective, randomized, controlled trial" across 10 clinical centers. The exact number of patients or surgeons is not provided in this summary.
• Data Provenance: The pivotal clinical study was conducted at "10 clinical centers in the United States and Europe." This indicates a prospective collection of clinical data from these regions.

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

• Not Applicable. This is a device for surgical access, not an AI algorithm that requires expert annotation for "ground truth" establishment in a diagnostic or interpretive sense. The "ground truth" for this device's performance is derived from clinical outcomes and surgeon's ability to perform the procedure as intended. The "experts" observing the performance would be the surgeons and clinical staff involved in the studies, assessing patient outcomes and device function.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in expert interpretations (e.g., image readings) to establish a definitive ground truth for AI model training or evaluation. This concept does not apply to the evaluation of a surgical access device. The clinical study would have had its own statistical analysis plan and potentially an independent data monitoring committee, but not expert adjudication in this sense.

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. MRMC studies are specific to evaluating diagnostic AI systems and their impact on human reader performance. This device is a surgical instrument and has no "readers" or "AI assistance" component in that context. The pivotal clinical study was a "randomized, controlled trial" comparing the device-assisted approach to "routine laparoscopic surgery," which is a comparative effectiveness study, but not of the MRMC type.

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

• Not Applicable. This is a physical surgical device, not an algorithm. Standalone performance is a concept for AI models.

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

• The "ground truth" for this device's efficacy and safety was established by clinical outcomes data from the randomized controlled trial. This includes metrics like overall procedure time, number of instrument changes, conversion rates, direct operation costs, time to return to normal activity, and morbidity and mortality. The "operating principles" were initially validated by direct observation and feedback from surgeons in the pilot study.

8. The sample size for the training set

• Not Applicable. This summary describes a traditional hardware medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As there is no AI/ML training set, there's no ground truth to establish for it.

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This device is to be used to protect and retract an incision in the abdominal wall. This is accomplished by placing one o-ring through the incision into the peritoneum cavity while the other o-ring remains outside of the incision. The outside o-ring is then rolled down against the skin. This lines the wound to protect against contamination and holds the incision open.

The PROTECTOR® Retractor is a sterile, disposable device. The PROTECTOR® Retractor consists of an open-ended cylinder with a flexible o-ring at each end. The PROTECTOR® Retractor with a drape is the same configuration, except that it has a drape that is an integral part of it.

This 510(k) summary provides limited information regarding detailed acceptance criteria and a formal study proving device performance against specific metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices through a combination of lab testing, pig studies, and clinical observations.

However, based on the provided text, I can infer and extract some information, although it will be less structured than requested for typical AI/ML device evaluations.

Here's an attempt to answer your questions based on the provided text:

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

Based on the document, explicit quantitative acceptance criteria are not stated. The performance assessment is qualitative and comparative.

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

• Test Set Sample Size:
  • Pilot Clinical: 41 subjects
  • Pivotal Clinical: "presently in a pivotal clinical." (Ongoing, so the "to date" results are based on an unspecified number of subjects from this ongoing study).
  • Lab Testing: "on a fake abdominal wall" (sample size not specified).
  • Pig Studies: (sample size not specified).
• Data Provenance: Not specified (e.g., country of origin). The clinical studies are described as "pilot clinical" and "pivotal clinical," indicating they are prospective clinical trials.

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)

The document does not mention the use of experts to establish "ground truth" in the sense of independent review for diagnostic accuracy, as might be typical for AI/ML devices. The "ground truth" here seems to be the direct observation of the device's function and safety by clinical staff during the pilot and pivotal clinical studies. The qualifications of these clinical staff are not detailed.

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

No formal adjudication method is described for the clinical data. The summary states "The results of the pilot clinical... is that the PROTECTOR® Retractor works safely and effectively," suggesting direct clinical observation and judgment.

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

No. This is a medical device for surgical retraction and wound protection, not an AI/ML diagnostic imaging device. Therefore, an MRMC study and effects on human reader performance are not applicable or described.

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. Performance is inherently "standalone" in that its physical function is evaluated, but it is always used "with human-in-the-loop" during surgery.

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

The "ground truth" for demonstrating the device's function appears to be:

• Direct observation of physical performance in lab tests ("fake abdominal wall").
• Direct observation of physical performance in animal studies ("pig studies").
• Direct observation of clinical function (wound protection, wound retraction) and safety in human subjects during pilot and pivotal clinical studies. This would likely involve surgeon's assessment and patient outcomes.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for a physical device.

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