Search Results

The JRP Wound Spreader is a non-invasive superficial wound retractor with integrated guard that is used for wound care and positioning of small superficial wounds in the skin of up to 1/4" in width, 1/4" in depth and 1/2" in length.

The JRP Wound Spreader is a manually operated handheld non-invasive superficial wound retractor with an integrated guard that can accommodate a needleless syringe for the purpose of facilitating the retraction, observing the wound and flushing of small superficial wounds in the skin if deemed necessary. The JRP Wound Spreader consists of an array of four small tensioning fingers, which can be positioned on the skin astride a small superficial wound or incision.

This document (K152538) describes the JRP Wound Spreader, a non-invasive superficial wound retractor. The information provided heavily emphasizes comparison to a predicate device and does not contain detailed acceptance criteria and performance data for a new AI/software-based medical device. Therefore, a direct response to all parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided as it pertains to AI/software.

However, I can extract what is present in the document regarding performance and testing for this manual surgical instrument:

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

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

• Sample size for test set: 40 people
• Data provenance: Not explicitly stated, but the study was conducted to demonstrate substantial equivalence for a device seeking FDA clearance in the USA. It is implied to be a prospective study designed for regulatory submission.

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 a physical device and the "ground truth" would be related to observed performance in the study participants. The study involved "performance and assembly tasks" where success was likely objectively determined based on the device's intended mechanical function.

4. Adjudication method for the test set:

• Not explicitly stated, but given the nature of the device (a mechanical wound spreader), adjudication for "performance and assembly tasks" would likely be based on direct observation of whether the device performed its intended function as described (e.g., successful retraction, secure connection).

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 manual surgical instrument, not an AI or software-based device that would involve "human readers" or "AI assistance."

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

• Not applicable. This is a manual surgical instrument.

7. The type of ground truth used:

• The ground truth for the performance testing was based on the successful demonstration of the device's mechanical functions and safety in practical tasks performed by the 40 participants. This would be observational performance data rather than expert consensus, pathology, or outcomes data in the usual sense for diagnostic AI tools.

8. The sample size for the training set:

• Not applicable. This is a manual surgical instrument, not an AI/ML model that requires a training set.

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

• Not applicable. No training set for an algorithm is involved.

Ask a specific question about this device

The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue.

The OTELO®LL Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The OTELO®LL Retractor System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.

I am sorry, but based on the provided document, I cannot fulfill your request. The document describes a 510(k) summary for a medical device called the OTELO LL Retractor, which is a manual surgical instrument. The content focuses on demonstrating substantial equivalence to a predicate device and includes pre-clinical verification and validation test results for aspects like biocompatibility, cleaning, sterilization, and mechanical performance.

However, the provided text does not contain information about:

• Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets (as it's not a diagnostic study)
• Data provenance, number of experts, adjudication methods, or ground truth for diagnostic accuracy studies
• Multi-reader multi-case (MRMC) comparative effectiveness studies with human readers
• Standalone (algorithm only) performance
• Training set details

The "acceptance criteria" discussed in the document are related to engineering and biological performance (e.g., no cytotoxic potential, no breakage of blades, successful cleaning and sterilization) rather than diagnostic performance against clinical ground truth.

Ask a specific question about this device

The ThoraTrakTM minimally invasive cardiac surgery (MICS) retractor system is intended to provide surgical access for minimally invasive cardiothoracic procedures, including minimally invasive coronary artery bypass grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.

The ThoraTrak™ minimally invasive cardiac surgery (MICS) retractor system is designed for use with a minimally invasive thoracotomy, an incision in the chest wall into the pleural space, for procedures that include Coronary Artery Bypass Grafting (CABG) and Left Internal Mammary Artery (LIMA) harvesting. It consists of a retractor rack, 2 sets of LIMA blades, 4 sets of thoracotomy blades, and 2 extended mount blades. The retractor rack and blades are chromecoated stainless steel. They are non-sterile, nonpyrogenic, and reusable.

This document K132645 is a 510(k) summary for a Class I manual surgical instrument (ThoraTrak™ MICS Retractor System). Class I devices generally have the lowest risk and typically do not require extensive clinical studies or performance data to demonstrate substantial equivalence to a predicate device.

The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for devices requiring performance testing (e.g., diagnostic devices, software devices).

Here's why and what can be inferred:

• Device Type: The ThoraTrak™ MICS Retractor System is a manual surgical instrument, specifically a retractor. For such devices, the primary considerations for substantial equivalence often revolve around material safety, mechanical integrity, and equivalence in design and intended use to existing predicate devices.
• Regulatory Class: It is classified as Class I (21 CFR 878.4800, Product Code: GAD). Class I devices are subject to general controls, which generally focus on aspects like good manufacturing practices, labeling, and adverse event reporting, rather than extensive clinical performance studies.
• 510(k) Summary Content: The summary focuses on comparing the modified device to a legally marketed predicate device, highlighting similarities in intended use, technological characteristics, operating principle, design features, base materials, and shelf life. This is the typical approach for demonstrating substantial equivalence for Class I devices where fundamental safety and effectiveness are established by the predicate.

Therefore, for this specific device and submission, the following points would apply if we were to try and complete the requested table and information, recognizing that the supplied text does not detail all items:

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

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

• Sample Size: Not applicable/Not provided. The submission focuses on substantial equivalence based on design and material comparison to a predicate, not on a clinical or performance test set with a sample size as typically understood for diagnostic or interventional devices.
• Data Provenance: Not applicable/Not provided. There is no "data" in the sense of patient or test results presented in this 510(k) summary. The comparison is based on device specifications and regulatory assessment.

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/Not provided. There was no "test set" requiring expert-established ground truth for a device like this.

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

• Not applicable/Not provided.

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/Not provided. This device is a manual surgical retractor, not an AI-assisted diagnostic or interventional system.

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

• Not applicable/Not provided. This device is a manual surgical retractor, not an algorithm.

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

• Not applicable/Not provided. The "ground truth" for this filing is the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its history of use and prior regulatory clearance.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" for a device of this type.

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

• Not applicable/Not provided.

Ask a specific question about this device