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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.

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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.

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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.

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The DASH™ is a deformable shape memory padded retractor, which is intended to retain or hold back organs and tissue in the course of surgical procedure. At the same time it serves as means of cushioning and absorption to the surgical area.

The DASH™ is a deformable shape memory padded retractor

The provided text is a 510(k) clearance letter from the FDA for a manual surgical instrument named DASH™. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment for device performance. It is a regulatory clearance document, not a clinical or performance study report.

Therefore, I cannot provide the requested information based on the input text.

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The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable abdominal retractor consisting of two flexible plastic rings connected by a sleeve of soft, high yield strength, clear plastic film. The internal ring has a circular cross-section (o-ring) and the external ring has a cruciform cross-section (quad-ring). The inner diameter of the internal o-ring limits the radius of abdominal retraction. The diameter of the external quad-ring is the same as the diameter of the internal o-ring and the sleeve. When completely unwound, the height of the cylinder is 10.6 inches. When the quad ring is rolled down, the sleeve is wrapped around the circumference of the ring reducing the height of the sleeve by 1.5 inches per rotation. Because the sleeve film is radially unyielding, the reduction in height causes the radial retraction of the incision site.

The provided text describes a 510(k) summary for the Apple Medical OB/Mobius® Elastic Retractor. This is a medical device submission, not an AI/ML device, and therefore the information typically requested in an acceptance criteria and study description for AI/ML devices (like sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not applicable or present in this document.

The "Testing" section only states: "The Apple Medical OB/Mobius Elastic Retractor has been clinically evaluated for the cesarean section indication and shown to be substantially equivalent to the predicate mechanical abdominal retractors."

Given the information in the document, here's what can be extracted:

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

The document does not explicitly list acceptance criteria in a quantitative or qualitative manner typical for performance metrics. Instead, the basis for approval is "substantial equivalence" to predicate devices. The performance is indirectly described by its intended use and successful clinical evaluation to achieve substantial equivalence.

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified, other than "clinically evaluated." It does not mention country of origin or whether it was retrospective or prospective.

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

• This information is not provided as the device is a physical retractor, not an AI/ML diagnostic tool requiring expert ground truth establishment in the same way. The "clinical evaluation" would likely involve surgeons and medical staff, but specific numbers and qualifications for ground truth are not detailed.

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

• Not applicable/Not specified for this type of device and submission.

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 is a physical surgical retractor, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a manual surgical instrument, always used with human involvement.

7. The type of ground truth used:

• Not explicitly defined in terms of "ground truth" as it would be for an AI model. The "clinical evaluation" would have assessed the device's performance against clinical outcomes and the performance of existing predicate devices.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical device.

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The MAST QUADRANT™ Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive approach.

The MAST QUADRANT™ Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANT™ Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.

The MAST QUADRANT™ 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 MAST QUADRANT™ 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.

This document is a 510(k) summary for the MAST QUADRANT™ Retractor System. It describes the device and its intended use, and states that substantial equivalence was demonstrated to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on demonstrating substantial equivalence to existing devices rather than presenting performance data against specific acceptance criteria.

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The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine. This will provide as access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(****) MicroEndoscopic Discectomy System" The comparisons of these devices are shown in Table I These retractors and dilators will be sold as a kit (See Kit Certification- Attachment F).

Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).

The provided text is a 510(k) summary for the Clarus Model 6000 Discectomy System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all components of your request regarding acceptance criteria and a study proving device performance, especially in the context of AI/ML-based medical devices.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds or performance metrics with numerical targets. The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states: "The Clarus Model 6000 Discectomy System contains a set of dilators and retractors that is similar to the Sofamor Danek (K unknown) dilators and retractors in their MED MicroEndoscopic Discectomy System." and "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices." This is the core "performance" claim in a 510(k) – that it performs equivalently to an already approved device. The "performance" is implicitly tied to its mechanical function (dilating and retracting tissue) being similar to the predicate.

Given the nature of this submission (a 510(k) for a mechanical surgical device from 1998, not an AI/ML device), the concept of "acceptance criteria" and "reported device performance" as you might expect for an AI model (e.g., sensitivity, specificity, AUC thresholds) is not applicable here. The evaluation focuses on design, materials, and intended use as being equivalent to a known device.

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

• Not applicable / Not provided. This document does not describe a clinical study or a test set as would be used for an AI/ML device. The "test" for a 510(k) of this type is primarily a comparison against a predicate device.

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. This information is relevant for studies involving human interpretation or ground truth establishment, which is not described in this 510(k) summary for a mechanical device.

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

• Not applicable / Not provided. Same as above.

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 510(k) for a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness claim is present.

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

• Not applicable. This device is a manual surgical tool; there is no algorithm or AI component.

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

• Not applicable / Not provided. For this type of mechanical device, "ground truth" would be related to its manufacturing specifications and mechanical function meeting design requirements, which are implicitly covered by demonstrating equivalence to a predicate. There's no diagnostic component requiring a ground truth in the usual sense.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" for a mechanical device.

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

• Not applicable / Not provided. There is no "training set" for a mechanical device.

Summary of what is present in the document relevant to a 510(k) for a mechanical device:

The "study" that proves the device meets (implicitly, the substantial equivalence) criteria is the comparison presented in "Summary of Equivalence" and "Table I" (though Table I content is not provided).

• Acceptance Criteria (Implicit): That the Clarus 6000 SITEtrac Discectomy System is "substantially equivalent" to the Sofamor Danek "MED(*tm) MicroEndoscopic Discectomy System" in terms of design, materials, intended use, and performance, raising no new safety or effectiveness issues.
• Study Proving Acceptance: The submission itself acts as the "study." It provides a comparison of the Clarus Model 6000 Discectomy System (specifically the dilators and retractors) to the predicate Sofamor Danek MED MicroEndoscopic Discectomy System. This comparison is primarily based on:
  • Device Description: "The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine."
  • Equivalence Claim: "These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(*) MicroEndoscopic Discectomy System." The submission explicitly states "The comparisons of these devices are shown in Table I" (though Table I itself is missing from the provided text). This table would have detailed the specific features or specifications demonstrating the equivalence.
  • Safety/Effectiveness Claim: "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices."

In essence, for this type of medical device 510(k), the "study" is the detailed technical comparison and rationale provided by the manufacturer to the FDA, demonstrating that the new device functions similarly to a legally marketed predicate device. This is a regulatory pathway for devices that pose no new questions of safety or efficacy.

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