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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Plastic and Reconstructive surgery, Orthopedic Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary malignant and spinal tumors, including but not limited to meningiomas and gliomas

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

The CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide optional electrosurgical capability.

The information provided describes a 510(k) premarket notification for the CUSA® Clarity Ultrasonic Surgical Aspirator System, primarily focusing on a modification to its Indications for Use to include more specific gynecological surgery indications. The submission claims substantial equivalence to a predicate device (K182809) and did not involve any design or technological changes to the device itself. Therefore, the "acceptance criteria" and "device performance" in the traditional sense of a new or modified device's functional characteristics are not directly presented as a series of quantitative benchmarks met by a specific study on the device's technical performance. Instead, the "acceptance criteria" here refer to demonstrating that the expanded indications for use for gynecological surgery are safe and effective, supported by existing literature and showing no new safety or effectiveness concerns compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The "test set" in this context refers to the body of clinical evidence reviewed to support the expanded indications.

• Sample Size: 1,465 patients. This total is comprised of:
  • 272 patients for dysplasia or condyloma.
  • 630 patients for debulking procedures (cancers).
  • 18 patients for endometriosis.
  • The remaining patients likely fall into categories not specifically broken down or represent overlaps in articles.
• Data Provenance: The data was derived from an "analysis of peer-reviewed articles." This indicates a retrospective review of published clinical literature. The country of origin of the data is not specified but would likely span various international institutions given the nature of peer-reviewed publications over an extended period.

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

Not applicable in the typical sense. This was a literature review, not a study where experts established ground truth for a novel dataset. The "ground truth" is implicitly established by the reported outcomes in the published clinical studies themselves, which are conducted by various medical professionals (surgeons, pathologists, etc.) in their respective fields. The submission does not specify an independent panel of experts reviewing the collected literature to establish a "ground truth" for the purpose of this 510(k).

4. Adjudication method for the test set

Not applicable. There was no explicit adjudication method for a test set as this was a review of existing peer-reviewed literature. The outcomes reported in the individual studies within the literature served as the evidence.

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. The device is an ultrasonic surgical aspirator system, not an AI or imaging diagnostic device that involves human "readers" interpreting output. This submission focuses on the safety and effectiveness of the existing device for expanded (gynecological) indications.

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

Not applicable. The CUSA Clarity is a surgical instrument used by a surgeon, not a standalone algorithm.

7. The type of ground truth used

The "ground truth"-like evidence used was outcomes data and reported effectiveness/safety from published clinical studies. This includes:

• Achievement of desired treatment outcomes (e.g., successful removal of tissue).
• Reported presence or absence of postoperative complications.
• Preservation of vessels and nerves.
• Comparison of procedure durations.

8. The sample size for the training set

Not applicable. This was a 510(k) submission for an existing device with expanded indications, not an AI/algorithm development where a training set would be used. The "evidence" supporting the expanded indications comes from published literature.

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

Not applicable. As above, there was no training set for an algorithm.

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3M™ Clarity™ Aligners with Quick Attachments are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

3M™ Clarity™ Aligners with Quick Attachments, is a clear plastic sequential aligner that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. 3M™ Clarity™ Aligners with Quick Attachments utilize the option of pre-formed and pre-cured attachments offering a more accurately shaped attachment. Attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement. 3M Clarity Aligners with Quick Attachments provide the option to form the attachments via an empty attachment template that is filled with adhesive and cured on the teeth or by pre-formed 3D printed custom attachments. The aligners, with or without attachments, are for orthodontic treatment of malocclusions.

The provided document describes the 3M™ Clarity™ Aligners with Quick Attachments and its substantial equivalence to a predicate device, 3M™ Clarity™ Aligners (K231464).

Acceptance Criteria and Device Performance:

The document states that the proposed Quick Attachment alternative attachment delivery mechanism completed functional and performance testing, including but not limited to abrasion, bond strength, flexural strength, and stain resistance. The conclusion drawn is that the alternative Quick Attachment delivery mechanism does not impact the safety and effectiveness profile of the 3M™ Clarity™ Aligners and is substantially equivalent to the predicate device.

However, the document does not provide a specific table of acceptance criteria with numerical targets and the reported device performance against those targets. It only states that testing was performed and that the device met the safety and effectiveness profile.

Regarding the study that proves the device meets the acceptance criteria, the following information is available from the document:

This document summarizes a 510(k) premarket notification, which establishes substantial equivalence, implying that the new device is as safe and effective as a legally marketed predicate device. In this context, detailed "acceptance criteria" and "study results" in the format typically seen for a new drug or high-risk medical device might not be explicitly outlined with quantitative data in this summary. Instead, the focus is on demonstrating that the modifications (Quick Attachments) do not alter the safety and efficacy profile from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific numerical acceptance criteria and detailed quantitative results for abrasion, bond strength, flexural strength, and stain resistance are not provided in this 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the functional and performance testing for the Quick Attachments. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The tests mentioned (abrasion, bond strength, flexural strength, stain resistance) are typically objective laboratory or mechanical tests rather than those requiring expert ground truth in a clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided in the document, as the tests described are objective performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical orthodontic product, and the testing described relates to its physical and material properties. There is no mention of an algorithm or AI component in this context.

7. Type of Ground Truth Used:

The "ground truth" for the functional and performance testing (abrasion, bond strength, flexural strength, stain resistance) would be the established scientific and engineering standards and methods for measuring these material properties. It is not an expert consensus, pathology, or outcomes data in the clinical sense for this type of device.

8. Sample Size for the Training Set:

Not applicable. The document describes functional and performance testing of a physical device component, not an AI or algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned or implied for this device.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well.

The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

The provided text describes the CUSA Clarity Ultrasonic Surgical Aspirator System, specifically focusing on a modified CEM nosecone accessory for the 23 kHz components. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes various non-clinical tests undertaken to ensure the safety and efficacy of the device and its substantial equivalence to the predicate.

The reported device performance is broadly stated as:

• "Testing was determined successful and supports the conclusion that all product specifications and design inputs have been met."
• "The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the CUSA Clarity 23 kHz Expanded CEM Nosecone is substantially equivalent to the predicate device."

Therefore, a table of quantitative acceptance criteria and specific reported device performance cannot be generated from the provided text. The information indicates that all tests were passed and specifications met, implying the device performed within acceptable limits.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing but does not specify a "test set" in terms of subject or patient data. The tests are focused on device characteristics rather than clinical outcomes with a patient population.

• Sample size for test set: Not applicable in the context of device performance testing described. The tests are on the device itself (e.g., handpiece life, functionality, mechanical properties).
• Data provenance: Not applicable in the context of patient data. The provenance is from internal testing conducted by Integra LifeSciences Corporation. There is no mention of country of origin for data related to clinical or patient studies, as none were performed. The tests are prospective as they were conducted as part of the submission process.

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

• Number of experts: Not applicable. The "ground truth" for the non-clinical tests is established by engineering specifications, recognized standards (FDA guidance documents, ISO standards for biocompatibility, EMC, and electrical safety), and comparison to the predicate device's established performance.
• Qualifications of experts: Not specified as a separate set of experts for ground truth. However, the development and testing would have been overseen by Integra LifeSciences Corporation's engineering and regulatory teams.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. The testing described is objective device performance (e.g., sterilization, biocompatibility, electrical safety, mechanical, thermal effects). Success or failure is determined by meeting predefined engineering specifications and regulatory standards, not by an adjudication process between human experts on a specific outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No. The document explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device."
• Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study or study involving human readers with or without AI assistance was conducted. The device is a surgical aspirator system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone study: Not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on:

• Established engineering specifications and design inputs: Ensuring the device functions as intended.
• Compliance with FDA guidance documents and recognized standards: Such as those for sterilization, biocompatibility, EMC, electrical safety, thermal effects, and capacitive coupling.
• Substantial equivalence to the legally marketed predicate device (CUSA® Clarity Ultrasonic Surgical Aspirator System K190180): This implies that the predicate's established safety and effectiveness profile serves as a benchmark for the new component.

8. The Sample Size for the Training Set

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is assessed through traditional engineering and regulatory compliance testing.

9. How the Ground Truth for the Training Set Was Established

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device.

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3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force. 3M™ Clarity™ Aligners-Flex) are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The present Premarket Submission is for the simplification in the number of formulations of the aligner material. This simplification allows for streamlined manufacturing processes so that both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be composed of the same material with differing flexibilities. The aligners will still be named 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex).

3M is offering a treatment plan with two different aligner flexibilities where the dental health professional will determine which degree of flexibility to use during the treatment plan. 3M Clarity Aligners-Flex is designed to be more flexible thereby increasing patient comfort and ease of insertion and removal. 3M Clarity Aligners-Force is designed to be more rigid increasing the force persistence. 3M will continue to offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.

A dental health professional (e.g., orthodontist or dentist), prescribes 3M™ Clarity™ Alieners (3MTM Clarity™ Aligners-Force, 3MTM Clarity™ Aligners-Flex) based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved. 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment from the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

This document is a 510(k) Premarket Notification for the 3M™ Clarity™ Aligners. The core purpose of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K211190) rather than to present a study proving the device meets specific acceptance criteria for clinical performance that would allow it to be used as a standalone diagnostic or screening tool.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing conducted to show that the new material formulation of the aligners does not negatively impact safety and effectiveness compared to the predicate device. The information provided heavily focuses on bench testing and biocompatibility rather than clinical efficacy studies.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria with numerical targets and corresponding device performance values in detail. Instead, it states that "All performance testing shows acceptable results for all tested samples." The acceptance is based on demonstrating that the subject device's performance is comparable or equivalent to the predicate device, especially considering the change in material.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each type of performance testing (translucency, abrasion, etc.). It generally refers to "all tested samples" from "bench testing." The data provenance is internal to 3M™ Company, arising from their in vitro and ex vivo laboratory testing. This is retrospective data collected for regulatory submission purposes. There is no information about country of origin for the data that would be relevant to clinical studies in this context.

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

This question is not directly applicable in the context of this 510(k) submission, as it relates to clinical efficacy studies or diagnostic performance evaluations. The "ground truth" here is established by the accepted scientific and engineering principles for material and device performance testing. For biocompatibility, a "Diplomate of the American Board of Toxicology" assessed the safety.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a bench testing and material change submission, not focused on human interpretation of clinical data in a test set.

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 submission is for an orthodontic aligner device, not an AI-assisted diagnostic or imaging device.

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 a software algorithm. While software is used in the manufacturing process, the submission does not present performance data for the software itself in a standalone context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing is based on established scientific and engineering standards for material properties and device functionality, often evaluated against the previous (predicate) device's performance, as well as relevant ISO standards (e.g., ISO 10993 for biocompatibility) and FDA guidance documents. For biocompatibility, the assessment by a board-certified toxicologist serves as the expert evaluation.

8. The Sample Size for the Training Set:

Not applicable. This submission focuses on a physical device and its material properties, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI algorithm.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery – including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the CUSA® Clarity 23kHz Single-Sided Bone Tip Pack that is intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. All CUSA systems are surgical aspirators that use ultrasonics and cavitation with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures.

The CUSA Clarity 23kHz Single-Sided Bone Tip Pack has the same intended use and technological characteristics as the predicate CUSA Clarity system, including all predicate tip pack accessories. A bone tip is currently cleared with the predicate CUSA Clarity system (CUSA Clarity 23 kHz Bone Tip). The primary modification of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack when compared to the currently cleared CUSA Clarity bone tip is that the subject device has a limited abrasive fragmentation surface at the distal end of the tip when compared to the existing bone tip.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. It appears to be a 510(k) summary for a medical device (CUSA® Clarity Ultrasonic Surgical Aspirator System) focusing on establishing substantial equivalence to a predicate device.

The information provided describes:

• Device Name: CUSA® Clarity Ultrasonic Surgical Aspirator System
• Indication for Use: Surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue are desirable. This includes various surgical specialties like neurosurgery, gastrointestinal, urological, general, and laparoscopic surgery.
• Predicate Device: CUSA® Clarity Ultrasonic Surgical Aspirator System K200774
• Device Description: The subject device is a CUSA® Clarity 23kHz Single-Sided Bone Tip Pack. The primary modification compared to the predicate bone tip is a limited abrasive fragmentation surface at the distal end.
• Non-clinical testing performed: Sterilization, shipping, stability, biocompatibility, EMC, electrical safety, and bench testing to verify requirements like tissue fragmentation rate, tip life, torque functionality, and functionality within environmental variations.
• Conclusion: The non-clinical testing indicates substantial equivalence to the predicate device.
• Clinical Studies: No clinical studies were performed or required, as performance tests were deemed sufficient to support substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, or type of ground truth, as these details are not present in the provided document.

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The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D and S systems are intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity 2D and S systems may also be used for additional diagnostic workup of the breast. Additionally, the Planmed Clarity 2D and S systems can be used to provide digital x-ray images of breast biopsy specimens.

The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

Acceptance Criteria and Study for Planmed Clarity 2D and S

This response synthesizes the information provided about the Planmed Clarity 2D and S mammography systems, focusing on the acceptance criteria and the studies conducted to demonstrate compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details performance testing rather than explicitly stated acceptance criteria with numerical targets. However, based on the descriptions, we can infer the acceptance criteria. The device's performance is deemed acceptable if it meets these inferred criteria and demonstrates clinical image quality comparable to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 6 patients particpated in routine breast cancer screening. The clinical evaluation used images from these 6 patients, with some cases also including diagnostic mammograms (spot and/or magnification images).
• Data Provenance: The data was obtained from two sites: one in Belgium and one in Bulgaria. The study appears to be prospective in nature, as images were "taken at one site in Belgium and one site in Bulgaria where altogether 6 patients participated to routine breast cancer screening."

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

• Number of Experts: Three
• Qualifications: "MQSA qualified experienced US interpreting physicians independently."

4. Adjudication Method for the Test Set

The document states, "The images were then reviewed by three MQSA qualified experienced US interpreting physicians independently." This indicates that there was no formal adjudication method (e.g., 2+1 or 3+1 consensus) described. Each expert provided an independent assessment, and the aggregate finding (all images rated good or excellent) was reported.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not described in the provided text. The study primarily focused on the standalone performance of the image processing algorithm and its impact on image quality for human interpretation. The clinical image evaluation assessed if the image quality produced by the new software was acceptable for human readers, not whether AI assistance improved human performance.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the new image processing algorithm (CORE) was implicitly performed. While not in the context of a "standalone algorithm" in isolation from the hardware, the "Clinical image evaluation" aimed to determine if the images processed with the new Planmed CORE software algorithm were of "sufficiently acceptable quality for mammographic usage when reviewed by MQSA qualified experienced interpreting physicians." This assesses the algorithm's output quality as a standalone component contributing to the overall system's diagnostic utility. The physical laboratory testing also evaluates the image chain, including the processing, in a standalone manner from actual diagnostic human interpretation.

7. Type of Ground Truth Used

For the clinical image evaluation, the "ground truth" used for assessing image quality was expert consensus on image quality acceptability. The experts rated images as "good" or "excellent," and the overall judgment ("acceptable for all cases and image types") served as the ground truth criterion. The selection of cases with BI-RADS score 1 or 2 suggests that the intent was to evaluate images from non-cancerous breasts (or breasts with benign findings) to assess general image clarity, rather than a diagnostic accuracy study where pathology or outcomes data would be directly compared.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set for the CORE image processing algorithm. The algorithm is described as "developed by Planmed in-house," but details on its development data (training, validation, testing) are not included in this summary.

9. How the Ground Truth for the Training Set Was Established

As no information is provided about a training set, the method for establishing its ground truth is not described in the document.

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The CUSA® Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of beingn or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in lapatic resection, lobectomy or trisegmentectony, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The devices within the scope of this premarket notification are the CUSA® Clarity 23kHz Laparoscopic Tip Packs that are intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. There are three (3) systems currently marketed in the United States: CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity), CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA Excel+) and CUSA® NXT Ultrasonic Tissue Ablation System (CUSA NXT). All CUSA systems are surgical aspirators that use ultrasonics and cavitation, in combination with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures.

The CUSA Clarity 23kHz Laparoscopic Tip Packs have the same intended use and technological characteristics as the predicate CUSA Clarity and CUSA Excel+ systems, including the predicate tip pack accessories. The primary modification of the subject tips compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the subject tips is to continue to fill out the CUSA Clarity Tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs; the CUSA Excel+ system has a tip design very similar to the subject tips. Additionally, testing confirmed that the modifications reduce the frictional force between a trocar and the flue as compared to the predicate CUSA Excel+ Laparoscopic Tip, making the device easier to insert and retract from the trocar during surgical use.

The provided text K221763 is a 510(k) summary for the CUSA® Clarity Ultrasonic Surgical Aspirator System, specifically for new 23kHz Laparoscopic Tip Packs. The submission claims substantial equivalence to predicate devices, and therefore, does not present a typical study with acceptance criteria and device performance analysis as one would expect for a de novo device or a device requiring clinical trials.

The document states: "No clinical studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices." This means the FDA cleared the device based on non-clinical (bench) testing, demonstrating that it performs as intended and is as safe and effective as existing legally marketed predicate devices.

Therefore, the requested information, which typically pertains to studies proving a device meets acceptance criteria, is not fully applicable in the context of this 510(k) summary claiming substantial equivalence. However, I can extract the relevant information regarding the non-clinical testing performed and the conclusions drawn.

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

The document lists types of bench testing performed but does not explicitly provide a table of quantitative acceptance criteria and corresponding device performance results for each criterion. It broadly states that "Bench testing to verify requirements" was conducted.

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

The document does not specify the sample sizes used for each non-clinical test. Given these are bench tests for substantial equivalence, the "data provenance" would be laboratory testing conducted by the manufacturer, Integra LifeSciences Corporation, in the USA.

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

This section is not applicable. For bench testing used in a 510(k) to demonstrate substantial equivalence, ground truth as established by human experts (e.g., radiologists) is not typically required. Performance is measured against engineering specifications and regulatory standards.

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

This section is not applicable, as it pertains to human interpretation/adjudication of results, which was not part of this non-clinical testing.

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

This section is not applicable. No clinical or comparative effectiveness studies involving human readers or AI assistance were performed or required for this 510(k) submission.

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

This section is not applicable. The device is a surgical aspirator, not an AI algorithm.

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

For the non-clinical testing, the "ground truth" refers to established engineering specifications, recognized industry standards (e.g., ISO for biocompatibility, IEC for electrical safety), and FDA guidance documents. Tissue fragmentation rate, tip life, and mechanical performance would be measured against internal design requirements and predicate device performance.

8. The sample size for the training set

This section is not applicable. This is not an AI/ML device, and therefore no "training set" of data was used.

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

This section is not applicable for the same reason as point 8.

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Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.

Follicle Clarity is a cloud-based software application package (software as a medical device, SaMD). Follicle Clarity automatically calculates the number and size of hypoechoic structures in the received transvaginal ultrasound images and displays the data graphically and in tabular format in the Follicle Clarity application. Graphic displays include both measurements made by the clinician (as measured by the ultrasonographer) as well as those calculated by Follicle Clarity. Graphs can be adjusted for various views of the data. Ultrasound images received are also displayed within the Application to allow the user to verify the resolution, contrast and anatomic completeness. The user is able to enter patient information such as cycle day, estradiol level and progesterone level in the patient profile for tracking. The user also has the ability to add or delete measurements as they feel are appropriate.

The provided text describes the Follicle Clarity Software, a medical device for quantifying ovarian follicles in ultrasound images. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with specific quantitative thresholds. However, it describes validation activities and states that the device "met the predetermined endpoints" and "demonstrated substantially equivalent performance." Based on the performance data section, the implicit acceptance criteria would likely be a demonstration of accuracy, precision, and agreement with established manual/SonoAVC measurements within a clinically acceptable margin of error.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes for the "second validation trial" (ovaries with ≤ 3 follicles) and "third validation trial" (ovaries with ≥ 10 follicles) or the "prospective study." It broadly refers to "a phantom trial" and "a prospective study."
• Data Provenance: The document only states that the clinical validation was performed in a "prospective study." It does not specify the country of origin.

3. Number of Experts and Qualifications for Ground Truth

• The document implies that "manual measurements" by "ultrasonographer" were used as a basis for comparison in the validation trials.
• For the clinical study, it compares Follicle Clarity to "manual (ultrasonographer) measurements" and "SonoAVC measurements."
• The number of ultrasonographers or their specific qualifications (e.g., years of experience, board certification) are not specified in the provided text.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set. It suggests direct comparison to "manual measurements" and SonoAVC.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly stated as having been done involving human readers improving with AI vs. without AI assistance. The clinical study focused on comparing Follicle Clarity's performance to manual measurements and SonoAVC, not on human-in-the-loop performance improvement with the AI.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was assessed. The "Validation of the tracking and measurement accuracy of the platform was conducted through a phantom trial" and the "second and third validation trials" which compared Follicle Clarity results directly to manual measurements or internal controls appear to be assessments of the algorithm's standalone performance. The clinical study also directly evaluated Follicle Clarity's measurements against SonoAVC and manual measurements without necessarily describing human-AI interaction.

7. Type of Ground Truth Used

• Expert Consensus/Manual Measurements and Predicate Device Output:
  • For the phantom trial and two ovarian follicle validation trials (low and high count), the ground truth appears to be based on "manual measurements of phantom targets" or "manual measurements of follicles" conducted "within a DICOM viewer." This implies expert-derived measurements.
  • For the clinical validation, the algorithm's performance was compared to "manual (ultrasonographer) measurements" and "SonoAVC measurements." SonoAVC is a component of a predicate device (Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System), effectively serving as a form of established clinical truth or a benchmark cleared device.

8. Sample Size for the Training Set

• The document mentions "Machine Learning Algorithm Training" but does not specify the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

• The document states: "The software utilizes 'locked' (non-adaptive) machine learning algorithms to identify the contours of the targeted structure within the ultrasound image."
• It does not explicitly detail how the ground truth for training data used by these machine learning algorithms was established (e.g., by manual annotation by experts, specific protocols, etc.).

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3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The 3M Clarity Aligners, 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The present Premarket Submission is for the addition of a new form of the aligner called 3M Clarity Aligners-Flex to the 3M Clarity Aligner system. 3M will continue to offer aligners composed of the same material as previously cleared (K192119) as 3M Clarity Aligners-Force. 3M will offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.

A dental health professional (e.g. orthodontist or dentist), prescribes 3M Clarity Aligners, 3M Clarity-Flex, 3M Clarity Aligners-Force based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

This document outlines the acceptance criteria and the study proving the device meets these criteria for the 3M™ Clarity™ Aligners (Force and Flex), based on the provided FDA 510(k) submission summary.

Executive Summary:

The 3M™ Clarity™ Aligners-Flex device is being introduced as an addition to the already cleared 3M™ Clarity™ Aligner system (predicate device K192119). The primary difference is the introduction of a new material, "3M Flex Thermoplastic Material", alongside the existing "3M Force Thermoplastic Material". The submission argues for substantial equivalence by demonstrating that the new material and combination treatment plans do not alter the fundamental indications for use, manufacturing processes, design, or device features as compared to the predicate device. Performance testing confirms acceptable results for optical properties, mechanical stability, staining, transportation, use life, force, and conditioning. Biocompatibility testing was also conducted and found the product safe for its intended use.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not detail explicit quantitative acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or AUC that would typically be associated with AI/ML diagnostic or prognostic devices. Instead, the acceptance criteria appear to be qualitative and relate to demonstrating that the new 3M™ Clarity™ Aligners-Flex are substantially equivalent to the predicate device (3M™ Clarity™ Aligners, K192119) across various performance aspects, particularly concerning its physical and material properties, and its continued safety and efficacy for its stated indications.

The "study" in this context refers to the performance testing conducted to support the substantial equivalence claim, rather than a clinical trial comparing the diagnostic accuracy of an AI system.

Here's an interpretation of the acceptance criteria and reported performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states "acceptable results for all tested samples" for the performance testing (optical properties, mechanical stability, etc.). However, it does not specify the exact number of samples used for each test.
• Data Provenance: The document does not specify the country of origin of the data. It's implicitly retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency, but it's not a clinical study on patients. The data is derived from laboratory and material testing.

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

• This information is not applicable to this submission. The "ground truth" here is not based on expert clinical consensus or interpretation of medical images/data, but rather on direct physical and material property measurements and biocompatibility testing against established standards. The device is a physical orthodontics product, not an AI diagnostic tool requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

• This is not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations, as the testing involves objective physical measurements and adherence to material standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• This is not applicable. The device is an orthodontic aligner, not an AI diagnostic or assistive tool. Therefore, no MRMC study, AI assistance, or human reader improvement effect size is relevant to this submission.

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

• This is not applicable. This describes a physical medical device (orthodontic aligner) and not an AI algorithm. While it leverages proprietary CAD/CAM software in its manufacturing, the submission does not present performance data for the software in a standalone "algorithm only" context, as the software's performance is intrinsically linked to the physical output of the aligners.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on objective physical and chemical properties measurements, engineering specifications, and established biocompatibility standards. It's not clinical outcomes data, pathology, or expert consensus in a diagnostic sense. The ground truth for the "acceptability" of these measurements is predefined by internal company specifications and relevant industry/regulatory standards (e.g., ISO standards for plastics, FDA guidance for biocompatibility).

8. The Sample Size for the Training Set

• This is not applicable. The device is a manufactured physical product. There is no "training set" in the context of machine learning or AI algorithm development. The manufacturing processes are established through engineering design, material science, and quality control, not data training.

9. How the Ground Truth for the Training Set was Established

• This is not applicable for the same reason as point 8.

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The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.

The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS. respectively), as a format of modality worklist. Subsequently, the images are acquired. processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

Here's a breakdown of the acceptance criteria and study information for the Planmed Clarity 2D and Clarity S device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 6 patients
• Data Provenance: One site in Bulgaria. The cases selected also included diagnostic mammograms (spot and/or magnification images) in addition to routine screening images (BI-RADS score 1 or 2).
• Retrospective/Prospective: The text does not explicitly state if the study was retrospective or prospective. Given that "6 patients participated to routine breast cancer screening" and images were then selected for evaluation, it suggests a prospective acquisition for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Number of Experts: Two
• Qualifications: MQSA qualified experienced US radiologists.

4. Adjudication Method for Test Set:

• Method: The two MQSA qualified experienced US radiologists reviewed the images independently. There is no mention of a formal adjudication process (like 2+1 or 3+1) if their independent ratings differed. The statement "All images were rated good or excellent" suggests they either agreed or the individual assessments were sufficient.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done?: No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed as described in the provided text. The study focused on physician perception of image quality from the new device rather than reader performance with AI.

6. Standalone (Algorithm Only) Performance Study:

• Was it done?: No, a standalone algorithm-only performance study was not described. The evaluation focused on the overall system's image quality as reviewed by human experts.

7. Type of Ground Truth Used (Test Set):

• Type: The ground truth for the clinical image evaluation was based on expert consensus/review by two MQSA qualified experienced US radiologists, who rated the images as "good or excellent" for mammographic usage. The images themselves were selected based on BI-RADS scores 1 or 2 (indicating negative or benign findings), and some diagnostic mammograms.

8. Sample Size for Training Set:

• The provided text does not mention a training set or any machine learning/AI components requiring a training set. The descriptions relate to the hardware and software of a digital mammography system and its image quality validation.

9. How Ground Truth for Training Set was Established:

• Not applicable, as no training set for a machine learning model is mentioned.

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