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The RetroArc™ Retropubic Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The RetroArc System is a sterile, single use system, consisting of one plastic handle, two stainless steel delivery needles and a sling assembly. The tip portion of each delivery needle is configured to allow for passage through tissue. The opposite end of the needle is configured to connect with the plastic handle. The handle is detachable and is used to direct both delivery needles through tissue. The sling assembly includes one piece of loosely knitted polypropylene mesh with an integrated adjustment suture, two removable plastic insertion sheaths, and two connectors attached to the insertion sheaths. The adjustment suture is an integral feature woven into the mesh which limits the overall stretch of the mesh arms during the procedure. The integrated suture and mesh, allow for adjustment of the sling after initial placement in the patient without the use of additional tools. The two plastic sheaths overlap during placement and allow for convenient travel of the sling through the tissue. The connectors, sheaths, and delivery instruments are used to facilitate placement of the mesh assembly, and are not implanted. The mesh component is not absorbed by the action of tissue in-growth or tissue enzymes

Here's an analysis of the provided information regarding the RetroArc™ Retropubic Sling System, focusing on acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance

Study Details

This submission does not describe a study to prove the device meets specific acceptance criteria in terms of clinical efficacy or diagnostic accuracy for an AI/CADe device. Instead, it describes non-clinical testing to demonstrate the substantial equivalence of a medical device (a surgical sling system) to a predicate device.

Here's the breakdown based on the request, adapted for the provided information:

1. A table of acceptance criteria and the reported device performance:
   (See table above)

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

   • Test Set (for non-clinical performance and cadaver studies): The document does not specify exact sample sizes for the bench tests (e.g., how many instruments were tested for torsional strength). For the cadaver studies, the sample size is also not explicitly stated (e.g., "Physician Questionnaire," "Cadaver Evaluation," "Cadaver Dissection" imply a limited number of cadavers and physicians, but no numbers are provided).
   • Data Provenance: Not specified beyond being "bench testing" and "cadaver testing." No country of origin is mentioned. These are non-clinical studies.

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):

   • For Bench Testing: "Bench testing was performed to support this submission." The experts here would be the engineers/technicians performing the tests and comparing results to product specifications. Their number and qualifications are not provided.
   • For Cadaver Testing: "Physician Questionnaire," "Cadaver Evaluation," "Cadaver Dissection." These imply physician involvement. The number of physicians and their qualifications are not provided. They would be establishing a "ground truth" on the usability and handling of the device in a cadaveric setting, not a clinical outcome.

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

   • No adjudication method is described. The non-clinical tests likely followed standard engineering validation protocols. The cadaver evaluation seems to involve direct assessment, but no multi-reader/adjudication process is mentioned.

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 MRMC study was done. This document is for a surgical sling system, not an AI/CADe device. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

   • No standalone (algorithm only) performance study was done. This is not an AI algorithm.

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

   • For Bench Testing: The ground truth is based on predefined product specifications and engineering requirements.
   • For Cadaver Testing: The ground truth seems to be an assessment of device handling, placement, and anatomical interaction by physicians in a simulated environment (cadavers). This would be a form of expert assessment of physical performance, not clinical outcomes.

8. The sample size for the training set:

   • Not applicable. This device is a physical surgical implant and delivery system, not an AI model requiring a training set.

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

   • Not applicable. This device does not use a training set as it is not an AI model.

Conclusion:

The K132655 submission for the RetroArc™ Retropubic Sling System does not involve AI or CADe technology. Therefore, many of the requested details regarding AI-specific studies (MRMC, standalone performance, training sets, ground truth for AI models) are not applicable.

The submission focuses on establishing substantial equivalence to a predicate device (SPARC® Sling System K081613) through non-clinical bench testing and cadaver studies. The acceptance criteria are primarily related to the mechanical performance of the delivery instruments and the usability in a cadaveric setting, demonstrating that the design modifications (primarily to the delivery instruments) do not negatively impact the fundamental performance or safety compared to the predicate device. No clinical testing was performed for this submission. The "ground truth" for the non-clinical tests was established by meeting engineering specifications and by qualitative assessment during cadaveric evaluation.

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AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite: The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite: The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor. The devices are identical to the predicate device AMS Elevate PC Prolapse Repair System with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.

The provided text describes a 510(k) premarket notification for a medical device, the "AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite" and "AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite". This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for performance.

Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, expert involvement, and ground truth establishment are not applicable or not found in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission is for a modification to a previously cleared device. The focus is on demonstrating that the modifications do not negatively impact safety and effectiveness compared to the predicate device, rather than meeting new, specific quantitative performance acceptance criteria.

The submission states:

• "The test results for design verification, biocompatibility, sterilization, and packaging are virtually equivalent to the predicate device." (Section 2)
• "The proposed Elevate PC Anterior and Elevate PC Posterior device performance and fundamental scientific technology remains unchanged." (Section 2)

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

Not applicable. No specific 'test set' in the context of an efficacy study is described. The document refers to "test results for design verification, biocompatibility, sterilization, and packaging" (Section 2), implying engineering and materials testing, but does not provide details on sample sizes or data provenance for these tests.

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

Not applicable. No ground truth establishment for a test set in the context of device performance or efficacy is described.

4. Adjudication method for the test set

Not applicable. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical mesh system, 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 device is a surgical mesh system, not an algorithm.

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

Not applicable. Ground truth, in the context of an efficacy study, is not described as this is a substantial equivalence submission for a surgical device modification.

8. The sample size for the training set

Not applicable. No training set for an algorithm is described.

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

Not applicable. No ground truth for a training set is described.

Summary of Device and Rationale for Substantial Equivalence (as provided in the document):

The submission details a change to the AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite and the AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite.

The modification is solely to the Apical Needle Passer Sheath (a non-implantable surgical aid). There are no changes to the mesh design, shape, size, material, or Indications for Use.

The rationale for substantial equivalence is based on the following points:

• The devices are identical to the predicate device with the single exception of the Apical Needle Passer Sheath modification.
• There are no changes to the existing indications for use.
• The modifications are deemed equivalent, with no changes to the device indications for use/intended use and/or device functional scientific technology.
• The subject devices use the same surgical approach and mesh placement procedures as the predicate devices.
• Components underwent design verification, biocompatibility, sterilization, and packaging tests, with results "virtually equivalent" to the predicate device.
• The proposed devices have identical indications for use/intended use, identical implant materials, identical sterilization methods, and similar delivery tool materials/characteristics as the predicate.
• The proposed device performance and fundamental scientific technology remain unchanged.
• The differences between the proposed device and the predicate device do not have any negative effect on the safety and effectiveness of the device.

Therefore, the submission asserts that the modified devices are substantially equivalent to their predicate devices, implying that their safety and effectiveness are maintained despite the minor modification. No new clinical or performance studies demonstrating effectiveness against specific acceptance criteria are presented because the modification is considered minor and does not alter the fundamental performance or intended use of the device.

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The MiniArc Precise™ Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The MiniArc Precise Single-Incision Sling System (MiniArc Precise) is a modification of the currently commercialized device, MiniArc Single-Incision Sling System (MiniArc), which consist of one sterile mesh sling and one sterile surgical instrument · used for sub-urethral sling placement. The minor modifications to MiniArc for the development of the MiniArc Precise are as follows: Self-fixating tips on the mesh sling are for a "secure connection" (snap-fit) to 0 the delivery tool needle tip. Delivery tool has an actuating needle tip release mechanism for the mesh sling. ● Mesh slings center-length dimensions are modified and the mesh sling arms 0 are knit with reinforcement fibers. The MiniArc Precise is available in two configurations; each configuration contains one sterile mesh sling and one sterile delivery tool. The identical delivery tool is used with both configurations. The configurations are identified by the mesh sling option, either the short center-length mesh or the long center-length mesh. The mesh sling and mesh arms material for MiniAre Precise is the same knitted polypropylene monofilament material used in the predicate, MiniArc. MiniArc Precise uses the same surgical approach and the same mesh placement procedures as the predicate device. MiniArc. The MiniArc Precise device is for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). MiniArc Precise device is for single use only and is not to be re-sterilized.

The provided text describes a 510(k) premarket notification for a medical device called the MiniArc Precise™ Single-Incision Sling System. This submission focuses on demonstrating substantial equivalence to a predicate device (MiniArc® Sling System) rather than presenting a de novo study with acceptance criteria in the traditional sense of a performance study.

Therefore, the information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in AI/diagnostic device submissions, is not applicable here.

This submission relies on non-clinical testing to show that the minor modifications to the MiniArc Precise device do not change its fundamental scientific technology, intended use, or product performance specifications compared to the predicate device.

Here's an breakdown of the information that is available based on your request, with an emphasis on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are effectively the demonstrations of equivalence or adherence to standards, rather than specific performance metrics like sensitivity/specificity for a diagnostic device. The "reported device performance" is a confirmation that these criteria were met.

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for human subjects or data sets in the context of device performance testing. The "test sets" refer to the subjects/materials used in bench testing, animal testing, and cadaver lab testing.
• Data Provenance:
  • Bench testing: In-house laboratory testing (implied).
  • Animal testing: Performed as per FDA 21 CRR: Part 58 Good Laboratory Practice Regulations (location not specified, but typically conducted in regulated lab environments).
  • Cadaver lab testing: Performed using human cadavers (location not specified).

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

• Not Applicable. This submission does not involve a diagnostic AI algorithm or a study requiring expert readers to establish ground truth for a test set. The validation is based on engineering principles, material science, and biological response assessments (animal/cadaver models) to demonstrate physical and functional equivalence to a predicate device.

4. Adjudication method for the test set

• Not Applicable. As there are no expert readers establishing ground truth for a test set in statistical terms (e.g., image interpretation), no adjudication method is relevant.

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 a surgical implant (suburethral sling system), not a diagnostic device assisted by AI. Therefore, an MRMC study or AI assistance effect size is irrelevant.

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

• Not Applicable. This is a hardware medical device (surgical sling) and does not involve any algorithms or AI for standalone performance.

7. The type of ground truth used

• For bench testing: Engineering specifications and performance standards.
• For animal testing: Histopathological and physiological assessment of tissue response and fixation.
• For cadaver lab testing: Observational assessment of surgical procedure and device placement/fixation, likely by surgeons/medical professionals.

8. The sample size for the training set

• Not Applicable. This submission does not involve machine learning or AI, and therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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The GreenLight™ XPS Laser System is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, Urology.

This GreenLight XPS Laser System consists of a console, a fiber optic delivery device, a camera filter and safety glasses that are required in order to use the system. The GreenLight XPS Laser System design and principles of operation are based upon the AMS GreenLight HPS Surgical Laser System & Accessories (K062719) that was successfully introduced to the market in 2006.

The provided text describes a 510(k) premarket notification for the GreenLight™ XPS Laser System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, the requested information regarding acceptance criteria, study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) is not explicitly present in the provided document for the GreenLight™ XPS Laser System.

Here's an explanation based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in the format of a clinical trial. For a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to the predicate device.
• Reported Device Performance: The document states that "All necessary bench testing was conducted on the proposed GreenLight XPS Laser System to support a determination of substantial equivalence to the predicate device." However, the specific results of this bench testing or a table of performance metrics are not provided.

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

• Sample Size: Not applicable/not provided. This device relies on "bench testing" to demonstrate substantial equivalence, not a clinical test set in the traditional sense with patient data.
• Data Provenance: Not applicable/not provided.

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

• Not applicable. The substantial equivalence determination is based on a comparison to a predicate device and bench testing, not on expert-established ground truth for a test set of data.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set data or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No, an MRMC comparative effectiveness study was not performed or referenced in this 510(k) summary. This type of study is more common for diagnostic devices where human interpretation is involved.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is a laser surgical system, not an algorithm or AI device. It does not have "standalone performance" in the context of an algorithm.

7. The Type of Ground Truth Used:

• The implicit "ground truth" for a 510(k) in this context is the performance and safety profile of the predicate device (GreenLight HPS™ Surgical Laser System & Accessories K062719). The new device aims to be substantially equivalent to this established device. Bench testing would assess if the new device's physical and functional characteristics meet established engineering and safety standards, aligning with the predicate.

8. The Sample Size for the Training Set:

• Not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The design and development of the device would leverage engineering principles and prior knowledge from the predicate device.

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

• Not applicable. No training set is involved.

In summary:

This 510(k) application for the GreenLight™ XPS Laser System focuses on demonstrating substantial equivalence to an existing predicate device (GreenLight HPS™ Surgical Laser System & Accessories K062719) through bench testing. The document explicitly states: "The GreenLight XPS Laser System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed GreenLight XPS Laser System is substantially equivalent to the predicate device."

The types of studies and criteria requested (MRMC, ground truth, training sets, etc.) are typically associated with diagnostic algorithms or devices requiring de novo clearance or PMAs, where clinical performance against a true gold standard needs to be established. For a 510(k) for a surgical laser system, the bar is demonstrating that it's as safe and effective as a device already on the market.

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AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.

The provided text describes a 510(k) summary for the "PFR Sling System, Part of the AMS Pelvic Floor Repair System," which is a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a device output.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.

The document states:

• "The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." (Page 1, under "Summary of Testing")

This indicates that a comparison was made against existing, legally marketed devices. However, the details of what "performance requirements" were and how "substantial equivalence" was demonstrated in terms of specific metrics, acceptance criteria, or a detailed study are not included in this summary.

In summary, the provided document does not contain the information necessary to fulfill the request as it describes a regulatory submission based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and device performance metrics.

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The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

The AMS Spectra™ Concealable Penile Prosthesis consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. Each device consists of two cylinders and may include rear tip extenders (RTEs) for additional length. All components consist of implantable, biocompatible materials. The cylinder consists of a malleable section of articulating polymer and metal segments. A cable extends through the center of the articulating segments. The proximal and distal ends of the cable are each connected to a spring that is encased in a metal housing. The entire outside surface of the cylinder is made of silicone. The articulating segments, held together by the cable and spring assemblies, provide sufficient friction and rigidity. This allows the patient to position the device for concealment or for intercourse. Spectra cylinders are available in 9.5-, 12-, and 14-mm diameters. Each cylinder diameter is available in three lengths: 12-, 16-, and 20-cm. The total cylinder length can be adjusted by adding rear tip extenders (RTEs) to the proximal cylinder end. A range of RTE lengths is included to accommodate the patient's total intracorporal length. Rear tip extenders may be attached to the Spectra™ cylinders in 0.5-cm increments, and may extend the cylinder lengths from 0.5- to 7.5-cm, with the exception of 7-cm. The RTEs are the same as those used with the inflatable AMS 700™ CXR and CX/LGX models (D970012). These RTE components' functional performance has been demonstrated in use with the 700™ IPP products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AMS Spectra™ Concealable Penile Prosthesis:

Acceptance Criteria and Device Performance

Study Information

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

   • Test Set Size: Not explicitly stated as a number of devices. The document refers to "mechanical performance tests" on "the Spectra™ product" and "the Spectra™ device." It implies an adequate number of devices were tested to establish meeting the criteria for each test type.
   • Data Provenance: The studies were nonclinical performance tests conducted by the manufacturer, American Medical Systems Inc. (AMS). The country of origin for the data is not specified but is implicitly the United States, given the submission to the FDA. The tests are prospective in nature as they were conducted to evaluate the new device.

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

   • Not Applicable. This device is a medical device (penile prosthesis) and the evaluation relied on mechanical performance tests, not human interpretation of data for diagnostic purposes. Therefore, there was no "ground truth" derived from expert consensus for the test set. The ground truth was the objective measurement against pre-established acceptance criteria for mechanical properties.

3. Adjudication Method for the Test Set:

   • Not Applicable. As the evaluation was based on objective mechanical testing, there was no need for expert adjudication.

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

   • No. An MRMC study was not conducted. The document explicitly states: "Because the intended use and technological characteristics of the predicate Spectra™ and DURA II® devices were maintained in the subject AMS Spectra™, a clinical study was not conducted for the subject Spectra™ device." MRMC studies are typically used to assess the impact of a new diagnostic aid on human reader performance, which is not relevant for this type of medical device submission.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, in the sense of the device's mechanical performance. The nonclinical performance tests assessed the device's performance in isolation, without human interaction beyond operating the testing equipment. This represents the "standalone" performance of the physical device.

6. Type of Ground Truth Used:

   • Objective Mechanical Measurements and Specifications. The "ground truth" for the performance tests was defined by the pre-established "acceptance criteria" for each mechanical test (cycle life, springback angle, column strength, bend force, and packaging).

7. Sample Size for the Training Set:

   • Not Applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes for the device would be informed by engineering principles and prior device experience, but not through a formal "training set" of data.

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

   • Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this submission. The "ground truth" for the device's design and engineering would be based on established engineering standards, material science, and performance requirements for penile prostheses, likely derived from extensive industry experience with similar devices.

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The Elevate Prolapse Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.

This document is a 510(k) summary for a medical device called the "Elevate Prolapse Repair System with PC Coated IntePro Lite". This is a regulatory submission for a surgical mesh, and as such, it does not describe a study in the way one would for an AI/ML device or diagnostic test.

Instead, the document details a comparison to a predicate device and performance testing to demonstrate substantial equivalence, which is the regulatory pathway for this type of device.

Here's an analysis of the provided text in the context of your request, highlighting where the information is present or not applicable:

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 specified in this 510(k) summary. The summary refers to "testing" performed but does not quantify the sample sizes for any tests conducted.
• Data Provenance: Not specified. This would typically be internal testing conducted by the manufacturer, American Medical Systems. The nature of the device (surgical mesh) suggests bench testing and potentially in vitro/in vivo animal studies would be used rather than human clinical data in this type of submission for a modification. It is likely prospective testing on material samples or animal models.

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. For a surgical mesh modification, "ground truth" as you'd define it for an AI/ML or diagnostic device (e.g., expert consensus on images) is not relevant. The "ground truth" here is the established safety and performance profile of the predicate device, against which the modified device's performance is compared through engineering and material testing. The experts involved would be engineers, material scientists, and regulatory specialists within the company assessing the test results.

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

• Not Applicable. Adjudication methods are typically for clinical endpoints or image interpretations. For this device, the "adjudication" would involve internal review and approval of the test protocols, results, and conclusions by the manufacturer's R&D, quality, and regulatory departments, followed by FDA's review of the 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 medical device (surgical mesh), not an AI/ML diagnostic or image analysis tool. Therefore, MRMC studies are not relevant nor performed for this type of submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For this type of device, the "ground truth" (or more accurately, the comparator) is the established performance and safety profile of the legally marketed predicate device (Elevate Prolapse Repair System with IntePro Lite). The testing (e.g., mechanical properties, biocompatibility, coating adhesion) aims to demonstrate that the new device meets or exceeds these established parameters and introduces no new risks.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

Summary of the Study (as described in the 510(k) summary):

The "study" in this context is a Design Failure Mode Effects and Criticality Analysis (dFMECA) of the modification (adding a PC coating) to the predicate device. This analysis identified potential performance parameters that could be affected by the coating. Subsequently, performance testing was conducted to evaluate these identified parameters. The results of this testing formed the basis for demonstrating that the modified device is substantially equivalent to the predicate. The key finding reported is that: "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised."

In essence, this is a substantive equivalence demonstration based on engineering and performance testing rather than a clinical efficacy trial or an AI/ML performance study.

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The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The AMS Elevate Anterior and Apical Prolapse Repair System is a modification of the Perigee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh assembly and non-implantable surgical instruments that can be used as aids to place the mesh assembly in the pelvic floor. The mesh assembly is made from knitted polymeric mesh.

The provided document is a 510(k) summary statement for a surgical mesh device (AMS Elevate™ Anterior and Apical Prolapse Repair System with IntePro® Lite™). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device.

Therefore, the information requested in the prompt, which is typically relevant to the evaluation of AI/software devices (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance), is not present in the provided text.

The document states:
"The components of the AMS Elevate Anterior and Apical Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device."

This indicates that the assessment was based on comparing the new device's physical and biological properties to an already approved device, rather than a clinical performance study with predefined statistical endpoints.

Therefore, I cannot populate the requested table or provide answers to the specific questions regarding acceptance criteria and study details for an AI/software device based on this document.

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The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension. reconstruction of the pelvic floor and tissue repair.

The AMS Elevate Apical and Posterior System consists of a permanently-implanted mesh assembly and non-implantable surgical instruments that can be used as aids to place the mesh assembly in the pelvic floor. The mesh assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from non-viable porcine dermis.

The provided text is a 510(k) summary statement for a surgical mesh device, the AMS Elevate™ Apical and Posterior Prolapse Repair System. It details the device's description, indications for use, and a summary of testing for biocompatibility and performance.

However, the text does not contain any information about:

• Specific acceptance criteria (e.g., quantifiable performance metrics like sensitivity, specificity, accuracy, or physical properties thresholds).
• A detailed study proving device meets acceptance criteria. It only states that components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device." This is a high-level statement, not a detailed study description.
• Sample sizes for test sets, training sets, or data provenance.
• Number of experts or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used or how it was established.

This document is a regulatory submission for a medical device (surgical mesh), not an AI or diagnostic device that would typically involve the kind of performance studies expected in your request. The "Summary of Testing" section indicates that the testing revolved around biocompatibility and meeting performance requirements for substantial equivalence to a predicate device, which is different from a clinical performance study with statistical metrics.

Therefore, I cannot populate the table or answer the specific questions based on the provided text, as the information is not present.

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The AMS Spectra™ Concealable Penile Prosthesis is a sterile, nonpyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

The AMS Spectra™ Concealable Penile Prosthesis consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. Each device consists of two cylinders and may include rear tip extenders (RTEs) for additional length. All components consist of implantable, biocompatible materials.

The cylinder consists of a malleable section of articulating polymer segments. A cable extends through the center of the articulating segments. The proximal and distal ends of the cable are each connected to a spring that is encased in a metal housing. The entire outside surface of the cylinder is made of silicone.

The articulating segments, held together by the cable and spring assemblies, provide sufficient friction and rigidity. This allows the patient to position the device for concealment or for intercourse.

Spectra cylinders are available in 9.5-, 12-, and 14-mm diameters. Each cylinder diameter is available in three lengths: 12-, 16-, and 20-cm.

The total cylinder length can be adjusted by adding rear tip extenders (RTEs) to the proximal cylinder end. A range of RTE lengths is included to accommodate the patient's total intracorporal length.

Rear tip extenders may be attached to the Spectra™ cylinders in 0.5-cm increments, and may extend the cylinder lengths from 0.5- to 7.5-cm, with the exception of 7-cm. The RTEs are the same as those used with the inflatable AMS 700™ CXR and CX/LGX models (D970012.) These RTE components' functional performance has been demonstrated in use with the 700™ IPP products.

The AMS Spectra™ Concealable Penile Prosthesis did not include a clinical study. The device's acceptance criteria and performance were established through non-clinical performance tests, comparing it to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each non-clinical test. The tests were performed on the "Spectra™ product," which refers to the device itself.
Data Provenance: The data is from non-clinical performance tests conducted by American Medical Systems Inc. (AMS). These are laboratory tests and a cadaveric evaluation, not data from human subjects. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense of clinical studies.

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

For the cadaveric evaluation, "physicians" were involved. The specific number and qualifications (e.g., Urologist, years of experience) are not provided in the document. For the other non-clinical tests (cycle life, strength, etc.), ground truth was established by engineering specifications and industry standards relevant to the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. This was not a human observer study requiring an adjudication method. The non-clinical tests involved objective measurements against a predetermined, internal acceptance criterion.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The device is a physical implant, not an AI or imaging diagnostic tool.

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

This question is not applicable as the AMS Spectra™ Concealable Penile Prosthesis is a physical medical device, not an algorithm or AI. It does not perform a diagnostic or interpretive function that would require "standalone" performance evaluation in that context. The "standalone" performance here would refer to the device's functional integrity as an implant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the non-clinical performance tests was based on pre-established acceptance criteria derived from engineering specifications and the performance characteristics of the predicate devices. For the cadaveric evaluation, the ground truth was likely based on physician feedback and assessment of the device's functionality and implantability.

8. The Sample Size for the Training Set

There is no training set in the context of this device. This device is a physical implant, not a machine learning model.

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

Not applicable, as there is no training set.

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