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SureFlex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). SureFlex is designed primarily for holmium (Ho:YAG) lasers, but may be used with any laser wavelength between 500nm and 2200nm that has been cleared for surgical use, e.g. Nd:YAG, KTP, Alexandrite, Argon, Ruby, Diode
Specific, by Surgical Specialty (most common use first)
Urology -
Urinary Lithotripsy including but not limited to endoscopic and laparoscopic fragmentation, ablation and vaporization of urinary calculi found from the lower pole of the kidney to the urethra and distal impacted fragments of steinstrasse.
Urological Surgery (vaporization, coagulation, hemostasis, excision and incision of soft tissue) including, but not limited to open, endoscopic and laparoscopic surgery for the removal of superficial and invasive bladder tumors and lesions, including condylomas, treatment of ureteral strictures obstructions, polyps, vascularities and hemangioma as well as prostatectomy (BPH).
Gastroenterology -
Laser-based surgical procedures including, but not limited to open, endoscopic and laparoscopic gastroenterological surgery for ablation, vaporization, fragmentation, coagulation, hemostasis, incision, excision, resection, and hemostasis of biliary calculi, lesions, neoplasms, polyps, ulcers, tears, erosions and tumors.

The SureFlex™ Lithotripsy Laser Fiber (SureFlex fiber) is a fiber optic laser delivery device consisting of a patented, high energy termination (Black Hole™); a length of silica/silica fiber with a UV cured polymer secondary cladding and an ethylene tetrafluoro-ethylene copolymer (ETFE) jacket. The standard fiber output is a laser polished tip. SureFlex fibers are designed for use in a wide variety of surgical procedures as an integral part of a surgical laser system.

This document is not about an AI/ML powered medical device, but rather a traditional medical device (laser fibers). Therefore, the requested information regarding acceptance criteria and study details for an AI/ML powered device does not apply directly.

However, I can extract the information pertinent to the described device, the SureFlex Lithotripsy Laser Fibers, from the provided 510(k) summary.

Acceptance Criteria and Study for SureFlex Lithotripsy Laser Fibers (K140679)

This 510(k) pertains to a modification of an existing device (SureFlex Lithotripsy Laser Fibers, K050108), specifically a change in the resin for the fluoroacrylate resin material and a labeling update for the maximum power of the 200 um fiber. As such, the testing focuses on demonstrating that the modified device remains equivalent to the predicate and meets its intended product specifications.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Bench testing was performed to support this submission." It does not specify a distinct "test set" in the context of clinical data, as no clinical testing was performed. The non-clinical testing appears to have used samples of the device itself. The document does not provide details on the number of samples used for each bench test.

• Data Provenance: Non-clinical bench testing. No country of origin for data or retrospective/prospective nature is applicable as no human data was used.

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

This is not applicable as no clinical data or expert-adjudicated ground truth was used. The evaluation was based on non-clinical, objective bench testing.

4. Adjudication Method for the Test Set

This is not applicable as no clinical data requiring expert adjudication was used.

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

No MRMC study was conducted. The device is a physical laser fiber, not an AI/ML algorithm requiring human reader performance evaluation.

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

No standalone algorithmic study was conducted. This device is not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was established through product specifications and performance requirements as demonstrated by non-clinical bench testing.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve AI/ML models that require training sets.

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

This is not applicable as there is no training set for a physical device.

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Sparc System: Intended for the placement of pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Monarc. Monarc + and Monarc C Systems: Intended for the placement of suburethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Sparc device is a sterile, single use procedure kit consisting of: Two stainless steel, curved, 21-cm long, needle passers. One end of each . needle passer is keved to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. One piece of AMS Polypropylene sling mesh with attached connectors. The AMS . Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.1 cm width x 50 cm length. An absorbable tensioning suture is threaded into the length of the sling mesh to allow for tensioning adjustment of the sling mesh after placement in the patient is achieved. Two plastic sheaths that overlap in the center of the sling mesh cover the sling mesh and protect it during placement. The connectors are attached to the vaginal ends of the Sparc needle passers during the procedure. The AMS Polypropylene sling mesh is intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue ingrowth or tissue enzymes.

The Monarc devices are sterile, single use procedure kits, each consisting of: Two stainless steel, curved needle passers. The tip portion of each needle . passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. An assembly including one piece of loosely knitted polypropylene mesh, two . removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.

This document is a 510(k) summary for a medical device (Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock Systems). It is a regulatory submission for demonstrating substantial equivalence to a predicate device, not a study demonstrating device performance against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available within this document. The document primarily focuses on establishing that the proposed device is substantially equivalent to a previously cleared predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Not applicable. This document does not present a table of acceptance criteria or new device performance data. The basis of this 510(k) is that the "Proposed Device Description" and "Summary of the Technical Characteristics Compared to the Predicate Device(s)" state: "All characteristics of the proposed device are identical to those of the predicate, including design, material construction, manufacturing process, and intended use. There is no change to the technical characteristics for this 510(k)." This implies that the acceptance criteria and performance are presumed to be the same as the predicate device.

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

• Not applicable. No new clinical or performance test set is described. This device is cleared based on substantial equivalence to a predicate, not new performance testing against a test set.

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. No ground truth establishment for a test set is described.

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

• Not applicable. No test set or 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 document is for a surgical mesh system for SUI, not an AI software/device. Therefore, MRMC studies or AI involvement are irrelevant and not discussed.

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

• Not applicable. This is not an algorithm-only device.

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

• Not applicable. No ground truth for device performance is described as this is a substantial equivalence submission, not a de novo performance study.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. No training set or ground truth for it is relevant or described.

Summary based on the provided text:

This 510(k) submission for the Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock Systems does not contain a study proving that the device meets specific acceptance criteria via new performance data. Instead, it relies on the principle of substantial equivalence to a previously cleared predicate device (Sparc Sling System and Monarc, Monarc + and Monarc C Subfascial Hammock device; K081613). The document explicitly states that the proposed device is identical in all characteristics (design, material, manufacturing, and intended use) to its predicate. Therefore, its safety and effectiveness are considered to be equivalent to the predicate, and no new performance studies are presented or required for this type of submission.

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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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The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.

The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The mesh has bi-directional elasticity and resists unraveling. The mesh is provided as a sterile, single use device in a pre-formed Y-shape for sacrocolpopexy procedures.

This document describes a 510(k) submission for the IntePro® Y-Mesh. The key information is that the device is identical in all technical characteristics (design, materials, manufacturing, intended use) to its predicate device, the IntePro® AMS Large Pore Polypropylene Mesh (K040521).

Therefore, the submission does not include a study to prove the device meets acceptance criteria in the way you've outlined. This is because the regulatory pathway chosen, a 510(k) for substantial equivalence, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. When a device is identical to its predicate, no new performance studies are typically required to establish new acceptance criteria.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This determination is based on the claim of identity to the predicate.

Therefore, many of the requested fields are not applicable to this 510(k) submission. I will indicate "Not Applicable" or explain why the information isn't present based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary states, "All technical characteristics of the proposed device are identical to those of the predicate, including device design, materials of construction, manufacturing process and intended use." Because the device is claimed to be identical to a previously cleared predicate device (IntePro® AMS Large Pore Polypropylene Mesh, K040521), specific new acceptance criteria and a study to prove performance against new criteria are not presented in this summary. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.

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

Not Applicable. No new performance testing in a "test set" for clinical data is described for this specific device in the provided summary, as it relies on substantial equivalence to an identical predicate.

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

Not Applicable. No new clinical performance testing requiring expert ground truth establishment for a test set is described.

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

Not Applicable. No new clinical performance testing requiring adjudication for a test set 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 is a surgical mesh device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

Not Applicable. This is a surgical mesh device, not an algorithm or AI system.

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

Not Applicable. No new clinical performance testing requiring ground truth for this device is described. The basis for clearance is identity to a predicate device.

8. The sample size for the training set

Not Applicable. This is a surgical mesh device, not an algorithm requiring a training set.

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

Not Applicable. This is a surgical mesh device, not an algorithm requiring a training set and associated ground truth.

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The MiniArc® Pro 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 MiniAre Pro Sling System is designed to treat female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is comprised of a piece of polypropylene monofilament mesh with polypropylene self-fixating tips (anchors), a mid-line mark, and elongation feedback system. The elongation feedback system is attached to the sling intraoperative adjustment/tensioning and allows for objective measurement of sling elongation during the implant procedure. The sling is intended to remain in the body as a permanent implant with the polypropylene self-fixating tips providing short-term fixation prior to tissue in-growth. The elongation feedback system is intended to be removed prior to closure of the vaginal incision. The delivery tool (needle) is designed to interface with the self-fixating tips and deliver it to the obturator internus muscle, retaining the self-fixating tip until it is selectively released by the physician.

The provided 510(k) summary for the MiniArc® Pro Single-Incision Sling System does not detail specific acceptance criteria or a study proving that the device meets those criteria in the traditional sense of a clinical trial for a novel AI or diagnostic device. Instead, this submission is for a medical device that is demonstrated to be substantially equivalent to a predicate device already on the market.

Therefore, the "acceptance criteria" here refers to the criteria used to establish substantial equivalence with the predicate device, and the "study" is the non-clinical testing performed to show that the new device meets its own product specifications and performance requirements, which are comparable to the predicate device.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

Given this is a 510(k) for substantial equivalence to a predicate device, the "study" is primarily a non-clinical assessment rather than a traditional clinical trial.

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

   • Test Set (Non-Clinical): Not explicitly stated in terms of specific numbers for each test, but categories of testing are listed.
     • Bench Testing: Conducted to assess characteristics like "Feedback System Repeatability," "Feedback System Attachment," "Feedback System Dimensional," "Feedback System Removal Force," and "Feedback System Stiffness." The exact number of samples for each of these tests is not provided in the summary.
     • Cadaver Testing: Performed for "Physician Questionnaire" and "Cadaver Evaluation." The number of cadavers or physicians involved is not specified.
   • Data Provenance: The testing was conducted internally or by contracted labs as part of the device development and submission process. The country of origin is implicitly the United States, given the submitter is American Medical Systems located in Minnetonka, MN, and the submission is to the FDA. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.

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

   • Cadaver Performance Testing: A "Physician Questionnaire" and "Cadaver Evaluation" were performed. This implies medical experts (physicians) were involved in evaluating the device's performance in a cadaveric setting. The exact number and their qualifications (e.g., years of experience, specialty) are not specified in the summary.

3. Adjudication method for the test set:

   • For the non-clinical tests, the adjudication method is typically predefined pass/fail criteria for each test (e.g., within a specified range for dimensional, sufficient removal force). No specific adjudication method like "2+1" or "3+1" (common in human-reader studies) is described, as it's not applicable to bench or cadaver testing of device mechanics.

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

   • No. This is a medical device (surgical sling system), not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

   • No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable here. The device's performance is intrinsically linked to its physical properties and intended use by a surgeon.

6. The type of ground truth used:

   • For Bench Testing: The ground truth is engineering specifications, validated test methods, and predefined acceptance criteria (e.g., material properties, dimensional tolerances, force measurements). These are objective and measurable.
   • For Cadaver Performance Testing: The ground truth would be based on expert opinion and observations from qualified physicians regarding the ease of use, deployment, and overall performance of the device in a simulated anatomical environment (cadaver).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an algorithm that requires a "training set" in the context of machine learning.

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

   • Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment in this context.

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Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.

Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite).

The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.

The provided document, K121612, is a 510(k) summary for the Elevate® Anterior and Apical Prolapse Repair System, Elevate® Apical and Posterior Prolapse Repair System, and Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP. This document states that the devices are substantially equivalent to their predicate devices and focuses on non-clinical testing for a modified sheath component. It explicitly states that no clinical testing was required. Therefore, a study demonstrating device performance against acceptance criteria in a clinical setting, including details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

The document primarily addresses the substantial equivalence of the modified devices to their predicates based on manufacturing process and design verification of a component (sheath).

Here's a breakdown of the available information from the document related to testing, recognizing that it does not provide the clinical study details requested:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study demonstrating device performance against acceptance criteria is described, a direct table cannot be created as requested. The document focuses on performance of a modified sheath through non-clinical testing.

Note: The document only states that these tests were performed and that the modified devices are considered substantially equivalent, implying the tests met their internal acceptance criteria for design verification. No specific numerical results or thresholds are provided in this summary.

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

• Test Set Sample Size: Not applicable in the context of clinical performance. For the non-clinical design verification tests of the sheath, the sample sizes are not specified.
• Data Provenance: Not applicable for a clinical study. For design verification, the data would be laboratory-generated from American Medical Systems, Inc.

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 was established by experts from a clinical study for this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set or human 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

No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance.

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

This is not applicable as the device is a surgical mesh kit, not an algorithm or an AI-based system.

7. The type of ground truth used

Not applicable in the context of clinical performance. The "ground truth" for the non-clinical testing was defined by the specifications and parameters of the design verification tests for the components.

8. The sample size for the training set

Not applicable. This document describes a surgical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (and why no clinical study is presented):

The document K121612 outlines that the device (Elevate® Prolapse Repair Systems) underwent a 510(k) submission for a modification to an existing, legally marketed device. The modification was specifically to the "Apical Needle Passer Sheath" component.

The core of the submission relies on demonstrating substantial equivalence to the predicate devices (K082677, K082730, and an unnamed system). The rationale is that:

• There were "no changes to the implant graft design, shape, size, and material."
• There were "no modifications made to the packaging or sterilization."
• There was "no change to the intended use or the implant procedure."

Therefore, the only testing required was non-clinical design verification and biocompatibility testing for the modified sheath. These tests included:

• Sheath compression strength and depth stop strength.
• Trigger/sheath locking interface push strength.
• Sheath cutout shear off strength and trigger/sheath locking interface pull strength.
• Sheath engagement force into lock.
• Cytotoxicity & physiochemical testing for biocompatibility.

The document explicitly states: "no clinical testing was required to support the sheath modification" because "the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices." The acceptance criteria for these non-clinical tests would have been internal design specifications to ensure the modified sheath performed as intended and did not negatively impact the safety or effectiveness of the overall device compared to the predicate. The document concludes that based on these non-clinical tests and the unchanged nature of the implant and procedure, the modified devices are "substantially equivalent to the predicate devices."

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Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.

Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.

The provided document describes a 510(k) premarket notification for a medical device, the American Medical Systems Model Number 0010-2400 GreenLight MoXy™ Fiber Optic. This is a special 510(k) submission, indicating a modification to an already cleared device, the Fiber One (K100746). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo approval.

As such, the document does not contain information related to a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement in the way one would expect for a new or significantly modified device requiring such studies. The assessment here is based on non-clinical (bench) testing and comparison of technological characteristics to the predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" for this Special 510(k) are implied by demonstrating that the modified device (Model 0010-2400) maintains substantial equivalence to the predicate device (Fiber One) through non-clinical testing and comparison of specifications.

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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 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.

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 permanentlyimplanted synthetic 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 is identical to the predicate device AMS Elevate Prolapse Repair System with PC Coated IntePro Lite, with the following exceptions: (1) The anterior needle passer has been modified to add a release mechanism on the handle; and (2) as a result of the anterior needle passer modifications, the connection interface for the tissue fixation elements of the anterior center graft that correspond with the anterior needle passer also changed. The geometry of the internal diameter and the base of the tissue fixation elements changed slightly to accommodate the new shape of the anterior needle tip. There are no changes to the mesh design, shape, size, or material.

The document provided describes a Special 510(k) Device Modification for the AMS Elevate® PC Prolapse Repair System with IntePro® Lite, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that modifications do not raise new questions of safety or effectiveness and primarily relies on non-clinical testing to prove equivalence, rather than extensive clinical studies with human participants.

Therefore, many of the requested categories related to clinical study design, human reader performance, and ground truth establishment from patient data are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "N/A" for Acceptance Criteria: The document states that the components were "subjected to testing which included design verification, biocompatibility, sterilization, packaging, and product performance requirements." It does not provide specific quantitative acceptance criteria for each of these tests, but rather states that the results conclude substantial equivalence. In a 510(k) submission, the "acceptance criteria" for these non-clinical tests would typically be defined internally by the manufacturer (e.g., specific tensile strength thresholds, cytotoxicity limits) and compared against the predicate's performance or established standards. The summary statement provides the overall conclusion of meeting these criteria.

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

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (design verification, biocompatibility, sterilization, packaging, product performance), not a clinical test set from patients.
• Data Provenance: Not applicable. The data is generated from laboratory and bench testing of the device components.

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

• Not applicable. Ground truth as typically defined in diagnostic AI/clinical studies (e.g., patient outcomes, pathology) is not relevant for this non-clinical submission. The "ground truth" for the non-clinical tests is established by industry standards, engineering specifications, and comparison to the predicate device's known performance.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" of patient data requiring adjudication in this context.

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 medical device modification notification focused on non-clinical equivalence, not an AI-enabled device or a comparative effectiveness study involving human readers.

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

• Not applicable. This is not an algorithm-only or AI device.

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

• For the non-clinical tests, the "ground truth" is established by engineering specifications, material science standards, and performance characteristics of the predicate device. For instance, biocompatibility would be assessed against ISO standards, and mechanical performance against the predicate's known capabilities.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

• Not applicable. There is no "training set" for which ground truth would be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a summary of non-clinical testing. This testing included:

• Design Verification: To ensure the modified anterior needle passer and connection interface for tissue fixation elements function as intended and meet design specifications.
• Biocompatibility: To demonstrate that the device materials are safe for implantation.
• Sterilization: To validate the sterilization process ensures the device is sterile.
• Packaging: To confirm the packaging protects the device and maintains sterility during shelf life.
• Product Performance Requirements: To show the device performs mechanically and functionally equivalently to the predicate.

The conclusion of these non-clinical tests "substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite" serves as the proof that the device meets the acceptance criteria for a 510(k) modification. The key modifications were the addition of a release mechanism to the anterior needle passer handle and slight changes to the geometry of the internal diameter and base of the tissue fixation elements to accommodate the new needle tip shape. The study demonstrated that these changes did not negatively impact the safety or effectiveness, thus proving substantial equivalence to the legally marketed predicate device.

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Fiber One is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.

Fiber One is a fiber optic delivery device that is supplied as a sterile, single-use device. Fiber One is intended for use with the GreenLight XPS Laser System for its FDA cleared indications for use. It can access the tissue in multiple planes. Fiber One is a liquid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.

Fiber One features a side firing mechanism delivering up to 180W of 532nm light to tissue. Fiber One can be used 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.

Fiber One will deliver 532nm laser energy from a compatible laser console (GreenLight XPS Laser System) to tissue during surgical procedures, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH).

The provided text describes a medical device, "Fiber One," and its 510(k) premarket notification. However, it does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies as requested in your prompt.

The document focuses on:

• Device Information: Description of Fiber One as a fiber optic delivery device for use with the GreenLight XPS Laser System.
• Predicate Device: Stating substantial equivalence to the 2090 Fiber (K062719).
• Intended Use and Indications for Use: General surgical applications and specifically for photoselective vaporization of the prostate for BPH.
• Substantial Equivalence Determination: Mentioning "bench and animal testing" but without details of the studies, their results, or how they meet specific acceptance criteria.
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot populate the table or answer most of your specific questions from the provided text. The document states "All necessary bench and animal testing was conducted on Fiber One to support a determination of substantial equivalence to the predicate device," but it does not elaborate on what that testing entailed, what the acceptance criteria were, or the performance outcomes.

If you have other documents that provide technical reports, study designs, or performance data for Fiber One, I would be able to extract the requested information.

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