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The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Coloplast Altis Single Incision Sling (SIS) System includes one implantable single incision midurethral sling and two Altis introducer needles. The Altis Single Incision Sling System is provided sterile (ethylene oxide sterilization) and is for single use only.

The Altis Single Incision Sling is an implantable, synthetic, knitted, low-elasticity, monofilament polypropylene, single incision midurethral sling. The mesh sling body measures approximately 7.75 cm long by 1.1cm wide. The Altis sling assembly is connected on each end to an anchor. One end of the sling assembly is connected to a short length of USP size 1 polypropylene monofilament suture connected to a static (non-tensioning) polypropylene anchor. The other end of the sling connects to a longer length of suture with a dynamic (tensioning) polypropylene/polyurethane anchor. The dynamic anchor is intended to allow intraoperative adjustment and tensioning of the sling, resulting in urethral support during instances of increased abdominal pressure, thereby preventing urine leakage. The Altis sling is non-absorbable and is intended to be permanent.

The Altis introducers are helical-type instruments (one right), used to assist in the surgical placement of the Altis Single Incision Sling a transobturator technique, via a single incision vaginal approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Altis Single Incision Sling System in accordance with the Instructions for Use.

The Coloplast Aris Transobturator Sling System includes an implantable midurethral sling and disposable introducer needles. The Aris sling and Aris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Aris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Aris sling is non-absorbable and intended to be permanently implanted.

Aris introducers (helical pair and flat curve) are instruments used to assist in the correct surgical placement of the Aris sling via the transobturator approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Aris sling.

The Coloplast Supris Retropubic Sling System includes an implantable midurethral sling and disposable introducer needles. The Supris sling and Supris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Supris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Supris sling is non-absorbable and intended to be permanently implanted.

The Supris introducers are instruments used to assist in the correct surgical placement of the Supris sling via a retropubic approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Supris sling.

No information regarding acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML powered medical device, as described in the prompt's requested information points (1-9), is available in the provided text.

The document discusses the substantial equivalence (510(k) clearance) of a physical medical device: the Altis Single Incision Sling System, Aris Transobturator Sling System, and Supris Retropubic Sling System, which are surgical meshes for treating stress urinary incontinence.

The "Performance Data" section (VII) lists various bench testing conducted to support the substantial equivalence determination for changes to the mesh material, including:

• Biocompatibility Testing (ISO 10993-1)
• Performance Testing (Mesh Density, Thickness, Pore Size, Sling Length, Width, Tensile Strength, Elongation at Break, Elasticity, Stiffness, Suture Pull-Out Strength, Mesh Tear Resistance, Suture/Mesh Weld Strength, Shelf-life testing)
• Sterilization (Ethylene Oxide)
• Packaging and Distribution

The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This confirms that there was no human reader study, no standalone algorithm performance, or any of the other AI/ML specific criteria mentioned in the prompt.

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The Altis® Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.

The provided text is related to a 510(k) premarket notification for the "Altis® Single Incision Sling." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data for a new or modified device. As such, the document explicitly states:

"Performance data was not necessary for the substantial equivalence determination as the subject device and the predicate device have identical intended use, target population, sterilization technique, biocompatibility features, overall device design features, and duration of use."

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and the study that proves the device meets them from this document. The document primarily discusses regulatory aspects of the device, specifically its substantial equivalence to a previously cleared predicate device due to identical technical characteristics and intended use. The only change mentioned is revised labeling to include information from a completed 522 study, but details of that study are not provided here.

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The Desara One mid-urethral mesh implant is intented for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.

Desara® One Single Incision Sling System

The provided text is a 510(k) premarket notification clearance letter for a medical device called the "Desara One Single Incision Sling System." This type of document is an approval from the FDA, signifying that the device is substantially equivalent to a predicate device already on the market.

However, the 510(k) clearance letter does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. Such detailed performance studies and their results are typically found in the full 510(k) submission, which is a much more extensive document than the clearance letter itself.

Therefore, I cannot provide the requested information from the given text. The text primarily focuses on:

• The FDA's determination of substantial equivalence.
• The device's trade name and regulation details.
• The indications for use.
• General regulatory requirements for medical devices.

To answer your questions, I would need access to the actual scientific and clinical data submitted for the 510(k) premarket notification, which is not present in this document.

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The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Altis System is a single-incision mini-sling.. The sling material is manufactured using the commercialized Aris polypropylene mesh (K050148). Altis sling is made of a 0.08mm (nominal) diameter monofilament polypropylene mesh, knitted into a sling 1.1 cm wide by 7.75 cm long. One end of the sling assembly connects to a short length of USP size 1 monofilament polypropylene suture and to a polypropylene static (non-tensioning) anchor. The second side of the sling assembly terminates to a longer section of USP size 1 monofilament polypropylene suture. This suture is then positioned through the second anchor that is dynamic with an integrated tensioning system. The tensioning capability is accomplished by threading the suture through a polyurethane tensioning collar which is assembled onto the anchor. The anchor/suture assembly wraps around the anchor, resulting in a gap between the anchor and the collar providing constant pressure on the suture, preventing it from moving on its own, or during a pelvic stress event. Tensioning is achieved by pulling on the suture loop, thus applying increased tension of the sling to the urethra until desired support is achieved. The Altis anchors perform an acute mechaning the desired position and tension through the acute post-operative tissue healing and in-growth phase, The Altis sling assembly is packaged with two (2) helical type introducers (one right, one left) that are used to place the sub-urethral sling. The Altis introducers are designed with the appropriate curvature and length to reach the obturator foramen through a single vaginal incision. The tip of the needle is designed to fit into the anchors to facilitate placement into the obturator foramen during the surgical implant procedure. The sling assembly pouch and introducers are placed in a tray sealed with a Tyvek lid. The Altis system (implant plus introducers) is provided sterile (ethylene oxide) and is for single use only.

Here's a breakdown of the acceptance criteria and study information for the Coloplast Altis® Single Incision Sling System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical study to assess safety and efficacy. The acceptance criteria are essentially derived from the primary and secondary effectiveness objectives of this study. The reported performance is the "Success" rate for each endpoint.

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Ajust® Helica! Adjustable Single-Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Ajust® Helical Adjustable Single-Incision Sling System is a sterile, single use procedure kit that consists of a mesh sling implant and instruments, flexible stylet and two helical shaped introducers, which aid in the placement of the mesh in the pelvic floor. The product is offered in a single kit and dispenser pack of 5 individual kits. The sling implant is composed of four primary components - polypropylene flat mesh, polypropylene tube mesh, polypropylene anchors and a polypropylene sling lock. The adjusting tab is only used during adjustment and is not part of the permanent implant. The flexible stylet is a thin, flexible, Nitinol wire that allows the stylet to conform and flex to follow the path of the tube mesh to push the sling lock into position. The stainless steel helical shaped introducers allow for placement of the anchors in the obturator membrane/muscle by rotation of the handle of the introducer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ajust® Helical Adjustable Single-Incision Sling:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide specific numerical acceptance criteria or detailed results for each test. Instead, it broadly states that the tests were performed for "design verification and validation" and that the product performance is "substantially equivalent" to the predicate device. This is common for 510(k) submissions, especially for modifications to existing devices, where the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate.

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

This information is not provided in the document. The text describes a series of "design verification and/or validation testing" on the modified introducers, but it does not specify the number of units tested, the origin of any data (e.g., in-house lab testing, animal studies, human clinical studies), or whether it was retrospective or prospective. Given the nature of the submission (Special 510(k) for a device modification), it's highly likely these were bench tests performed internally by the manufacturer.

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

This information is not applicable/not provided in the context of this 510(k) submission. The "ground truth" here is the successful performance of the device's mechanical and biocompatibility characteristics, determined through engineering tests rather than expert interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective assessments, such as interpreting diagnostic images. The tests described are engineering and materials assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. An MRMC comparative effectiveness study is used for evaluating diagnostic imaging AI. The Ajust® Helical Adjustable Single-Incision Sling is a surgical mesh product, not a diagnostic AI tool.

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

This information is not applicable/not provided. This device is a physical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device's "performance data summary" appears to be based on engineering specifications and established test methodologies to evaluate the mechanical properties and biocompatibility of the introducers. For example, "Introducer compression and side load strength" would have a pre-defined acceptance range based on engineering requirements for the device's function. The ultimate "ground truth" for the overall device is its demonstrated "substantial equivalence" to the predicate device, meaning it performs as expected for its intended use based on these tests.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a "training set."

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

This information is not applicable/not provided for the same reason as point 8.

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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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Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.

This document is a 510(k) summary for the Ophira™ Mini Sling System, a medical device for treating female stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for the new device. Therefore, the information requested regarding acceptance criteria and performance studies is not fully present in the provided text.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Ophira™ Mini Sling System itself. Instead, it relies on demonstrating substantial equivalence to a 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):

The provided text does not contain information about a test set sample size or data provenance for a performance study of the Ophira™ Mini Sling System. The 510(k) summary focuses on substantial equivalence based on material, design, and intended use comparison to a predicate device, rather than patient performance data for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document as there is no described clinical performance study or test set with ground truth established by experts.

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

This information is not provided in the document as there is no described clinical performance study requiring adjudication.

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

This is not applicable. The device is a surgical sling, not an AI-assisted diagnostic tool or a device where "human readers" would be involved in interpreting results.

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

This is not applicable. The device is a physical surgical implant, not an algorithm.

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

As no performance study with a test set is described, no ground truth is mentioned for the Ophira™ Mini Sling System. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the legally marketed predicate device, the MiniArc Precise™ Single-Incision Sling (K100807), and the demonstration that the new device is substantially equivalent in its characteristics.

8. The sample size for the training set:

This is not applicable. The device is a physical surgical implant and not an AI/machine learning model that would require a training set.

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

This is not applicable as there is no training set for a machine learning model.

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Desara Mini is intended to be used in females to position a suburethral mesh sling for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence resulting from urethral hypermobility. The mesh is placed transvaginally using a reusable introducer (sold separately)

The Desara Mini is a sterile, single-use pubourethral sling. The device is comprised of monofilament polypropylene yarn, which is knitted into a mesh, two self-fixating tips and two guiding suture loops at each end of the device. The device contains a visible midline marker to assist the surgeon in placement of the device.

The Desara Mini is available in one configuration and a reusable introducer is available separately.

The provided 510(k) summary for the Caldera Medical Desara Mini surgical mesh primarily focuses on establishing substantial equivalence to predicate devices through technical and performance characteristic comparisons, rather than presenting a study to prove acceptance criteria for a new, unique performance claim. As such, the information needed to fully respond to your request regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study is not present in this document.

However, I can extract the available information regarding performance data and testing methods used to demonstrate substantial equivalence, which serves a similar purpose in the medical device approval process:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way for novel performance endpoints. Instead, it demonstrates that the Desara Mini meets the established characteristics and performance benchmarks of its predicate devices. The "reported device performance" is essentially that the Desara Mini's characteristics are "substantially equivalent" to the predicate devices.

Here's an interpretation of the performance data in relation to the predicate devices:

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

The document does not specify a "test set" in the context of human data or clinical studies for performance evaluation. The testing described involves bench testing for material properties and mechanical performance, and cadaver lab testing for functional performance. No sample sizes for these tests are provided. Data provenance is not specified beyond being "bench" and "cadaver lab" testing. This is common for a 510(k) submission where substantial equivalence is primarily based on material and design similarities, rather than new clinical effectiveness.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This document describes a medical device submission based on substantial equivalence through material and functional testing, not a study requiring expert readers to establish ground truth for image interpretation or diagnosis.

4. Adjudication Method:

Not applicable, as no expert consensus or ground truth establishment process is described.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a surgical mesh and its performance relies on physical and mechanical properties, not on diagnostic accuracy enhanced by AI.

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

Not applicable. The Desara Mini is a physical surgical device, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance claims in this submission is the established performance characteristics and safety profile of the predicate devices (Desara Mesh and MiniArc), as well as established industry standards and FDA guidance for surgical mesh testing. For instance, the mesh characteristics were assessed against standards, and biocompatibility was assessed against ISO-10993.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device submission where the relevant "training" would be the historical data and performance of the predicate devices and general knowledge of surgical mesh properties, not a machine learning training set.

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

Not applicable. (See #8).

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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 Ajust™ Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Ajust™ Adjustable Single Incision Sling is for use in urological and gynecological procedures for the treatment of stress urinary incontinence in women. The sling is secured in the patient's tissue using two soft tissue anchors. An introducer is used to insert the anchors using a similar approach to a transobturator sling. The implant design allows independent adjustment of the mesh relative to the anchors, after which, the mesh is secured in place using a small locking mechanism.

The provided text is a 510(k) summary for the Ajust™ Adjustable Single Incision Sling. It details the device's description, intended use, and states that bench, pre-clinical, and clinical data were used to determine equivalence to predicate devices. However, the document does not provide explicit acceptance criteria or a detailed study report with performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I elaborate on specific aspects of a study that would demonstrate the device meets those criteria.

The information regarding sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established is not present in the provided text.

The document primarily focuses on establishing substantial equivalence based on the predicate devices and general performance testing, without disclosing the detailed results or methodologies that would be required to answer your specific questions.

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