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Advantage Ultra System and Advantage Fit Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures.

Lynx Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

Advantage Ultra System and Advantage Fit Ultra System

The Advantage Ultra System and the Advantage Fit Ultra System are sterile, single-use systems each consisting of one delivery device and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device.

The Advantage Ultra System and the Advantage Fit Ultra Systems are each packaged with their respective delivery device (Advantage Ultra or Advantage Fit Ultra delivery device). This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System includes the same mid-urethral mesh implant as the Advantage Ultra System but differs in the design of the dilators and delivery devices. The needle portion of the Advantage Fit Ultra delivery device has a smaller outer diameter and a smaller bend radius and is offered to provide physicians with surgical options. The Advantage Fit Ultra dilators also have a smaller diameter to accommodate for the different needle size.

Lynx Ultra System

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device.

This document is a 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, surgical mesh devices for treating female stress urinary incontinence. The core of this submission is to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K211223). The primary change in these new submissions is related to procedural steps in the electronic Instructions for Use (eIFU), specifically regarding the release and removal of disposable components of the mesh assembly.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on ensuring that the changes (eIFU modifications) do not negatively impact safety or effectiveness, and that the device remains substantially equivalent to its predicate. There isn't a traditional performance study proving clinical efficacy against a disease endpoint, as this is a 510(k) submission for substantial equivalence.

Here's an interpretation of your request based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) for eIFU changes)

Since the document explicitly states "there are no changes to the intended use or indications for use, design, materials, sterilization, technological and performance characteristics, or principle of operation," the acceptance criteria are implicitly tied to demonstrating that the eIFU modifications do not introduce new safety or effectiveness concerns and allow the device to function as intended.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The studies performed are "Performance bench testing" in the form of "Design Validation" and a "Summative Usability Evaluation."

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

   • Test Set Sample Size: The document does not specify the exact number of participants (users) or instances for the "Design Validation" and "Summative Usability Evaluation." It refers generally to "performance bench testing."
   • Data Provenance: Not specified, but "bench testing" typically implies laboratory or simulated environments, not patient data.

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

   • Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes). The "ground truth" here is the successful and safe use of the device according to the eIFU. The design validation and usability studies themselves aim to verify this by testing user interaction and performance. The document does not specify the number or qualifications of evaluators/experts involved in conducting or assessing these bench tests.

3. Adjudication method for the test set:

   • Not explicitly stated. For bench testing and usability studies, adjudication might involve expert review of test results, error analysis, and user feedback, but no specific method like "2+1" or "3+1" is mentioned.

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:

   • Not applicable. This is not an AI/imaging device. The study type is bench testing and usability evaluation for a surgical mesh delivery system with modified instructions for use.

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

   • Not applicable. This is a medical device (surgical mesh and delivery system), not an algorithm.

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

   • The "ground truth" for this submission's studies is the successful and safe operation of the device according to the updated eIFUs. This is assessed via controlled testing environments (bench testing) and usability studies, rather than clinical endpoints, pathology, or outcomes data, as this 510(k) specifically addresses changes to the instructions for use, not the fundamental device design or clinical performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

   • Not applicable (as above).

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The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.

The provided document is a 510(k) summary for the Intelivation LLC's Advantage Lumbar System, which is an intervertebral body fusion device. The document explicitly states that no performance testing was required for this device.

The rationale provided is that the "subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981."

Therefore, based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets the acceptance criteria, as no such study was conducted or deemed necessary by the FDA for this particular 510(k) clearance due to the device's substantial equivalence to already cleared predicates.

All sections of your request related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered as the submission states no testing was required for this particular device.

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The Advantage-C PEEK Cervical Interbody Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disease (DDD) with / without radicular symptoms at one level from C2 - T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Advantage-C PEEK Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft.. The Advantage-C PEEK Cervical Interbody Fusion Device is supplied sterile and is intended for one-time use.

The proposed Intelivation Advantage-C Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK; ASTM F2026) device and Tantalum (ASTM F560), available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant should be used with supplemental spinal fixation systems and with autogenous bone graft.

The provided text describes a 510(k) premarket notification for the "Advantage-C PEEK Cervical Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically required for a new device. Therefore, the information provided for acceptance criteria and studies will be geared towards non-clinical performance and biological compatibility.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Notes on Acceptance Criteria: For some tests (like subsidence), a "characterization" is performed, implying that the results are within expected limits for the material and design, even if an explicit "Pass" is not stated in the summary. The core acceptance criterion for a 510(k) is often "substantial equivalence" to a predicate device, which these non-clinical tests help to demonstrate.

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

• Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document refers to "the proposed device" and "this testing" which implies standard sample sizes for each test method as per the referenced ASTM and ISO standards would have been used, but specific numbers are not given.
• Data Provenance: The studies are non-clinical (laboratory tests). No country of origin is mentioned for the data, but the submitter is Intelivation, LLC, based in Saint Simons Island, Georgia, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the non-clinical performance and sterilization tests described. Ground truth, in the clinical sense, is not established for these types of engineering and material property tests. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards.

4. Adjudication method for the test set:

Not applicable. The tests are objective, laboratory-based physical and chemical evaluations following standardized protocols. There is no human adjudication process involved as there would be with clinical image interpretation or diagnosis.

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 physical interbody fusion implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or is relevant for this product.

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

Not applicable. This device is an implantable medical device, not an algorithm or software.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is based on the objective measurements and performance specifications defined by the referenced industry standards (ASTM, ISO). For example, for strength tests, the ground truth is the measured yield/ultimate force or fatigue resistance compared against a predefined standard. For wear particle analysis, it's the measured size, shape, and distribution. For sterilization, it's the achievement of a specific sterility assurance level (SAL).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for physical medical device performance testing in this context. The manufacturing process and quality control would involve internal testing, but not a "training set" in the machine learning sense.

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

Not applicable, as there is no "training set" for these non-clinical tests.

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The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Ultra System is packaged with the Advantage™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device. The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. Each is a single-use disposable delivery device that consists of a handle with a curved needle with a needle slot for connection to the mesh assembly. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

The provided text describes the 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, which are surgical meshes for treating female stress urinary incontinence. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the information required for "a table of acceptance criteria and the reported device performance" and the details of a study proving those criteria are not explicitly present in the provided text in the way one might expect for a typical performance validation study with specific metrics like sensitivity, specificity, or accuracy for an AI/CADe device.

However, based on the provided text, the closest interpretations for acceptance criteria and the "study" demonstrating their fulfillment are related to performance testing to ensure the device functions as intended and meets specifications compared to its predicates.

Here's an analysis based on the available information:

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

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength value) explicitly alongside reported performance results. Instead, it broadly states that performance testing was conducted, and the results "demonstrate that the proposed products function as intended and meet specification requirements."

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

The document does not specify the sample sizes for the performance tests (dimensional, tensile, functional, user evaluations, packaging, sterility, biocompatibility). It also does not mention the data provenance in terms of country of origin or whether a retrospective or prospective study was conducted for establishing clinical performance (as this submission is focused on substantial equivalence based on materials and design, not clinical outcomes from a trial). The "samples" referred to are likely physical devices or components of the device itself (non-aged and accelerated aged for shelf life testing).

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 applicable and not provided in the document. The performance tests described (dimensional, tensile, functional, biocompatibility, sterility) are technical evaluations of the device's physical properties and safety, not assessments requiring expert "ground truth" in a clinical diagnostic sense. "User evaluations" are mentioned, which would involve experts (e.g., surgeons or medical professionals) interacting with the device, but the number and qualifications are not detailed.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to establish ground truth or handle discrepancies, neither of which is described as part of the performance testing for this surgical mesh.

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 as the device is a surgical mesh, not an AI/CADe system for diagnostic imaging interpretation. Therefore, no MRMC study or AI-related effectiveness details are provided.

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, not an algorithm.

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

For the performance testing, the "ground truth" would be the established engineering specifications, material standards (e.g., ISO 10993-1:2018 for biocompatibility), and regulatory requirements for sterility and packaging integrity. These are objective measures and standards rather than clinical "ground truth" derived from patient data or expert consensus on a diagnosis.

8. The sample size for the training set

This is not applicable as the device is a physical surgical mesh, not an AI model requiring a training set.

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

This is not applicable as the device is a physical surgical mesh, not an AI model.

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The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

• Titanium alloy AdvantageRib Bridge with threaded locking posts
• Commercially pure locking caps
  When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.

The provided FDA 510(k) summary for the AdvantageRib System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document discusses a medical device for bone fixation (rib fractures) and its equivalence to a predicate device. It focuses on mechanical testing, material specifications, and sterilization validation for a physical implant, not a software algorithm.

Therefore, I cannot extract the following information from the provided text:

• Table of acceptance criteria and reported device performance related to an AI/ML algorithm.
• Sample size and data provenance for a test set (as no AI/ML test set is mentioned).
• Number and qualifications of experts for ground truth (as no AI/ML ground truth is mentioned).
• Adjudication method (as no AI/ML ground truth is mentioned).
• MRMC comparative effectiveness study or effect size of human improvement with AI (as no AI is discussed).
• Standalone algorithm performance (as no algorithm is discussed).
• Type of ground truth used (as no AI/ML ground truth is mentioned).
• Sample size for the training set (as no AI/ML training set is mentioned).
• How ground truth for the training set was established (as no AI/ML training set is mentioned).

The document describes the non-clinical testing performed for the AdvantageRib System as follows:

Non-Clinical Testing Information Provided:

Additional Context from the Document:

• Device Name: AdvantageRib System
• Intended Use: Fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
• Predicate Device: MatrixRIB Endo Thorascopic Rib Plating System (K141241)
• Modifications vs. Predicate: Includes option for different titanium alloys, optional washer, increased lengths of locking posts and locking caps with an internal X-drive feature (vs. external hex), and ability for all implants to be steam sterilized (vs. predicate's gamma radiation for some components).
• Conclusion: "The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate."

In summary, the provided document is a 510(k) summary for a physical medical implant device, not an AI/ML diagnostic or therapeutic algorithm. Therefore, the specific details requested regarding AI/ML performance, ground truth, and study design are not present. The acceptance criteria and performance discussed relate to the mechanical and sterilization properties of the physical implant.

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The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.

I am sorry, but the provided text does not contain the acceptance criteria and study details as requested. The document is a 510(k) premarket notification letter from the FDA regarding the "AdvantageRib Anterior System." It states that clinical testing is not necessary to demonstrate substantial equivalence and refers to performance evaluation in accordance with ASTM standards and engineering/geometric analysis.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design features, dimensions, function, surgical technique, labeling, and adherence to specific ASTM standards (F382, F543, F2193) through engineering and geometric analysis.

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The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.

The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.

The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.

The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.

The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.

The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.

The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.

Advantage™ System and Advantage Fit™ System: The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement.

Lynx™ System: The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

Solyx™ SIS System: The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.

Obtryx™ System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Obtryx™ II System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent as per your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format for a diagnostic or AI device. Instead, it details that the device met "applicable design and performance requirements" and various "special controls."

However, we can infer the types of performance aspects that were evaluated:

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

The document does not provide information on specific sample sizes for test sets, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective) for any performance data. The tests described are related to device engineering and material performance, not clinical data or diagnostic accuracy.

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 and not provided as the submission is for a surgical delivery device, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance testing" described is for mechanical, material, and sterility validation.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

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 and not provided as the device is a surgical delivery tool, not an AI-assisted diagnostic or interpretation system.

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

This information is not applicable and not provided as the device is a physical surgical delivery tool, not an algorithm.

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

The concept of "ground truth" in the context of diagnostic or AI performance is not applicable here. For the engineering and biocompatibility tests, the "truth" is established by adherence to recognized standards, test methodologies, and objective measurements (e.g., sterility validation protocols, mechanical stress limits, chemical analysis for biocompatibility).

8. The sample size for the training set

This information is not applicable and not provided as the device is a physical surgical instrument and does not involve AI or machine learning models that require a "training set."

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

This information is not applicable and not provided for the reasons stated in point 8.

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Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.

The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).

The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.

Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.

The provided text describes the regulatory submission for the "Advantage Plus Pass-Thru Automated Endoscope Reprocessing System" (K172677). The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study involving human readers or expert consensus for AI performance.

Therefore, much of the requested information regarding AI-specific criteria, human expert involvement, ground truth establishment for training and test sets, and MRMC studies, is not applicable or not present in this document. This submission pertains to a medical device for high-level disinfection of endoscopes, not an AI/ML-driven diagnostic or image-analysis device.

However, I can extract the acceptance criteria and performance for the non-clinical performance tests that were conducted to demonstrate substantial equivalence of this device.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The device is an Automated Endoscope Reprocessor (AER) intended for high-level disinfection. The performance testing conducted was to demonstrate its physical and microbiological effectiveness in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for an endoscope reprocessing system rather than an AI/ML device, the following points are not applicable or not mentioned in the document:

2. Sample size used for the test set and the data provenance:
* Not applicable for AI/ML data sets. The "test set" here refers to the number of reprocessing cycles or endoscope samples tested in the described performance studies. The exact number of cycles/samples for each test type (Simulated-Use, Clinical In-Use, etc.) is not explicitly stated in this summary, nor is the country of origin or whether the data was retrospective/prospective in the context of an AI/ML clinical study. The studies are described as "Performance bench testing" and "Clinical In-Use Testing," implying a prospective experimental design for product validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth for an AI/ML system, especially relating to expert consensus, is not relevant to the validation of an endoscope reprocessing device. The "ground truth" in this context is based on quantifiable microbiological reduction (e.g., 6-log reduction of test organisms, absence of viable organisms) and chemical residual levels, measured by laboratory methods, not human expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. Adjudication methods are typically used to resolve discrepancies in human expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.

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 pertains to the evaluation of AI assistance for human readers, which is outside the scope of this device's function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. The "performance" of this device is its ability to disinfect endoscopes, and its "standalone" performance is what these non-clinical tests evaluate – the device working as intended without human intervention in the disinfection process itself, beyond loading/unloading and initiation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth for this device's performance relies on microbiological testing results (e.g., colony-forming unit (CFU) counts of test organisms to determine log reduction, confirmation of no viable organisms, biofilm analysis) and chemical analyses (e.g., measurement of chemical residuals, verification of minimum recommended concentration, material properties). It is not based on expert consensus, pathology, or patient outcomes data in the sense of a diagnostic device.

8. The sample size for the training set:
* Not applicable. This device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
* Not applicable. As above, there is no AI/ML training set.

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The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins.

The ADVANTAGE Laser System with the D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9. and 12 months.

The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, caféau-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.

The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles.

The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The ADVANTAGE Laser System with D1-1064 Handpiece is a treatment handpiece, intended to be used with ADVANTAGE Laser System 510(k) cleared in K113502 on April 5, 2012. The ADVANTAGE Laser System with D1-1064 Handpiece delivers laser energy through a 10 x 10 mm tip with a fluence of up to 100 J/cm2. The settings for this handpiece are pulse duration from 5-400 msec, and a pulse repetition rate up to 3 Hz maximum. The ADVANTAGE Laser System with D1-1064 Handpiece is water-cooled to provide active skin cooling.

This document is a 510(k) premarket notification for the Lutronic Corporation ADVANTAGE Laser System. It discusses the device's indications for use and states that it is substantially equivalent to previously cleared predicate devices.

However, the document explicitly states: "7. Performance Data: None presented."

Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets such criteria. The document relies on substantial equivalence to predicate devices rather than new performance data.

As a result, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, experts, adjudication, or MRMC studies, as this data is not present in the provided text.

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The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.

The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth opening, while still permitting a degree of mouth opening through spacers and resiliency. The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.

The provided text describes the CPAP/Pro Interface with Advantage™, a device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). Based on the information available, a detailed acceptance criteria table and study breakdown can be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a specific "test set" in the context of a clinical study or performance evaluation for the Advantage™ component. The summary mentions "Bench testing was performed" and "Validation was also satisfactory completed," but does not provide details on the number of subjects or cases involved in these validations for the new device. Instead, it relies heavily on the substantial equivalence to the predicate device (CPAP/PRO, K992384).

The data provenance is largely retrospective in the sense that the new device's safety and effectiveness are supported by "Post-market studies of CPAP/Pro [the predicate device]." There is no mention of a prospective clinical trial specifically for the Advantage™ component to establish its independent performance metrics.

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

This information is not provided in the document. As the evaluation relies on bench testing, validation, and equivalency to a predicate, the concept of "ground truth established by experts" in a clinical setting for a test set is not directly applicable or reported here.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described clinical test set involving human interpretation that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the CPAP/Pro Interface with Advantage™ as described in this document. The submission focuses on demonstrating substantial equivalence through bench testing, validation, and material/design similarities to the predicate.

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

Yes, if we interpret "standalone performance" as the device functioning independently to meet its design specifications and demonstrating performance (e.g., material properties, fit, mechanical function), then this aligns with the "Bench testing" and "Validation" mentioned. These tests would evaluate the device itself, without human interpretation or real-time clinical assessment beyond general use.

7. The Type of Ground Truth Used

The "ground truth" for the Advantage™ device appears to be primarily based on:

• Engineering specifications and design requirements: For bench testing and validation where the device's physical and functional properties are assessed against predetermined criteria.
• Predicate device's established safety and effectiveness: The new device's safety and effectiveness are inferred by its substantial equivalence to a legally marketed predicate device, for which post-market studies had already supported its performance.

8. The Sample Size for the Training Set

This information is not applicable as the device is a mechanical medical product, not an AI/ML algorithm that requires a training set.

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

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

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