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The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid procedure. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

The Repose™ Bone Screw System consists of three main components: a bone screw attached to surgical suture material, a bone screw inserter, and a suture passer. The Repose™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. I suture crimped into its base. The Repose™ Bone Screw Inserter is a disposable, battery operated, single use device. The Repose™ Suture Passer is designed to assist in passing the suture through the floor of the tongue in a tongue base advancement procedure or through the neck during a hyoid suspension procedure.

This document describes a medical device, the Repose™ Bone Screw System, and its substantial equivalence to predicate devices, rather than presenting a study focused on AI/algorithm performance. Therefore, many of the requested categories related to AI/algorithm performance and study design are not applicable.

Here's an analysis based on the provided text:

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

The document does not explicitly state "acceptance criteria" but rather focuses on meeting voluntary standards for materials and demonstrating substantial equivalence to predicate devices.

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

The document refers to "a series of in vitro and in vivo studies" previously submitted under K972023 for the Sleep-In™ Bone Screw System. However, it does not provide details on the sample size used for these studies, data provenance, or their retrospective/prospective nature.

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 as the document is not describing a study with a ground truth established by experts in the context of an AI/algorithm. The "testing and approval" mentioned refers to traditional medical device testing, likely mechanical or biological, not diagnostic performance.

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

This information is not provided as it pertains to expert review for AI/algorithm ground truth, which is not applicable 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:

This document is for a physical medical device (bone screw system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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 physical bone screw system, not an algorithm.

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

The concept of "ground truth" as typically applied to AI performance evaluation is not applicable here. The "proof" of the device's performance relies on its material properties (meeting ASTM standards) and its functional equivalence to predicate devices through in vitro and in vivo studies (details not provided in this document). For a physical implantable device, this would typically involve mechanical testing, biocompatibility studies, and potentially animal or human clinical trials assessing safety and efficacy outcomes, but not establishing a "ground truth" for diagnostic accuracy.

8. The sample size for the training set:

There is no training set as this is not an AI/algorithm study.

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

There is no training set and thus no ground truth to be established for it.

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The Cryo-Mono Cryogenic System is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissues. Cryo-Mono with TUF probe is specifically indicated for the ablation of prostate tissue in cases of benign prostatic hyperplasia ("BPH").

The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: The primary technological differences between the Cryo-Mono with TUF probe and the Cryo-Hit are: (1) Cryo-Mono with TUF accepts only one cryoprobe, the TUF probe, which is one of the options for the Cryo-Hit; (2) The Cryo-Mono with TUF probe is smaller than Cryo-Hit; (3) The Cryo-Mono with TUF probe has fewer gas cylinders; (4) The physician manually applies the Cryo-Mono's probe while with the Cryo-Hit, the physician has the option to use the "Stick" mode, which automatically adheres the probe to the tissue; (5) The Cryo-Mono with TUF probe has an optional foot pedal control; (6) The Cryo-Mono with TUF probe delivers preset amounts of argon for cooling while the Cryo-Hit adjusts the amount of argon delivered based on the tissue temperature measured by its thermocouples; (7) The Cryo-Mono with TUF probe's iceball size is monitored by transrectal ultrasound; the use of ultrasound, as well as external theromcouples, is optional with the Cryo-Hit; and (8) The Cryo-Mono's TUF probe is delivered transurethrally through a cystoscope rather than transperineally as with the Cryo-Hit. The only modification to the device' s software was the removal of the "stick" option mentioned above. The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.

The provided text describes a 510(k) premarket notification for the Cryo-Mono Cryogenic System with TUF probe. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with explicit acceptance criteria for device performance. Therefore, many of the requested elements (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance studies, etc.) are not typically included or required in a 510(k) submission focused on substantial equivalence based on technological characteristics and intended use.

The performance data mentioned pertains primarily to biocompatibility and compliance with general safety standards, not a specific clinical performance study for a machine learning algorithm.

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:

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate devices. There are no explicit performance metrics like "sensitivity" or "specificity" provided for an AI algorithm.

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/Not provided. This submission relies on demonstrating substantial equivalence based on technological characteristics and prior clearances, not on a new clinical study with a test set of patient data to evaluate an algorithm's performance. The "performance data" refers to engineering and material compliance.

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/Not provided. No clinical test set requiring expert ground truth was described.

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

• Not applicable/Not provided. No clinical test set requiring adjudication was 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. This device is a cryosurgical system, not an AI software/algorithm designed to assist human readers. Therefore, an MRMC study is not relevant to this submission.

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

• No. This device is a physical cryosurgical system, not an AI algorithm.

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

• Not applicable/Not provided pertaining to an algorithm's performance. For biocompatibility and safety, the "ground truth" is adherence to established standards (e.g., IEC, ASTM) and the FDA's prior clearances for the predicate materials and devices.

8. The sample size for the training set

• Not applicable/Not provided. This submission does not describe an AI/machine learning component that would require a training set in the typical sense. The "modified software" mentioned simply involved removing a "stick" option, not a re-training of a predictive model.

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

• Not applicable/Not provided. As there is no described AI training set, there is no ground truth establishment method.

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The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The StapleTac Bone Anchor System is substantially equivalent to Influence, Inc.'s MicroTac Bone Anchor System cleared under K990160 with respect to intended use, materials and performance of the bone anchors. The major difference between the two systems is that the anchor of the StapleTac Bone Anchor System is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate device is designed for use with sutures in both sling procedures and cystourethropexy.

The provided document is a 510(k) summary for the Influence, Inc.'s StapleTac Bone Anchor System. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not include detailed clinical study data with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader, multi-case studies as you might find for software-as-a-medical-device (SaMD) or diagnostic devices.

The information provided focuses on the device's intended use, materials, and performance testing for demonstrating equivalence to a predicate device (Influence, Inc.'s MicroTac Bone Anchor System, cleared under K990160), rather than establishing novel safety and effectiveness against specific performance metrics for an AI/algorithm-based device.

Therefore, most of the requested information cannot be extracted from this document, as it outlines a device clearance based on substantial equivalence for a physical surgical implant system, not a study proving an algorithm's performance against specific acceptance criteria.

However, I can extract the following based on the prompt's categories:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" is essentially substantial equivalence to the predicate device, the MicroTac Bone Anchor System (K990160). The "reported device performance" is that the StapleTac Bone Anchor System meets this equivalence.

The following information cannot be extracted from the provided 510(k) summary because it is not relevant to a substantial equivalence determination for a physical surgical device, and implies a clinical/AI performance study which is not described here:

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" for an algorithm is described.
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" for an algorithmic output is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No "test set" for an algorithm 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 physical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No "ground truth" for an algorithmic output is described.
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 "training set" for an algorithm is described.

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The Cryo-Mono Cryogenic system is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthesia presents an increased risk.

The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: (1) Cryo-Mono can support one cryoprobe only, while its predicate, Cryo-Hit, is capable of supporting up to 8 probes; (2) the Cryo-Mono is smaller than Cryo-Hit. (3) the Cryo-Mono has 4 gas cylinders compared to the Cryo-Hit' s six; (4) Cryo-Mono software has been modified, and does not have a "Stick" option for holding the probe to the tissue during freezing; (5) Cryo-Mono can accommodate needle shaped, tonsillectomy and turbinectomy specific probes; (6) Cryo-Mono has an optional foot pedal; (7) The Cryo-Mono does not have external thermosensors, which the Cryo-Hit has; and (8) The Cryo-Mono's single-use turbinectomy and tonsillectomy cryoprobes do not have built-in thermosensors, unlike the Cryo-Hit and Cryo-Mono' s multi-use probes.

This 510(k) summary for the Cryo-Mono Cryogenic System explicitly states that no new performance data or clinical studies were conducted to establish its safety and effectiveness. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device, the Cryo-Hit Cryogenic System.

Therefore, the following information regarding acceptance criteria and a study to prove performance cannot be provided as it was not part of this 510(k) submission.

Explanation for Absence of Information:

The core of this 510(k) submission is to assert that the Cryo-Mono is "substantially equivalent" to an already approved device. Substantial equivalence means that the new device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the differences do not raise new questions of safety and effectiveness.

In this case, the submitter argues that the Cryo-Mono's differences from the Cryo-Hit (e.g., smaller size, fewer probes, no "stick" option, foot pedal, modified software, fewer gas cylinders, and acceptance of tonsillectomy and turbinectomy specific probes) do not raise any new questions of safety and effectiveness.

Instead of presenting new performance data, the submission points to:

• Biocompatibility: Based on the FDA premarket clearance of the Cryo-Hit, as the Cryo-Mono's probes are made of the same materials.
• Conformance with Standards: Influence, Inc. certified conformance with IEC 60601-1, IEC 60601-1-2, and ASTM F882-84. These are safety and quality standards, not performance evaluations related to tissue ablation efficacy.
• Literature Review: Influence, Inc. summarized representative articles in the published medical literature regarding cryotonsillectomies and cryoturbinectomies. This is a review of existing knowledge about the procedure and its effectiveness in general, not a specific study on the Cryo-Mono device's performance against acceptance criteria.

Key Takeaway: For this specific 510(k), the "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to the predicate device, thereby leveraging the predicate's prior approval and established safety/effectiveness. No new, specific performance study with defined acceptance criteria for the Cryo-Mono was performed or required for this clearance.

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The MicroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures. It is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The MicroTac Bone Anchor System, consisting of the MicroTac Bone Anchor and the MicroTac Bone Anchor Inserter. The inserter of the MicroTac Bone Anchor System is designed for single use and is manual.

The provided text describes a 510(k) submission for the MicroTac Bone Anchor System, comparing it to a predicate device (In-Tac Bone Anchor System). This document focuses on demonstrating substantial equivalence for a medical device, which is a different regulatory pathway than providing detailed clinical study results with acceptance criteria and specific performance metrics for AI/software-based devices.

Therefore, the input does not contain the information necessary to fill out the requested table or answer most of the questions, as the submission primarily discusses device modifications and risk analysis to show equivalence. It does not present a study with quantitative acceptance criteria for its performance in the context of AI or diagnostic accuracy.

However, I can extract information related to the device and its regulatory context:

Device Information:

• Device Name: MicroTac Bone Anchor System
• Intended Use: Soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures.
• Indications for Use: Cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
• Predicate Device: Influence, Inc.'s In-Tac Bone Anchor System (cleared under K964953)

Response to Specific Questions based on the Provided Text:

As the provided text describes a 510(k) submission for a physical medical device (bone anchor system) and not an AI/software-based one, the requested detailed information about acceptance criteria, study design for AI models, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an algorithm is not applicable and therefore not available in this document.

The submission focuses on establishing substantial equivalence through risk analysis and performance testing related to the modifications from the predicate device. It indicates that "performance data gathered" and "performance testing" were used to demonstrate equivalence, but it does not provide specific quantitative acceptance criteria or detailed results in the format requested for an AI/diagnostic study.

Therefore, it's impossible to create the table or answer the specific questions as if this were a study proving an AI device meets acceptance criteria. The document's purpose is to show that the device modifications do not raise new questions of safety or effectiveness compared to a predicate device.

Summary of Unavailable Information:

• Acceptance Criteria Table: Not specified in the document.
• Device Performance: Not detailed in quantitative metrics that would align with AI/diagnostic studies. The document states "performance testing provided in the application demonstrates equivalence," but no data points are given.
• Sample Size (Test Set) and Data Provenance: Not applicable/not provided for an AI study.
• Number/Qualifications of Experts for Ground Truth: Not applicable/not provided.
• Adjudication Method: Not applicable/not provided.
• MRMC Comparative Effectiveness Study: Not applicable/not performed for this type of device submission.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical medical device.
• Type of Ground Truth: Not applicable/not provided (no diagnostic accuracy study).
• Sample Size (Training Set): Not applicable/not provided.
• How Ground Truth for Training Set was Established: Not applicable/not provided.

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The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:

1. Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
2. Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
3. Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
4. Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
5. Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

The Orthopedic Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. The design and materials of the Orthopedic Straight-In and Short shaft Straight-In systems are identical. The differences are that the Inserter of the Orthopedic Straight-In is designed for use in 10 procedures, while the predicate device is designed for single use.

The provided text describes a 510(k) submission for the "Straight-In - Orthopedic Bone Screw Fixation System," which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting a full clinical trial to establish new safety and effectiveness criteria.

As such, the document does not contain the detailed information typically found in a study designed to prove a device meets specific, quantitative acceptance criteria for performance, especially concerning an AI/ML model for which your questions are framed. Instead, it relies on demonstrating equivalence in design, materials, and performance testing to previous FDA-cleared devices.

Here's an analysis of the provided text in relation to your questions, highlighting what is not present:

Key Takeaway: This document describes a medical device clearance via substantial equivalence to predicate devices, not a study that proves the device meets new acceptance criteria for an AI/ML model.

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

• Not Applicable / Not Provided. The document states: "Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance."
• It does not list specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum displacement under load, etc.) for the new device or present a table comparing them to its measured performance. It implies that the test results supported equivalence to the predicate's performance.

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 / Not Provided. This document does not describe a "test set" in the context of clinical data or AI/ML model validation. The "performance testing" mentioned would refer to benchtop mechanical tests, material analyses, and potentially cadaveric studies, not a data-driven test set for an algorithm. Therefore, information about data provenance is not relevant here.

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 / Not Provided. "Ground truth" and expert reviews are concepts relevant to diagnostic AI/ML models or clinical studies where expert consensus is needed to classify outcomes. This is a submission for a mechanical fixation system, not a diagnostic tool.

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

• Not Applicable / Not Provided. See 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

• Not Applicable / Not Provided. An MRMC study is specific to evaluating diagnostic performance, often with AI assistance for human readers. This device is an orthopedic fixation system, not a diagnostic imaging aid or an AI-powered diagnostic tool.

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

• Not Applicable / Not Provided. This device does not involve an algorithm.

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

• Not Applicable / Not Provided. As this is a mechanical device, its "performance" would be assessed through engineering specifications (e.g., mechanical strength, fatigue life, biocompatibility) rather than a "ground truth" derived from clinical outcomes or expert consensus on observations. The "ground truth" for demonstrating equivalence would be the established performance characteristics of the predicate devices.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no AI/ML model involved, so no training set.

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

• Not Applicable / Not Provided. See point 8.

Summary of what the document does provide:

• Device Name: Straight-In - Orthopedic Bone Screw Fixation System
• Intended Use: Soft tissue fixation to bones by means of bone screws threaded with sutures.
• Specific Clinical Indications: Repair of instability in shoulder, elbow, hand/wrist, knee, and foot/ankle due to various ligament/tendon tears or separations (a comprehensive list is provided).
• Predicate Devices:
  • Short Shaft Straight-In Bone Screw System (K982155) - The new device is stated to be identical in design and materials, differing only in the inserter's intended use (multiple vs. single procedure).
  • Anchorlok™ Soft tissue anchor system (K971282) - Substantially equivalent in intended use and performance of the bone screws.
• Equivalence Claim: Based on "information and performance testing," the device is substantially equivalent to the predicate devices regarding intended use, technological characteristics, and performance.

In conclusion, this document is a regulatory submission for a physical medical device (an orthopedic bone screw system) using the 510(k) pathway, which hinges on demonstrating substantial equivalence to existing devices. It does not address the specific questions about AI/ML model validation, ground truth, or expert review panels that your template is designed for.

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The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.

The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.

The provided text states that the In-Probe II Urodynamics System is "substantially equivalent" to two predicate devices: Influence, Inc.'s In-Probe Urodynamics System and Andronic Devices, Ltd.'s Insight electronic alignment indicator. The document also mentions "Performance testing and information in the application demonstrated that the In-Probe II system is biocompatible and provides equivalent performance to the original In-Probe Urodynamics System."

However, the provided text does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It mainly focuses on the FDA 510(k) clearance process based on substantial equivalence to predicate devices. Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided document.

To properly answer your request, more detailed performance study reports or technical specifications for the In-Probe II Urodynamics System would be required.

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The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy).

This 510(k) notification describes a device intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy). The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.

The provided text describes a 510(k) submission for a medical device, the "Short Shaft Straight-In Bone Screw Fixation System." It details the device's intended use and claims substantial equivalence to a predicate device (Influence, Inc.'s Straight-In Bone Screw System, K972622).

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with advanced AI/ML medical devices. This is because the submission is for a mechanical fixation system, not a software-driven diagnostic or treatment algorithm.

Therefore, many of the requested categories (expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The submission is for a mechanical surgical device, not a data-driven diagnostic tool. Performance equivalence was likely assessed through bench testing and comparison of design specifications with the predicate device. No "test set" in the context of data points is mentioned.

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

Not applicable. As this is not an AI/ML device, there is no mention of expert-established ground truth for a test set in this document.

4. Adjudication method for the test set

Not applicable. No "test set" in the context of data is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are typically for diagnostic imaging software or similar devices involving human interpretation. This is a mechanical surgical device.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

Not applicable. The "truth" here relates to the safety and effectiveness of the mechanical fixation system, assessed through engineering principles, material science, and comparison to a legally marketed predicate device, rather than a "ground truth" derived from expert labels or pathology.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is a mechanical device, not an AI/ML system.

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

Not applicable. There is no training set.

Summary of the Study Information Provided in the Document:

The document states: "Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance."

• Study Type: This would have been an un-detailed equivalence study focused on showing that the new device (Short Shaft Straight-In Bone Screw Fixation System) performs comparably to the predicate device (Straight-In Bone Screw System, K972622).
• Nature of Study: Given the device type (mechanical bone screw), this likely involved:
  • Mechanical bench testing: To compare properties like screw strength, pull-out force, material properties, and dimensional conformity.
  • Design analysis: A review of the design and materials to confirm their identity or equivalence to the predicate.
  • Clinical rationale: Justification for the shorter inserter not negatively impacting performance, potentially through physician feedback or direct observation during simulated use.
• Key Finding: The only stated difference between the new device and the predicate is the shorter inserter for improved maneuverability. The 510(k) summary asserts that this difference does not alter the fundamental technological characteristics or performance of the device in comparison to its predicate.

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The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.

The Influence Clip System has two components, a suture clip and an applier. To fixate sutures, the stainless steel clip is inserted into the applier. Two strands of suture are threaded through the clip and the applier inserted into the trocar (if a laparoscopic procedure is performed). The applier's handle is then tightly squeezed which causes a rod within the applier's shaft to crimp the clip around the sutures. The sutures' ends are cut close to the clip (alternative version of applier with suture cutter may be used). The system is provided sterile and the applier is disposable, for single patient use.

The provided document is a 510(k) summary for the Influence Clip System, which focuses on the regulatory clearance process for a medical device. It does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the document states that the device's safety and effectiveness were demonstrated through bench testing and that its performance is substantially equivalent to a previously cleared 510(k) device.

Therefore, it is not possible to fill out all the requested information concerning acceptance criteria, study details, ground truth establishment, sample sizes, or expert adjudication for a performance study from this document.

However, based on the information provided, we can infer the primary "acceptance criterion" from a regulatory perspective:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

• 2. Sample sizes used for the test set and the data provenance: Not mentioned. The testing was "bench testing," meaning lab-based, not clinical data involving patients.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to expert review of clinical cases, which was not the nature of the testing described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication by experts 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 clip, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm. Bench testing would assess the device's physical performance.
• 7. The type of ground truth used: For a medical device like this, the "ground truth" for bench testing would likely be based on engineering specifications and physical measurements (e.g., tensile strength tests, slip resistance tests for the clip on sutures), rather than expert consensus on clinical findings or pathological diagnoses. The document vaguely states "bench testing has demonstrated that the device is safe and effective."
• 8. The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission focused on substantial equivalence based on bench testing. It does not describe a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement as would be typical for an AI/diagnostic device.

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The TriAngle Sling is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.

The TriAngle Sling is a knitted patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.

This document does not include information about acceptance criteria or a study proving that a device meets such criteria.

The provided text is a 510(k) summary for the TriAngle Sling, which is a medical device for treating urinary stress incontinence. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria in the manner you've requested.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria & Reported Device Performance: The document states, "Performance testing and information in the application demonstrated that TriAngle sling is biocompatible and provides equivalent performance to the In-Sling." It does not list specific quantitative acceptance criteria (e.g., tensile strength, pore size, elasticity ranges) nor does it provide the measured performance values for the TriAngle Sling against those criteria. It relies on a general statement of equivalence to the predicate.
• Study Design Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present because a 510(k) summary for a Class II device like this typically does not require a comprehensive clinical trial or an in-depth performance study with human readers/experts. The demonstration of substantial equivalence often relies on material characterization, mechanical testing, biocompatibility testing, and comparison of technological characteristics to a legally marketed predicate device.
• Training Set Information: Similarly, there is no mention of a training set, as the evaluation type described doesn't involve machine learning algorithms that require training data.

In summary, the provided K980482 document for the TriAngle Sling is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study with the specific performance criteria and study methodology you've inquired about.

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