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The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set (herein referred to as Optima set), model 14000ES16, consists of a sheath, vessel dilator, introducer, and in-sheath dilator. The Optima set is available with inner sheath diameter of 16 French and is used to facilitate introduction and removal of compatible devices used with the Edwards transcatheter heart valve (THV) systems into/from the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer jacket expands by stretching radially, temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The 29mm loader (included with the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The provided text is a 510(k) clearance letter for a medical device called the Edwards eSheath Optima Introducer Set. It outlines the regulatory process and asserts the device's substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that an AI/software device meets those criteria, as typically seen in AI/ML medical device submissions.

The document pertains to a physical medical device (catheter introducer) and its non-clinical performance testing. The "summary of non-clinical testing" section lists various engineering and biocompatibility tests performed on the device itself, not on an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/software device.
2. Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how training ground truth was established, because this information is not present in the provided document regarding an AI/software device.

The document is about a physical medical device and its non-clinical (engineering and biocompatibility) testing, not an AI/ML-based device.

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The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal.

The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.

The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation

The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor.

The system is compatible with the following applicators:

• DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL)
• LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA)
• VASCULAZE 1064 (previously cleared as Vasculaze)
• FORMA (previously cleared as Forma (Plus))
• PLUS (previously cleared as Plus/Plus)
• MORPHEUS8
• MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)

The provided text describes the FDA 510(k) clearance for the Optimas MAX System, comparing it to predicate devices. However, it does not contain information about acceptance criteria or specific study details proving the device meets those criteria, particularly regarding an AI component or machine learning performance.

The document focuses on the substantial equivalence of the hardware and general system functionality, including:

• Indications for Use: Listing the intended applications of the system's various applicators (hair removal, vascular lesions, pigmented lesions, muscle aches/pains, soft tissue coagulation/hemostasis).
• Technological Characteristics: Describing the system as a computerized device generating Laser, IPL, and RF energies, with a new industrial design and an upgraded operating system (Linux from Windows CE). It explicitly states that "The specifications for the critical components of the system remain unchanged," and "The system components, handpiece connectors, and the operating parameters of each handpiece remains unchanged."
• Non-Clinical and/or Clinical Tests Summary: Mentions "software validation testing to demonstrate that the system's new Burst and Scale Modes for the Morpheus8 handpieces function as expected" and new electrical testing against various IEC standards.

Therefore, based solely on the provided text, I cannot describe acceptance criteria and a study proving the device meets them in the context of AI or machine learning performance, as that information is not present. The clearance process described is typical for a hardware device with minor software updates and cosmetic changes, relying on substantial equivalence to previously cleared devices.

To answer your request, if an AI/ML component was implicitly part of "software validation testing" or "Burst and Scale Modes," the document does not provide the specifics you're asking for.

If this were an AI/ML device, the FDA clearance would typically include sections detailing:

• Performance Metrics: Sensitivity, specificity, AUC, etc.
• Dataset Details: Size, provenance, diversity.
• Ground Truth: How it was established (e.g., expert consensus, pathology).
• Reader Study: If human-in-the-loop performance was evaluated.

Since none of that information is in the provided text, I must state that the document does not contain the details to fulfill your request.

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The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor.

The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias.

The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

The provided text is a 510(k) Clearance Letter and a 510(k) Summary for the OptiMap™ System. While it details the device, its intended use, and substantial equivalence to a predicate, it does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies of testing (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The relevant section, "VII. Summary of Non-Clinical Performance Testing," states:

"Software verification and validation testing was completed on the subject device demonstrating that the OptiMap System with Version 1.3 Software (including ACP functionality) successfully performed at the unit, integration and system levels. All open issues from the verification and validation activities have been resolved or documented as unresolved anomalies. The OptiMap System met the acceptance criteria listed in the test protocols, performs as designed, and is suitable for its intended use."

This statement confirms that testing was performed and acceptance criteria were met, but it does not provide the specific criteria or the quantitative results of these tests. Therefore, I cannot populate the requested tables and information based solely on the provided text.

To answer your request, the necessary information (specific performance metrics, acceptance thresholds, sample sizes, ground truth details, etc.) would typically be found in the actual validation study report, which is not part of this 510(k) clearance letter or summary.

If such a document were available, the information would likely be organized as follows:

Acceptance Criteria and Device Performance Study

Since the provided text does not contain the specific performance study details, the following tables and sections are illustrative, showing what information would be required to fulfill the request. This information was not found in the provided 510(k) document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: (Not provided in the document. Would typically specify number of patient cases, EGM recordings, or arrhythmias analyzed.)
• Data Provenance: (Not provided in the document. Would specify country of origin, if retrospective or prospective data collection, and if multi-center.)

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: (Not provided in the document. Would specify the count of experts.)
• Qualifications of Experts: (Not provided in the document. Would specify their medical specialization, board certifications, and years of experience, e.g., "3 Board-Certified Electrophysiologists, each with >10 years of experience in cardiac arrhythmia diagnosis and treatment.")

4. Adjudication Method for the Test Set

• Adjudication Method: (Not provided in the document. Common methods include:
  • 2+1: Two experts review independently, and a third adjudicates disagreements.
  • 3+1: Three experts review independently, and a fourth adjudicates if necessary, or majority agreement is used.
  • Consensus: All experts discuss and reach a consensus.
  • None: A single expert's reading is considered ground truth, or adjudicated by a pre-defined process.)

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

• MRMC Study Conducted?: (Not provided in the document. Typically stated if human-in-the-loop performance with and without AI assistance was evaluated.)
• Effect Size (if applicable): (Not provided in the document. Would quantify the improvement in human reader performance, e.g., "Radiologists' diagnostic accuracy improved by X% (from Y% to Z%) when using OptiMap™ System assistance compared to without assistance.")

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Conducted?: Yes, the summary for "Software verification and validation" implies that the system's performance was evaluated independently, as it describes the system successfully performing at unit, integration, and system levels. However, the specific metrics and results are not detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: (Not provided in the document. For cardiac arrhythmia diagnosis, this could be:
  • Expert Consensus: Agreement among multiple expert electrophysiologists based on clinical data.
  • Electrogram Analysis: Detailed analysis of raw EGM signals by experts, potentially correlated with clinical outcomes.
  • Clinical Outcomes Data: Correlation with patient outcomes (e.g., successful ablation, recurrence of arrhythmia).
  • Pathology/Histology: Less common for electrophysiology mapping, but relevant for some cardiac conditions.)

8. Sample Size for the Training Set

• Training Set Sample Size: (Not provided in the document. This is distinct from the test set and crucial for machine learning model development.)

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: (Not provided in the document. Similar methods to the test set ground truth would apply, but often with a larger scale and potentially more automated or semi-automated labeling steps initially, followed by expert review.)

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The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The loader (included in the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The provided document is an FDA 510(k) clearance letter and summary for the Edwards eSheath Optima introducer set. It demonstrates substantial equivalence to a predicate device based on non-clinical testing. However, it does not contain a detailed study meeting the specific criteria you've outlined, particularly for AI/algorithm performance. The information provided relates to the physical and functional performance of a medical device, not an AI or software component.

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

• 1. A table of acceptance criteria and the reported device performance: While the document mentions various bench tests were "successfully completed" and "all design requirements were met," it does not provide specific quantitative acceptance criteria or detailed numerical results for each test.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as this is non-clinical bench testing of a physical device, not an AI or software study with a test set of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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, as this device does not involve AI or human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable in the context of AI/software performance. For a physical device, the "ground truth" would be the engineering specifications and established test methods.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

The document describes the Edwards eSheath Optima introducer set, a physical medical device.

Device Description:
The introducer set comprises a sheath, vessel dilator, introducer, and in-sheath dilator. It's designed to facilitate the introduction and removal of compatible devices used with Edwards transcatheter heart valves. Key features include an expandable inner member and outer jacket, a radiopaque marker, a hydrophilic coating, hemostatic seals, and an optional in-sheath dilator.

Non-Clinical Testing:
A list of bench tests was performed to demonstrate substantial equivalence to the predicate device and that all design requirements were met. These tests cover various physical and functional aspects of the device, including:

• Recovered Outer Diameter (OD)
• In-Sheath Dilator (ISD) Max Distal OD
• Tip OD
• ISD Insertion & Retrieval
• Tip Inner Diameter (ID)
• Sheath Insertion & Retrieval
• Sheath Working Length
• ISD Working Length
• Hemostasis
• Kink Radius
• Fishmouth
• Lubricity and Durability
• Bond Tensile Strengths (Sheath Housing to Shaft, Sheath Shaft to Tip, Flush Tube to Housing, Stopcock to Flush Tub, ISD Hub to Shaft)
• Transcatheter Heart Valve (THV)/Sheath Interaction
• Device Interaction
• Guidewire Compatibility
• Delivery System Insertion & Retrieval
• Crimped THV Retrieval
• Radiopacity
• Particulate Testing
• Sterilization Validation
• Biocompatibility (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity)

The document states that these tests were "successfully completed" and that "all design requirements were met," leading to the conclusion that the device is substantially equivalent to the predicate. However, it does not provide specific acceptance criteria values or the quantitative results from these tests.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text describes a 510(k) premarket notification for a medical device called the Optima Coil System (OptiBlock Line Extension). This submission focuses on demonstrating substantial equivalence to a predicate device (Optima Coil System, K223386) for which it is a modification or line extension.

Here's an analysis of the acceptance criteria and study information provided:

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

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

The document explicitly states "The following non-clinical bench testing was performed to evaluate the device changes and to demonstrate substantial equivalence...". It mentions "test samples" but does not specify the sample size for either of the tests performed. The data provenance is from bench testing for a medical device line extension, not involving human subjects or clinical data in this submission. Therefore, country of origin is not applicable in the context of clinical data.

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

This information is not provided in the document. Given that the studies are non-clinical bench tests, the "ground truth" would be established by engineering specifications and objective measurements rather than expert consensus on clinical cases.

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

This information is not provided and is generally not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases.

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 as the described device is a neurovascular embolization coil system, not an AI software or a device that assists human readers in interpreting medical images. There is no mention of AI in the document.

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

This information is not applicable for the same reasons as point 5. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For the "Visual Inspection, Dimensional Inspection, and Resistance Check," the ground truth would be engineering specifications and manufacturing tolerances. For "Simulated Use," the ground truth would be pre-defined performance criteria within a clinically relevant model, also based on engineering and functional specifications for the device's intended operation. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these non-clinical tests.

8. The sample size for the training set:

This information is not provided and is not applicable given that this is not an AI/machine learning device. The concepts of "training set" and "ground truth for the training set" are relevant to machine learning model development, not for a physical medical device.

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

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

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The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.

The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

The provided text describes mechanical testing performed to demonstrate substantial equivalence for the Forma Medical Optimal Plating System. It does not contain information about an AI/ML-enabled device or a study involving human readers. Therefore, many of the requested fields are not applicable.

Here's the relevant information:

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

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

The document does not explicitly state the sample size (number of screws or plates) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable for mechanical testing of a physical 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)

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert consensus.

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

Not applicable. Adjudication methods are relevant for subjective assessments, not for objective mechanical testing.

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 bone fixation system, not an AI-enabled diagnostic tool.

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

Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

The ground truth for the mechanical testing is based on established engineering standards (ASTM F543-23, ASTM F382-17) and an analytical formula (Chapman analytical formula for pullout strength).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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1. AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular Repair, Acetabular Labral Repair.

2. AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor

The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are non-absorbable threaded suture anchor manufactured in PEEK Material. Generally, it is indicated for the attachment of soft tissue to the bone.

The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue.

AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is a fully threaded suture anchor featuring dual threads to maximize cortical and cancellous fixation. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor has a flat tip to protect the sutures and to facilitate the insertion. The anchor is particularly suitable for repairing rotator cuff and associated pathologies. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is available in diameter of 4.5, 5.5 and 6.5mm. This anchor is available with two or three BioBraid suture. The anchors are also available with needles which are ideal for mini-open rotator cuff repair procedures.

AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchors are fully threaded knotless anchors. These anchors are designed to be used with sutures or tapes for rotator cuff repair employing the 'bridge' technique. Moreover, the 'knotless' technique consists of passing sutures or tapes of the medial row anchors through the tissue. They are finally inserted into the bone socket once they're loaded through the Rotador anchor eyelet. This technique eliminates possible complications caused by knots compared to other conventional anchors. The anchor is available in 4.75, 5.5 and 6.25mm diameter with PEEK OPTIMA anchor body and eyelet.

These implants are sold in sterile conditions (Ethylene Oxide Sterilization).

The system is indicated for use in adult patients only. All implants are for single use only.

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor consists of Peek OPTIMA (Grade LT1) as per ASTM F2026-17 implantable Class II, Anchors, UHMWPE (Ultra-High Molecular Weight Polyethylene) Suture as per ASTM F2848-17.

This document is a 510(k) Premarket Notification from Auxein Medical Private Limited for two suture anchors: AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor. It seeks to demonstrate substantial equivalence to legally marketed predicate devices.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

The document describes a submission for Class II medical devices (AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor) under the regulation 21 CFR 888.3040 for "Smooth or threaded metallic bone fixation fastener" (Product Code MBI). The primary intention of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices, not to prove clinical superiority or a novel mechanism of action requiring robust, comparative clinical trials with human subjects.

Therefore, the "acceptance criteria" and "study" described are primarily focused on bench testing and material compliance to demonstrate that the new device performs equivalently to the predicate devices and meets relevant industry standards for safety and fundamental function. There is no mention of an AI algorithm, human-in-the-loop performance, MRMC studies, or complex ground truth establishment for diagnostic accuracy as would be typical for AI/ML-based medical devices or diagnostic tools.

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

The document does not present a formal table of "acceptance criteria" for clinical performance against a specific standard endpoint (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it focuses on demonstrating equivalence in terms of design, material, operating principle, indications for use, sterilization, shelf-life, and mechanical properties compared to the predicate devices. The "performance" reported is primarily in the context of meeting various ASTM and ISO standards for materials, biocompatibility, sterilization, and mechanical integrity.

Here's a summary of the comparative criteria and implied performance from the document:

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text is a 510(k) Summary for a medical device called the "Optima Coil System." It describes the device, its intended use, and its comparison to a predicate device. It also includes a table of performance data from bench testing. However, this document does not contain information about a study involving human readers or AI assistance, or any data related to diagnostic accuracy, sensitivity, or specificity.

The "acceptance criteria" and "device performance" described are for bench testing only, which evaluates the physical and functional characteristics of the device itself, not its performance in a clinical scenario involving human interpretation or AI.

Therefore, I cannot fulfill the request for information related to:

• A table of acceptance criteria and reported device performance in a human-AI study. The provided table only covers bench tests.
• Sample size used for the test set and data provenance for a human-AI study.
• Number of experts used to establish ground truth and their qualifications for a human-AI study.
• Adjudication method for a human-AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a human-AI study.
• Sample size for the training set for an AI study.
• How ground truth for the training set was established for an AI study.

The document's "Performance Data - Bench" section is directly relevant to the acceptance criteria of the device's physical properties and functionality, not an AI or diagnostic performance study.

Here's the information that can be extracted from the provided text regarding device acceptance criteria and performance (bench testing):

Device Acceptance Criteria and Reported Performance (Bench Testing)

Explanation of the Bench Study (based on the provided text):

The performance data presented is from non-clinical bench testing. Its purpose was to evaluate changes made to the Optima Coil System (e.g., new coil sizes and combinations of dimensions) and to demonstrate its substantial equivalence to the previously cleared predicate device (K200030).

• Sample size: Not explicitly stated for each bench test, but implied to be "test samples."
• Data provenance: Bench testing results, implying in-house lab testing, not clinical data from patients or specific countries. It is retrospective in the sense that it evaluates a final product design.
• Experts for ground truth: Not applicable for this type of bench testing. Ground truth is based on engineering specifications, physical measurements, and performance standards.
• Adjudication method: Not applicable. Results are based on physical measurements and functional checks against pre-defined engineering criteria.
• MRMC Comparative Effectiveness Study: No, this document does not describe such a study.
• Standalone Performance: Not applicable in the context of AI; this refers to the physical device's performance.
• Type of Ground Truth: Engineering specifications, physical dimensions, material properties, and functional performance in simulated environments.
• Training Set Sample Size/Ground Truth for Training Set: Not applicable, as this document describes bench testing of a physical medical device, not the development or training of an AI algorithm.

In summary, the provided document focuses solely on the substantial equivalence of a physical neurovascular embolization device based on bench testing of its modifications. It does not contain any information related to AI performance, human-in-the-loop studies, or diagnostic efficacy.

Ask a specific question about this device

The Amputee Garment for use with Lympha Press Optimal Plus is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: · Primary Ivmphedema · Secondary Ivmphedema - - · Venous insufficiency - Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reduction of wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema

Amputee Garment for use with Lympha Press Optimal Plus

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "Amputee Garment for use with Lympha Press Optimal Plus." This document describes the device's regulatory clearance and its intended uses, but it does not contain any information about acceptance criteria, a specific study proving device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies (like MRMC or standalone AI performance studies).

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device