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The CoolSculpting Elite System is a skin cooling or heating device. It can be used in cooling or heating mode.

Cooling Mode
• Indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, banana roll, thigh, abdomen, and flank (or "love handles") in individuals with a Body Mass Index (BMI) of 30 or less.
• Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2.
· Intended to affect the appearance of visible fat bulges in the upper arm, bra fat, banana roll, submental and submandibular areas, thigh, abdomen, and flank.
· When used for cold-assisted lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.

• · Can be used to minimize pain and thermal injury during laser and dermatological treatments.
• · Can be used as a local anesthetic for procedures that induce minor local discomfort.

Heating or Cooling Mode

• · Can be used to minimize pain post-trauma and post-surgery.
• · Can be used to provide temporary relief of minor aches, pains, and muscle spasms.
  • The ZELTIQ Pretreatment Skin Wipe and gel pad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.

The CoolSculpting Elite System is a portable thermoelectric cooling device that applies controlled cooling to a treatment site. The CoolSculpting Elite System comprises of a control unit, detachable applicators, and accessories such as cycle cards, CoolAdhesive gelpads, gel traps, pretreatment skin wipes, liners, foam borders, and comfort straps. The device treats a target temperature down to -11°C with an accuracy of ±0.5°C. The device will automatically stop the treatment if the interface temperature goes past the target temperature by more than 1°C when treating below 5°C

While the provided text describes the CoolSculpting Elite System, its indications for use, and a 510(k) summary, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria, particularly not for AI/ML-based performance parameters.

The document outlines a traditional 510(k) submission for a software update (including Wi-Fi functionality) and a new S180 applicator for the CoolSculpting Elite System. The primary focus of the performance testing mentioned is to demonstrate equivalence to the predicate device and confirm that the modified system functions as intended, without raising new safety or effectiveness concerns.

The 510(k) summary explicitly states: "The modified CoolSculpting Elite System is identical to the predicate device in terms of principle of operation, mechanical features, performance specifications, software, hardware, algorithm, and treatment workflow." This indicates that there isn't a new AI/ML algorithm being introduced with this submission that would require detailed performance metrics against specific acceptance criteria for AI-driven diagnostic or treatment recommendations. The Wi-Fi functionality is for data transfer (logs, errors, diagnostics) and not for achieving the device's intended use.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving the device meets them, as it pertains to AI/ML performance, because this information is not present in the provided document. The document concerns a hardware and minor software update to an existing device, not the validation of a new AI/ML component.

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NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.

NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.

NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.

NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.

The provided text is an FDA 510(k) clearance letter and summary for a medical device: "NATRELLE INSPIRA® Single Use Sizers." This document does not contain information about an AI/ML-driven device or a study involving human readers or ground truth establishment relevant to AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Natrelle® Re-Sterilizable Breast Implant Sizers) through non-clinical performance data, primarily mechanical testing and biocompatibility. The device itself is a physical sizer filled with silicone gel, used by surgeons during breast augmentation procedures.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including:

• Table of acceptance criteria and reported device performance (for AI/ML): Not applicable. The "performance data" mentioned in the document refers to non-clinical tests like mechanical testing and biocompatibility, not AI performance metrics.
• Sample size and data provenance (for AI/ML test set): Not applicable. There is no AI test set.
• Number of experts and qualifications (for AI/ML ground truth): Not applicable. There is no AI ground truth establishment.
• Adjudication method (for AI/ML test set): Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is a physical medical device, not an AI system.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The ground truth for this device's testing relates to physical properties and biocompatibility, not diagnostic or clinical accuracy determined by experts or pathology.
• Sample size for training set (for AI/ML): Not applicable. There is no AI training set.
• How ground truth for training set was established (for AI/ML): Not applicable.

The document explicitly states that "Non-clinical performance data including mechanical testing and biocompatibility data were submitted to support clearance... All pre-established acceptance criteria were met." However, these acceptance criteria and the associated study are not related to the performance of an AI/ML device, human reader improvement, or ground truth for diagnostic accuracy, which are the typical focus of the questions posed.

To summarize, the provided text describes a traditional medical device and its clearance process, not an AI/ML device study.

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The TrueTear Intranasal Tear Neurostimulator provides a tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.

The TrueTear device is a prescription only, non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. The device's technological principle is the application of low-level electrical stimulation to sensory neurons located in the nose to acutely increase tear production and improve dry eye symptoms. The device consists of three distinct non-sterile subassemblies - a base unit which controls and produces electrical stimulation waveform and enables the patient to control the neurostimulation, a disposable tip that is inserted into the nose and provides the contact surface for the stimulation to the target tissue located in the nose, and a charger case that protects the device and replenishes the sealed battery inside the base unit between uses.

The provided text describes a 510(k) summary for the TrueTear Intranasal Tear Neurostimulator, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories in the prompt, such as data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information (which are relevant to AI/ML studies), are not applicable to this device submission.

The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, primarily related to electrical output specifications, biocompatibility, electrical safety, software validation, wireless communications, and mechanical durability. The document states that no animal or clinical studies were required due to the nature of the modifications and the equivalence to the predicate device whose clinical safety and effectiveness were previously established.

Here's an attempt to answer the prompt given the available information, noting the inapplicability of AI/ML specific criteria:

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

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

This information is not applicable as the submission primarily relies on bench testing and comparisons to a predicate device, rather than a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects for novel device performance. The performance data listed (electrical output, biocompatibility, safety, software, wireless, mechanical)是由实验室测试得出的。

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. The device performance is assessed against engineering and regulatory standards (e.g., ISO, IEC) through bench testing, not expert-adjudicated ground truth as would be relevant for an AI/ML diagnostic device.

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

Not applicable. This is relevant to expert review processes for AI/ML ground truth, not device performance testing against engineering standards.

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 not an AI/ML device that assists human readers.

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

Not applicable. This is a physical neurostimulation device, not an algorithm.

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

The "ground truth" for the device's performance is compliance with established engineering and safety standards (e.g., electrical output parameters, biocompatibility standards, EMC standards, software validation standards) and mechanical design specifications, demonstrated through verified bench testing and documented in the 510(k) submission.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or "training set" for this device.

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

Not applicable. There is no AI/ML algorithm or "training set" for this device.

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REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

This document is a 510(k) Summary for the REFRESH® RELIEVA™ FOR CONTACTS device. It describes the device, compares it to predicate devices, and summarizes testing performed to support its substantial equivalence. The document is a regulatory submission for a medical device and does not inherently describe a study that uses AI, nor does it provide detailed acceptance criteria related to AI performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as this document pertains to a medical device (contact lens solution), not an AI/ML powered device.

However, I can extract the information relevant to the performance of the device as described in this document.

Device Name: REFRESH® RELIEVA™ FOR CONTACTS

Device Description: A sterile, buffered, isotonic, preserved solution containing carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%).

Indications for Use: To lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

Predicate Devices:

• REFRESH® Contacts Lubricating and Rewetting Drops (K992028)
• REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for an AI/ML device. Instead, the "acceptance criteria" are implied by the requirement for "substantial equivalence" to predicate devices, which the studies aimed to demonstrate. The performance is reported in terms of safety and efficacy.

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

• Sample Size for Test Set:

  • Clinical Study: The document states "A 3-month clinical study was conducted... in contact lens wearers." However, the exact number of participants (sample size) in this clinical study is not provided in the available text.
  • Biocompatibility/Stability: Not applicable as these are bench/lab tests, not human test sets.

• Data Provenance: Not explicitly stated (e.g., country of origin). The clinical study was conducted to evaluate the device against a marketed predicate, implying a controlled clinical trial setting. The studies are prospective as they were specifically performed to support the 510(k) submission.

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

This section is not applicable as the described studies are for a contact lens solution, not an AI/ML powered device where expert readers typically establish ground truth. Clinical endpoints in this context would likely be based on participant reporting of symptoms and potentially objective ophthalmological assessments, not "expert ground truth" for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Clinical study endpoints would be collected and analyzed, but "adjudication" in the sense of resolving discrepancies between expert interpretations of data (as typically seen in AI/ML performance studies) 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

This section is not applicable. This document describes the safety and effectiveness testing for a contact lens comfort solution, not an AI/ML diagnostic or assistive device. There are no "human readers" interpreting images with or without AI assistance in this context.

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

This section is not applicable. The device is a physical product (contact lens solution), not an algorithm.

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

For the clinical study, the "ground truth" or primary endpoints would likely be based on:

• Patient-reported outcomes (PROs): Subjective relief of dryness, discomfort, and irritation; comfort upon lens insertion.
• Clinical assessments: Potentially objective measures of ocular surface health or lens-eye interaction, as assessed by an optometrist or ophthalmologist, though specific measures are not detailed in this summary.
• The study aimed to demonstrate substantial equivalence in safety and efficacy compared to a predicate device, meaning its performance was judged against the established acceptable performance of the predicate.

For biocompatibility, the ground truth involves adherence to and successful completion of established test methods (e.g., cytotoxicity, irritation, sensitization) as per FDA guidance.

For stability, the ground truth involves chemical, physical, and microbiological specifications being met over time.

8. The sample size for the training set

This section is not applicable. The device is a contact lens solution, not an AI/ML model that requires a training set.

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

This section is not applicable for the reasons stated above.

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The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Natrelle® 133 Plus MICROCELL™ Tissue Expanders are designed to develop tissue flaps as part of 2-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a MICROCELL™ textured surface, an orientation line, three suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.

The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expander, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The provided text is a 510(k) summary for the Natrelle® 133 Plus MICROCELL™ Tissue Expander. It describes the device, its intended use, and its technological characteristics. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic or assistive tool.

The "Performance Data" section states:

"Non-clinical performance data, including mechanical testing data and biocompatibility data, were submitted to support clearance of Natrelle® 133 Plus MICROCELL™ Tissue Expanders. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met."

This refers to physical device performance, mechanical properties, and biocompatibility, not the performance of an AI system, human-in-the-loop performance, or the use of ground truth established by experts.

Therefore, I cannot fulfill your request for the specific details outlined (AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI) because this information is not present in the provided document. The document pertains to a medical device (tissue expander), not an AI system.

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The Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Natrelle® 133S Plus Tissue Expanders are designed to develop tissue flaps as part of two-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of a smooth surface expansion envelope, an orientation line, suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.

The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The document describes the Natrelle® 133S Tissue Expander, a medical device, and its substantial equivalence to a predicate device. The information provided heavily focuses on non-clinical performance data and does not involve AI or human reader performance. Therefore, many of the requested points related to AI/human reader studies, ground truth derivation for AI, and specific expert qualifications/adjudication methods are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values (e.g., minimum bond strength, pressure resistance for injection port) are not provided in this summary but are indicated to have been met.

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

The document refers to "mechanical testing data" and "non-clinical performance data." It does not specify a "test set" in the context of patient data or clinical imaging. The testing performed is related to the physical and mechanical properties of the device.

• Sample Size for Test Set: Not specified in terms of number of devices or units tested for each specific mechanical test.
• Data Provenance: The data is from non-clinical performance testing conducted by Allergan or its contractors. No information on country of origin for data is provided as it's not patient-level data. The data is by nature prospective in the sense that the tests were conducted specifically for this submission.

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

Not applicable. This device is a physical tissue expander, and the "ground truth" for its performance is established through objective mechanical and physical testing according to standards like ASTM F1441-03. There's no interpretive clinical data requiring expert consensus or ground truth establishment in the way AI models typically do.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated in point 3.

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

No. An MRMC study is relevant for AI-assisted image interpretation or diagnostic performance involving human readers. This submission concerns a physical medical implant (tissue expander).

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

No. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is based on pre-established objective performance criteria derived from engineering standards (e.g., ASTM F1441-03) and risk analysis, validated through mechanical testing data.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI model for this physical medical device submission.

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

Not applicable for the reasons stated in point 8.

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The TrueTear Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.

The TrueTear Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to increase tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms. The device consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base Unit, a reusable Charging Station, and a reusable Cover. The device design has not been significantly modified from the device granted under DEN160030, with technical changes including enabling Bluetooth functionality for one-way wireless communication, removal of material used in the disposable tip, disabling of the tip detection feature in the Base Unit, and addition of an optional mobile application (TrueTear App) for reading and summarizing device usage data.

Here's a breakdown of the acceptance criteria and the study details for the TrueTear Intranasal Tear Neurostimulator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in the provided text for overall device performance regarding dry eye symptom improvement. Instead, the FDA's decision to grant De Novo classification is based on a benefit-risk determination and the device's ability to demonstrate "meaningful improvement in symptoms." The reported device performance is presented as the proportion of subjects achieving a clinically important change (MCID) in their OSDI score.

• At Day 7 (MCID 7.3): 42.86% (33/77) improved, 12.99% (10/77) worsened
• At Day 30 (MCID 7.3): 38.67% (29/75) improved, 12.00% (9/75) worsened
• At Day 7 (MCID 13.4): 23.38% (18/77) improved, 5.19% (4/77) worsened
• At Day 30 (MCID 13.4): 25.33% (19/75) improved, 6.67% (5/75) worsened

Conclusion: "There were more participants with severe dry eve symptoms that had a meaningful improvement in symptoms as measured with the Ocular Surface Disease Index (OSDI) than the number with clinically significant worsening of symptoms at day 7 and at day 30." |
| Probable benefits outweigh probable risks. | Based on the above OSDI results, and a low incidence of self-limited, non-serious adverse events, the FDA concluded: "The probable benefits outweigh the probable risks for the TrueTear Intranasal Tear Neurostimulator." |

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

• Test Set Sample Size:
  • Overall enrolled participants: 97
  • Participants with severe dry eye symptoms at screening (used for primary analysis): 77
  • Participants with severe dry eye symptoms seen at Day 30: 75
  • The moderate dry eye group's sample size was "too small to make meaningful inferences."
• Data Provenance: The study was a prospective clinical trial (OCUN-010) conducted by the applicant (Allergan). The document does not specify the country of origin of the data, but Allergan is based in Irvine, California.

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

The ground truth for device effectiveness was established using patient-reported outcomes via the Ocular Surface Disease Index (OSDI). Therefore, traditional "experts" like radiologists establishing a ground truth in image analysis are not applicable here. The "ground truth" for severity categories was based on OSDI scores (Severe dry eye: OSDI total score of 33 or more).

4. Adjudication Method for the Test Set

Not applicable. The study relied on a patient-reported outcome measure (OSDI) rather than expert adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. This device is not an AI diagnostic tool that assists human readers in interpreting cases. It's a medical device for direct patient treatment. The study design focused on the patient's self-reported improvement in symptoms.

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

Yes, the effectiveness study (OCUN-010) evaluated the device's performance standalone, meaning its direct effect on patients (human-with-device) without a human interpreter in the loop. The device itself is the "standalone" treatment. The study assessed the device's ability to improve dry eye symptoms through neurostimulation. While patient training was involved, the performance being measured was that of the device and the patient's physiological response, not an AI algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used

The primary ground truth used was patient-reported outcomes data, specifically the Ocular Surface Disease Index (OSDI). Clinically meaningful change was defined using published Minimal Clinically Important Difference (MCID) thresholds from Miller et al. (Arch Ophthalmol. 2010;128(1):94-101).

8. The Sample Size for the Training Set

No separate "training set" is mentioned in the context of clinical efficacy for this device. The clinical trials (OCUN-009 and OCUN-010) are described as pivotal studies for effectiveness and safety. For software development and validation, specific training set information is not provided, but it states "The submission contained all the elements of software documentation corresponding to the "Moderate" level of concern, as outlined in the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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

As there's no explicitly defined "training set" for clinical efficacy in the provided text, this question is not directly applicable. For software ground truth, internal specifications and hazard analyses would have guided the verification and validation (V&V) testing.

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The XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

The XEN Glaucoma Treatment System consists of the XEN45 Gel Stent preloaded into the XEN Injector. The XEN45 Gel Stent is composed of a gelatin derived from porcine dermis, formed into a tube, and then cross-linked with glutaraldehyde. The inside diameter of the tube is approximately 45 um, its outside diameter is approximately 150 um, and it has a length of approximately 6 mm. The XEN45 Gel Stent creates a permanent channel through the sclera allowing aqueous flow from the anterior chamber to the subconjunctival space.

The XEN45 Gel Stent is preloaded into an injector designed to place the XEN45 Gel Stent in the intended position. The injector with the preloaded implant is sterilized via gamma irradiation and is provided sterile. The injector is discarded after a one-time use.

The document provided is a 510(k) summary for a medical device (XEN Glaucoma Treatment System) and details the performance data used to demonstrate substantial equivalence to predicate devices, rather than formally outlining acceptance criteria for AI/ML-based device performance and a study proving it meets those.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training, training set build) are not applicable or cannot be extracted from this document, as they relate to AI/ML device validation, which is not the subject of this 510(k) summary.

However, I can extract information related to the clinical effectiveness and safety evaluation of the XEN Glaucoma Treatment System, which serves as its "performance data" in this context.

Here's an attempt to structure the available information relevant to "acceptance criteria" and "device performance" as per the document provided, interpreting "acceptance criteria" as the measures of effectiveness and safety used to demonstrate equivalence.

Device: XEN Glaucoma Treatment System

Study Type: K161457 510(k) Premarket Notification - demonstrating substantial equivalence to predicate devices.

Interpretation of "Acceptance Criteria" for this device: For this type of medical device (an aqueous shunt), acceptance criteria are primarily demonstrated through clinical effectiveness in lowering intraocular pressure (IOP) and an acceptable safety profile, comparable to legally marketed predicate devices. The "performance data" presented is the evidence that these clinical objectives were met.

1. Table of "Acceptance Criteria" (Effectiveness and Safety Measures) and Reported Device Performance

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The Natrelle® 133 Plus Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Natrelle® 133 Plus Tissue Expanders are designed to develop tissue flaps as part of 2stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, an orientation line, three suture tabs (optional), a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.

The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The provided text is a 510(k) summary for the Natrelle® 133 Plus Tissue Expander, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria based on a clinical study for AI or diagnostic performance. Instead, it focuses on non-clinical performance data and technological characteristics.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is not applicable to this document. This document does not describe a study proving a device meets acceptance criteria related to AI or diagnostic performance.

Explanation based on the provided text:

• Type of device: The Natrelle® 133 Plus Tissue Expander is a physical medical device (tissue expander made of silicone elastomer) used for breast reconstruction, scar revision, and tissue defect procedures. It is not an AI or diagnostic software/device.
• Purpose of the 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
• Performance Data mentioned: The document states: "Non-clinical performance data were submitted to support the substantial equivalence of the Natrelle® 133 Plus Tissue Expander to the predicate device. These data included biocompatibility data and mechanical testing data. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met."

This refers to engineering and material testing (e.g., strength, durability, biocompatibility), not clinical diagnostic accuracy or AI performance. The "acceptance criteria" here would be specific thresholds for these physical properties and material safety, not metrics like sensitivity, specificity, or AUC for an AI model.

In summary, as this document pertains to a physical medical device and a 510(k) submission focused on substantial equivalence through non-clinical testing, the requested information about AI/diagnostic study setup is not present.

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SERI™ Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.

SERI™ Surgical Scaffold is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from silk that has been BIOSILK™ purified to yield ultra pure fibroin. The device is a mechanically strong and biocompatible bioprotein. SERI™ Surgical Scaffold is a sterile, single use only product and is supplied in a variety of sizes ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI™ Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction. SERITM Surgical Scaffold is designed to slowly bioresorb in parallel to neovascularization and native tissue ingrowth which results in eventual replacement of As bioresorption occurs, load bearing responsibility is SERI™ with native tissue. transferred to the new tissue ingrowth such that mechanical integrity is maintained at the site.

The provided document is a 510(k) summary for the Allergan SERI™ Surgical Scaffold. This document is a regulatory submission for a medical device and describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies to meet acceptance criteria, sample sizes, expert qualifications, or ground truth establishment for an AI/algorithm-based device.

Therefore, I cannot extract the requested information from the provided text as it pertains to a traditional medical device (surgical scaffold) and not an AI/algorithm-driven device that would involve such performance metrics and studies.

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