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The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

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I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text is a 510(k) clearance letter for the Allura™ Vaginal Stent and does not contain information about acceptance criteria or supporting studies. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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The Platinum Depthalon® Depth Electrodes are intended for temporary (

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "PMT Platinum Depthalon Depth Electrodes". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation number.
• The indication for use of the device.
• General controls provisions and other compliance requirements for the manufacturer.
• Contact information for FDA divisions.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

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The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).

The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:

• Static magnetic field strength of 1.5-T only
• Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less
• The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times.
• The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan.
• Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)

The PMT® TruScan® Surface Electrodes are non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP).

The reusable TruScan® Surface Electrodes have a disc with a diameter of 10 mm coated with silver / silver chloride (Ag/AgCl). Each disc is permanently adhered to an insulated lead wire. An extension cable is required to connect the Truscan® Surface Electrodes to the recording equipment. The extension cable is electrically insulated and terminated by a molded touch proof connector that is compliant to the safety requirements outlined in IEC 60601-1 subclause 56.3(c).

During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes.

Numbered and color coated lead wires are provided to facilitate identification.

The electrodes are provided non-sterile and can be reused.

This 510(k) summary (K122376) describes the PMT TruScan® Surface Electrodes. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and MR compatibility conditions.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic device). Instead, the performance is detailed through technical specifications, material characteristics, and compliance with MR conditional guidelines. The "acceptance criteria" here are implied by the conformity to these specifications and the statement of MR conditions.

• Static magnetic field strength of 1.5-T only.
• Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less.
• Connector hub near center MR bore, >= 20-cm from MR system's bore wall.
• Extension cable must be disconnected before and during MR scan.
• Normal Operating Mode of MR system with max whole body averaged SAR of 2.0-W/kg for 15 minutes of scanning. |
  | Material Composition (Sensor Cup): Silver/silver chloride. | Silver/silver chloride. |
  | Cup Diameter: 10 mm. | 10 mm. |
  | Assembly to Cup Material: ABS/Carbon fiber composite. | ABS/Carbon fiber composite. |
  | Lead Wire Core Material: Nichrome. | Nichrome. |
  | Lead Wire Insulation Material: PVC. | PVC. |
  | Electrode + Cable Length: 60". | 60". |
  | Lead Wire Connection Compliance: IEC 60601-1 subclause 56.3(c).| 1.5 mm Brass/Polypropylene IEC 60601-1 subclause 56.3(c) compliant. |
  | Packaging: Non-sterile, sealed in PE pouch or equivalent. | Non-sterile, sealed in PE pouch or equivalent. |

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

The provided 510(k) summary does not contain information about a test set with a specific sample size or data provenance (e.g., country of origin, retrospective/prospective). This device is a surface electrode for physiological signal acquisition, not a diagnostic algorithm. The "testing" referred to in the document involves adherence to material specifications and MR compatibility standards, likely through engineering tests and simulations rather than patient-based clinical studies with specific sample sizes.

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

This information is not applicable and not present in the document. As mentioned above, this filing pertains to a medical device (electrode), not an AI/ML diagnostic system that would require expert-established ground truth from clinical cases. The "ground truth" for this device relates to its physical and electrical properties, and its safe use under MR conditions, which are typically verified through technical testing by engineers and physicists.

4. Adjudication Method for the Test Set

This information is not applicable and not present in the document for the reasons explained in point 3. Clinical adjudication methods (e.g., 2+1, 3+1) are relevant to the evaluation of diagnostic performance where expert disagreement needs resolution, which is not the case for this type of medical device filing.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. This type of study is specifically designed for evaluating the performance of diagnostic algorithms or imaging interpretations, often comparing human readers with and without AI assistance. The TruScan® Surface Electrodes are hardware devices for signal acquisition, not an interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (algorithm only) was not done and is not mentioned. This concept is relevant for AI/ML diagnostic algorithms, not for physical medical devices like electrodes.

7. The Type of Ground Truth Used

The "ground truth" for the PMT TruScan® Surface Electrodes relies on physical measurement, engineering testing, and compliance with recognized standards (e.g., IEC 60601-1) and MR conditional safety guidelines. This is primarily focused on:

• Material properties and composition: Verification of specified materials (e.g., silver/silver chloride, Nichrome, PVC, ABS/Carbon fiber composite).
• Dimensional accuracy: Verification of cup diameter and electrode/cable length.
• Electrical safety and performance: Adherence to standards like IEC 60601-1.
• MR compatibility and safety: Demonstration that the device meets the specified MR conditional criteria through testing following guidelines relevant to MR safety (e.g., heating, artifact generation).

8. The Sample Size for the Training Set

This information is not applicable and not present in the document. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is.

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

This information is not applicable and not present in the document for the reasons explained in point 8.

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The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

• Static magnetic field of 1.5T and 3T only .
• Maximum spatial gradient magnetic field of 720 Gauss/cm or less .
• Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities.

To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.

The provided text describes the PMT Halo System, a device for cervical immobilization. It details the device's components, materials, and its MRI compatibility. However, the document does not contain information about acceptance criteria, specifics of a study proving device performance against such criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use, particularly its MR Conditional designation.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted or inferred:

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

The document does not explicitly state "acceptance criteria" or a study proving performance against them. It states:

• Maximum spatial gradient magnetic field of 720 Gauss/cm or less
• Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning (per pulse sequence). |
  | Sterility | Skull pins, rings, and positioning pins ETO Sterilized to ANSIAAMI/ISO 11135:2007 and EN556:2001 |

Comment: The "acceptance criteria" appear to be compliance with specific ASTM and ISO standards, and safe operation under defined MRI conditions. The "reported device performance" is that the device meets these standards and conditions.

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

This information is not provided in the document. The document refers to meeting standards (ASTM F1559:1994, ANSIAAMI/ISO 11135:2007, EN556:2001) for performance and sterility, which implies testing was performed, but details of the test sets (sample size, provenance) are absent.

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

This information is not provided in the document.

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

This information is not provided in the document.

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

This is not applicable as the device described (PMT Halo System) is a physical medical device (halo system for cervical immobilization), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers with/without AI assistance would be relevant or 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 medical device, not an algorithm.

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

The "ground truth" for this type of device would likely be adherence to engineering specifications, material properties, and functionality under test conditions. The document states that the "Halo ring and skull pins meet ASTM F1559:1994" and sterility meets specific ISO standards. These standards themselves define the "ground truth" for performance.

8. The sample size for the training set

This is not applicable for a physical medical device. There is no "training set" in the context of machine learning.

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

This is not applicable for a physical medical device.

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Catalog Numbers 2110-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (

PMT Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.)

The Subdural Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is too small and or too deep within the brain to produce a recordable EEG seizure. The Subdural Cortical Electrode strip and grid electrode are used in cases where it is necessary to establish a high degree of confidence in the electrical localization (foci), seizure frequency, severity type and other electro-clinical characteristics.

Macro Electrodes use 2mm, 3mm or 4.5mm diameter platinum circular recording discs. Micro Electrodes are single wires with the distal tip exposed and flush with the surface of the silicone. They are made of the same material used in the assembly of the Electrode. The Micro electrode allow for more precise definition of the Epileptic activity. They can be used solo or in combination with Macro recording discs.

The PMT device consists of one or more electrically contacts. The model number 2110 indicates a platinum alloy wire and platinum alloy electrode contacts. The electrodes' contacts are molded into a silicone rubber matrix in a fixed pattern. Insulated wires extend from each electrode through a flexible silicone tube to connector for EEG monitoring.

The electrode material for the 2110-XXX is 90:10 platinum iridium

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity for diagnostic devices).

This submission is for PMT Subdural Cortical Electrodes, which are physical electrodes used for recording, monitoring, and stimulating electrical signals on the surface of the brain. The 510(k) process for such devices typically focuses on demonstrating substantial equivalence to existing predicate devices, primarily regarding their materials, design, technological characteristics, and intended use, rather than performance metrics like sensitivity or specificity.

Here's why the requested information isn't present in this document:

• Acceptance Criteria & Device Performance: The document states, "The technological characteristics of the product are not affected in this submission." This indicates that the device's fundamental function (recording/stimulating electrical signals) is considered equivalent to the predicate devices, and therefore, specific performance metrics for this function are not detailed or tested in this submission. The "performance" being discussed is more about the physical and electrical properties being similar to the predicate.
• No Clinical Study Details: This document does not describe any clinical trials or studies that would involve a test set, ground truth experts, adjudication, or comparative effectiveness studies (MRMC). The 510(k) process often relies on non-clinical testing (e.g., biocompatibility, electrical safety, mechanical integrity) and comparison to predicates, especially for devices like these electrodes.
• Ground Truth: For a device that records electrical signals, "ground truth" often refers to the actual physiological electrical activity. Establishing this for training or testing an algorithm based on these signals would be relevant for an AI device, but this is a physical electrode.
• Training Set: There's no mention of a training set because this is a physical device, not an AI algorithm that requires training data.

Therefore, it's not possible to populate the requested table and answer the study-related questions based on the provided text. The 510(k) summary focuses on establishing equivalence rather than presenting detailed performance study results with acceptance criteria.

If this were a submission for a diagnostic AI device, the content would be vastly different and would include the information you are asking for.

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The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

The Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in single-use 10 mL vials.

The provided text is a 510(k) summary for a medical device called Endomark™ Sterile India Ink. This is a premarket notification for a Class II medical device, and as such, it does not typically involve a detailed study with acceptance criteria and device performance as seen in clinical trials for new drug applications or more complex-device PMAs.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device, primarily through technological characteristics and, in this case, limited performance testing.

Therefore, many of the requested categories for a study proving acceptance criteria are not explicitly present in the provided document.

Here's an analysis based on the available information:

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

The document does not explicitly state acceptance criteria in a quantitative or qualitative table format that is then directly linked to reported device performance metrics in the way a clinical trial would. The "performance testing" mentioned is focused on demonstrating safety and equivalence.

The closest we can come to "acceptance criteria" and "reported device performance" from the text is:

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 mentions "clinical experience" as part of the performance testing but does not provide details on:

• Sample size used.
• Country of origin of the data.
• Whether the data was retrospective or prospective.

Given the context of a 510(k) for a relatively low-risk device, "clinical experience" might refer to data from investigator use, previous marketing of similar products, or limited observational studies, rather than a formal, large-scale clinical trial.

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

This information is not provided in the document. The concept of "ground truth" established by experts in a structured test set is not detailed here, as the submission relies on demonstrating equivalence rather than proving novel clinical efficacy with a defined ground truth.

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

This information is not provided in the document. An adjudication method is typically part of a formal clinical study design, which is not described 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

No, an MRMC comparative effectiveness study was not done. This device is an India ink marker for endoscopic use, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device is a physical marker, not an algorithm.

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

The document does not explicitly state the "type of ground truth used" in a formal sense for the "clinical experience." For a simple marker, the "ground truth" would likely be the visual confirmation by an endoscopist that the mark was successfully placed, visible, and persistent for the intended duration. However, the document does not detail how this "ground truth" was formally established or measured.

8. The sample size for the training set

This is not applicable as this device is not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above.

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The PMT SPHENOIDAL Electrode is indicated for Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain. It is not intended for long term monitoring.

The PMT Sphenoidal electrode consists of an insulated Platinum/lridum or Stainless Steel wire with an exposed distal portion used to record EEG activity. The proximal end of the wire terminates in a connector. The connector attaches to an Interconnection cable external to the patient and connected to the EEG equipment.

The PMT Sphenoidal electrode is introduced to the recording site via an introducer. Once in place, the introducer is removed leaving the electrode available for recording EEG patterns from the inferior mesial temporal lobe.

The PMT Sphenoidal Electrode is provided sterile for single use and for Intraoperative use only.

The provided text describes a Premarket Notification [510(k)] for the PMT Sphenoidal Electrode. This is a medical device submission to demonstrate substantial equivalence to a predicate device, not a study focused on establishing specific performance metrics against pre-defined acceptance criteria in the way a clinical trial or a machine learning algorithm validation would.

Therefore, many of the requested categories in the prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI performance are not applicable to this type of regulatory submission. The goal of a 510(k) is to prove equivalence, not to quantify specific performance beyond what is required for safety and effectiveness, often relying on existing standards and predicate device performance.

Here's a breakdown of the information that is available, and why other categories are not applicable:

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)

• Not Applicable. This 510(k) summary does not describe a clinical study with a "test set" in the context of performance evaluation (e.g., for an AI algorithm). The testing mentioned refers to engineering and biocompatibility tests designed to meet standards, not a specific patient data set for performance metrics.

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. There is no "ground truth" establishment in the context of expert review of data for performance evaluation described in this 510(k) summary. The ground truth for sterility and biocompatibility is established by accepted laboratory methods and standards.

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

• Not Applicable. No human adjudication of a "test set" is described for this device.

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 Sphenoidal Electrode for recording electrical signals, not an AI-powered diagnostic tool. There is no mention or relevance of an MRMC study or AI assistance.

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

• Not Applicable. This device is a physical electrode, not a standalone algorithm.

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

• The "ground truth" in this context refers to established scientific and regulatory standards for device characteristics:
  • Substantial Equivalence: Features and performance of the predicate device (Wyler Sphenoidal Electrode).
  • Mechanical Biocompatibility: ASTM, ANSI/AAMI standards.
  • Sterility: Sterility Assurance Level (SAL) of 10⁻⁶, confirmed by validated sterilization processes (ethylene oxide).
  • Pyrogen-Free: Limulus Amebocyte Lysate Test (LAL test) results.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. As above, no training set for an AI model.

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Management of hypertrophic and keloid scars.

PMT®'s Model 5100 New Beginnings™ GelShapes™ & Amend™ consist of a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing. Certain GelShapes™ & Amend™ also have reinforcement material for added strength. The silicone gel sheeting is used on hypertrophic or keloid scars in order to soften or lighten the color of these scars. The model 5100 New BeginningsTM GelShapes™ & Amend™ are used only externally and on intact skin.

The provided text is a 510(k) premarket notification for the PMT® New Beginnings™ GelShapes™ & Amend™ device, which is a silicone gel sheeting used for the management of hypertrophic and keloid scars. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria, human reader studies, or detailed ground truth methodologies typically associated with software-as-a-medical-device (SaMD) or AI-powered devices.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample sizes, expert qualifications, adjudication, MRMC, standalone performance), and detailed ground truth establishment is not present in this 510(k) submission.

Here's an attempt to answer the questions based on the available information, noting when the information is not provided:

Acceptance Criteria and Study for PMT® New Beginnings™ GelShapes™ & Amend™

This 510(k) submission (K972597) for the PMT® New Beginnings™ GelShapes™ & Amend™ device demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria through clinical studies in the way an AI/software device would. The "study" here refers to the documentation and claims made within the 510(k) to support this substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable or not specified. This 510(k) submission does not describe a specific clinical "test set" or study on patients to evaluate performance against acceptance criteria. The submission relies on the established use and safety profile of similar predicate devices.
• Data Provenance: Not applicable, as no new clinical data from a "test set" is presented in the summary for performance evaluation. The submission refers to "a number of different articles within this submission" regarding the common procedure of managing scars with gel sheeting, implying existing literature, but does not detail a specific new study's data provenance.

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

• Not applicable. As there is no specific "test set" and ground truth validation study described in the 510(k) summary, no experts were detailed for this purpose.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or adjudication process is described in the 510(k) summary.

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

• No. An MRMC study was not conducted for this 510(k) submission. This is a medical device (silicone sheeting), not an AI/software diagnostic tool that would typically involve MRMC studies to evaluate human reader performance with and without AI assistance.

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

• Not applicable. This device is a physical product (gel sheeting), not an algorithm or software. It does not have "standalone" algorithm performance. Its efficacy is based on its physical properties and interaction with biological tissue for scar management, likely supported by general understanding and existing literature on silicone gel sheeting.

7. The Type of Ground Truth Used

• Not explicitly defined. For a physical device like silicone gel sheeting, "ground truth" for efficacy would typically be established through clinical outcomes (e.g., blinded assessments of scar appearance, pliability, color, patient reported outcomes) in well-designed clinical trials. This 510(k) relies on the "common procedure" and "equivalence" to predicate devices whose efficacy is presumably well-established clinically. No specific ground truth methodology for a new study is detailed here.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set" in the computational sense.

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

• Not applicable. No training set exists for this device.

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Not Found

The PMT Depth Electrode Anchor Bolt is an accessory used in cases where it's necessary to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode during intraoperative electroclincal characterization. The PMT Depth Electrode Anchor Bolt is attached onto the skulls with the insertion of the Anchor Bolt Tapered Screw Threads into a pre-drilled burr hole, through a skin incision. Once installed on to the skull a PMT Depthalon® Depth Electrode (510(k) number K802151 and K802152) can be inserted into the Anchor Bolt Screw Cap Port Hole through the Silicone Gasket and into the cranium. The PMT Depth Electrode Anchor Bolt is made of Titanium alloy (Ti 6Al 4V) with a silicone gasket. The gasket is designed to accept the PMT Depthalon® Depth Electrode. The port hole of the PMT Depth Electrode Anchor Bolt is designed to accommodate depth electrodes with a diameter of 0.050 ± .005 inches. Additional designs will be made available to accommodate different manufactures and models of Depth Electrodes with various diameters. Once the Depth Electrode is at the intended foci, the Port Hole Screw Cap can be tightened to fixture the PMT Depthalon® Depth Electrode . The Device is designed to withstand a longitudinal ( push/ pull)100 gram force. The PMT Depth Electrode Anchor Bolt is available in 25mm, 30mm, 35mm and 40mm lengths to accommodate neurophysiologist preference. The PMT Depth Electrode Anchor Bolt is provided in a primary and secondary pouch. The pouch is a Tyvek and cellophane configuration. The Tyvek pouch with the chevron design feature provides a 1- 3 lb. pull apart strength. The PMT Depth Electrode Anchor Bolt is provided sterile or non-sterile. The type of sterilization used is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a non-sterile unit of 10°. The PMT Depth Electrode Anchor Bolt is provided pyrogen free. The method of determination is the Limulus Amebocyte Lysate Test. The Bacterial Endotoxin test is conducted as described in the USP Endotoxin Reference Standard. The pyrogen limit for the PMT Depth Electrode Anchor Bolt is 2.4 Eu/device. The PMT Depthalon® Electrode Anchor Bolt is tested for biocompatibility. The silicone gasket material has been tested per the General Program Memo # G95-1. the device is classified as an implant device, contacting tissue/ bone with an "A" class duration of contact (

Here's an analysis of the provided text in the context of acceptance criteria and a study demonstrating device performance.

Based on the provided text, there is no study described that directly proves the device meets specific acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device. The document is a 510(k) Premarket Notification summary for a physical medical device (an anchor bolt), focusing on its design, materials, sterilization, and biocompatibility.

Therefore, many of the requested fields regarding AI/diagnostic device performance studies (like sample size, ground truth, experts, MRMC studies, effect size, standalone performance, training set details) are not applicable or derivable from this document.

However, I can extract the acceptance criteria related to its physical and material properties and how some of them are "met" by stating design specifications or testing methods.

Acceptance Criteria and Reported Device "Performance" (Based on Design and Material Testing)

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The Cortac Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity or Electroencephalography (EEG) when less invasive methods do not provide the electrophysiology data necessary. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is to small and or to deep within the brain to produce a recordable EEG seizure. The Cortac Cortical Subdural strip and grid electrode are used in cases where it's necessary to establish a high degree of confidence in the electrical localization (Foci), seizure frequency, severity type and other electroclincal characteristics.

This 510(k) premarket notification describes a medical device called the "PMT Cortac Cortical Electrode," and primarily focuses on demonstrating its substantial equivalence to existing devices, rather than presenting a study proving performance against specific acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. This document is a regulatory submission for a physical medical electrode, not a software algorithm.

However, I can extract information related to what might be considered "acceptance criteria" for a physical device, and any "studies" mentioned, even if they are fundamentally different from those associated with AI.

Here's the information extracted and organized to the best of what the document provides:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device, the "acceptance criteria" are related to its physical and functional specifications, sterilization, biocompatibility, and pyrogenicity. The "performance" is reported as meeting these specifications.

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