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Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.

The provided text is a 510(k) summary for the Sofsilk™ Coated Braided Silk Suture. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain information about an AI/ML-based device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not discussed in the provided document. The document describes a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence, primarily through bench testing for physical and mechanical performance, and biocompatibility.

The "study" mentioned refers to mechanical and physical bench tests of the suture, not a clinical or AI performance study.

Here's what the document does provide regarding the device's performance evaluation:

• Acceptance Criteria (implied standards compliance):

  • Meets or exceeds requirements of U.S.P. (United States Pharmacopeia) for nonabsorbable surgical sutures.
  • Meets or exceeds requirements of E.P. (European Pharmacopeia) for nonabsorbable surgical sutures.
  • Compliant with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing" for biocompatibility.
  • Sterility Assurance Level (SAL) of 10^-6 for ETO sterilization.

• Reported Device Performance (bench tests):

  • USP/EP diameter: Tested, found equivalent to predicate.
  • USP needle attachment: Tested, found equivalent to predicate.
  • USP tensile strength: Tested, found equivalent to predicate.
  • Biocompatibility: Evaluated and confirmed compliant with ISO 10993-1 for its intended patient contact profile.
  • Shelf life: Stability studies conducted, proposed 5-year shelf life demonstrated.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that there was no clinical study, let alone one involving AI/ML performance.

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The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).

The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.

This FDA 510(k) summary for the Signia™ Circular Adapter (K240881) does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The device in question, the Signia™ Circular Adapter, is a surgical stapler component. The document describes its physical and functional characteristics, and the non-clinical testing performed to establish its substantial equivalence to a predicate device. This testing primarily focuses on device performance, safety, and manufacturing quality, not on the performance of a diagnostic or therapeutic AI/software.

Therefore, I cannot provide a response to your request, as the provided input does not include the details regarding acceptance criteria for an AI/SaMD or a study to demonstrate its performance.

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The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement.

Features and benefits:

• Fully enclosed sensor helps ensure patient safety
• Satin Slip™ finish for easy insertion ●
• Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

• 1. Tube Blue
• 2. Sleeve GP
• 3. Thermistor Assembly
• 4. Slurry Mixture

The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A".

A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device.

Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.

The provided text is a 510(k) summary for the Mon-a-Therm™ General Purpose Temperature Probe 400TM. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on benchtop performance testing and adherence to relevant standards. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts for image analysis.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, and studies involving human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies, are not applicable or described in this document.

However, based on the provided text, I can infer the acceptance criteria for the temperature probe's performance and what demonstrates that the device meets those criteria for certain aspects, primarily focusing on its temperature measurement accuracy.

Here's a breakdown of the available information:

Implied Acceptance Criteria and Reported Device Performance for the Mon-a-Therm™ General Purpose Temperature Probe 400TM

Since this is a thermal probe and not an AI/ML device, the acceptance criteria are not for diagnostic performance metrics like sensitivity, specificity, or AUC, but instead for physical and performance characteristics of a temperature measurement device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that the subject device (Mon-a-Therm™) has been updated to align with the latest regulation EN ISO 80601-2-56:2017, which expanded the required temperature range.

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VLFT10GEN: The Valleylab FT10 energy platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.

Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN): The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN): The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.

Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

The provided text is a 510(k) summary for a medical device, the Valleylab™ FT10 Energy Platform Software Version 5.0. It describes the device, its intended use, a comparison to a predicate device, and performance data. However, this document does not contain details about a study evaluating a device based on AI/ML. Instead, it describes an electrosurgical generator and highlights performance data related to electrical safety, EMC, software verification/validation, and mechanical testing.

Therefore, I cannot extract information pertaining to:

1. A table of acceptance criteria and the reported device performance regarding AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The document refers to "acceptance criteria" for engineering and safety tests, not for AI performance.
2. Sample sizes used for the test set and the data provenance for AI/ML evaluation.
3. Number of experts used to establish the ground truth for an AI/ML test set and their qualifications.
4. Adjudication method for an AI/ML test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
8. The sample size for the training set for an AI/ML algorithm.
9. How the ground truth for the training set was established for an AI/ML algorithm.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means that no clinical studies (which would typically involve human readers for an MRMC study or large datasets for standalone AI performance) were conducted or included in this 510(k) submission. The "Software verification and validation testing" mentioned is general software quality assurance, not specific to AI/ML model performance.

In summary, the provided text does not contain the information requested about AI/ML device performance and testing.

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The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772.

The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.

This document pertains to the 510(k) premarket notification for the Valleylab™ SM Smoke Management Pencil and accessories. It's important to note that this device is a physical electrosurgical tool and does not contain an AI component. Therefore, much of the requested information regarding acceptance criteria and studies for AI-driven devices (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training set details) is not applicable here.

However, I can extract and present the acceptance criteria and performance testing conducted for this device, which are relevant to its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The substantial equivalence determination for the Valleylab™ SM Smoke Management Pencil and accessories is based on meeting various performance standards and demonstrating safety and efficacy comparable to its predicate device (Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772).

Here's a summary of the performance testing and their acceptance criteria, as reported in the 510(k) summary:

Study Details Regarding Acceptance Criteria (as applicable to a non-AI medical device)

Given that this is a 510(k) submission for an electrosurgical pencil and accessories, and not an AI-driven device, the detailed questions regarding AI study methodology are largely not applicable. However, I will address what is known from the provided text for each point:

1. A table of acceptance criteria and the reported device performance: See the table above.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • The document does not specify exact sample sizes for each test (e.g., number of units tested for sterilization, biocompatibility, electrical safety, or bench performance).
   • The data provenance is not explicitly stated in terms of country of origin but is from Covidien LLC, a Medtronic company. The tests would be prospective in nature, as they involve testing the actual device prototypes or production samples against established standards.
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 for this type of device testing. Ground truth (e.g., sterility, electrical safety, mechanical integrity) is established by adherence to recognized international and national standards, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device performance against technical standards is typically assessed through objective measurements, not human adjudication.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, "ground truth" refers to the objective, measurable parameters defined by recognized international and national standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety and EMC, ASTM for packaging and shelf-life).
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In conclusion, the Valleylab™ SM Smoke Management Pencil and accessories have undergone rigorous non-clinical performance evaluations against established medical device standards to demonstrate substantial equivalence to a predicate device. The nature of this product as a physical electrosurgical tool means that many of the AI-specific questions are not relevant.

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Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea.
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.

The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

This document is a 510(k) Summary for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP, and it details the device's substantial equivalence to predicate devices, supported by performance data.

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

1. 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)

• Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It states that "terminally sterilized samples" were tested. For biocompatibility, it mentions "testing was performed on final finished subject device" for sizes 8.5mm to 10.0mm, and testing from the predicate device was leveraged for sizes 3.0mm to 8.0mm.
• Data Provenance: The document does not provide details on data provenance such as country of origin or whether the studies were retrospective or prospective. It describes laboratory bench testing and biocompatibility testing.

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

This section is not applicable as the document describes bench testing and biocompatibility assessments, which do not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies do. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified international standards.

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

Not applicable. As stated above, this pertains to objective bench and biocompatibility testing following established international standards, not clinical adjudication by experts.

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. A MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool.

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

Not applicable. This device is an endotracheal tube; it does not involve an algorithm or AI.

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

The "ground truth" for the performance data in this submission consists of the acceptance criteria defined by international consensus standards (ISO 5361, ISO 5356, ISO 18190, ISO 10993-1) and specific test protocols for mechanical properties, biocompatibility, and sterilization, along with human factors standards (EN 62366-1).

8. The sample size for the training set

Not applicable. This document describes the clearance of a physical medical device (an endotracheal tube), not a machine learning model that requires a training set.

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

Not applicable. See point 8.

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The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility.

For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.

The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.

For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.

The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.

The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis.

The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC).

The BIS™ Advance Monitor displays:

• The current BIS™ number .
• . Raw EEG waveforms in real time
• . Various signal quality indicators (EMG. SQI)
• 트 Trend graphs of processed EEG parameters (including various options)
• I Processed EEG variables:
  • . Electromyography (EMG)
  • Signal Quality Index (SQI)
  • . Suppression Ratio (SR)
  • . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only)
  • . Suppression Time (ST)
  • I Spectral Edge Frequency (SEF)
  • Median Frequency (MF)
  • EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only)
• I Alarm Indicator and Messages

The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor.

For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows:

A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.

The acceptance criteria for the BIS™ Advance Monitoring System are primarily related to its proposed changes: a narrowed indication for use and a new monitor design. The submission aims to demonstrate substantial equivalence to the predicate device (BIS EEG Vista Monitor System and BISX, K072286).

Here's an analysis of the acceptance criteria and the studies presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating that the new device's performance is equivalent or better than the predicate, especially for the new monitor design, and that the narrowed indications for use are clinically supported.

However, based on the comparative effectiveness study for the Indications for Use, we can infer some performance aspects:

2. Sample Size for the Test Set and Data Provenance

• OLIVER Study (Adults):
  • Sample Size: 143 subjects
  • Data Provenance: Multicenter, prospective study conducted across 3 sites in the United States.
• BTIGER Study (Pediatrics):
  • Sample Size: 170 subjects
  • Data Provenance: Multicenter, prospective, randomized control study conducted across 8 sites in the United States.

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

The document does not detail the number or qualifications of experts used to establish ground truth for the clinical studies. However, for studies involving "level of consciousness" and "unresponsiveness to verbal command" in the OLIVER study, and "anesthetic administration" in the BTIGER study, licensed healthcare practitioners would have been involved in assessing these clinical endpoints. The studies were conducted under the "direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use," as stated in the Indications for Use.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies.

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

• Was an MRMC study done? The document describes two clinical studies (OLIVER and BTIGER) that compare BIS™ guidance to standard practice or assess the correlation of BIS™ with clinical endpoints. While these are comparative studies, they are not framed as "multi-reader multi-case" studies in the typical sense of AI-assisted image interpretation. The comparison is between a device-guided approach and non-device-guided approaches or correlation with physiological states, rather than human readers interpreting cases with and without AI assistance.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable in the traditional MRMC context, as the studies are not designed to measure improved human reader performance with AI assistance for interpretation. Instead, the BTIGER study showed that the BIS™ guided treatment group achieved statistically significantly lower end-tidal sevoflurane administration compared to the standard practice group, indicating a direct effect on patient management rather than an improvement in human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The core of the BIS™ Advance Monitoring System is mentioned as processing raw EEG signals to produce a single number, the Bispectral Index (BIS value), which correlates with the patient's level of hypnosis. The device also displays raw EEG waveforms, signal quality indicators, and processed EEG parameters. The clinical studies (OLIVER and BTIGER) inherently evaluate the performance of this algorithm output (BIS Index) in a clinical setting, effectively testing its "standalone" diagnostic utility in influencing anesthetic administration and correlating with consciousness levels. The output (BIS index) as a predictor of consciousness or a guide for anesthetic use is evaluated.

7. Type of Ground Truth Used

• OLIVER Study: The ground truth for correlating BIS™ with the level of sedation appears to be based on clinical assessment of patient responsiveness, specifically "response to a verbal command."
• BTIGER Study: The ground truth for evaluating the impact of BIS™ guidance was the clinical outcome of "mean end-tidal sevoflurane (ETSevo) administration" during the maintenance phase of anesthesia, and the clinical decision-making by practitioners.

8. Sample Size for the Training Set

The document focuses on the performance of the current BIS™ algorithm and its new monitor. It states that "no software changes were performed to the BISx/BISx4 module (the unit that performs the computation for EEG acquisition), the BIS algorithm nor to the algorithm database structure." This suggests the core BIS algorithm was developed and trained prior to this submission. The document does not provide information on the sample size for the training set of the BIS algorithm itself. It only provides information for the clinical validation studies (test sets).

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

As with the training set sample size, the document does not provide information on how the ground truth was established for the training set of the BIS algorithm, as the algorithm itself was not modified in this submission. The core algorithm's development and training would have occurred during the development of earlier versions of the BIS monitoring system (e.g., the predicate device K072286).

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The GIATM stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ staplers and cartridges with Tri-Staple™ technology are currently available in 60mm and 80 mm length. The subject device provides the thin/medium staple size. Staplers for thin/medium tissue (tan) deploy three height-progressive rows of 2.4 mm, 2.7 mm and 3.0 mm titanium staples. Each GIA™ stapler with Tri-Staple™ technology may be reloaded with a GIAT™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument. The GIA™ Stapler with Tri-Staple™ Technology is a single-use device. It is packaged and sterilized via ETO (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure.

This document is a 510(k) summary for a medical device called the "GIA™ Stapler with Tri-Staple™ Technology". It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to a legally marketed predicate device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/Software device meets acceptance criteria. The document is for a surgical stapler, which is a physical medical device, not a software or AI product.

Therefore, I cannot provide the requested information, as the input document does not contain details about an AI medical device or its validation studies.

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The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.

The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.

The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.

The MaxTack™ Motorized Fixation Device is a medical device for fixing prosthetic material to soft tissue in minimally invasive hernia repair. The FDA's 510(k) summary provides details on non-clinical performance data to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the MaxTack™ Motorized Fixation Device does not explicitly list quantitative acceptance criteria with specific thresholds alongside reported device performance. Instead, it indicates that "applicable design verification and validation activities... showed conformance to applicable technical design specifications and performance" and that the design differences from the predicate device "were found to have no impact on safety or effectiveness."

The "Summary of Studies" section outlines various performance tests conducted. While specific quantitative results are not provided in this summary document, the implication is that the device met the internal specifications and standards set for these tests to demonstrate substantial equivalence.

To illustrate, based on the document, here's a conceptual table of what acceptance criteria might have been inferred, along with the reported high-level outcome:

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes for each of the non-clinical tests (benchtop, ex-vivo, reliability, in-vivo, in-vitro studies, usability testing). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. However:

• Non-clinical (benchtop, ex-vivo, in-vitro) studies: These are typically conducted in a controlled laboratory setting (prospective by nature of setting up experiments). The document mentions a "Rat Model" for the in-vivo strength study, which is a controlled animal study.
• Usability study: These are prospective studies involving human users in a simulated or actual use environment.
• Reliability study: Typically prospective testing under defined conditions.

3. Number of Experts used to establish Ground Truth and Qualifications:

The document does not describe the use of human experts to establish ground truth for this device in the way it would for an AI/CADe device. The MaxTack™ Motorized Fixation Device is a mechanical fixation device, not an image analysis or diagnostic AI device. Therefore, the "ground truth" is established through physical, chemical, and mechanical performance testing, as well as biological response studies (e.g., biocompatibility) against established engineering specifications and regulatory standards, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a hardware/mechanical device with software control, not an AI diagnostic system requiring adjudication of interpretations. Performance is measured against physical and engineering metrics, not expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic or assistive devices, where the performance of human readers with and without AI assistance is evaluated. The MaxTack™ Motorized Fixation Device is a surgical tool, not an AI diagnostic assistant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a motorized surgical tool, not a standalone algorithm. Its "performance" is inherently tied to its mechanical and software functions as a complete system.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established through empirical data from various non-clinical tests, including:

• Pre-defined Engineering Specifications: Performance metrics (e.g., force required for tack deployment, fixation strength, battery life, dimensional tolerances) are compared against predetermined design and functional requirements.
• Biocompatibility Standards: Adherence to ISO 10993 series and FDA guidance for biological safety.
• Usability Metrics: Compliance with IEC 62366-1 regarding safety and effectiveness of use.
• Electrical Safety and EMC Standards: Adherence to IEC 60601-1 and IEC 60601-1-2.
• Sterilization and Packaging Standards: Compliance with SAL of 10-6 and packaging integrity standards (ASTM D4169, EN ISO 11607-1).
• Benchtop and In-Vitro Measurements: Direct measurements of physical properties and performance in controlled environments.
• In-Vivo (Animal Model) Outcomes: Biological responses and material degradation in a living system (rat model).

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical/software system, not a machine learning model that requires a "training set" in the context of AI. The software within the device controls the motor and tack deployment, and its "training" or development would involve traditional software engineering and validation, not machine learning model training.

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

Not applicable, as there is no "training set" in the machine learning sense for this device. The software's truth is established by its design specifications and validated through software verification and validation activities (e.g., unit testing, integration testing, system testing, compliance with IEC 62304) to ensure it correctly executes the intended functions (e.g., motor control for tack deployment, low tack count indication).

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The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.

The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

The provided document describes the Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, a direct response to your request, which focuses on acceptance criteria and studies for AI/ML devices, cannot be fully generated from the provided text.

The document does not contain information on:

• Sample sizes for test sets (training or test data)
• Data provenance (country of origin, retrospective/prospective)
• Number of experts, their qualifications, or adjudication methods for ground truth
• Multi-reader multi-case comparative effectiveness studies
• Standalone algorithm performance
• How ground truth was established for "training sets" (as this is not an ML device)

However, I can extract the acceptance criteria and the performance results for the physical device based on the information provided in the "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Study Information (Based on available document sections):

This document describes a medical device clearance for an endotracheal tube, not an AI/ML powered device. Therefore, the specific questions related to AI/ML device studies (such as sample sizes for AI training/test sets, data provenance for AI, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to the provided content.

The studies conducted were bench-top performance testing, biocompatibility testing, and a human factors/usability study to demonstrate substantial equivalence to predicate devices and compliance with relevant ISO standards.

• Type of Ground Truth Used: For the physical device, the "ground truth" is defined by compliance with established engineering and medical device standards (e.g., ISO 5361:2016, ISO 10993-1:2009, IEC 62366-1:2015) and comparison to the performance of predicate devices. There is no "ground truth" of the kind used for AI/ML validation (e.g., expert consensus on medical images or pathology results).
• Sample Size for Training Set & Ground Truth for Training Set: These concepts are not applicable as this is not an AI/ML device. The "training" for this device would be its design and manufacturing process, optimized to meet design specifications and regulatory standards.

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