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The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.

The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator.

Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator.

The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules.

The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.

The provided document describes a 510(k) premarket notification for the "LIFEPAK® Invasive Pressure Adapter Cable." It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general performance testing.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide the available details:

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

This information is not provided in the document. The document states "Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications." However, the specific acceptance criteria and the numerical results of these tests are not detailed.

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 provided in the document. The document only mentions "Biocompatibility Evaluation" and "Design Verification Testing" were completed.

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 document does not describe a study involving expert-established ground truth.

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

Not applicable. The document does not describe a study with 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. The device is an adapter cable, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. The device is a physical cable, not an algorithm.

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

Not applicable. The document does not describe a study that uses ground truth in this context. The "performance data" refers to engineering and biocompatibility testing.

8. The sample size for the training set:

Not applicable. The device is a physical cable, not a machine learning algorithm that requires a training set.

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

Not applicable. The device is a physical cable, not a machine learning algorithm.

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The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.

Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator.

The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.

The provided text describes a 510(k) premarket notification for Sterilizable Internal Defibrillation Paddles. It's important to clarify that this document is for a medical device (hardware), not an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training/test set sizes) are not directly applicable in the same way.

Instead, the acceptance criteria for such a device typically revolve around demonstrating substantial equivalence to a predicate device, as well as meeting established safety and performance standards through design verification and validation.

However, I will extract the information that is comparable or relevant to your questions, and specify where the requested information is not applicable for this type of device.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting design specifications related to safety and performance.

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

Non-Applicable / General Information for Hardware Devices

The following questions are primarily relevant to AI/ML software performance studies and are not directly applicable to this hardware device's 510(k) submission as described.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device in the context of AI/ML test sets. Performance testing for hardware involves laboratory, animal, and simulated use testing, not "test sets" of data in the AI/ML sense. Data sources for such tests are internal (e.g., test benches, animal studies).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML test set is not a concept used for this type of hardware device's testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a hardware device, not an AI assistance tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory to a defibrillator and requires a highly-trained medical professional for use. It is a human-operated device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a hardware device means meeting its engineering and safety specifications, and performing its intended function.
• 8. The sample size for the training set: Not applicable for hardware.
• 9. How the ground truth for the training set was established: Not applicable for hardware.

Summary of Device-Specific Study Information (Performance Data)

The submission highlights that no human clinical studies were submitted as part of this 510(k) Premarket Notification. This is typical for devices seeking substantial equivalence where predicate device experience or non-clinical data is deemed sufficient.

The performance data that supports the acceptance criteria for this hardware device includes:

• Design Verification Testing: To ensure the device meets established design specifications.
• Biocompatibility Testing: To ensure materials are safe for biological contact.
• Electrical Safety and Electromagnetic Compatibility Testing: To ensure the device operates safely within electrical and electromagnetic parameters.
• Design Validation Testing: Which encompassed:
  • Animal Testing: To evaluate performance in a living biological system.
  • Simulated Use Testing: To assess performance under conditions mimicking clinical use.

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Manual Defibrillation:
Indications: Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.

Noninvasive Pacing:
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

12-lead Electrocardiography:
Indications: The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).

Pulse Oximetry:
Indications: Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.

Noninvasive Blood Pressure Monitoring:
Indications: Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.

End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Invasive Pressure Monitoring:
Indications: Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.

Temperature Monitoring:
Indications: Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances. Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead. 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO, and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, invasive pressure monitoring, and temperature monitoring. The LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries or from AC power sources via an AC power adapter or DC power sources via a DC power adapter. The primary difference between the proposed LIFEPAK 15 monitor/defibrillator and the previously cleared predicate device is a combination of software and hardware modifications completed to support component obsolescence. The proposed LIFEPAK 15 monitor/defibrillator includes the same monitoring features, defibrillation waveform, pacing waveform, and Shock Advisory System™ algorithm as the previously cleared predicate device. Additionally, there are no changes to the intended use or indications for use of the previously cleared predicate device.

The provided text is a 510(k) Premarket Notification for the Physio-Control LIFEPAK 15 monitor/defibrillator. The document focuses on demonstrating substantial equivalence to a previously cleared device, primarily due to software and hardware modifications for component obsolescence. It does not provide detailed acceptance criteria or a specific study demonstrating performance against such criteria for the entire device's functionalities in the context of an AI/algorithm-driven medical device submission.

However, based on the information provided regarding the "Shock Advisory System™ algorithm," we can infer the aspects that would typically involve performance criteria for an automated external defibrillator (AED) algorithm.

Here's an attempt to answer your questions based on the available information, noting that much of the specific detail for AI/algorithm performance is not present in this 510(k) submission, as it predates the widespread regulatory focus on standalone AI algorithm performance studies. The Shock Advisory System™ algorithm mentioned is likely a rule-based algorithm rather than a modern AI/ML algorithm.

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

The document states: "The proposed LIFEPAK 15 monitor/defibrillator includes the same monitoring features, defibrillation waveform, pacing waveform, and Shock Advisory System™ algorithm as the previously cleared predicate device."

This implies that the performance of the Shock Advisory System™ algorithm is assumed to be equivalent to the predicate device. For AED algorithms, typical acceptance criteria would involve sensitivity (true positive rate for shockable rhythms) and specificity (true negative rate for non-shockable rhythms). While specific numerical acceptance criteria are not presented in this document for the current submission, for similar AED algorithms, these often fall within ranges like:

Study Proving Acceptance Criteria:
The document states: "No human clinical studies were submitted as part of this 510(k) Premarket Notification." Instead, the submission relies on "Performance Testing" including:

• Design Requirements Testing
• Hardware Verification
• Software Performance
• Electrical Safety and Electromagnetic Compatibility
• Design Validation via Animal Studies and Simulated Use Testing

The core claim is substantial equivalence to previously cleared LIFEPAK 15 monitor/defibrillators (K082937, K103567). The performance of the Shock Advisory System™ algorithm is explicitly stated as unchanged from the predicate device. Therefore, the "study" proving acceptance criteria for the algorithm's performance would have been conducted for the predicate devices, and the current submission relies on that prior clearance and the assertion that the algorithm itself has not changed.

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

Not provided in this document. Information on test set size and data provenance for the Shock Advisory System™ algorithm would have been part of the original 510(k) submission for the predicate devices. This document explicitly states: "No human clinical studies were submitted as part of this 510(k) Premarket Notification."

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 provided in this document. This information would be specific to the ground truth establishment for the predicate device's algorithm validation.

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

Not provided in this document. This information would be specific to the ground truth establishment for the predicate device's algorithm validation.

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 MRMC study was done or reported in this 510(k) submission. The Shock Advisory System™ algorithm in an AED is typically a standalone algorithm designed to automatically detect shockable rhythms, rather than an AI-assisted interpretation tool for human readers in the context of MRMC studies. The device is intended for use by trained medical personnel, including those using the "Automated External Defibrillation" mode, which implies the algorithm is acting as a decision-maker (shock/no shock) rather than an assistant to a human interpreter in the sense of a diagnostic imaging AI.

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

Yes, for the Shock Advisory System™ algorithm, its function in AED mode is inherently standalone in its determination of whether a rhythm is shockable or not. The document states: "Automated External Defibrillation: AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm." This "analysis" is performed by the algorithm. The performance of this standalone algorithm would have been assessed during the predicate device's clearance. This 510(k) asserts the algorithm is unchanged.

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

Not explicitly stated in this document. For AED algorithms, ground truth for rhythm classification (e.g., ventricular fibrillation, asystole, normal sinus rhythm) is typically established by:

• Expert Consensus on ECG Tracings: Review by cardiologists or emergency physicians.
• Simulated Rhythms: Using synthesized or recorded rhythm libraries with known classifications.
• Clinical Outcomes/Events: Correlation with actual patient response to therapy, though less direct for algorithm validation.

It's highly probable that expert consensus on ECG tracings was used for the predicate device.

8. The sample size for the training set

Not provided in this document. This information would be specific to the development and validation of the Shock Advisory System™ algorithm for the predicate devices. Modern AI/ML algorithms often have very large training sets; for the kind of algorithms in AEDs cleared in 2009/2011, training sets might have been smaller, focusing on diverse representations of specific arrhythmias.

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

Not provided in this document. Similar to question 7, ground truth for the training set (if applicable, as the algorithm might be rule-based rather than machine learning trained) would have been established by expert review of ECG tracings or use of labeled rhythm databases.

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The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. Thev are intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.

Indications for Use (for both the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors):

Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 (and LIFEPAK 20e) defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors were designed especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. Features of the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are powered by AC power and a backup internal battery. The LIFEPAK 20 defibrillator/monitor utilizes a nickel-metal hydride internal battery while the LIFEPAK 20e defibrillator/monitor utilizes a lithium-ion internal battery. The LIFEPAK 20e defibrillator/monitor also has a battery status indicator on the device screen.

In addition to the features described above, the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors have a new CO2 monitoring feature, CPR metronome feature, wireless data transmission capability and a new optional accessory named the CodeManagement Module™.

This document describes the Physio-Control LIFEPAK® 20 defibrillator/monitor and LIFEPAK® 20e defibrillator/monitor. The notification focuses on a new CO2 monitoring feature and a CPR metronome feature added to these existing devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the new features in the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are similar to the CO2 monitoring and CPR metronome features in the predicate LIFEPAK 15 monitor/defibrillator.

The conclusion of testing states: "The information in this 510(k) notification demonstrates that the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are substantially equivalent to the predicate LIFEPAK 20 defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and the LIFEPAK 15 monitor/defibrillator with respect to safety, effectiveness, and performance."

Since the primary claim for the new features is substantial equivalence to existing predicate devices, the "acceptance criteria" are implicitly met by demonstrating that the new features function comparably to the predicate device, the LIFEPAK 15 monitor/defibrillator. The provided text does not explicitly list quantitative acceptance criteria for the CO2 monitoring or CPR metronome features, nor does it provide a table of "reported device performance" in terms of specific metrics like accuracy, sensitivity, or specificity for these new features. Instead, it relies on the established performance of the predicate device.

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

• Sample Size: Not specified. The document states "Performance testing of the proposed devices consisted of bench testing."
• Data Provenance: Not specified, but generally, bench testing would involve laboratory-generated or simulated data. It does not mention real patient data or country of origin.
• Retrospective/Prospective: Not applicable as no clinical studies were performed.

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

• Not applicable. No experts or ground truth establishment relevant to algorithm performance (like image interpretation) using a test set is described. The evaluation was bench testing based on substantial equivalence.

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

• Not applicable. No human adjudication for a test set is described.

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

• No. The document explicitly states: "No clinical studies or non-clinical (i.e. animal) studies were submitted as part of this 510(k) notification." This means no MRMC study was conducted.

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

• Yes, in a sense, as the performance testing described as "bench testing" would evaluate the device's CO2 monitoring and CPR metronome features independently, likely against known physiological parameters or simulated conditions. However, the exact methodology and metrics are not detailed beyond "bench testing."

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

• For "bench testing," the ground truth would typically be established by known, controlled inputs (e.g., a gas mixture with a specific CO2 concentration, or a mechanical device simulating CPR compressions at a known rate). The document does not specify the exact nature of the ground truth for the bench testing, but it would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. The document describes a 510(k) submission for device modifications (CO2 monitoring and CPR metronome) based on substantial equivalence to a predicate device. It is not an AI/ML algorithm requiring a training set in the conventional sense. The features are presented as being "similar to" those in the predicate, implying established engineering principles and likely internally validated existing algorithms from the predicate device.

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older.

The TrueCPR coaching device provides rescuers with real-time feedback on chest compressions during cardiopulmonary resuscitations (CPR) in accordance with current guidelines.

This device is a CPR coaching device, meaning it provides real-time feedback on chest compressions. The provided text, however, focuses on administrative information related to the 510(k) submission and does not contain detailed information about the specific acceptance criteria or the study that demonstrates the device meets these criteria.

Therefore, for aspects related to precise performance metrics, sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies, the information is not available in the provided text. The text states that the 510(k) includes documentation related to verification and validation activities but does not elaborate on their specifics.

Based on the provided snippets, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text. The submission mentions "Performance Standards" and "verification and validation activities supporting the safe and effective use of TrueCPR," but it does not detail specific quantitative acceptance criteria or the device's reported performance against them (e.g., accuracy of depth measurement, rate measurement, etc.).

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

This information is not available in the provided text. The document refers to "Bench Testing (Comprehensive verification testing)" and "Simulated Use Testing" but does not specify the sample sizes or data provenance for these tests.

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

This information is not available in the provided text.

4. Adjudication method for the test set

This information is not available in the provided text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is a "coaching device" to assist rescuers, not an AI-assisted diagnostic tool that would typically involve "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply here in the typical sense of interpreting medical images or data.

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

The device is explicitly a "coaching device" intended to "provide feedback to assist rescuers," which inherently implies a human-in-the-loop scenario. The text does not describe any standalone algorithm-only performance testing in the context of interpretation or diagnosis. However, "bench testing" and "simulated use testing" would likely involve evaluating the device's ability to accurately measure and provide feedback on CPR parameters independently, but these are not referred to as a "standalone algorithm performance" in the context of diagnosis.

7. The type of ground truth used

The text does not explicitly state the type of ground truth used for specific performance evaluations. For a CPR coaching device, ground truth would typically refer to accurate measurements of compression depth, rate, recoil, etc., obtained through high-precision sensors or standardized testing apparatus in a laboratory or simulated environment, rather than expert consensus, pathology, or outcomes data, which are more common for diagnostic devices.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

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Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. .

The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.

The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.

ECG Monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring

The LIFPAK 1000 defibrillator is a semi-automatic defibrillator with optional manual mode and ECG display. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. There are 3 modes of operation for the LIFEPAK 1000 defibrillator: AED mode (automated external defibrillation), manual mode (operator ECG interpretation, operator control of charge and shock functions), and ECG mode (ECG display allows for rhythm and heart rate monitoring). The currently marketed LIFEPAK 1000 defibrillator is powered by a non-rechargeable lithium-manganese battery.

The proposed LIFEPAK 1000 defibrillator has the same features and functions as the predicate LIFEPAK 1000 defibrillator with an additional battery option - a rechargeable lithium-ion battery.

The provided document is a 510(k) summary for the LIFEPAK 1000 defibrillator, seeking substantial equivalence to a previously cleared device. The key information is that the only change is the addition of a rechargeable lithium-ion battery option. The document explicitly states that the "defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed LIFEPAK 1000 defibrillator are unchanged from the previously cleared LIFEPAK 1000 defibrillator."

This directly implies that no new clinical studies were conducted to prove device performance or meet acceptance criteria related to its core defibrillation or ECG analysis functions. The substantial equivalence is based on the fact that these critical functional components remain identical to the predicate device, and new testing was likely focused on the safety and performance of the new battery option (though specifics of this testing are not detailed in this summary).

Therefore, this document does not contain the information required to answer most of your questions about acceptance criteria and associated studies for the device's functional performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states that the defibrillation waveform and ECG analysis system are unchanged from the predicate device. It does not provide acceptance criteria or performance metrics for these functions for the current submission, nor does it refer to specific studies done for this submission.

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

• Cannot be provided. No clinical performance test set details are presented for the updated device in this submission.

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

• Cannot be provided. No clinical performance test set details are presented.

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

• Cannot be provided. No clinical performance test set details are presented.

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:

• Cannot be provided. This device is an external defibrillator, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant here.

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

• Cannot be provided. While defibrillators have algorithms for AED mode, no specifics of standalone algorithm performance studies are described in this summary for the updated device. The document emphasizes the unchanged nature of the ECG analysis system from the predicate.

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

• Cannot be provided. No specific studies requiring ground truth establishment are detailed for this submission.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is discussed in this submission.

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

• Cannot be provided. No training set is discussed.

Summary of available information:

• Device: LIFEPAK 1000 defibrillator
• Change: Addition of a rechargeable lithium-ion battery option.
• Justification: Substantial equivalence based on the core functional components (defibrillation waveform, ECG analysis system, monitoring and defibrillation features) being unchanged from the predicate device (K042404).
• Conclusion: The 510(k) notification argues that due to the only change being a battery option and the core functions remaining identical to a previously cleared device, the updated device is substantially equivalent to the predicate, implying that specific clinical performance studies for defibrillation efficacy or ECG analysis were not required for this particular submission.

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The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients.

Automated external defibrillation mode is intended for use on patients eight years of age and older.

Indications for Use:

Manual Defibrillation:
Indications
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.

Noninvasive Pacing
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).

Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.

Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.

End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Invasive Pressure Monitoring:
Indications
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.

Temperature Monitoring:
Indications
Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances.

Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninyasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO. and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring and invasive pressure monitoring. The existing LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries.

The proposed LIFEPAK 15 monitor/defibrillator includes all of the same features and functions as the predicate device plus 2 new features: 1) temperature monitoring and 2) auxiliary power. The temperature monitoring feature allows continuous monitoring of body temperature with the use of temperature probes. The temperature reading can be trended and displayed on the LIFEPAK 15 monitor/defibrillator screen. The temperature trend graph can also be printed or saved and transmitted to the Physio-Control CODE-STAT" software for post event review.

The new auxiliary power feature gives users an additional option for powering the LIFEPAK 15 monitor/defibrillator. In addition to the existing rechargeable lithium-ion batteries, users will have the option to operate their device from AC power sources via an AC power adapter or from DC power sources via a DC power adapter. The LIFEPAK 15 monitor/defibrillator charges installed batteries when connected to auxiliary power.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria for the new features (temperature monitoring and auxiliary power). Instead, it states: "The information in this 510(k) notification demonstrates that the LIFEPAK 15 monitor/defibrillator is substantially equivalent to the predicate LIFEPAK 15 device with respect to safety, effectiveness, and performance." This implies that the new features are considered substantially equivalent to existing, cleared technologies and thus a comprehensive study with acceptance criteria might not have been performed or documented in this summary.

Here's a breakdown of what can be inferred and what is missing, based on your requested information:

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

This information is not provided in the document. The document primarily focuses on describing the device, its intended use, and its equivalence to a predicate device.

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

This information is not provided. As no specific study proving the device meets acceptance criteria for the new features is detailed, there's no mention of a test set, its sample size, or data provenance.

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

This information is not provided.

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

This information is not provided.

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 is a monitor/defibrillator adding temperature monitoring and auxiliary power, not an AI-assisted diagnostic tool for human readers.

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 medical monitoring and intervention device, not an algorithm being tested in a standalone capacity.

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

This information is not provided.

8. The sample size for the training set:

This information is not provided.

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

This information is not provided.

Summary of available information regarding acceptance criteria and studies:

The document concludes with: "The information in this 510(k) notification demonstrates that the LIFEPAK 15 monitor/defibrillator is substantially equivalent to the predicate LIFEPAK 15 device with respect to safety, effectiveness, and performance." This statement suggests that the new features (temperature monitoring and auxiliary power) were likely evaluated against established standards for vital sign monitoring and power supply systems, rather than requiring a new, extensive clinical study with specific acceptance criteria outlined in this summary. The "substantial equivalence" argument is the primary method used to demonstrate that the device with these new features is safe and effective.

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Manual Defibrillation:
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for postdefibrillation recovery analysis.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring:
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.

The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments. critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either AC power or battery power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring.
The proposed LIFEPAK 12 defibrillator/monitor has the same features and functions as the predicate LIFEPAK 12 defibrillator/monitor and includes an additional battery option; a rechargeable lithium-ion battery. Use of the proposed lithium-ion battery in the LIFEPAK 12 defibrillator/monitor provides an increase in the available operating time and an increase in the number of 360-Joule discharges available while on battery power as compared to using the existing batteries.

The provided document is a 510(k) Premarket Notification for the Physio-Control Inc. LIFEPAK 12 defibrillator/monitor. It focuses on demonstrating substantial equivalence to a predicate device due to the addition of a new battery option (rechargeable lithium-ion battery).

However, the document does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way medical device AI submissions typically do. This submission is for a hardware modification (battery) to an existing device, not a new or modified AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truthing, sample sizes for test and training sets, and MRMC studies is not applicable or cannot be extracted from this document.

Here's what can be gathered, and an explanation of why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission focuses on substantial equivalence based on a hardware change (battery) where the core functionalities (defibrillation waveform, ECG analysis, monitoring, and defibrillation features) remain unchanged from the predicate device.

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

Not applicable. There isn't a "test set" in the context of evaluating an AI algorithm's performance against ground truth. The testing mentioned would have been related to the safety and performance of the new battery option within the existing device.

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

Not applicable. There is no AI algorithm being evaluated against a ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size:

Not applicable. This document does not describe the evaluation of an AI algorithm's impact on human reader performance.

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

Not applicable. There is no standalone AI algorithm being evaluated.

7. The Type of Ground Truth Used:

Not applicable.

8. The Sample Size for the Training Set:

Not applicable. There is no AI algorithm being trained.

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

Not applicable.

Summary of what the document does state:

• Device: LIFEPAK 12 defibrillator/monitor with a new rechargeable lithium-ion battery option.
• Change: The only difference is an additional rechargeable lithium-ion battery.
• Impact of Change: The new battery provides an increase in available operating time and an increase in the number of 360-Joule discharges compared to existing batteries.
• Unchanged Features: The defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed device are unchanged from the previously cleared predicate LIFEPAK 12 defibrillator/monitor.
• Conclusion: The submission demonstrates that the LIFEPAK 12 defibrillator/monitor with the new battery is "substantially equivalent to the predicate LIFEPAK 12 device with respect to safety, effectiveness, and performance." This substantial equivalence is the primary "acceptance criterion" for a 510(k) submission, and the "study" is the documentation proving this equivalence through testing relevant to the battery's performance and safety within the device, although specific details of those tests are not in this summary.

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The LIFENET System is an optional data transmission system that provides the capability to transmit real time 12-Lead ECG reports and other physiological data to a receiving destination at a remote location. Data received from the field can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

The system is an optional data transmission system that is used in conjunction with monitoring devices. The system provides real time data transfer from the originating/transmitting device to a user selected remote receiving destination (RD). The users of the LIFENET System are qualified medical professionals and include Advanced Life Support providers (e.g. Paramedics) and Basic Life Support providers (e.g. Emergency Medical Technicians) in a variety of hospital and pre-hospital settings. The system is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical, clinics, physician offices, and cardiac catheterization labs). The system is also used for hospital transport (air and ground ambulance, in-hospital transport, etc). The modified system includes optional data management features that provide the user with expanded data management capabilities and increased efficiencies. Additionally, a new feature, the LIFENET Consult, provides users the capability to forward unattered patient information for review and comment, by initiating a clinician consult. Upon receipt of patient data, health care professionals, using a hand held wireless device are able to view patient information and provide a "consult" reply to the hospital user intended for purposes of diagnosis, disposition, and therapy decisions.

The provided text describes a 510(k) premarket notification for the Physio-Control Inc LIFENET System. This system is an optional data transmission system for physiological monitors, allowing real-time transfer of 12-lead ECG reports and other physiological data. The text explicitly states that the "modified LIFENET System performs and functions in the same manner as the predicate system" and that its "Technological Characteristics" are similar to the previously cleared predicate device.

The FDA 510(k) submission process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device (LIFENET System (K093925)). When substantial equivalence is claimed through this pathway, the focus is often on comparing the new device's technological characteristics and performance to the predicate device, rather than requiring new clinical studies to establish independent acceptance criteria and performance against a gold standard for specific diagnostic or therapeutic outcomes.

Therefore, the provided document DOES NOT contain information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• A standalone algorithm-only performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document's conclusion states: "The information in this 510(k) demonstrates that the modified LIFENET® System is substantially equivalent to the predicate LIFENET System with respect to safety, effectiveness, and performance." This indicates that the demonstration of effectiveness relied on showing similar functionality and performance to the predicate device, not on new studies specifically establishing performance against explicit acceptance criteria.

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The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illiotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

The FOOTPRINT RCX PK Suture Anchor is a suture anchor manufactured from PEEK polymer. The screw-in anchor can be loaded with up to four strands of suture and facilitates arthroscopic repair of soft tissue to bone. The design allows the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.

This document is a 510(k) summary for a medical device (Suture Anchor), not a study analyzing the performance of an AI/ML diagnostic device with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present. This document describes the device itself and its equivalence to a predicate device.

However, I can extract the information that is available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not provided in the document as it's not applicable to this type of submission):

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

Explanation Based on Document Type:

This document is a 510(k) Premarket Notification for a suture anchor, which is a physical medical device. The "performance testing" mentioned in the document refers to engineering and biomechanical tests (e.g., insertion force, pull-out strength, material properties) to demonstrate that the new device performs equivalently to a previously cleared predicate device. It is not a study involving diagnostic accuracy, therefore, the concepts of "test set," "ground truth," "experts," "AI," or "MRMC studies" are not applicable here. The "acceptance criteria" discussed would pertain to engineering specifications and regulatory requirements for proving substantial equivalence to a predicate device.

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