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SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.

The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.

Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.

The provided text is a 510(k) summary for the Arrow SnapLock Catheter Adapter. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document outlines performance testing for the new device to show it meets specific "acceptance criteria." However, it is not a study that proves a device meets acceptance criteria in the context of medical AI/imaging devices, which typically involves clinical studies with human readers, ground truth establishment, and statistical analysis of performance metrics like sensitivity, specificity, AUC, etc.

The acceptance criteria and performance data described here are for mechanical and material properties of a medical device (a catheter adapter), not for an AI/imaging diagnostic device. Therefore, many of the requested points in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document's content.

Here's an interpretation based on the provided document, addressing the applicable points:

Device: Arrow SnapLock Catheter Adapter (a non-AI medical device; specifically, an adapter for pain management and nerve block catheters)
Purpose of the Study (as described in the document): To demonstrate substantial equivalence to predicate devices through performance testing related to mechanical properties, material biocompatibility, and functional aspects.

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

The document provides tables for Biocompatibility Testing and Performance Testing with their respective acceptance criteria and results.

Table 1: Biocompatibility Testing Acceptance Criteria and Results

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The Tzoar Negative Pressure Wound Therapy (NPWT) System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System includes a pump and two types of dressings: Tzoar NPWT Foam Kits and Tzoar NPWT One Piece Dressing. The Tzoar 207 NPWT pump is a portable, battery powered pump which may promote wound healing through the drainage and removal of wound exudates, infectious material, and tissue debris from the wound bed using continuous and/or intermittent negative pressure. The Tzoar NPWT One Piece Dressing and the Tzoar NPWT Foam Kits are both Tzoar Wound Dressings intended to be used with an NPWT device to manage acute and chronic wounds.

The provided document is a 510(k) premarket notification for the Tzoar 207 Negative Pressure Wound Therapy (NPWT) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies directly, especially for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria for AI models, study design, expert ground truth, and specific performance metrics for AI will not be present in this document.

The document mainly covers the technological characteristics, performance tests of the device's physical functions, biocompatibility, and electrical safety.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the context of an overall device performance metric that would be suitable for an AI/ML device. Instead, it lists several performance tests conducted on the physical device components. The conclusion drawn from these tests is that the device is "performing as intended" and is "substantially equivalent to the predicate."

Here's a table summarizing the tests mentioned and the general conclusion:

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

The document does not describe a "test set" in the context of data for an AI/ML device. The "tests" mentioned are for the physical components and functionality of the NPWT system. The sample sizes for these physical performance tests are not specified in this summary document. Data provenance is not applicable as this is a device clearance, not an AI model clearance.

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. This device is a Negative Pressure Wound Therapy system, which is a physical medical device. It does not appear to incorporate AI/ML technology that would require expert-established ground truth on a test set of data.

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

Not applicable, as there is no mention of a test set requiring adjudication for AI/ML performance.

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

Not applicable. This device is a physical wound therapy system and does not involve human "readers" or AI assistance in interpretation.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

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

Not applicable. The "ground truth" for this device would be its ability to perform its stated functions (e.g., maintain pressure, seal, battery life) according to engineering specifications and relevant standards. This is assessed through physical performance tests, not through expert review of data or pathology.

8. The sample size for the training set

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

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

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

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The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy. The TZ Skull Pin is used during neurosurgical procedures to immobilize the head in reference to the torso and to provide cervical immobilization.

Here's a breakdown of the acceptance criteria and study information for the TZ Skull Pin Adult device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes (number of pins or animals) for each specific test in the "Summary of Performance Testing" section. It refers to testing being conducted but provides general results rather than specific numerical data for each test condition. The studies are laboratory-based and use animal models for biocompatibility tests (guinea pigs, rabbits, mice) and mechanical testing of the pins. Data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.

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

This information is not applicable and not provided in the document. The tests performed are primarily mechanical and biological (biocompatibility) evaluations based on established international standards (ASTM and ISO), not human reader evaluations or clinical trials. The "ground truth" for these tests is defined by the specific parameters and outcomes outlined in the referenced standards (e.g., absence of cell lysis, holding a load without failure).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies to establish a consensus ground truth. The tests described are objective, laboratory-based evaluations against predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The TZ Skull Pin is a physical medical device (neurosurgical skull pin), not an AI algorithm or an imaging device to be read by human experts. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant to this device's submission.

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

This information is not applicable. As explained above, this device is a physical skull pin, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (Skull Pin System Testing, Max Load Test, Creep Test) is defined by the pass/fail criteria of established engineering standards, specifically ASTM F1831-97 (implicitly referenced for performance) and the general requirement that the device performs safely and effectively without material failure or slipping.

For the biocompatibility studies (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity), the ground truth is defined by the objective criteria and endpoints specified in the relevant international ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11), such as the absence of cell lysis, dermal contact sensitization, irritation, or systemic toxicity.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this physical medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable, as there is no training set for this device.

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Classic and Speed Sintering: Fully anatomic crowns and bridges in the posterior and anterior tooth region. Bridges with max. two pontics.

Super Speed Sintering: Fully anatomic crowns.

The inCoris TZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris TZI ceramics constitute blocks comprised of zirconia ceramics (Zr)2). The blocks are initially manufactured in a partially sintered state; then, they are individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. Grinded restorations are colored by dipping the restoration in color liquid prior final sintering.

The provided document describes the Sirona Dental Systems inCoris TZI device, which is a block of zirconia ceramics used for dental restorations. The document is a 510(k) summary for premarket notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested items related to clinical study design, acceptance criteria, and performance metrics are not explicitly available in the provided text.

Here is an attempt to address your request based only on the provided information, noting where information is not present:

Acceptance Criteria and Device Performance for Sirona Dental Systems inCoris TZI

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

Based on the provided document, the acceptance criteria are primarily related to meeting material standards and demonstrating physical and chemical properties similar to a predicate device. The performance is reported in terms of these material properties.

• Complies with ISO 6872: 2008, "Dentistry -- Ceramic materials"
• Complies with ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"
• Biocompatibility according to ISO 10993-1: 2009 | - The document states: "Both devices [inCoris TZI and predicate] meet ISO 6872: 2008... and ISO 13356: 2008..."
• "The material is biocompatible according to ISO 10993-1: 2009..." |
  | Physical Properties (Final technical data of densely sintered inCoris TZI):
• Density
• Fracture toughness KIC
• Thermal expansion coefficient (20 - 500 °C)
• Bending strength | - Density: 6.08 g cm-3
• Fracture toughness KIC: 6.4 MPa m1/2
• Thermal expansion coefficient: 10.4 x 10-6 K-1
• Bending strength: > 900 MPa |
  | Chemical Properties:
• ZrO2+HfO2+Y2O3 content
• Y2O3 content
• Al2O3 content
• Fe2O3 content
• Other oxides content | - ZrO2+HfO2+Y2O3: ≥ 99.9%
• Y2O3: 5.4%
• Al2O3: ≤ 0.35%
• Fe2O3: ≤0.01%
• Other oxides: ≤ 0.2% |
  | Mechanical properties (appropriate for indications for use) | - Sintering tests performed show appropriate mechanical properties. |

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

The document explicitly states: "Clinical tests have not been performed." (Section 10).
The testing mentioned (sintering tests, physical/chemical property measurements) are laboratory-based material characterization tests. The document does not specify a "test set" in the context of clinical or human subject data, nor does it provide details on the sample size for these material tests or their provenance.

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 is not applicable as no clinical tests were performed, and therefore no human observers or experts were used to establish ground truth for a test set. The "ground truth" for the material properties was established by standard laboratory measurement methods.

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

Not applicable, as no clinical tests or human subject evaluations requiring adjudication were performed.

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

Not applicable. This device is a dental material (zirconia blocks) and not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not applicable. This device is a dental material, not an algorithm or software. Its performance is intrinsic to its physical and chemical properties.

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

For the material properties, the "ground truth" was established by standardized laboratory measurement techniques and adherence to ISO standards for dental ceramic materials (ISO 6872:2008 and ISO 13356:2008).

8. The sample size for the training set

Not applicable. This is a material product, not a machine learning algorithm, so there is no concept of a "training set" in the context of AI development.

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

Not applicable, for the same reason as above.

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The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.

Patients include, but at are not limited to, those requiring monitoring for a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy, b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.

Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded, c) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.

Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).

Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.

Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.

Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.

Data from this device may be used by another device to analyze , measure or report QT interval . The device is not intended to sound any alarms for QT interval changes.

The Aera CT is an ECG Device with auto trigger capability using MCOT compliant wireless technology for monitoring ambulatory patients with non-life threatening conditions.

The device is composed of patient (ECG) leads, monitor, and charging wall board adapter.

A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm or when the event processing event key is depressed, the data is transmitted by RF to a data storage location monitored by receiving center. The transmission may occur via Cellular RF modem, RF, or TTL via a landline telephone. The data is received and reviewed by the appropriately trained healthcare professionals or technicians. Request for additional data can be sent to MCT device via SMS text formatted message that will originate from the receiving software.

The provided document for the Aera CT device does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics, intended use, operating principles, and technological characteristics. The submission states that:

"The TZ Medical has developed tests using the same requirements that CardioNet (K072558) and (K100155) have used and stated that their devices comply with in their respective 510k submission. The TZ Medical device and the two predicated devices are tested to and comply with all applicable tests and requirements in the relevant standards as stated in this submission."

And, "TZ Medical will compile and analyze clinical test data at a trial site prior to use. Results of data will be used as part of the validation and verification data submitted with the design file. Clinical test will be conducted at facilities that are familiar with predicate devices and will submit reports verifying substantial equivalence to competitive products and on performance to specifications."

However, the specific performance data, acceptance criteria, or a detailed study report are not included in this 510(k) summary. The submission asserts compliance with standards like AAMI EC 38:2007 (Ambulatory Electrocardiographs) and ANSI/AAMI EC 57:1998 (Testing & reporting performance results of cardiac and ST-segment measurement algorithms), which would inherently imply certain performance thresholds, but these thresholds and the device's measured performance against them are not explicitly listed in the document.

Therefore, many of the requested details about acceptance criteria and a specific study cannot be extracted directly from this submission.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what is missing:

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

A specific table of acceptance criteria and reported device performance is not explicitly provided in the document. The submission implies that the device meets the performance requirements outlined in referenced standards (EC 38 compliant, and tested to all applicable tests in relevant standards). However, the quantitative acceptance criteria for parameters like accuracy, sensitivity, specificity for arrhythmia detection, and the device's measured performance against those criteria are not detailed.

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

This information is not provided in the document. The submission mentions "clinical test data at a trial site" to be compiled and analyzed, but does not specify the sample size, whether the data is retrospective or prospective, or its country of origin.

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. The document states that "Interpretation and diagnosis is the responsibility of a trained healthcare professional or physician," implying that expert review would establish ground truth for clinical data, but specifics regarding the number and qualifications of experts for a test set are absent.

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 information is not applicable/provided. The Aera CT is an "Arrhythmia Detector and Alarm" system that analyzes ECG signals with "automated arrhythmia analysis algorithms" and "does not provide interpretive or diagnostic statements." Its function as described is not primarily for AI-assisted human reading to improve diagnostic accuracy, but rather for automated detection and transmission of data to be read by professionals. Therefore, an MRMC study on human reader improvement with AI assistance is not described or implied for this device.

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

The submission implies extensive standalone testing of the algorithm against relevant performance standards. It states, "A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm... the data is transmitted..." This describes a standalone algorithmic function. The claim of "EC 38 compliant" and compliance with "all applicable tests and requirements in the relevant standards" (which includes ANSI/AAMI EC 57:1998 for testing performance of cardiac algorithms) suggests that standalone algorithm performance testing was central to the submission, although the specific results are not provided.

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

Since no specific study results are provided in this summary, the type of ground truth used is not explicitly stated. However, for arrhythmia detection algorithms, ground truth is typically established by expert review (e.g., experienced cardiologists or electrophysiologists) of the ECG tracings.

8. The sample size for the training set

This information is not provided. The document does not discuss the development or training of its proprietary algorithm.

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

This information is not provided.

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This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.

The device is a spring loaded, disposable biopsy needle.

This document is a 510(k) summary for the "TZ®" Biopsy Needle, dated January 3, 1997. It describes a spring-loaded, disposable biopsy needle intended for taking histological core samples from soft tissues. The summary states that the device is identical in technological characteristics to its predicate device, the ProMedical Ltd. - PRO-B Biopsy Needle (K824598).

The document does not contain any information regarding acceptance criteria related to device performance in terms of diagnostic accuracy or clinical outcomes. The "tests" mentioned (Firing Test, Pyrogen Test, Biocompatibility) appear to be related to manufacturing quality, sterility, and material safety, not diagnostic performance. Therefore, I cannot construct a table of acceptance criteria and reported device performance as requested in point 1, nor can I answer points 2 through 9, as they pertain to a study proving diagnostic performance, which is not present in this document.

Here's a breakdown of what is and is not in the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the context of diagnostic accuracy. The tests listed are "Firing Test," "Pyrogen Test (LAL)," and "Biocompatibility," all of which "Passed." These relate to manufacturing and material safety, not how well the device performs its intended diagnostic function in terms of tissue quality or diagnostic yield.
• 2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic performance study described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical biopsy needle, not an algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and basic safety/manufacturing tests. It does not provide any clinical study data for diagnostic performance.

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