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510(k) Data Aggregation
(213 days)
The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.
The subject Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.
The subject Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the subject Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The subject Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
This FDA 510(k) clearance letter pertains to a medical device, not an AI/ML software. Therefore, the detailed acceptance criteria and study information requested, which are typical for AI/ML device evaluations, are not applicable in this context.
The document discusses the CPS Locator 3D Delivery Catheter, a physical medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing (bench testing, biocompatibility, sterilization, etc.) and, in this case, some real-world usage data. It does not involve AI/ML performance metrics like sensitivity, specificity, or ground truth established by expert consensus for diagnostic accuracy.
Here's a breakdown of why many of your requested points are not applicable, followed by the information that can be extracted:
- Acceptance Criteria Table & Reported Performance: Not available in an AI/ML context. The document focuses on demonstrating the device's functional integrity and equivalence to a predicate.
- Sample Size (Test Set) & Data Provenance: Not applicable for an AI/ML test set. The clinical data mentioned is retrospective/real-world observational data on the previously cleared device.
- Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic AI/ML algorithm requiring ground truth establishment by experts.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable.
- Standalone Performance: Not applicable as it's a physical catheter, not an AI/ML algorithm.
- Type of Ground Truth: Not applicable. The "ground truth" for a physical device is its functional performance and safety during use.
- Sample Size (Training Set): Not applicable as there's no AI/ML model to train.
- How Ground Truth for Training Set was Established: Not applicable.
Information that can be extracted from the provided document regarding the CPS Locator 3D Delivery Catheter:
The document describes the acceptance criteria and study to demonstrate substantial equivalence for a physical medical device, not an AI/ML system. Therefore, many of the requested fields related to AI/ML software evaluation are not directly applicable.
Here's a summary of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests/Performance Evaluated | Reported Device Performance (Summary) |
|---|---|---|
| Material & Biocompatibility | Biocompatibility testing (per ISO 10993-1) | Device passed all required biocompatibility tests. |
| Sterilization | Sterilization validation (per ISO 11137) | Device passed sterilization validation. |
| Packaging Integrity | Packaging validation (per ANSI/AAMI/ISO 11607-1) | Device passed packaging validation. |
| Manufacturing Quality | Visual Inspection | Not explicitly stated "passed," but implied by clearance. |
| Functional Performance (Simulated) | Simulated use testing (including use/compatibility with ancillary devices) | Device performed as intended in simulated use. |
| Leakage | Valve liquid leak test | Not explicitly stated "passed," but implied by clearance. |
| Mechanical Strength | Tensile tests | Not explicitly stated "passed," but implied by clearance. |
| Dimensional Accuracy | Sheath and Dilator Dimensional verification (OD/ID, working length) | Dimensions verified (similar to predicate, 9.0F OD, 7F ID). |
| Fluid Flow | Flush test | Not explicitly stated "passed," but implied by clearance. |
| Clinical Performance (Real-World Observational Data on K230363) | Post-market study (physician surveys) | 100% successful delivery of ancillary device to target location. 31/44 cases specifically targeted LBB/LBBA. Minor blood loss reported by 5 of 42 physicians. No adverse events or unexpected complications. |
| Retrospective observational study 1 (US centers, LBBAP implant procedures) | LBBAP successfully achieved in 95% of patients using the device. No reported complications or adverse events. | |
| Retrospective observational study 2 (US centers, LBBAP implant procedures) | Out of 66 patients undergoing successful lead implantation, 49 achieved LBBAP with device aid. No reported complications or adverse events. | |
| Publication in HeartRhythm (defibrillator lead at LBBAP) | Defibrillator lead successfully deployed in 7 of 8 patients targeting LBBA. One failure due to patient anatomy. No reported adverse events or complications. |
2. Sample size used for the test set and the data provenance
- Test Set (Bench/Performance Testing): Not explicitly stated as a separate "test set" for the new submission, but the document mentions "All testing was performed on test units representative of finished devices." The specific number of units for each bench test is not provided in this summary.
- Clinical Data (Real-World Evidence):
- Post-market study: Data collected from 42 physicians at multiple US centers.
- Retrospective Observational Study 1: Not explicitly stated sample size, but mentioned "patients."
- Retrospective Observational Study 2: 66 patients.
- HeartRhythm Publication: 8 patients.
- Data Provenance: Primarily United States (US) centers. The data is described as post-market, real-world observational, and retrospective from the previously cleared predicate device (K230363).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device clearance, not an AI/ML diagnostic device requiring expert-established ground truth for performance metrics like sensitivity/specificity. The "ground truth" for the clinical data related to lead delivery success was based on actual surgical outcomes reported by physicians.
4. Adjudication method for the test set
- Not Applicable. No expert adjudication for an AI/ML algorithm's output was 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 is a physical medical device, not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used
- For the clinical data, the "ground truth" was based on observed clinical outcomes (e.g., successful lead delivery, achievement of LBBAP, reported complications/adverse events) as documented and reported by treating physicians and study investigators. This is akin to patient outcomes data in real-world settings.
8. The sample size for the training set
- Not Applicable. There is no AI/ML algorithm with a training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI/ML algorithm with a training set.
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(29 days)
As a TENS device, the CP Relief Wand Rx - TENS/NMES is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post surgical and post-traumatic pain.
As an EMS device, the CP Relief Wand Rx - TENS/NMES is intended for use for relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining on increasing range of motion.
The CP Relief Wand Rx - TENS/NMES®("Wand") is a multitherapy medical device that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
The CP Relief Wand Rx - TENS/NMES is portable with self-contained electrodes. The device is powered by a standard non-rechargeable 9-volt alkaline battery. A charger is not used due to the low current drain and long battery life of the low power circuitry.
In operation, the electrode end of the CP Relief Wand Rx - TENS/NMES is positioned to touch the skin. The electrical pulses travel from one electrode, through the skin, through the underlying tissue, and back through the skin to the other electrode. Controls on the unit are provided for power, intensity, pulse width, and pulse polarity.
This FDA 510(k) clearance letter pertains to a TENS/NMES device, not an AI/ML-driven medical device. Therefore, the information typically found in a study proving an AI/ML device meets acceptance criteria (such as performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present in this document.
The document discusses the substantial equivalence of the "CP Relief Wand Rx - TENS/NMES" to predicate devices based on regulatory parameters, specifications, and the leveraging of performance testing from the primary predicate. It does not describe a new study specifically designed to assess the performance of the device against acceptance criteria in the context of an AI/ML model.
Therefore, I cannot provide the requested information for acceptance criteria and study details as they relate to an AI/ML device, as this document does not contain that type of data.
The document primarily focuses on:
- Substantial Equivalence: Arguing that the new device is as safe and effective as previously cleared devices.
- Expansion of Indications for Use: Adding EMS functionality, which is justified by comparison to a second predicate device that already has EMS indications.
- Performance Data (Leveraged from Predicate): Citing existing standards compliance from the primary predicate device, rather than new performance studies on an AI/ML algorithm.
If you have a document describing an AI/ML device and its validation study, I would be happy to analyze it for the requested information.
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(100 days)
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
The modified Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter indicated for the introduction of various types of catheters and pacing or defibrillation leads.
The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
This document describes the FDA 510(k) clearance for the CPS Locator 3D Plus Delivery Catheter, a medical device. Based on the provided text, the device is a percutaneous catheter used for introducing various types of catheters and pacing or defibrillator leads. The clearance is based on its substantial equivalence to a predicate device (CPS Locator 3D Delivery Catheter, K230363).
However, the provided text does not contain any information about an AI/ML-based device or any study that would typically be described with the requested criteria (e.g., sample sizes, expert adjudication, MRMC studies, ground truth establishment, training sets). The acceptance criteria mentioned are related to engineering and biological performance of a physical medical device (catheter) rather than the performance of an AI/ML algorithm.
Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on this document. The document describes a traditional medical device clearance, not an AI/ML software clearance.
**If your intention was to ask about the acceptance criteria and supporting studies for a physical medical device as described in the document, here is the information: **
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance tests conducted, implying these tests have acceptance criteria which the device met ("passed the following tests"). Specific quantitative acceptance criteria (e.g., "leak rate must be < X ml/min") and exact reported performance values are not detailed in this summary, but the general categories of testing are listed.
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility | Passed testing per FDA Final Guidance Document, "Use of International Standard ISO 10993-1" (2023) |
| Sterilization Validation | Passed per ISO 11137 |
| Packaging Validation | Passed per ANSI/AAMI/ISO 11607-1 |
| Visual Inspection | Passed (implies meeting visual quality standards) |
| Simulated Use Testing | Passed (includes use/compatibility with ancillary devices) |
| Valve Liquid Leak Test | Passed |
| Tensile Tests | Passed (implies meeting strength and integrity requirements) |
| Sheath and Dilator Dimensional Verification | Passed (includes OD/ID, working length within specifications) |
| Flush Test | Passed |
2. Sample sizes used for the test set and the data provenance:
The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample sizes for any of the performance tests. Given this is a physical medical device, the "data provenance" would refer to the characteristics of the test units themselves (e.g., manufacturing lot, material specifications) rather than typical software data provenance like country of origin or retrospective/prospective data. This information is not provided.
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 or provided for a physical device clearance where performance is typically measured through engineering tests and adherence to standards, not human expert interpretation for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided for the type of testing described (engineering performance tests).
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 or provided. The device is a physical catheter, not an AI/ML software tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable or provided. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the engineering and physical performance tests, the "ground truth" would be established by the defined specifications, engineering tolerances, and regulatory standards (e.g., ISO, ANSI/AAMI standards). For biocompatibility, it's compliance with established biological safety profiles and regulatory guidance. No "expert consensus," "pathology," or "outcomes data" is explicitly mentioned for establishing ground truth for these performance tests.
8. The sample size for the training set:
This information is not applicable or provided. The device is a physical catheter; there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
This information is not applicable or provided.
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(249 days)
The Sensinel™ CPM System is a wireless remote monitoring system intended for use by healthcare professionals for spot-checking of physiological data in home and healthcare settings. This can include:
- ECG
- Heart Auscultation Sounds
- Skin Temperature (Obtained from left chest area)
- Thoracic Impedance (including changes in Thoracic Impedance)
- Respiration Rate and relative changes in Tidal Volume
- Heart Rate
- Diastolic Heart Sounds Strength
- Body Posture (including Tilt Angle)
Data are transmitted wirelessly from the Sensinel™ CPM Wearable and Base Station for storage and analysis. The CPM Wearable is intended for use on general care adult patients 18 years of age or older to provide physiological information. The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment.
The CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot-checking and does not have continuous monitoring capability. The CPM Wearable does not produce alarms and is not intended for active patient monitoring (in real-time).
The Sensinel™ CPM System is contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested in your prompt.
The document is an FDA 510(k) clearance letter for the "Sensinel™ CPM System," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use, regulatory class, and general compliance requirements.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number of experts, adjudication methods, or the type of ground truth used for any test set or training set.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
To answer your questions fully, I would need a detailed study report or a section of the 510(k) submission that specifically addresses the performance testing and validation of the device against predefined acceptance criteria.
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(28 days)
The CPS Direct™ Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and other devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, the CPS Direct Universal slittable outer quide catheters can work with inner catheters as a system.
The device description of the CPS Direct™ Universal slittable outer guide catheter, 3D, is as follows.
· The CPS Direct™ Universal slittable outer quide catheter lead delivery during cardiac resynchronization therapy (CRT) procedures. The CPS Direct Universal provides access to the coronary venous system and acts as a conduit for contrast medium. The key design features of the CPS Direct™ Universal sittable outer quide catheter, 3D, has only undergone minimal changes to the shaft length, the curve design, and the package tray configuration. The diator packaged with the catheter has undergone a change in shaft length to accommodate the shaft length of the 3D catheter. The accessories listed in the device instructions for use have not changed. The key design features of the catheter are listed below:
- · Braid reinforced, varying durometer PEBAX shaft with molded proximal hub.
- · Atraumatic distal soft tip.
- · The outside surface and inside surfaces of the catheter shaft are coated with Siloxane to provide lubricity during use.
- · The distal end of the shaft has gold marker bands and tungsten stripes for fluoroscopic visibility.
- · Hub contains a sideport with extension tubing for contrast delivery, aspiration, or saline flush using a 3-way stopcock.
- · Accessories such as VBT used to assist the insertion of Abbott Devices (leads, quidewires, inner catheters, etc)
The provided document is a 510(k) summary for the Abbott Medical CPS Direct™ Universal slittable outer guide catheter (DS2C029). This document does not contain the acceptance criteria or study details in the format requested.
The document states that "limited functional and packaging design verification (DV) testing, compatibility testing, and a sterilization adoption assessment study" were conducted. It concludes that "Completion of all verification activities demonstrated that the modified catheter with associated components meets its predetermined design and that the subject CPS Direct™ Universal slittable outer guide catheter model DS2C029 (3D curve) is substantially equivalent to the predicate device."
However, it does not provide specific acceptance criteria, reported device performance (numerical metrics), sample sizes, data provenance, ground truth establishment, expert qualifications, or details on comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot populate the table or answer the specific questions about the study design fully based on the provided text. The document confirms that non-clinical tests were performed to demonstrate substantial equivalence, but it does not elaborate on the specifics of these tests.
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(54 days)
CP620G/CP620 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
CP620G/CP620 LCD Monitor is the display system with the high resolution (30002000), high luminance (500 cd/m2), and 4398 billion colors, built-in DICOM standard LUT. Monitor is portable and light, the 750g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.(There is no difference between CP620G and CP620 except for labeling as they are marketed in different areas. CP620G is global sales, CP620 is domestic sales .It does not affect their safety or effectiveness in any terms. ) The product is consisted of the following components: - 13.5" Color-TFT LCD Panel - DMS3400AR0/6 layers/214150mm/1.0mm/REV:1.0 - CP620G LCD Monitor software - Power Adapter - Data Cable. In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the CP620G/CP620 LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. the software doesn't include any functions of image manipulation. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
The information provided describes the Nanjing Jusha Display Technology Co., Ltd. CP620G LCD Monitor / CP620 LCD Monitor. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of measurable thresholds for diagnostic accuracy (e.g., sensitivity, specificity for an AI algorithm). Instead, the performance data presented focuses on the technical specifications of the display and compliance with established electrical safety and electromagnetic compatibility (EMC) standards. The "predicate device" is used as the benchmark for substantial equivalence.
| Attribute | Acceptance Criteria (Predicate Device K200472) | Reported Device Performance (CP620G / CP620 LCD Monitor - K230643) |
|---|---|---|
| Screen Technology | 13.5" Color TFT LCD Panel | 13.5" Color TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 170°, Vertical 170° |
| Resolution | 3000x2000 | 3000x2000 |
| Display Area | 285.3(V)x190.2(H)mm | 285.3(V)x190.2(H)mm |
| Contrast Ratio | 1800:1 | 1800:1 |
| Scanning frequency (H; V) | 94.94~123.84kHz; 60Hz | 94.94~123.84kHz; 60Hz |
| Recommended Luminance | 300cd/m2 | 500cd/m2 |
| Pixel Pitch | 0.0951x0.0951mm | 0.0951x0.0951mm |
| Backlight | LED | LED |
| Display Colors | 14-bit, 4398 billion colors | 14-bit, 4398 billion colors |
| Luminance Calibration | General calibration sensor | General calibration sensor |
| Video Signal Input | Type-C x1, Mini DP x1 | Type-C x2, HDMI x1 |
| Display Controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Power Consumption/Save Mode | 15W / N/A | 20W / NA |
| Applicable Standards | IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14; IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015 | IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14; IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015 |
Discussion of Differences:
- Recommended Luminance: The proposed device has a higher recommended luminance (500cd/m2) than the predicate (300cd/m2), which is considered an improvement ("CP620G is better than CP610").
- Video Signal Input: The proposed device has different input ports (Type-C x2, HDMI x1 vs. Type-C x1, Mini DP x1). This difference is stated to "only shows that they have different input, has nothing to do with the display function."
- Power Consumption/Save Mode: The proposed device has a higher power consumption (20W vs. 15W). This is attributed to "components used in the LCD Monitor" and is stated to have "nothing to do with the display function."
- Dimensions w/o stand: Slight differences are noted (312.3mmx220mmx11.5mm vs. 323mmx225x11.5mm), explained as "Different housing design due to the different glass size."
- New Features: The proposed device includes new features: Bidirectional power supply function, dual-screen display function, gravity sensing function, adaptive environment brightness function, and screen touch function. These are all described as making the product "more convenient" and "has nothing to do with the display function" (except for dual-screen display, which allows two independent 3MP windows side-by-side).
2. Sample size used for the test set and the data provenance
The document describes bench testing for the CP620/CP620G. There is no mention of a "test set" in the context of clinical images or patient data. The testing pertains to the physical and electrical performance of the display monitor itself. Therefore, concepts like sample size and data provenance (country, retrospective/prospective) are not applicable in the way they would be for an AI diagnostic algorithm. The tests conducted include:
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display screen
- Measurement of the chromaticity non-uniformity characteristics of the display screen
- Measurement of small-spot contrast ratio
- Measurement of temporal response
- Performance data on luminance stability
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. The device is an LCD monitor for displaying medical images, not an AI algorithm that provides diagnostic interpretations requiring expert ground truth setting for a dataset. The "ground truth" for this device relates to its physical performance characteristics meeting technical specifications, which are verified through various physical and electrical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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 comparative effectiveness study was done. This device is an LCD monitor, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance acceptance is based on:
- Technical Specifications: Measured physical and electrical properties of the display (luminance, contrast, resolution, viewing angle, color, etc.) matching or exceeding the predicate device's specifications.
- Compliance with Standards: Adherence to recognized medical device safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
8. The sample size for the training set
This information is not applicable. The device is a monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
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(27 days)
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads. The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.
The provided text, a 510(k) summary for the CPS Locator 3D Delivery Catheter, does not contain the information requested about acceptance criteria or a study proving that an AI/device meets specific performance criteria.
This document describes a medical device (a delivery catheter) and its substantial equivalence to a predicate device, focusing on physical and functional characteristics, indications for use, and manufacturing/sterilization compliance, not on an AI-driven diagnostic or performance study.
Therefore, I cannot provide the requested information, which typically pertains to the validation of AI-based medical devices or diagnostic tools. The document's purpose is to demonstrate that the catheter itself is substantially equivalent to an already cleared device, not to present data on a new, AI-driven performance metric.
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(14 days)
The CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for delivery of contrast medium and Abbott Medical devices (such as guidewires and implantable left heart leads). In addition, the CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) can work with outer guide catheters as a system.
The CPS Aim™ Universal II Slittable Inner Catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. It is an introducer that is used to cannulate the coronary venous system and act as a conduit for contrast medium, implantable coronary leads, or other devices.
The CPS Aim™ Universal II Slittable Inner Catheter design is based on the currently marketed CPS Aim™ Universal Slittable Inner Catheter design and components. Three modifications were made:
- Modified hydrophilic coating: the subject device uses a different hydrophilic coating material as compared to the currently marketed CPS Aim Universal catheters.
- Use of a modified braid design pattern to provide improved kink resistance: the predicate device braid is a single braided wire, and the subject braid contains paired braided wires.
- Reduction in shelf-life from three (3) years to two (2) years.
The CPS Aim™ Universal II Slittable Inner Catheter will be added as a line extension to the currently marketed family of CPS catheters. New. unique model numbers will distinguish the CPS Aim™ Universal II inner catheter models from existing CPS catheter models.
The CPS Aim™ Universal II Slittable Inner Catheters will be available in the same working lengths, 59 cm and 65 cm, as the predicate device, and will be available with the same shape of curves as the predicate device. The key design features of the CPS Aim™ Universal II Slittable Inner Catheters have only undergone a minimal change to support the coating and braid change. There is no change to the accessories, including the slitter and valve bypass tool (VBT).
The key design features CPS Aim Universal and CPS Aim Universal II Slittable Inner Catheters and their accessory, the CPS Valve Bypass Tools include:
- Braid reinforced, varying durometer PEBAX catheter shaft with molded proximal hub.
- Inner diameter of the catheter is PTFE lined.
- Atraumatic distal soft tip.
- Embedded marker band on soft tip for fluoroscopic visibility.
- Outside surface of the catheter shaft is coated with a hydrophilic coating to provide lubricity during use.
- Hub of the catheter is fitted with a retention cap and an integrated valve that provides hemostasis and facilitates contrast injection. The hub also includes a sideport assembly with 3-way stopcock.
- The catheters are available in cannulator and sub-selector models.
- Accessories such as valve bypass tool (VBT) used to assist the insertion of Abbott Medical devices (leads, guidewires, inner catheters, etc.).
Similar to the existing CPS catheters, the CPS Aim™ Universal II Slittable Inner Catheters are supplied sterile (via ethylene oxide) in one package and are intended for single procedure.
There is no change in accessory product or process for the different models as a result of this line extension. The proposed indications for use is consistent with the cleared indications.
Based on the provided text, the device in question is a medical catheter, the CPS Aim™ Universal II Slittable Inner Catheter. The document describes a 510(k) premarket notification for this device, claiming substantial equivalence to a predicate device (CPS Aim™ Universal Slittable Inner Catheter, K130252). This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the information provided primarily pertains to design verification and biocompatibility testing against established standards and the predicate device.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantified acceptance criteria for each test and then present the specific performance numbers. Instead, it states that "performance testing demonstrated that the CPS Aim™ Universal II Slittable Inner Catheter performs in a substantially equivalent manner to the currently marketed predicate device" and that the device "meets its design specifications and is as safe and effective as the predicate devices."
However, it does list the types of tests conducted, which imply the areas where performance was assessed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (as per ISO 10993-1 and FDA GLP 21 CFR 58) | Met standards; testing included Cytotoxicity, Sensitization, Irritation, Materials-Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility (Direct Contact and Extract), Complement Activation Assay - SC5b-9, Partial Thromboplastin Time, Platelet & Leukocyte Counts, Particulate Matter per USP <788>, Surface Characterization. |
| Design Verification (Physical and Dimensional Characteristics) | Met design specifications. |
| Design Verification (Functional Characteristics) | Met design specifications. |
| Design Verification (Particulate Testing) | Met design specifications. |
| Design Verification (Hydrophilic Coating Lubricity and Durability) | Met design specifications. |
| Shelf-Life (Accelerated Aging) | Demonstrated 24-month shelf life. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes (number of units or batches) used for each individual test (biocompatibility, design verification, shelf-life). It also does not mention the country of origin of the data or whether it was retrospective or prospective, as these types of studies typically involve laboratory bench testing and animal model testing (where applicable for biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information, relating to expert consensus or clinical adjudication for establishing ground truth, is not applicable or provided in this 510(k) summary. The studies described are bench tests and biocompatibility tests, not clinical performance evaluations that would require human expert interpretation of device output.
4. Adjudication Method for the Test Set
Not applicable for the types of tests described (bench and biocompatibility testing).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and biocompatibility testing, not on comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical catheter, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.
7. The Type of Ground Truth Used
For biocompatibility testing, the "ground truth" is adherence to established biological safety standards (ISO 10993-1, FDA GLP 21 CFR 58), and for specific tests, it would be the absence of toxic reactions, irritation, etc., as measured by standardized assays. For design verification, the "ground truth" is adherence to predefined engineering specifications and functional requirements. For shelf-life, it's the maintenance of performance characteristics over the specified period.
8. The Sample Size for the Training Set
This device is not an AI algorithm, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(88 days)
The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only, Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)
The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core galvanized wire. The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string. The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm. The surgical masks are single-use, disposable devices, provided non-sterile.
The document describes the acceptance criteria and the study conducted to demonstrate that the CPL Surgical Face Mask meets these criteria.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Test Performed | Acceptance Criteria for Level 3 Classification (as per ASTM F2100 Requirements) | Reported Performance (Surgical Face Mask EL) | Reported Performance (Surgical Face Mask TO) | Result |
|---|---|---|---|---|---|
| 1. | Fluid resistance (ASTM F1862/F1862M-17) | Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Pass |
| 2. | Particulate Filtration Efficiency (PFE) (ASTM F2299 / F2299M - 03(2017)) | ≥ 98% | > 98% | > 98% | Pass |
| 3. | Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | > 98% | > 98% | Pass |
| 4. | Differential pressure (ΔΡ) (EN 14683 (Annex C): 2019) | < 6.0 mm H2O/cm² | < 4.0 mm H2O/cm² | < 5.0 mm H2O/cm² | Pass |
| 5. | Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | Pass |
| 6. | In-vitro Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Pass |
| 7. | Skin Irritation (ISO 10993-10:2010) | Non-irritating | Non-irritating | Non-irritating | Pass |
| 8. | Skin Sensitization (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing | Non-sensitizing | Pass |
2. Sample size used for the test set and data provenance:
- Sample Size: The performance testing was conducted using 3 nonconsecutive lots of the CPL Surgical Face Mask.
- Data Provenance: Not explicitly stated, but the applicant's address is listed as Himachal Pradesh, India, which suggests the testing was likely conducted in or around that region. The study is retrospective as it involves testing of manufactured products against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a study requiring expert readers or ground truth establishment in that manner. The testing involves standardized laboratory methods for evaluating physical and biological properties of the mask.
4. Adjudication method for the test set:
- Not applicable; this is not a study involving human adjudication of results but rather direct measurement against established performance standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/software device and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
7. The type of ground truth used:
- The "ground truth" for the performance tests are the pre-defined acceptance criteria set by international and national standards (e.g., ASTM F2100-19, ASTM F2101-19, ASTM F2299 / F2299M - 03(2017), EN 14683 (Annex C): 2019, ASTM F1862/F1862M-17, 16 CFR 1610, ISO 10993-5:2009, ISO 10993-10:2010). The device's performance is measured directly against these established standards.
8. The sample size for the training set:
- Not applicable. This is a medical device (surgical face mask) with performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a medical device (surgical face mask) with performance testing, not a machine learning model.
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(161 days)
The CPM Medical Consultants Tibial Revision Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthrius, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.
The CPM Medical Consultants Tibial Revision Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.
The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783.
The CPM Medical Consultants Tibial Revision Knee System is an extended design of The Modal Manufacturing Total Knee System (K142649/K150783). It is a cobalt-chromium-molybdenum (Co-Cr-Mo) metallic baseplate with a variety of components including tibial augments, stems, and offset adapters that provide more choice for surgeon treatment of their patients. The CPM Medical Consultants posterior stabilized plus inserts is a line extension to the previously cleared Modal Manufacturing posterior stabilized tibial insert (K142649). The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the previously cleared Modal Manufacturing Total Knee System (K142649/K150783) which is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Progressive Orthopaedic Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotation.
This document is a 510(k) summary for a medical device called the "CPM Medical Consultants Tibial Revision Knee System". It's a submission to the FDA to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices, meaning it's safe and effective for its intended use. Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum fatigue cycles, maximum stress values) for comparison. Instead, it refers to the performance of the predicate device as demonstrating substantial equivalence for the subject device. The reported device performance is that the testing confirms the components exhibit "appropriate mechanical characteristics" and are "substantially equivalent" to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Device components possess appropriate mechanical characteristics for tibial revision knee joint replacement. | "All components of the CPM Medical Consultants Tibial Revision Knee System exhibit the appropriate mechanical characteristics for tibial revision knee joint replacement." |
| Implicit: The subject device is substantially equivalent to the predicate devices in terms of mechanical performance. | "The results confirm that... [the subject device components] are substantially equivalent to the predicate devices." |
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 specify sample sizes for the performance tests conducted on the predicate devices. It states "Extensive preclinical testing was performed on the predicate devices per K142649 and K150783."
Data provenance (country of origin, retrospective/prospective) is not mentioned. Given that this is a 510(k) summary for a revision knee system, the testing is typically bench testing, not clinical trials with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of submission. The performance testing described is mechanical bench testing, not an evaluation that requires expert medical opinion to establish "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are physical and mechanical, not subject to human adjudication as would be the case in an image-based diagnostic study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study involving human readers or AI assistance. It's a submission for a mechanical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical performance in this context would be the established engineering standards and specifications for orthopedic implants, which the predicate device demonstrated compliance with.
8. The sample size for the training set
Not applicable. This is not an AI/ML device where a "training set" would be used.
9. How the ground truth for the training set was established
Not applicable.
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