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Found 19 results
510(k) Data Aggregation
(129 days)
Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017
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(175 days)
Nimbl (model PD08-N1)
The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing
The Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing. This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.
The provided text describes the 510(k) premarket notification for the Nimbl (model PD08-N1) pneumatic compression device. It establishes substantial equivalence to a predicate device (Entre, model PD08-U). The focus of this document is on the comparison of technological characteristics and performance testing to demonstrate similar safety and effectiveness.
Here's an analysis of the acceptance criteria and study data based on the provided text:
Important Note: The provided document is a 510(k) clearance letter and summary, not a detailed clinical study report for an AI/ML medical device. Therefore, many of the requested details regarding AI/ML-specific study design (e.g., number of experts for ground truth, MRMC studies, training set details) are not applicable or not present in this type of submission for a pneumatic compression device. Wearable/Pneumatic Compression devices typically rely on bench testing, electrical safety, software V&V, and usability testing to demonstrate equivalence, rather than large-scale clinical studies with AI components that require expert consensus on image interpretation or similar.
Key Findings from the Document:
The Nimbl device is a pneumatic compression device, not an AI/ML-driven diagnostic or interpretative system. The "Performance Data" section lists types of testing completed, which are typical for hardware devices:
- Electrical safety and electromagnetic compatibility (EMC) testing
- Software verification and validation (including cybersecurity)
- Mechanical bench testing (pressure verification, port strength, component life testing)
- Usability testing
- Environment and distribution testing
The document repeatedly emphasizes that the subject and predicate devices utilize "the same fundamental technology, mode of action, and principles of operation." The "Software-Concern Level" is listed as "Basic Documentation Level" for the Nimbl, although it notes "Moderate Level of Concern" for the predicate with "Minor software updates have been made." This suggests the software functionality is not for complex interpretation or diagnosis.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (pneumatic compression) and the document provided, "acceptance criteria" is typically defined by adherence to relevant standards and demonstration of comparable performance to the predicate through bench and usability testing. Specific quantitative "device performance" metrics in the context of diagnostic accuracy (like sensitivity, specificity, AUC) are not relevant or provided here.
| Acceptance Criterion (Implicit for Hardware Device Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Electrical Safety & EMC Compliance | Performed testing following IEC 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance). (Satisfied) |
| Software Verification & Validation | Performed testing following IEC 62304 (Medical device software - Software life cycle processes), including cybersecurity. Software "Concern Level" is noted as "Basic Documentation Level" (for Nimbl) / "Moderate Level of Concern" (for predicate, with minor updates for Nimbl) indicating low safety risk associated with software. (Satisfied) |
| Mechanical Performance & Durability | Performed mechanical bench testing, specifically mentioning: pressure verification, port strength, and component life testing. The device is designed for a 5-year lifetime, same as the predicate. The pressure range is 19-60 mmHg (subject) vs. 20-80 mmHg (predicate), noted as "Similar; upper limit lowered for patient comfort." The dwelling time and treatment time are the same as the predicate (25 seconds minimum, 1 hour maximum). (Satisfied, with minor difference in pressure range for patient comfort). |
| Usability | Usability testing completed. (Satisfied) |
| Environmental & Distribution Tolerance | Environment and distribution testing completed. (Satisfied) |
| Same Fundamental Technology, Mode of Action, Principles, and Intended Use | The document states: "The Nimbl device and the predicate Entre device are pneumatic compression devices that utilize the same fundamental technology, mode of action, and principles of operation." The "Indications for Use" for both devices are identical: treatment of chronic edema, lymphedema, venous insufficiency, and wound healing, by medical professionals and patients under medical supervision. (Satisfied) |
| Differences Do Not Raise New Safety/Effectiveness Questions | The document explicitly states: "These differences [Bluetooth connectivity, external battery, smaller controller, garment-controller connection updates] do not raise any different questions of safety or effectiveness for the Nimbl system compared to the predicate device." The "Performance Data" section is presented as evidence for this assertion. (Demonstrated through testing and comparative analysis). |
2. Sample Size Used for the Test Set and Data Provenance
As this is a hardware device clearance, rather than an AI/ML diagnostic algorithm, there isn't a "test set" in the context of diagnostic accuracy. The testing performed involves bench testing (e.g., pressure verification, component life testing, port strength), electrical safety/EMC testing, software verification and validation, and usability testing. The sample sizes for these tests would typically be defined by engineering standards (e.g., number of units tested for durability, number of cycles, number of users for usability). These specific details (e.g., 'N' for specific bench tests) are not provided in this summary document, as they would be in the detailed testing reports submitted to the FDA.
Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The data provenance here refers to the origin of the device and testing, which is Tactile Medical. The testing is assumed to be conducted in a controlled lab/test environment. It is not listed as retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This device does not generate medical diagnoses or interpretations that require expert human adjudication for "ground truth" establishment in the way AI/ML diagnostic devices do. The "performance" is mechanical and electrical, governed by engineering specifications and standards.
4. Adjudication Method for the Test Set
Not Applicable. See point 3 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
Not Applicable. This is 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
Not Applicable. This is a hardware pneumatic compression device. While it has software, it does not perform standalone diagnostic interpretation.
7. The Type of Ground Truth Used
Device Ground Truth: The "ground truth" for this device's performance relies on engineering principles, validated test methods against specifications (e.g., pressure accuracy against a manometer, force against a load cell), compliance with international standards (IEC 60601-1, IEC 62304), and comparability to the predicate device’s established safe and effective performance. Clinical outcomes data for efficacy (treating edema, lymphedema, etc.) are established for the class of devices and the predicate, not newly proven by this 510(k) submission, which focuses on substantial equivalence.
8. The Sample Size for the Training Set
Not Applicable. This device does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. See point 8 above.
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(145 days)
N1
N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.
The provided FDA 510(k) summary for the N1 device (K232012) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and electrical compliance.
The document states:
- "No clinical studies are submitted." (Page 5, Section 8)
- "We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors. The digital detectors used for testing are not part of the subject device." (Page 5, Section 7)
- "Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device." (Page 5, Section 7)
- The conclusion mentions some differences in specifications but states, "there was no significant difference in the safety / performance of the product, and it was confirmed that the Portable dental X-ray imaging device had better performance than the equivalent device in some specifications." (Page 6, Section 9) This implies a comparison to a predicate device, but no specific performance metrics or acceptance criteria are detailed.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met from this document. The submission focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical testing (electrical safety, EMC, software verification/validation) and comparing technical specifications, rather than reporting on a clinical or performance study with defined acceptance criteria for diagnostic accuracy or effectiveness.
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(141 days)
Titanium Abutment Blank Nobel Biocare N1 TCC
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.
The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.
All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.
The subject device is available for NP and RP implant platforms.
The subject device is used by dental healthcare professionals in dental offices and dental laboratories.
The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.
It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.
The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.
This document is a 510(k) summary for the Titanium Abutment Blank Nobel Biocare N1™ TCC. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of "acceptance criteria" for the overall device. Instead, it details various non-clinical performance tests conducted and indicates that the device met established performance specifications. The "reported device performance" is described through the outcomes of these tests.
However, based on the non-clinical test data section and the comparison table (Table 2), we can infer certain performance aspects that were evaluated against reference points (predicates or standards).
| Characteristic / Test | Acceptance Criteria (Inferred from Predicate/Standards) | Reported Device Performance |
|---|---|---|
| End-User Cleaning and Sterilization | In accordance with FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance... issued March 17, 2015" | Validation was conducted and met the guidance specifications. |
| Biocompatibility | In accordance with ISO 10993 | Testing was conducted, and no new issues regarding biocompatibility were raised. |
| Fatigue Testing | In accordance with FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", issued May 12, 2004, and demonstrated substantial equivalence to predicate/reference devices. | Testing conducted on the worst-case system demonstrated substantial equivalence to the predicate and reference devices. |
| Software Verification and End-to-end Workflow Validation | Applicable restrictions are in place and cannot be modified by the user; avoidance of damage or modification of implant-abutment connection geometry during milling; locking of restriction zones from user editing. | Validation was completed, demonstrating that applicable restrictions are in place and cannot be modified by the user, and showing avoidance of damage/modification of connection geometry, and locking of restriction zones. |
| MRI Compatibility | MR Conditional classification (leveraged from K212125). | Demonstrated that the subject device is MR Conditional. |
| Minimum Wall Thickness | Similar to predicate (0.4-0.5mm) and existing reference device #2 (0.3mm). | NP 0.38mm; RP 0.49mm, deemed substantially equivalent as demonstrated by fatigue testing. |
| Minimum Gingiva Height | Similar to predicate (0.5mm) and existing reference device #1 (0.3mm). | 0.335mm, deemed substantially equivalent as demonstrated by fatigue testing. |
| Minimum Diameter | Similar to predicate (3.0-6.0mm) and reference device #1 (2.52-6.0mm). | NP Ø3.21mm; RP Ø3.49mm, deemed similar. |
| Minimum Post Height | Similar to predicate (4mm) and reference device #1 (4mm). | 4.05mm, deemed similar. |
| Maximum Abutment Angulation | Similar to predicate (30°/20°) and reference device #1 (30°). | 30°, deemed identical. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., number of abutments for fatigue testing, or number of software test cases). It refers to tests being conducted on "the worst-case system" for fatigue testing.
The data provenance is internal testing conducted by the manufacturer, Nobel Biocare AB. The document does not specify a country of origin for the data itself, but the submitter is based in Sweden. These are retrospective tests conducted to support the premarket notification.
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 as the document describes non-clinical engineering and performance testing of a physical and software device, not a diagnostic or AI-driven decision support system requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
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
An MRMC study was not done. This device is a component for dental implants and does not involve human readers or AI in the context of comparative effectiveness for diagnostic or interpretive tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is primarily relevant for AI/ML-enabled diagnostic or decision-support software. While the device utilizes CAD/CAM software, the "standalone performance" in this context refers to the software's ability to accurately design and a milling machine's ability to accurately produce the customized abutment according to the design parameters and restrictions. The "Software verification and End-to-end workflow validation" addresses this by demonstrating that the software ensures applicable restrictions are in place and cannot be modified by the user, and that damage to the connection geometry is avoided during milling. It implicitly assesses the algorithm's performance within the manufacturing workflow.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Cleaning and Sterilization: The "ground truth" is adherence to established FDA guidance and validated protocols.
- Biocompatibility: The "ground truth" is compliance with ISO 10993 standards.
- Fatigue Testing: The "ground truth" is compliance with FDA guidance for dental implants and abutments and demonstrated substantial equivalence to the mechanical properties of predicate devices. This involves mechanical testing to failure or for a specified number of cycles under defined loads.
- Software Verification and End-to-end Workflow Validation: The "ground truth" is the established design parameters, manufacturing specifications, and the functionality requirements for the software (e.g., locking restriction zones, avoiding damage to connection geometry). It's based on engineering specifications.
- MRI Compatibility: The "ground truth" is the established MR Conditional specifications from the referenced K212125 clearance.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical device manufactured using a CAD/CAM workflow, not an AI/ML system that requires a "training set" in the conventional sense. The CAD/CAM software would have been developed and validated through its own software lifecycle, but that is distinct from an AI model training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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(221 days)
Esthetic Abutments Nobel Biocare N1
Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.
The acceptance criteria and device performance for the Nobel Biocare N1™ Esthetic Abutments are described based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Standard / Guidance) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Fatigue) | ISO 14801 and FDA Guidance Document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) | The tests demonstrated the Subject Devices are substantially equivalent to the Primary Predicate Device and Reference Device #1 (for TCC abutments) and to Predicate Device #2 and Reference Device #1 (for Base abutments). The Subject Device met the performance specifications. |
| Magnetic Resonance (MR) Compatibility | ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182 | MR Conditional |
| Biocompatibility | ISO 10993-1:2018 Biological Evaluation of Medical Devices | Biocompatible |
| Cleaning and Sterilization | ISO 17665-1 and AAMI TIR12 | Validation performed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. However, it mentions that dynamic loading (fatigue) testing was conducted in saline at 37 °C. The data provenance is from non-clinical testing, therefore not involving human subjects or data from a specific country of origin in the context of clinical studies. The testing was performed in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The reported performance data for this device (dental abutments) is based on non-clinical, laboratory-based testing (mechanical, MRI compatibility, biocompatibility, cleaning/sterilization), rather than expert assessment of clinical data or images to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As the testing mentioned is non-clinical and laboratory-based, an adjudication method in the context of human assessment is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic or AI-assisted interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical dental abutment, not an algorithm or software. The performance evaluations are of the physical product's characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria is established by adherence to recognized international and FDA standards for medical device testing. For example:
- Mechanical strength: Conformance to force/stress limits defined by ISO 14801.
- MRI compatibility: Conformance to safety and performance specifications outlined in ASTM F2052, F2213, F2119, F2182.
- Biocompatibility: Conformance to safety requirements defined by ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
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(204 days)
NobelProcera Zirconia N1 Base
· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:
- NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
- -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:
a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration
b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design
The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.
The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).
The provided document is a 510(k) premarket notification for a dental device, specifically the NobelProcera® Zirconia N1™ Base and its associated Prosthetic Screw. The notification aims to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria or proving performance against novel criteria through clinical studies. Therefore, much of the requested information regarding a device meeting specific acceptance criteria and the nature of the study that proves it, as it would apply to a new classification or a device with new indications requiring extensive clinical validation, is not directly available or applicable in the provided context of a 510(k) submission for substantial equivalence.
However, I can extract information related to the performance data used to support substantial equivalence, which serves a similar purpose to demonstrating acceptance criteria in this regulatory pathway. The acceptance criteria here are implicitly alignment with the performance of the predicate and reference devices.
Here's a summary based on the provided text, addressing what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a quantitative table format that a device must meet to be considered "safe and effective." Instead, it focuses on demonstrating substantial equivalence by comparing its characteristics and performance to legally marketed predicate and reference devices. The "reported device performance" is primarily comparative in nature.
Implicit Acceptance Criteria (Demonstrated Equivalence) & Reported Performance:
| Category | Implicit Acceptance Criteria (Comparative) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Indications for Use | Same as predicate/reference devices. | NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: Same as Primary Predicate (On1 Concept - K161655), expressed through similar wording. |
| Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Same as Reference Device No. 1 (Prosthetic Screw Nobel Biocare N1™ Base), expressed through similar wording. | ||
| Technological Characteristics | Similar to predicate/reference devices, with any differences not raising new concerns. | NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: Device design, compatible Implant/Base platforms (NP/RP), device connection/connector, materials of the connector, screw access, and device attachment method are identical or similar to the Primary Predicate. Ceramic material is Y-TZP, similar to predicate, and specifically "Nacera Pearl" (K143071), which is also used in Reference Device No. 1. Design methods, ASC angulation (0°-25°), and dimensions are similar to Reference Device No. 2. Maximum device body angulation limits are similar to Reference Device No.1, with differences substantiated by fatigue testing. |
Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Principle of operation, compatible Implant/Base platforms (NP/RP), device material (Ti6Al4V ELI), thread design, and screw interfaces (Omnigrip Mini) are the same as Reference Device No. 1. DLC coating applied to screw body, similar to Reference Device No. 1. Differences in screw body dimensions, anodization (subject device is not anodized), and packaging do not raise new concerns. |
| Performance (Non-clinical) | Performance as good as predicate/reference devices for intended use, as demonstrated by recognized standards (e.g., ISO 14801, ISO 10993-1, ASTM). | Fatigue Performance: Dynamic loading testing performed according to ISO 14801. Testing found acceptable, including evaluation of removal torque and no screw-loosening for run-out samples.
Biocompatibility: Demonstrated according to ISO 10993-1.
Wear Assessment: Light optical and SEM imaging following ISO 14801 fatigue loading showed similar wear patterns to reference device systems (NobelProcera® Zirconia Implant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746)).
Packaging System Performance: Tested per ASTM D4169.
Magnetic Resonance Compatibility: Tested according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182.
Cleaning and Sterilization Validation: End user cleaning and sterilization validation in accordance with ISO 17665-1 and AAMI TIR12. |
| Performance (Clinical/Real-World Evidence) | No evidence of new safety/effectiveness concerns with differences in materials or design. | Post-Market Surveillance (PMS) Data:
- NPr ASC Ab Zirconia CC (K132746): 8.1 years in patient, low complaint rates, no concerns regarding dissimilar materials (DLC-coated screw with Zirconia abutment).
- NobelProcera® Zr Implant Bridge (K202452): 1.7 years in patient, low complaint rates, no concerns regarding dissimilar materials.
Clinical Data: Five clinical studies on NPr ASC Ab Zirconia CC (K132746) with mean follow-ups of 0.6-3.6 years, reporting on 277 devices. No reports of wear debris from Zirconia/DLC-coated screw contact or other adverse events raising concerns about dissimilar materials. A gap analysis was provided to support the relevance and reliability of this real-world evidence. |
2. Sample Size for the Test Set and Data Provenance
The document does not define a single "test set" in the context of a clinical trial for direct performance measurement. Instead, it refers to various non-clinical tests and real-world evidence.
- Non-clinical testing (Fatigue, Wear, MRI Compatibility, Packaging): The sample sizes for these specific tests are not provided in the summary. For example, ISO 14801 fatigue testing typically involves a certain number of samples (e.g., n=10-12 per group) but this detail is omitted.
- Real-World Evidence (PMS Data):
- NPr ASC Ab Zirconia CC (K132746): Data collected from December 2013 up to January 2022. The longest time in a patient was approx. 8.1 years.
- NobelProcera® Zr Implant Bridge (K202452): Data collected from May 2020 up to January 2022. The longest time in a patient was approx. 1.7 years.
- Data Provenance: This is post-market surveillance data, likely originating from clinical use of the cleared predicate/reference devices, implicitly from various countries where Nobel Biocare products are marketed. It is retrospective in nature.
- Clinical Data (NPr ASC Ab Zirconia CC):
- Sample Size: 277 NPr ASC Ab Zirconia CC (K132746) devices were reported across 5 clinical studies.
- Data Provenance: The document states the studies were "included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study." The studies were published in international journals, suggesting prospective clinical studies from potentially diverse geographical origins, but specific countries are not mentioned (e.g., "[1] Greer, A.C., et al., Int J Prosthodont, 2017"). These are considered Real World Evidence in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This specific information is not provided in the document. For 510(k) submissions focusing on substantial equivalence, the "ground truth" for the test set is usually the performance of the predicate device as established by its clearance and recognized standards, rather than a new expert consensus process for the subject device. The clinical studies mentioned were about observing device performance in patients, not establishing a new ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective endpoints in clinical trials or for establishing ground truth from multiple expert readings (e.g., in AI/imaging studies). The provided clinical evidence references published studies with their own methodologies, which are not detailed here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies cited are focused on the clinical performance and safety of existing devices (predicates/references) and a "gap analysis" for using that as real-world evidence for the subject device, or non-clinical engineering tests. There is no mention of comparing human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental abutment and prosthetic screw, not an AI algorithm or software. Therefore, there is no "standalone" performance in the context of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is primarily:
- Engineering Standards: Compliance with ISO 14801, ISO 10993-1, ASTM F2052, F2213, F2119, F2182, ISO 17665-1, AAMI TIR12.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate and reference devices (On1 Concept K161655, N1™ TiUltra™ TCC Implant system K211109, NobelProcera Angulated Screw Channel Abutment Conical Connection K132746, Nacera Pearl K143071).
- Outcomes Data/Real-World Evidence: Post-market surveillance data and clinical study outcomes for the predicate/reference devices, showing low complaint rates, good tissue health, and no unexpected adverse events related to material interactions. These outcomes serve as a proxy for acceptable performance.
8. The Sample Size for the Training Set
This concept is not applicable as the device is a physical dental component and not an AI/machine learning model that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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(353 days)
and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03
Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.
The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.
The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.
However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Mechanical Performance: |
- Comparable bending strength
- Comparable torsion strength
- Comparable axial pullout strength | Non-clinical tests performed:
- 4 Point Bending Test
- Torsion Test & Axial Pullout Strength Test
Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.) |
| Sterilization Efficacy: - Achieves sterility for pre-sterilized kits
- Compatibility with steam sterilization for non-sterile components | Non-clinical tests performed:
- Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)
- Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)
Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811." |
| Biocompatibility: - Biocompatible materials and design, similar to predicate | Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811." |
| Shelf Life: - Maintained functionality and sterility over intended shelf life (for pre-sterilized kits) | Non-clinical tests performed:
- Shelf life (only Neuro Plating System - Sterile Kit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
- Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.
7. The Type of Ground Truth Used
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.
8. The Sample Size for the Training Set
- Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no "training set" for this device.
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(251 days)
N1 TiUltra TCC Implant System
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.
The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.
Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.
Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:
1. Table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (N1™ TiUltra™ TCC Implant system) |
|---|---|
| Substantial Equivalence in Intended Use and Indications for Use. | N1™ TiUltra™ TCC Implant system shares the same or similar intended use and indications for use as predicate devices, with differences adequately addressed. |
| Sterilization Validation (SAL 10⁻⁶) | Successfully demonstrated sterility assurance level of 10⁻⁶ via gamma sterilization, confirming safety for use. |
| Endotoxin Levels (meeting USP , , ANSI/AAMI ST72) | Testing confirmed endotoxin levels are within acceptable limits, demonstrating pyrogen-free status. |
| End-User Cleaning & Sterilization Validation (for reusable components) | Validation performed per ISO 17665-1, AAMI TIR12, AAMI/ANSI ST79, ANSI/AAMI ST77, ISO 17664, ensuring safe reprocessing for reusable components. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Packaging Performance (maintaining sterility and device integrity) | Met standards (ISO 11607-1, ASTM D4169, D4332, F1886/F1886M, F2096, F1980), demonstrating packaging efficacy in maintaining sterility and integrity. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Biocompatibility (ISO 10993-1, -5, -12, -18) | All materials passed biocompatibility tests (cytotoxicity, chemical characterization), confirming safety for patient contact. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mechanical Resistance (ISO 14801, FDA Guidance) | Demonstrated sufficient fatigue resistance and mechanical stability in dynamic loading tests, comparable to predicate devices. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Insertion Parameters (Heat Generation, Torque) | Comparative testing demonstrated equivalence in heat generation and insertion torque to the Primary Predicate, indicating similar surgical experience and bone response. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Osseointegration (Animal Study) | Animal study showed representative osseointegration behavior comparable to the predicate (TiUltra Implants and Xeal Abutments) at 13 ± 2 weeks, supporting the new drilling technique. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mesostructure Design & Manufacturing (Software & E2E Validation) | Software verification for abutment design library ensured adherence to design limitations; validation confirmed locked specifications, and end-to-end (E2E) validation demonstrated proper manufacturing workflow. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| MR Conditional Labeling (Referencing K212125) | Met acceptable outcomes in MR conditional testing for safe use in specific MR environments, leveraging prior clearance. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Long-term Clinical Performance (MBLC, Survival, Safety, Tissue Health) | Primary Endpoint (MBLC): Non-inferiority to historical data for the predicate device (NobelActive implant system) was met with statistical significance (p |
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(139 days)
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
BeneVision N12/N15/N17/N19/N22
The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:
· C.O. monitoring and A-Fib are intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
· rSO2 monitoring is intended for use in individuals greater than 2.5kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.
BeneVision N1 Patient Monitor:
The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- PAWP, PNP, and PNC are intended for adult and pediatric patients only;
- A-Fib is intended for adult patients only;
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.
The subject BeneVision N Series Patient Monitors includes six monitors:
- BeneVision N12 Patient Monitor
- BeneVision N15 Patient Monitor
- BeneVision N17 Patient Monitor ●
- . BeneVision N19 Patient Monitor
- . BeneVision N22 Patient Monitor
- BeneVision N1 Patient Monitor ●
Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.
The provided document describes the BeneVision N Series Patient Monitors and their clearance by the FDA based on substantial equivalence to predicate devices, particularly focusing on changes and new features. The document details the device's intended use, technological comparisons, and performance data from various tests. However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. Instead, it states that "the results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device."
Specifically regarding "Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)" which is the relevant regulation name for the product code MHX (used by the BeneVision N Series Patient Monitors), the document states:
"Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module." (Page 9, Table 2 ECG section; Page 22, Table 3 ECG section).
And references "K200015 - ePM series Patient Monitors...: provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors." (Page 6, Section 4).
Given the information in the document, here's a structured response:
Acceptance Criteria and Device Performance Study for Arrhythmia Detection in Neonates
The provided FDA 510(k) summary (K202405) for the BeneVision N Series Patient Monitors primarily focuses on demonstrating substantial equivalence to a predicate device (K192972) and a reference device (K200015) for the new feature of neonatal arrhythmia detection. While it explicitly states that the device meets its accuracy specifications, it does not provide a specific table of acceptance criteria or detailed reported performance metrics for neonatal arrhythmia detection. Instead, it relies on general statements about meeting specifications and compliance with standards.
However, based on the document's information and common regulatory expectations for such devices, we can infer the type of acceptance criteria and the nature of the study.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table for the acceptance criteria and reported device performance for neonatal arrhythmia detection. It states that the device "meets its accuracy specification." For arrhythmia detection systems, typical performance metrics and acceptance criteria, often derived from standards like IEC 60601-2-27, would generally include:
| Metric | Acceptance Criteria (Inferred from regulatory standards and typical arrhythmia detector performance) | Reported Device Performance (Implicitly stated as "meets accuracy specifications" and "substantially equivalent") |
|---|---|---|
| Arrhythmia Detection Accuracy (Sensitivity/Specificity) | e.g., Sensitivity ≥ 90%, Specificity ≥ 95% for various arrhythmia types (e.g., asystole, bradycardia, tachycardia, PVCs) in applicable age groups (neonates) | Met (stated as "meets accuracy specification") |
| False Alarm Rate | e.g., False QRS detection rate |
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(85 days)
Everyway Analog OTC TENS, model N103A/N302
Everyway Analog OTC TENS, model N103A/N302 is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Everyway Analog OTC TENS, model N103A/N302." This document primarily focuses on the regulatory clearance process and does not contain information regarding the acceptance criteria, specific performance study details, or ground truth establishment for a medical device's AI or standalone performance.
Therefore, I cannot fulfill your request for the detailed information outlined in points 1-9 based on the provided text. The document confirms that the device is a Transcutaneous Electrical Nerve Stimulator For Pain Relief and is cleared for Over-The-Counter Use for temporary relief of pain associated with sore and aching muscles. However, it does not describe the technical performance evaluation or clinical study results that would typically be associated with AI or standalone device performance testing.
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