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510(k) Data Aggregation
(74 days)
Jupiter Endovascular
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(205 days)
K&J Consulting
IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.
IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.
This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.
Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.
Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.
The document states:
- "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
- "Clinical Tests: - N/A"
This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.
To answer your specific questions in the context of this document:
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A table of acceptance criteria and the reported device performance:
- Not Applicable (N/A) for AI/ML performance.
- For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.
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Sample sizes used for the test set and the data provenance:
- N/A for AI/ML performance.
- For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.
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Adjudication method:
- N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.
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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:
- N/A. This is a physical implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).
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The sample size for the training set:
- N/A. There is no training set as no AI/ML algorithm is involved.
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How the ground truth for the training set was established:
- N/A. There is no training set.
In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.
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(93 days)
Syrma Johari Medtech Limited
truFlex is indicated to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Strengthening, toning and firming of arms, buttocks, thighs, and calves
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
- To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
truFlex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use.
truFlex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
The fundamental scientific technology has not changed in the modified device. Changes are solely considered for addition of indication for use. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use.
The clinician can increase or decrease the intensity as per the desired stimulation. While modified device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.
The modified device, as described in this submission, have only addition of the indication for use and name the device
The device has two treatment types:
- Classic - In Classic mode, the treatment duration is 45 minutes.
- flex+ - In flex+ mode, the treatment duration is 15 minutes.
For ease of use and operation for the clinicians, we have 3 modes (suggestive):
- PREP mode creates a twisting motion to warm up and stretch the muscles and to slowly build a tolerance to muscle contractions. PREP mode is available for Classic treatments only.
- TONE mode contracts the muscles, holds it, and then relaxes to increase strength and muscle endurance. TONE mode is available for Classic and flex+ treatments.
- SCULPT mode uses fast, sequential contractions of the muscles which lead to toning and firming. SCULPT mode is available for Classic and flex+ treatments
Based on the provided FDA 510(k) Clearance Letter for the truFlex Muscle Stimulator, it's important to clarify that this document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy or performance through a traditional clinical study with defined acceptance criteria for de novo AI/ML devices.
The truFlex device is a Powered Muscle Stimulator, classified as Class II, and uses electrical muscle stimulation (EMS). Its clearance is based on the premise that its safety and effectiveness are "demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device," as stated on Page 4 and Page 9. This means the acceptance criteria are largely met by showing the device performs similarly to or within the established safety and performance parameters of already cleared, similar devices (predicates).
Therefore, the requested information points (1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, etc., typically apply to the rigorous clinical validation studies for novel medical devices, especially AI-driven ones where performance metrics like sensitivity, specificity, or AUC are critical. For a 510(k) based on substantial equivalence to predicate muscle stimulators, the "study" is often a combination of non-clinical bench testing, electrical safety testing, electromagnetic compatibility (EMC) testing, and comparison of technical specifications to demonstrate that the new device is as safe and effective as the predicate.
Given this context, I will address your points as best as possible based on the provided document, acknowledging where the information is not directly applicable or explicitly stated as it would be for a typical AI/ML clinical validation study.
Acceptance Criteria and Study for truFlex Muscle Stimulator
The acceptance criteria for the truFlex Muscle Stimulator, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by showing that the truFlex device has the same intended use, similar technological characteristics, and meets recognized safety and performance standards as its predicates, without raising new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a traditional medical device (not an AI/ML diagnostic/therapeutic device), the "acceptance criteria" are generally that the device performs within the established safety and effectiveness profiles of the predicates. The "reported device performance" is demonstrated through compliance with voluntary standards and direct comparison of specifications.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Submission) | Reference Pages |
|---|---|---|
| Safety: Compliance with recognized electrical safety standards (e.g., patient leakage, isolation). | Measured Patient Leakage: |
- Normal Condition: Less than 100µA (Predicate 1,2:
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(132 days)
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
The Jumao JM-P50A Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients (ages 22 and older) requiring respiratory therapy on a prescriptive basis. It may be used in the home or in professional healthcare facility.
Portable Oxygen Concentrator, model: JM-P50A is a portable oxygen generator that is intended to release oxygen for respiratory therapy by physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula (supplied separately) to channel oxygen from the concentrator to the patient. The JM-P50A is small, portable and may be used in the home or in a professional healthcare facility.
Portable Oxygen Concentrator, model: JM-P50A, uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an air tank. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.
Portable Oxygen Concentrator, model: JM-P50A, can be used in the home or in a professional healthcare facility. Power options include 100 – 240 V (50- 60Hz) AC power supply, rechargeable battery packs.
Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Portable Oxygen Concentrator, model: JM-P50A, senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.
The portable oxygen concentrator consists of main unit, battery, power adapter and carry case. The main gas pathway of oxygen concentrator is composed of particle filter, particle filters, air compressor, molecular sieve beds, manifold valve, sensors, air tank.
This is a 510(k) clearance letter for a Portable Oxygen Concentrator (JM-P50A). The document primarily focuses on demonstrating substantial equivalence to a predicate device (Inogen Rove 6 Portable Oxygen Concentrator) through bench testing and compliance with recognized consensus standards. It explicitly states that "There was no clinical testing performed."
Therefore, the provided document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop assessment. The information you're asking for, particularly points 1-7 from your prompt, typically applies to studies proving clinical effectiveness or diagnostic accuracy of AI/software as a medical device (SaMD), which is not the case here.
However, I can extract information related to the device's technical specifications and how its performance was evaluated against standards, which serve as a form of acceptance criteria for this type of device.
Here's an interpretation based on the provided document, addressing what can be extracted and noting what cannot be:
Acceptance Criteria and Device Performance for Portable Oxygen Concentrator (JM-P50A)
Based on the provided 510(k) clearance letter, the acceptance criteria and the "study" (bench testing and standards compliance) focus on demonstrating substantial equivalence to a predicate device and adherence to recognized performance and safety standards. There was no clinical testing performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance specifications of the predicate device and the requirements of various international standards. The "reported device performance" refers to the JM-P50A's demonstrated capability to meet these criteria through bench testing.
| Acceptance Criterion (Based on Predicate Device & Standards) | Reported JM-P50A Device Performance | Discussion of Meeting Criteria |
|---|---|---|
| Oxygen Delivery Mode: Pulse Dose | Pulse Dose | Meets criterion |
| Flow Control Settings: 1,2,3,4,5,6 (Pulse Dose) | Pulse dose setting 1,2,3,4,5,6 | Meets criterion |
| Output Flow (Total volume Per minute, ml/min) per ISO 80601-2-67 +/- 15%: | ||
| - Setting 1: 210 ml/min | 210 ml/min | Meets criterion (within limits) |
| - Setting 2: 420 ml/min | 420 ml/min | Meets criterion (within limits) |
| - Setting 3: 630 ml/min | 630 ml/min | Meets criterion (within limits) |
| - Setting 4: 840 ml/min (Table typo: listed as 84) | 840 ml/min | Meets criterion (within limits) |
| - Setting 5: 1050 ml/min | 1050 ml/min | Meets criterion (within limits) |
| - Setting 6: 1260 ml/min | 1260 ml/min | Meets criterion (within limits) |
| Oxygen Purity: 90% - 3%/+6% at all settings | 90% - 3%/+6% at all settings | Meets criterion |
| Maximum Outlet Pressure: |
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(200 days)
JJGC Indústria e Comércio de Materiais Dentários S.A.
Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.
Zi Transmucosal Cover Screw and Healing:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Zi Transmucosal Abutment Replacement Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.
The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.
The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.
The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.
The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.
The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A
The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A
The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A
All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.
The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.
Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.
Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:
Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System
The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.
1. A table of acceptance criteria and the reported device performance
As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.
Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.
| Acceptance Criteria Category (Implicit) | Standard/Guidance | Reported Device Performance (Summary) |
|---|---|---|
| Dynamic Fatigue Strength | ISO 14801, FDA Guidance (Class II Special Controls) | Demonstrated a level of performance substantial equivalent to predicate and reference devices in identical conditions. |
| Torsion Strength | Not specified | Adequate torsion strength in accordance with recommended IFU installation torque. |
| Insertion Torque | Not specified | Evaluated insertion torque in sawbones material (Bone type I, II, III, IV). (Specific values not given). |
| Implant Surface Area & Pull-Out Strength | Not specified | Greater surface area compared to reference devices; higher resistance values in Pull Out Test. |
| Software Validation (Sirona Digital Workflow) | Not specified | Accuracy requirement was met; critical design parameters (min wall thickness, max angulation) respected and monitored. |
| MRI Compatibility | K182620, FDA Guidance | MR conditional labeling from K182620 is applicable; safe for scanning under previously established parameters. |
| Biocompatibility | ISO 10993-1, ISO 10993-18, ISO 10993-5, FDA Guidance | Subject devices are equivalent in material and manufacturing processes to predicates; no new issues raised; no additional testing required. |
| Sterilization Validation (Ethylene Oxide) | ISO 11135:2014 | Validated to a Sterility Assurance Level (SAL) of 1x10⁻⁶; residuals below max allowable limits per ISO 10993-7. |
| Sterilization Validation (Moist Heat) | ISO 17665-1 | Validated using parameters described in IFU. |
| Endotoxin Test | ANSI/AAMI ST72:2011, ISO 11737-3, US Pharmacopeia chapter 85 | Results |
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(58 days)
JMS North America Corporation
JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off.
The subject device is the JMS CAVEO A.V. Fistula Needle Set (CAVEO) with an anti-needlestick safety feature. The Caveo is predicted to protect patients from the risks associated with venous needle dislodgement (VND) based on bench testing results. It contains an integrated stainless steel torsion spring mechanism and bottom footplate that provides an open/fluid path when the AV fistula set is fully cannulated into the access site. When the venous needle becomes completely dislodged from the patient's arm, this mechanism enables the footplate to partially occlude the blood path, generating an increased venous line pressure high enough to trigger automatic alarm and halt further blood pumping of the hemodialysis machine. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off. Based on bench testing results, this may significantly reduce patient blood loss in the event of a complete VND. The Caveo has a pre-attached anti-stick needle guard for prevention of needlestick injury at the time of needle withdraw after completion of a hemodialysis procedure.
In vitro performance testing using dialysis machine Fresenius 2008K supports the function of the Caveo VND feature with a venous pressure limit set to 200mmHg symmetric mode, a maximum dialyzer membrane surface area of 2.5 m2, minimum blood flow rate of 200 mL/min, maximum ultrafiltration rate of 4000 mL/hour, and simulated treatment duration of 8 hours. If different machine and/or setting are used, before introducing the device, refer to Directions for Use.
This document describes the FDA 510(k) clearance for the JMS CAVEO A.V. Fistula Needle Set. This device is a physical medical device, specifically a needle set for hemodialysis, and does not involve Artificial Intelligence (AI). Therefore, many of the requested criteria related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, and training datasets are not applicable.
The document primarily focuses on bench testing (in vitro performance) and a simulated clinical usability study to demonstrate device safety and effectiveness.
Here's a breakdown based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily demonstrated through various performance tests, with "Passed" as the acceptance. The document doesn't explicitly state numerical acceptance thresholds for all tests (e.g., how much "Force to Depress the Footplate" is acceptable), but it implies successful completion. For some, like needle penetration resistance and retraction lock strength, numerical criteria are provided.
| Acceptance Criterion (Test) | Reported Device Performance |
|---|---|
| Needle Penetration Resistance | |
| 14G | ≤ 40g (Predicate: ≤ 40g) |
| 15G | ≤ 35g (Predicate: ≤ 35g) |
| 16G | ≤ 30g (Predicate: ≤ 30g) |
| 17G | ≤ 30g (Predicate: ≤ 30g) |
| Needle Retention Strength | > 6.0kgf (Predicate: > 6.0kgf) |
| Needle Surface (Visually) | No dented/damaged needle (Predicate: No dented/damaged needle) |
| Product Leak | No air bubble should appear when subjected to air pressure 0.40 kgf/cm2 and immersed in water. (Predicate: Same) |
| Needle Retraction Final Lock Strength | ≤ 2.0kgf (Predicate: ≤ 2.0kgf) |
| Connector (Air tightness, Luer fit) | Passed (ISO 80369-7 compliant) |
| Connection Strength (Tube to Connector/Joint, Tube to Pivot Valve Core) | > 6.0kgf (Predicate: > 3.0kgf for Tube to Connector/Joint, > 6.0kgf for Tube to Hub) |
| Leakage by Pressure Decay (Female Luer Lock) | Passed |
| Positive Pressure Liquid Leakage (Female Luer Lock) | Passed |
| Sub-atmospheric Pressure Air Leakage (Female Luer Lock) | Passed |
| Stress Cracking (Female Luer Lock) | Passed |
| Resistance to Separation from Axial Load (Female Luer Lock) | Passed |
| Resistance to Separation from Unscrewing (Female Luer Lock) | Passed |
| Resistance to Overriding (Female Luer Lock) | Passed |
| Tube to Connector Pull Test (Female Luer Lock) | Passed |
| Luer Lock Cover Open Torque Test (Female Luer Lock) | Passed |
| Testing Activation of the Sharps Injury Protection Feature | Passed |
| Needle Pushback Strength Test | Passed |
| Needle Guard Detachment Strength Test | Passed |
| Appearance Check (Caveo) | Passed |
| Cover Pull with Hub (Caveo) | Passed |
| Air Leak Test (Caveo) | Passed |
| Positive Pressure Leak Test (Caveo) | Passed |
| Negative Pressure Leak Test (Caveo) | Passed |
| Needle Guard Retraction Final Lock Test (Caveo) | Passed |
| Tube to Hub Pull Test (Caveo) | Passed |
| Cannula to Hub Tensile Test (Caveo) | Passed |
| Dimensional Analysis of Footplate to Pivot Valve Core (Caveo) | Passed |
| TPE Front & Back Ends Internal Diameter (Y-axis) Measurements (Caveo) | Passed |
| TPE Surface Roughness (Caveo) | Passed |
| Cannulation at 15 and 45-Degree Angles (Caveo) | Passed |
| Occlusion After Taping (Caveo) | Passed |
| VND Performance (Venous Needle Dislodgement) | Passed |
| Baseline Pressure Comparison (Caveo) | Passed |
| Force to Depress the Footplate (Caveo) | Passed |
| Mechanical Hemolysis Testing (Caveo) | Passed |
| Simulated Clinical Usability Study | Successful |
| Transportation Test | Passed |
| Human Factors Testing | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Genotoxicity) | Passed (for all, per ISO 10993 standards) |
2. Sample Size for Test Set and Data Provenance
- Test Set (Clinical Trial): 15 subjects (2 females, 13 males).
- Data Provenance: The document does not explicitly state the country of origin. It describes the recruitment from "the general hemodialysis population," and mentions racial/ethnic demographics, but not geographic. Given the company is "JMS North America Corporation" (Hayward, CA), it is highly probable the study was conducted in the US. The study appears to be prospective as it involves recruitment and device use to confirm safety, performance, and usability.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is largely not applicable as the device is a physical medical device. The "ground truth" for performance is established through bench testing (objective physical measurements) and the success of the device in a simulated clinical setting. There is no mention of human experts establishing a "ground truth" for diagnostic or AI-related interpretations.
For the simulated clinical usability study, the "ground truth" is whether the device performed as intended and was usable, as observed by clinicians/researchers during the study. The qualifications of those assessing the usability are not specified, beyond the implication that they are competent to conduct a clinical trial for hemodialysis devices.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement in expert opinions needing a tie-breaker. This is not applicable here as:
- The primary "test set" involves objective performance characteristics (bench testing).
- The clinical usability study likely involved observing successful function and user feedback, not a diagnostic interpretation needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for evaluating the performance of AI systems or diagnostic tools where multiple human readers interpret cases, often with and without AI assistance, to see if the AI improves human performance. This device is a physical hemodialysis needle set, not an AI or diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the performance of an AI algorithm on its own. The device is a physical product. Its "standalone" performance is assessed through bench testing (e.g., VND Performance, Mechanical Hemolysis Testing, Needle Penetration Resistance). These tests evaluate the device's inherent functional characteristics independent of human interaction during the critical failure modes.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth is based on objective physical measurements and engineering specifications (e.g., force measurements, leak tests, dimensional analyses) and functional success/failure (e.g., did the VND feature trigger the alarm?).
- Simulated Clinical Usability Study: The ground truth is based on observed device performance during simulated use and the successful delivery of hemodialysis without impedance by the device's novel features. This is akin to outcomes data in a controlled simulated environment.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model.
In summary, the provided document details the non-clinical and limited clinical testing of a physical medical device (hemodialysis needle set). The acceptance criteria are largely met through rigorous bench testing demonstrating physical and functional robustness, and a small simulated clinical study confirming usability and safety in a controlled environment. AI-specific criteria are not relevant to this type of device.
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(194 days)
TSK Laboratory, Japan
The TSK Syringe is a low dead volume syringe intended for use in patients that need injection and withdrawal of substances for examination, treatment, diagnosis or prevention.
The TSK Syringe is a syringe intended for use with a needle to inject or withdraw substances, for general use. The TSK Syringe leaves a low volume of fluid when the plunger is fully depressed.
There are two model numbers for the TSK Syringe. The technological differences are as follows:
| Number | Syringe Nominal Capacity (mL) |
|---|---|
| TSY-0071P | 0.7 |
| TSY-0101Y | 1.0 |
The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TSK Syringe. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/human reader study.
This document describes a physical medical device (syringe), not a software or AI-powered medical device that would involve AI performance metrics, human reader studies, ground truth establishment, or training/test set sample sizes in the way you've outlined.
Therefore, I cannot provide the requested information from this document. The details about acceptance criteria and study design for AI-based performance evaluation are not present.
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(174 days)
TSK Laboratory, Japan
The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.
The TSK SELECT™ Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen needle intended for use with a luer-tip syringe. The TSK SELECT™ Needle consisting of a stainless-steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene, or polycarbonate, depending on the hub type, designed to be connected with a male luer fitting of a syringe. The TSK SELECT™ Needle is intended for manual use by health care professionals for administration of fluids. The TSK SELECT™ Needle is provided sterile, is single use only, non-toxic, non-pyrogenic, and sterilized by gamma irradiation.
There is no indication that the TSK SELECT™ Needle incorporates artificial intelligence (AI) or machine learning (ML). The provided 510(k) clearance letter and summary describe a physical medical device (hypodermic needle) and its non-clinical performance and biocompatibility testing.
Therefore, the specific information requested about AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device through:
- Indications for Use Comparison: Showing the new device has the same intended use as the predicate.
- Technological Comparison: Highlighting similarities and differences in materials, design, and features, and providing justification (e.g., "does not raise new or different questions of safety and effectiveness") for any differences.
- Non-Clinical Testing: Demonstrating compliance with recognized standards for physical performance, sterilization, and biocompatibility.
Since the request is specifically about AI/ML device criteria and studies, and this device is not an AI/ML device, I cannot provide the requested information based on the input. The document does not contain any data relevant to AI/ML performance metrics.
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(114 days)
Jiangsu Tingsn Technology Co., Ltd.
TINGS FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power.
The device is intended for use in Professional healthcare facility environment including echo lab, other hospital settings, operating room, Cath lab and EP lab.
The intended users of the Device is to be used exclusively by physicians who are appropriately trained personnel in a fully equipped electrophysiology or catheterization room or under their direct supervision.
The proposed TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is a Track 3 diagnostic device designed for imaging intracardiac anatomical structures and blood flow dynamics in adult patients. It comprises two primary components: the ultrasound console and the TINGSN Sonic Eyes 10 Eco Disposable Intracardiac Echocardiography Catheter. The console features a 17.3-inch touch-enabled LCD screen, a control panel, and interfaces for connectivity, powered by a rechargeable battery or AC adapter, with optional peripherals including a cart and foot switch. The catheter, a sterile, single-use device with a 95 cm insertable length and 10Fr diameter, is equipped with a 64-element phased array transducer at its tip for high-resolution imaging. It connects to the console via the Finders 2 Sonic Eyes Connector, featuring a locking mechanism to ensure secure attachment during procedures. The system supports multiple imaging modes—B-Mode, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, Power Doppler, and combined modes —along with advanced functionalities, displayed with real-time thermal (TI) and mechanical (MI) indices.
The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System. This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.
Crucially, the document explicitly states under "8. CLINICAL DATA": "No clinical data was included in this submission."
Therefore, based on the provided text, a study that proves the device meets acceptance criteria through clinical data (either standalone or MRMC comparative effectiveness) was not performed, or at least, not included in this submission. The entire submission relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.
As the request specifically asks for information about a "study that proves the device meets the acceptance criteria" and mentions clinical outcomes, it is impossible to provide the requested details from the given text.
However, I can extract the information related to the non-clinical tests that were performed to verify the device met design specifications and was substantially equivalent, which serve as the basis for clearance in lieu of clinical data.
Here's an interpretation based on the non-clinical data presented:
Device Acceptance Criteria and Performance (Based on Non-Clinical Data)
The TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System established its substantial equivalence (SE) based primarily on non-clinical testing and comparison to predicate devices, as no clinical data was included in the submission. The acceptance criteria and "performance" are therefore framed in terms of compliance with relevant standards and demonstration of functional equivalence.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Demonstrated via Compliance with Standards / Equivalence) | Reported Device Performance (Demonstrated via Non-Clinical Testing) |
|---|---|
| Safety & Essential Performance: Compliance with general medical electrical equipment safety standards. (IEC 60601-1 Ed 3.2) | Met: Non-clinical tests demonstrated compliance with IEC 60601-1 Edition 3.2. |
| Electromagnetic Compatibility (EMC): Compliance with EMC requirements for medical devices. (IEC 60601-1-2) | Met: Non-clinical tests demonstrated compliance with IEC 60601-1-2. |
| Specific Safety/Performance for Ultrasonic Equipment: Compliance with specific requirements for diagnostic ultrasound. (IEC 60601-2-37) | Met: Non-clinical tests demonstrated compliance with IEC 60601-2-37. |
| Acoustic Output Characterization: Compliance with methods for determining thermal and mechanical indices. (IEC 62359, NEMA UD2) | Met: Non-clinical tests demonstrated compliance with IEC 62359 and NEMA UD2. The device is a "Track 3" device, implying its acoustic output is within regulatory limits (global maximum derated ISPTA ≤720 mW/cm², MI ≤1.9 or ISPPA ≤ 190 W/cm²). |
| Intravascular Catheter Requirements: Compliance with standards for sterile, single-use intravascular catheters. (ISO 10555-1) | Met: Non-clinical tests demonstrated compliance with ISO 10555-1. |
| Biocompatibility: Evaluation and testing within a risk management process for medical devices. (ISO 10993-1) | Met: Non-clinical tests demonstrated compliance with ISO 10993-1 (specifically, Patient contact materials of the catheter shaft are "Pebax series Comply with ISO 10993-1"). |
| Packaging & Shipping Performance: Performance testing of shipping containers and systems. (ASTM D4169-2022) | Met: Non-clinical tests demonstrated compliance with ASTM D4169-2022. |
| Risk Management: Application of risk management to medical devices. (ISO 14971:2019) | Met: A thorough risk analysis was conducted, and risk controls were implemented to mitigate identified hazards. |
| Software Functionality & Safety: Compliance with FDA guidance for device software functions, meeting specifications and mitigating risks. (FDA Guidance for Device Software Functions) | Met: Software documentation included. Non-clinical tests (integration and functional) conducted. Test results support that all software specifications met acceptance criteria. Verification and validation testing found acceptable. |
| Functional Equivalence to Predicate Device (GE Vivid iq console): Similar intended use, imaging modes, principle of operation, and overall performance. | Demonstrated: The proposed device's indications for use are encompassed by the predicate. Technical differences in imaging modes, software, and compatible probes do not impact safety or effectiveness. Risk analysis assessed potential software-related risks. |
| Functional Equivalence to Predicate Device (SOUNDSTAR 3D Ultrasound Catheter): Similar indications for use, principle of operation, patient population, sterility, diameter, and transducer configuration. | Demonstrated: Slight differences in insertable length, imaging frequency range, and shelf life were determined not to impact safety or effectiveness. The proposed device's indications are encompassed by the predicate. |
| Shelf Life: Verification of product stability and packaging integrity for claimed shelf life. | Met: A 2-year shelf-life study was performed, verifying the claimed 2-year shelf life is scientifically reliable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific non-clinical tests. General statements indicate "non-clinical tests were conducted."
- Data Provenance: The tests were conducted internally by Jiangsu Tingsn Technology Co., Ltd. The document refers to "non-clinical tests (integration and functional) were conducted on the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System during product development."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable for non-clinical testing. The "ground truth" for non-clinical tests typically refers to engineering specifications, regulatory standards, and established physical principles, not expert interpretations of clinical data.
4. Adjudication Method for the Test Set
- Not applicable for non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth or compare diagnostic performance, which was not part of this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The submission explicitly states: "No clinical data was included in this submission." MRMC studies inherently involve human readers evaluating clinical cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance)
- Not applicable as an AI/algorithm-only device. The TINGSN FINDERS 2 is a diagnostic ultrasound system that produces images for human interpretation, not an AI algorithm performing diagnosis independently. The software features listed are for image optimization, measurements, and display, assisting the human user, not replacing them in a "standalone" diagnostic role.
7. The Type of Ground Truth Used
- For non-clinical testing: The "ground truth" was established by performance specifications, engineering requirements, and compliance with the international and national standards listed (e.g., IEC, ISO, NEMA, ASTM, FDA guidance). This includes electrical safety, mechanical robustness, image quality parameters (resolution, penetration, consistency), acoustic output levels, and software functionality validation against design requirements.
8. The Sample Size for the Training Set
- Not applicable. This device is a traditional ultrasound system, not an AI/ML product that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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(173 days)
Jiangxi AICARE Medical Technology Co., Ltd.
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia.
The Electronic Sphygmomanometers, including ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, is suitable for measurement of systolic blood pressure and diastolic blood pressure of adult person and adolescents 18 to 21 years old with arm circumference ranging from 22 cm to 42 cm by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.
The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V).
The device has a memory function that automatically stores 2*99 sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.
The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference.
The provided FDA 510(k) clearance letter and synopsis for the Electronic Sphygmomanometers (K250185) primarily focus on demonstrating substantial equivalence to a predicate device, rather than detailing a specific clinical study with granular acceptance criteria for an AI-powered diagnostic device. The application is for a standard medical device (blood pressure monitor), not an AI/ML-driven diagnostic tool. Therefore, many of the requested points for an AI study (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this document.
However, I can extract and infer information relevant to the device's accuracy and performance validation using the provided text, particularly concerning the mentioned standards and the comparative clinical study.
Here's an attempt to describe the acceptance criteria and study as best as possible given the provided non-AI-specific document:
Device: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Study Type: Comparative Clinical Study (for substantial equivalence to a predicate device and mercury sphygmomanometer) and Non-Clinical Performance Testing.
Regulation/Standard for Accuracy: IEC 80601-2-30, ISO 81060-2 (including Amendment 1(2020)), and FDA Guidance No-Invasive Blood Pressure (NIBP) Monitor Guidance.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for non-invasive blood pressure monitors, as per ISO 81060-2 (which is explicitly listed as a standard the device complies with), relies on statistical analysis of difference between the device's readings and a reference standard (usually mercury sphygmomanometer readings or an established method). The key metrics are:
- Mean Difference (Bias): The average difference between the device reading and the reference reading.
- Standard Deviation of the Differences: A measure of the spread of these differences.
The ISO 81060-2 standard (for clinical validation of automated measurement type) typically requires:
- Mean difference between the test device and reference measurement: $\leq \pm 5$ mmHg
- Standard deviation of the differences (SD): $\leq 8$ mmHg
| Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance (from "Accuracy" section) |
|---|---|
| Mean difference $\leq \pm 5$ mmHg | Pressure: $\pm 3$ mmHg ($\pm 0.4$ kPa) or 2% of the reading |
| Standard deviation $\leq 8$ mmHg | (Not explicitly stated, but implied compliance with ISO 81060-2) |
| Pulse Rate Accuracy: $\leq \pm 5$% | Pulse Rate: $\pm 5$% |
Note: The reported accuracy of $\pm 3$ mmHg or 2% of the reading for pressure is a general accuracy specification, not necessarily the mean difference and standard deviation from the clinical validation as per ISO 81060-2. However, achieving $\pm 3$ mmHg as a general accuracy implies that the device is likely to meet or exceed the ISO 81060-2 criteria. The document states compliance with ISO 81060-2, meaning it passed these criteria.
2. Sample Size and Data Provenance
- Test Set (Clinical Study): The document states, "We conducted a comparative clinical study to verify the performance of the proposed device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2."
- Sample Size: ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. The document does not explicitly state the exact sample size used in their study, but implies it met the requirements of the standard it followed.
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "comparative clinical study," which generally implies a prospective data collection for the purpose of the validation.
3. Number/Qualifications of Experts for Ground Truth
- Not Applicable / Not Specified: For a blood pressure monitor, the "ground truth" for blood pressure measurements is typically established using a reference standard like a mercury sphygmomanometer or an auscultatory method performed by trained observers, as outlined in ISO 81060-2. This is a measurement comparison, not an expert-based image interpretation or diagnosis that would require multiple reading experts in the AI sense.
4. Adjudication Method
- Not Applicable / Not Specified: Since this is a direct physiological measurement comparison, adjudication methods commonly seen in AI/image interpretation studies (e.g., 2+1, 3+1 consensus) are not relevant here. The ISO 81060-2 standard defines precise measurement protocols by trained observers for comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: This type of study is relevant for AI-assisted diagnostic aids where human readers' performance (e.g., accuracy, efficiency) is evaluated with and without AI. This device is a standalone measurement tool, not an AI diagnostic aid for human readers.
6. Standalone (Algorithm Only) Performance
- Implicitly Done: The "Performance Data" section explicitly states compliance with "IEC 80601-2-30" and "ISO 81060-2." These standards define the requirements for the automated (standalone) measurement of non-invasive blood pressure, requiring the device algorithm (oscillometric technique) to provide accurate pressure readings independently. The clinical study compares the device's automated readings against a reference standard.
7. Type of Ground Truth Used
- Reference Standard Measurement: The ground truth for blood pressure measurements was established using a mercury sphygmomanometer (or an equivalent valid reference method) during the comparative clinical study, as per the ISO 81060-2 standard. This is a direct, objective physiological measurement.
8. Sample Size for the Training Set
- Not Applicable: This is a traditional medical device (blood pressure monitor) that utilizes a deterministic oscillometric algorithm, not a machine learning or AI model that requires a "training set" in the context of deep learning. Its algorithm is based on established engineering principles for detecting pressure oscillations.
9. How Ground Truth for Training Set Was Established
- Not Applicable: As there is no "training set" for a machine learning model, this point is not relevant for this device.
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