Search Results

The ACE Cannula is intended to inject fluids intradermally.

The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient.

The provided document is a 510(k) summary for a medical device called the "ACE Cannula." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a clinical study or performance data based on human-in-the-loop or standalone AI performance.

Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment (for training and test sets) is not applicable to this type of submission. This document outlines bench testing for physical characteristics, material safety (biocompatibility), and sterility, all of which are laboratory-based and do not involve patient data or expert reader studies in the way you've described for AI/CADe devices.

Here's an analysis based on the information that is present in the document:

Device: ACE Cannula
Purpose: Intended to inject fluids intradermally.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE Cannula are based on compliance with international standards for medical devices, specifically hypodermic needles and cannulas, and biocompatibility. The "reported device performance" is the manufacturer's assertion that the device "Pass"ed all these tests.

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

• This is a 510(k) submission for a conventional medical device (a cannula), not an AI/CADe device. The "test set" here refers to samples of the device undergoing laboratory bench testing according to various ISO standards.
• The document does not specify the exact sample size for each individual bench test (e.g., how many cannulas were tested for bond strength). However, it implies that sufficient samples were tested to demonstrate compliance with the relevant standards.
• Data Provenance: The tests were conducted by Ace Medical Industry Co., Ltd. (Korea, as per company address in the 510(k) summary) or a qualified third-party lab under their direction. These are prospective tests performed on newly manufactured devices to demonstrate compliance.

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

• Not applicable. This device's performance is evaluated through physical, chemical, and biological laboratory tests against pre-defined, objective engineering and safety standards (e.g., ASTM, ISO standards). It does not involve subjective human interpretation of data (like medical images), so no human experts are needed to establish "ground truth" for a test set in the clinical sense.

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

• Not applicable. As above, the testing is objective and based on engineering/scientific measurements, not subjective human assessments requiring adjudication.

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

• Not applicable. This relates to AI/CADe devices assisting human clinicians. The ACE Cannula is a physical, sterile, single-use device for fluid injection, not an AI or imaging device.

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

• Not applicable. This relates to the performance of an AI algorithm. The ACE Cannula does not have an "algorithm" in this context. Its "performance" is its mechanical, material, and biological properties.

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

• For the tests performed, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, USP, ASTM). For example, "pass" for patency of lumen means the lumen was unobstructed as per the standard's definition; "pass" for cytotoxicity means the extracts did not cause a cytotoxic effect beyond the acceptable limits defined in ISO 10993-5. It is based on objective, measurable criteria rather than expert consensus or clinical outcomes data relevant to AI/CADx devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of device. The device is manufactured and then tested for compliance with established standards. There is no machine learning model being trained.

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

• Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The product's design and manufacturing rely on engineering principles, material science, and established quality control practices.

Ask a specific question about this device

The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

• Different handles (Large, Standard, for use with Rotating Shafts)
• Different shaft lengths (6-14 inches)
• Different Bite Sizes (0.5-6 mm)
• Different Angles (40° and 90°, up and down)
• Different Footplates (Standard, Thin and Ultra-Thin)
• With or without ejector
• Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

Here's a breakdown of the acceptance criteria and study information for the Ace Medical Surgical Instruments, based on the provided FDA 510(k) summary:

This device is a manual surgical instrument (rongeur), not an AI/ML-driven device. Therefore, many of the typical AI/ML study components (like expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable. The studies focus on the physical and functional characteristics of the surgical instrument.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Strength: The summary indicates that the predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing. The specific sample size for this predicate testing is not provided in this document. The subject device was deemed identical, so no separate test set was used for mechanical strength for the subject device.
• Cleaning: A cleaning validation was performed on a "worst case instrument." This implies a single instrument or a very small sample to represent the most challenging cleaning scenario.
• Sterilization: The validation used a "half-cycle approach," which is a common method for sterilization cycle validation, but the exact sample size (number of devices or cycles performed) is not specified.
• Biocompatibility: No specific test set was used for the subject device as it was determined to be identical to the predicate.

Data Provenance: Not applicable in the context of clinical data for a manual surgical instrument. The tests are laboratory/benchtop validations.

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

Not applicable for tests related to mechanical, cleaning, sterilization, and biocompatibility of a manual surgical instrument. Ground truth is established by test standards and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable for these types of benchtop tests. Results are typically determined by measurement against established standards rather than expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is a manual surgical instrument, not an AI-driven device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a manual surgical instrument.

7. The Type of Ground Truth Used

• Mechanical Strength: Ground truth is based on the performance characteristics of the predicate device as demonstrated through static and dynamic mechanical testing against engineering specifications for fatigue and cutting displacement.
• Cleaning: Ground truth is established by adherence to a recognized standard: AAMI TIR 30:2011 for protein and hemoglobin content, and visual inspection for soil.
• Sterilization: Ground truth is established by achieving a specific sterility assurance level (SAL) of 10^-6, which is a recognized regulatory benchmark for sterility.
• Biocompatibility: Ground truth is established by the predicate device's proven biocompatibility and the material equivalence of the subject device. Compliance with material standards (ASTM F899) is also implied.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable.

Ask a specific question about this device

The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis). transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder turnors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate.

The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.

The ACE Electrosurgical Resection and Vaporization Electrodes Series consist of an active tip, PTFE color code identification, and an insulator between the electrode tube, a guiding tube, telescope clip and arm (shaft). The design and dimensions of the electrode tips vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops or buttons. The system includes single-use electrodes that can be connected to a working element (only WA22366A – K100275), or the use of the single-use electrodes together other compatible electrosurgical cables as applicable. Compatible Generators to any of the electrodes include generators with output specifications that meet the following criteria: 100-120/220-240V, ~50-60Hz/1000VA, 310-380 kHz, 320W/200 Ω, Int 10s/30s.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "ACE Electrosurgical Resection and Vaporization Electrodes Series." This document primarily discusses the substantial equivalence of the new device to a predicate device, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Here's an analysis of the information, addressing your points where possible, and noting when the information is not present in this type of FDA submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific device performance metrics in the way you might expect from a clinical study report. Instead, it relies on demonstrating equivalence to an existing predicate device and conformance to recognized consensus standards.

Acceptance Criteria (Implied / Stated):

• Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device (K120418, Olympus Winter & Ibe GmbH Electrosurgical Resection and Vaporization Electrodes Series) in terms of:
  • Indications for Use
  • Principles of Operation
  • Technological Characteristics
  • Materials
  • Performance (demonstrated through bench testing and conformance to standards)
• Safety and Effectiveness: Does not raise new issues of safety or effectiveness.
• Electrical Safety: Conforms to IEC 60601-1.
• Thermal Safety: Conforms to IEC 60601-2-2.
• Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity.
• Sterilization: Ethylene Oxide (EO) with a Sterility Assurance Level (SAL) of 10-6.
• Risk Analysis: Performed in accordance with ISO 14971:2007.

Reported Device Performance:

The document states that "Design verification was performed to ensure the device functions according to its intended use, and the results met their acceptance criteria." However, it does not provide the specific numerical results of this design verification. It only confirms that the testing was performed and met the criteria.

The "Comparison of Characteristics" table (Table 5A) highlights the similarities between the applicant's device and the predicate device across various attributes. This comparison serves as the performance data in terms of demonstrating equivalence.

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

This document describes a 510(k) submission, which relies heavily on non-clinical (bench) testing and comparison to a predicate device, rather than a clinical trial with a "test set" of patients.

• Sample Size for Test Set: Not applicable in the context of human subjects or "test sets" as you might find in an AI/imaging study. The "test set" in this context refers to the samples used in bench testing (e.g., electrical safety tests, biocompatibility tests), the number of which is not specified in this summary.
• Data Provenance: Not applicable in terms of country of origin of patient data or retrospective/prospective studies, as no human clinical data is presented here to support the device's safety and effectiveness. The data provenance discussed relates to the manufacturer (Ace Medical Devices Pvt. Ltd., India) and the predicate device manufacturer (Olympus Winter & Ibe GmbH).

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

Not applicable. This is not a study involving expert review for establishing ground truth from patient data. The "ground truth" for this device's safety and effectiveness is established by its similarity to a device already on the market and its conformance to recognized engineering and safety standards.

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

Not applicable, as there is no "test set" in the context of human data requiring expert adjudication.

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

Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in that way.

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

Not applicable for the same reasons as above. This is an electrosurgical device, not an algorithm.

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

The "ground truth" for the substantial equivalence claim is multi-faceted:

• Predicate Device Performance: The primary ground truth is that the predicate device (Olympus K120418) has a history of safe and effective use in the market.
• Consensus Standards: Adherence to recognized consensus standards like IEC 60601-1 (electrical safety) and IEC 60601-2-2 (thermal safety), and ISO 14971:2007 (risk management).
• Bench Testing: Internal design verification testing results (not detailed here) that confirmed the device functions as intended and met acceptance criteria for engineering specifications.
• Biocompatibility Testing: Results indicating the materials are biocompatible.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable.

Ask a specific question about this device

The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites. Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The Autofuser system consists of a family of disposable infusion pumps and associated procedure kits. The pump is comprised of a balloon-style medication reservoir and an integrated flowrate-controlling administration set. When the Autofuser pump is packaged in a procedure kit, the kit includes legally marketed components such as filling syringe, catheter, catheter introducer, and pump carrying pouch.

Here's an analysis of the provided text regarding the Ace Medical Autofuser Elastomeric Infusion Pump System (K090300) and its performance criteria and study details:

Summary of Acceptance Criteria and Device Performance (Based on available information):

Detailed Study Information:

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

   • See the table above. The document broadly states that the modified device "met its predetermined performance specifications" and is "as safe and effective" as the predicate device. Specific numerical acceptance criteria or detailed individual performance metrics are not provided in this summary.

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

   • The document does not specify the sample size used for the test set.
   • The document does not specify the data provenance (e.g., country of origin) or whether it was retrospective or prospective. It only mentions "Performance testing was performed to verify/validate the modifications to the system."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This question is not applicable as the device is an infusion pump, not an AI/diagnostic device that typically relies on expert-established ground truth for a test set. The performance testing would likely involve engineering and functional tests rather than expert opinion on output.

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

   • This is not applicable for this type of device and study. Adjudication methods are typically used in studies involving human interpretation (e.g., medical image reading) where multiple experts or readers are involved.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers. This device is an elastomeric infusion pump.

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

   • This is not applicable in the AI sense. This device is a physical medical device (an infusion pump), not a software algorithm being tested for standalone performance. The "performance data" refers to the physical pump's functional integrity.

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

   • For a device like an elastomeric infusion pump, the "ground truth" would be established by engineering standards, predetermined specifications, and validated measurement techniques (e.g., flow rate accuracy, pressure limits, material compatibility, duration of infusion). The document broadly states that the device "met its predetermined performance specifications," implying these engineering benchmarks were used.

8. The sample size for the training set:

   • This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

   • This is not applicable for the same reason as point 8.

Conclusion:

The 510(k) summary for the Ace Medical Autofuser Elastomeric Infusion Pump System (K090300) indicates that the device met its predetermined performance specifications and was found to be as safe and effective as its predicate device (K060258) after modifications. However, the summary provides very high-level information about the "Performance Data." It does not include specific numerical acceptance criteria, detailed test methodologies, sample sizes for testing, or the specific types of "predetermined performance specifications" that were met. The document uses general statements to affirm substantial equivalence, rather than detailed quantitative results commonly found in AI/diagnostic device studies. Due to the nature of the device (an infusion pump), many of the questions related to AI studies (experts, ground truth for training/test sets, MRMC studies) are not relevant.

Ask a specific question about this device

The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites.

Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button.

General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.

Here's an analysis of the provided text regarding the Ace Medical Autofuser System (K060258), broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria for the device's performance (e.g., "flow rate must be within X% of target"). Instead, it states that:

From the text, "The design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met," implies that internal criteria were established and achieved, but the specific metrics are not detailed in this summary.

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

The provided document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on modifications to an existing device and demonstrating substantial equivalence through design verification and validation, rather than a clinical study with a patient-based test set.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation appears to be based on engineering verification and validation of the device's performance against internal specifications and comparison to predicate devices, not on expert consensus regarding clinical outcomes.

4. Adjudication Method for the Test Set

As no test set involving human assessment or expert review is described, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study. This submission is for modifications to an elastomeric infusion pump, which typically does not involve this type of study design. The focus is on the device's mechanical and functional performance, not on human interpretive tasks that would benefit from MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an elastomeric infusion pump. There is no "algorithm only" or "standalone" performance described in the context of AI or software. The performance assessed would be the physical pumping mechanism and its ability to deliver fluids at specific rates.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is implicit in its design specifications and functional requirements. For example, a target flow rate, reservoir size, and bolus delivery mechanism. The document states that "design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met." This implies the ground truth was based on engineering specifications and established performance benchmarks for infusion pumps, not on pathology, outcomes data, or expert consensus in a clinical sense.

8. Sample Size for the Training Set

As this is a submission for a medical device (an elastomeric infusion pump) and not an AI/ML algorithm that requires a training set, the concept of a "training set" does not apply to this document.

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

Since there is no training set for an AI/ML algorithm for this device, information on how its "ground truth" was established is not applicable.

Ask a specific question about this device

The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

The DePuy ACE A.I.M.® Titanium Tibial Nail is an intramedullary fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 11mm, 12mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE A.I.M.º Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5cm. The proximal end of the 10mm, 11mm, 12mm , and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nadiameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws and one 5mm long dynamization slot in the M-L plane. The distal end of the nail contains two 5.0mm holes in the M-L plane which accept 4.5mm solid cortical bone screws and one 5.0mm hole in the A-P plane positioned between the two transverse holes. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.

The DePuy ACE A.I.M. Titanium Tibial Nail is manufactured from Titanium 6A1-4V ELI (ASTM standard F-136).

The new DePuy ACE A.I.M.® Titanium Tibial Nail is the same basic design as the current DePuy ACE A.I.M. Titanium Tibial Nail, with the exceptions of adding a proximal dynamization slot in the M-L plane, which allows 5mm of length to dynamize across fracture site and that the two oblique proximal screw holes are moved more proximal to vield a longer working length for the nail. Also, there is an additional hole in the nail in the A-P plane. This is positioned between the current two distal transverse holes, allowing for oblique locking distally, which is more stable and allows the lagging of anterior fragments of the distal tibia. The additional holes and changes in placement are very similar to that of the Synthes Titanium Cannulated Tibial Nail and the Synthes Titanium Unreamed Tibial Nail.

The provided text describes a medical device, the DePuy ACE A.I.M.® Titanium Tibial Nail, which is an intramedullary rod for fixing tibial fractures. However, this document is a 510(k) summary and not a study report. Therefore, it does not explicitly define acceptance criteria or detail a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary regulatory pathway for this type of device. The "study" mentioned is a biomechanical testing study to compare the new device's strength to a predicate device.

Here's an analysis of the provided information in relation to your request, with the understanding that the nature of the document limits the direct answers to your specific questions about "acceptance criteria" for a cognitive task or "AI performance":

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics in the way one would define for a diagnostic or AI device (e.g., "sensitivity must be >X%", "AUC must be >Y%").
  • Implied Acceptance Criteria (for substantial equivalence): The new device must be "at least as strong or stronger" than the predicate device in biomechanical tests.
• Reported Device Performance:
  • "On all tests, the DePuy Tibial Nail was either at least as strong or stronger than the Synthes Tibial Nail."

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

• Sample Size for Test Set: Not specified. The document only mentions "Biomechanical testing was done." The number of different tests performed or the number of nails tested is not detailed.
• Data Provenance: Not specified. It's a biomechanical test, likely conducted in a lab environment rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This document describes a biomechanical test of physical strength, not a diagnostic or interpretive task that requires expert ground truth.

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

• Not applicable. This relates to expert consensus for ground truth, which is not relevant for a biomechanical strength test.

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

• No. This is a biomechanical study, not a study involving human readers or AI.

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

• Not applicable. There is no algorithm or AI involved. The "device" is a physical implant. The "standalone performance" metaphorically refers to the intrinsic mechanical properties of the nail itself.

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

• Not explicitly stated in these terms. For biomechanical testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., yield strength, ultimate tensile strength, fatigue life) compared against established engineering standards or the performance of a predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a biomechanical test for substantial equivalence.

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

• Not applicable. As above, no training set. The "ground truth" for biomechanical properties is derived from established material science and engineering principles and testing methodologies.

Ask a specific question about this device

The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.

The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.

Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.

The ACE Humerus Plates and Radius Plates are anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws. The humerus plates will offered in two configurations for both the left side and the right side. The plates are offered in three hole and five hole configurations.

The ACE Radius plates are also offered in a right and left configuration both for volar fixation and dorsal fixation. The plates are offered in a large and a small size.

Here's an analysis of the provided information, focusing on acceptance criteria, study details, and ground truth establishment:

Disclaimer: Based on the provided text, the device is a medical implant (bone plates) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, ground truth establishment for AI, and MRMC studies are not applicable. I will provide information relevant to the provided text for a physical medical device.

Acceptance Criteria and Device Performance (Based on Physical Device Testing)

Study Details (Applicable to Physical Device Testing)

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

   • Test Set Sample Size: The document does not specify the exact number of plates tested. It mentions "Three types of plates (proximal humerus, volar distal radius and dorsal distal radius) were tested," implying at least one sample of each type. It's likely more than one per type were tested for statistical validity, but this is not explicitly stated.
   • Data Provenance: Not explicitly stated. This was a laboratory study conducted by Ace Medical Company or a contracted lab. There is no mention of "clinical data" or "patient data," indicating it was a benchtop mechanistic test.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device's mechanical testing, "ground truth" is typically established by engineering standards and measurement accuracy, not expert consensus.

3. Adjudication method for the test set: Not applicable. This refers to consensus among experts, which is not relevant for benchtop mechanical testing. Results are typically determined by measurement and adherence to predefined engineering specifications or comparison thresholds.

4. 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 study refers to an AI/Software as a Medical Device (SaMD), not a physical orthopedic implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI/Software as a Medical Device (SaMD).

6. The type of ground truth used: For mechanical testing, the "ground truth" is defined by established engineering principles and the performance of predicate devices. The study compared the static bending strength of ACE plates to predicate devices (Synthes and DePuy plates). Therefore, the "ground truth" for performance was the established mechanical properties of these legally marketed, equivalent devices.

7. The sample size for the training set: Not applicable. This refers to an AI/Software as a Medical Device (SaMD). The design and development of physical implants do not typically involve "training sets" in the AI sense.

8. How the ground truth for the training set was established: Not applicable. This refers to an AI/Software as a Medical Device (SaMD).

Summary of Non-Applicable Sections for a Physical Device:

The provided text describes a submission for physical bone plates, not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested items related to AI device performance evaluation, such as:

• Sample size for the training set
• How ground truth for the training set was established
• Number of experts for ground truth
• Adjudication method for experts
• MRMC comparative effectiveness study
• Standalone algorithm performance

...are not applicable to this 510(k) summary. The study described focuses on benchtop mechanical testing to demonstrate substantial equivalence to predicate devices, a standard practice for physical orthopedic implants.

Ask a specific question about this device

Ask a specific question about this device