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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.

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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.

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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.

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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.

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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.

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• · Fixation of Metaphyseal Fractures of the Distal Tibia
• · Proximal Metaphyseal Tibial Fractures
• · Calcaneus Body Fractures
• · Proximal Humeral Head/Shaft Fractures
• · Distal Femur Fracture Comminuted Shaft Fractures
• · Fixation of soft tissue, such as tendon and ligaments, to bone

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

This document is a 510(k) summary for the DePuy ACE Spider Plate, seeking to expand its intended uses. It explicitly states that "The DePuy ACE Spider Plate has been previously cleared by the FDA for fracture fixation. Intended Uses are being expanded to include the fixation of soft tissue, such as tendon and ligaments, to bone."

The provided text does not contain information about specific acceptance criteria or a study proving the device meets them, especially not for the expanded indication. This document is a regulatory submission for substantial equivalence, not a clinical study report.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Acumed Suture Washer) for the expanded indication of soft tissue fixation.

The key statements supporting this are:

• "The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures."
• "The Acumed Suture Washer (K965028) is intended for soft tissue fixation, small and large bone fixation and is used in conjunction with a titanium bone screw."
• "The DePuy ACE Spider Plate and the Acumed Suture Washer are similar in design and function. Based on the above, DePuy ACE Medical Company considers the DePuy ACE Spider Plate to be substantially equivalent to the Acumed Suture Washer."

The FDA's response confirms substantial equivalence based on the submitted information for the expanded indications.

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• Pilon fractures distal tibial intra-articular fractures
• High medial malleolar fractures
• Low boot top type rotational distal extra-articular shaft fractures

The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia. The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).

The provided text describes a medical device, the DePuy ACE TiMAX™ Medial Pilon Plate, and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the DePuy ACE TiMAX™ Medial Pilon Plate is a "minor modification to the DePuy ACE TiMAX™ Pilon Plate and has been shown to have similar strength and bending properties." This suggests that a comparative analysis was performed to demonstrate "similar strength and bending properties" to an existing, cleared device, implying equivalence rather than performance against pre-defined acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not on a detailed performance study against specific acceptance metrics.

Here's what I can extract, which is that the device claims similar properties to a predicate device:

• Device: DePuy ACE TiMAX™ Medial Pilon Plate
• Predicate Device: DePuy ACE TiMAX™ Pilon Plate
• Claim of Equivalence: The new device "has been shown to have similar strength and bending properties" to the predicate.

To answer your request thoroughly, a different type of document (e.g., a detailed engineering report, a clinical trial summary, or a specific performance testing report) would be needed, which is not present in the provided 510(k) summary.

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• · Fixation of Metaphyseal Fractures of the Distal Tibia
• · Proximal Metaphyseal Tibial Fractures
• · Calcaneus Body Fractures
• · Proximal Humeral Head/Shaft Fractures
• · Distal Femur Fracture -- Comminuted Shaft Fractures

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

The provided text describes a 510(k) submission for a medical device called the "DePuy ACE Spider Plate." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the input does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to a predicate device (Acumed Suture Washer) based on similar design and function, rather than presenting a performance study against predefined acceptance criteria.

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• Distal intra-articular tibia fractures
• Proximal tibia fractures
• Proximal and distal humerus fractures

The DePuy ACE TiMAX™ Meta Plate has a triangular shaped projection at the end of a shaft portion. The shaft portion has compression slots with a pitch of 13mm which matches the small fragment, active compression plate. The plate thickness is 1.6mm in the shaft region and transitions to a thickness of 1mm in the triangular shaped metaphyseal region. A cut-out in the middle of the metaphyseal region provides an open architecture to facilitate contouring by the surgeon, to accommodate the anatomical topography of the distal tibia as well as other indicated anatomical regions, and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the 3.5mm cortical screw and the 4.0mm cancellous screw. The plate will be offered in two sizes: small (width=30mm) and large (width=38mm) with various lengths.

This document is a 510(k) summary for a medical device (DePuy ACE TiMAX™ Meta Plate), which focuses on establishing substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner an AI/software device would. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This document is for a traditional medical implant (bone plate), not a software or AI device. The "performance" assessment focuses on the physical and mechanical equivalence to an existing device, not on specific quantitative metrics or a study demonstrating achievement of pre-defined acceptance criteria in the context of an AI/software product. The acceptance criteria for this type of device generally relate to safety, material biocompatibility, mechanical strength (often through bench testing), and similarity in design and intended use to a predicate device. These are assessed through a broader regulatory review, not a single "performance study" as would be done for an AI algorithm.

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

• Not Applicable. There is no "test set" or "data provenance" in the context of an AI/software device for this submission. The "testing" for this bone plate would typically involve bench testing (mechanical and material properties) and potentially cadaver studies, but not a dataset in the way an AI algorithm uses it. The document does not provide details on sample sizes for these types of tests, if they were conducted.

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. No "ground truth" establishment in the context of an AI/software algorithm is described. For a bone plate, medical experts (e.g., orthopedic surgeons) would be involved in defining the intended use and potentially evaluating design, but not in establishing a "ground truth" for a dataset.

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

• Not Applicable. No "adjudication method" for a test set is described.

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

• Not Applicable. This is not a study about human readers or AI assistance.

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

• Not Applicable. There is no algorithm discussed.

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

• Not Applicable. No "ground truth" in the context of an AI/software algorithm is described. The "ground truth" for a bone plate would be based on established medical and engineering principles, material science, and clinical experience with equivalent devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set."

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

• Not Applicable. There is no "training set" or ground truth establishment in this context.

Summary of what the document does provide in relation to regulatory acceptance:

• Predicate Device: The DePuy ACE TiMAX™ Meta Plate is deemed substantially equivalent to the Synthes Cloverleaf Plate (P/N 240.23), which was a pre-amendment device (marketed prior to May 28, 1976). This substantial equivalence is the primary "acceptance criterion" for 510(k) submissions.
• Intended Use: The device is intended for distal intra-articular tibia fractures, proximal tibia fractures, and proximal and distal humerus fractures. This must align with the predicate device's intended use or be demonstrably safe and effective for similar uses.
• Device Description: The document describes the plate's physical characteristics (triangular shaped projection, shaft with compression slots, plate thickness, cut-out for contouring, screw hole design compatible with 3.5mm cortical and 4.0mm cancellous screws, two sizes). These features are compared to the predicate device to establish equivalence.
• Regulatory Decision: The FDA determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This decision is the formal acceptance of the device for market.

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Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.

Here's an analysis of the provided text regarding the DePuy ACE Composite Locking Nut, focusing on acceptance criteria and supporting studies:

It appears the provided document is a 510(k) summary for a medical device (DePuy ACE Composite Locking Nut). This type of document is for demonstrating substantial equivalence to a previously cleared device, not typically for reporting detailed performance against acceptance criteria from a comprehensive clinical trial with human subjects. Therefore, much of the requested information (like MRMC studies, multi-reader performance, expert ground truth for imaging, and large training sets) is not applicable to this type of submission.

The "study" referenced is a mechanical performance test to demonstrate a specific physical characteristic of the new device compared to its predicate devices, rather than a clinical study of diagnostic accuracy or comparative effectiveness in humans.

Here's the breakdown of what can be extracted from the provided text according to your request categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text refers to "Testing," suggesting a certain number of units were tested to determine the ultimate and insertion torque values.
• Data Provenance: The study was conducted by DePuy ACE Medical Company. No specific country of origin for the data is mentioned beyond the company's location in El Segundo, CA, USA. This was a retrospective engineering test on manufactured devices, not derived from patient data.

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

• Not applicable. The ground truth for this engineering test was the direct measurement of torque values. It did not involve expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" here refers to the physical devices undergoing torque testing. There was no human interpretation or adjudication process involved in measuring a physical property.

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 is a 510(k) for a mechanical device component, not an AI-powered diagnostic tool. The document does not mention any AI component or human reader studies.

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

• No. This is a mechanical device. There is no algorithm or standalone performance being evaluated.

7. The Type of Ground Truth Used

• The ground truth was direct objective measurement of physical properties: ultimate torque and insertion torque.

8. The Sample Size for the Training Set

• Not applicable. There was no "training set" as this is not a machine learning or AI-driven device.

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

• Not applicable. As there was no training set (see #8), no ground truth for a training set was established.

Summary of the "Study" (Test Report ET 63-001):

The only "study" mentioned in this 510(k) summary is "Test Report ET 63-001". This appears to be an internal engineering test conducted by DePuy ACE Medical Company.

• Purpose: To demonstrate that the DePuy ACE Composite Locking Nut allows for adequate fixation without accidental over-torque during application.
• Methodology: Measuring the ultimate torque (the torque at which the nut mechanically fails or rounds) and the insertion torque (the torque typically applied during surgical seating).
• Finding: The ultimate torque was found to be approximately 10 times that of the insertion torque.
• Conclusion: This 10x ratio is considered sufficient to allow surgeons to clearly identify when the nut is seated against the bone before accidental over-torque or rounding occurs. This finding directly supports the device's substantial equivalence and safe use.

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