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The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.

The Acumed Wrist Fusion Plate is spherical in shape. Holes or slots offer multiple screw placement options. The plate also has holes that may be utilized for provisional tacking or positioning with Kirschner wires to the bones prior to screw installation. A threaded hole in the center of the plate allows for optional accessories to be attached to the plate.

In this 510(k) submission for the Acumed Wrist Fusion Plate (K021321), no specific performance data or studies proving the device meets acceptance criteria are provided. The submission states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."

The basis for clearance is substantial equivalence to predicate devices (KMI Wrist Fusion System (K991873) and Acumed Congruent Bone Plate System (K012655)), rather than direct performance testing of the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from the provided document. The sections on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details are not applicable as these types of studies were explicitly stated to not have been performed or required for this submission.

Summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

Not applicable, as no performance study was conducted.

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

Not applicable, as no performance study was conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no performance study was conducted.

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

No, an MRMC comparative effectiveness study was not done.

6. Standalone Performance Study:

No, a standalone performance study was not done.

7. Type of Ground Truth Used:

Not applicable, as no performance study was conducted.

8. Sample Size for the Training Set:

Not applicable, as no performance study was conducted.

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

Not applicable, as no performance study was conducted.

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The Polarus Cap Screw is intended to be used in conjunction with the Polarus Humeral Rod. It engages the 5.0 mm proximal screw in the rod to prohibit / minimize the screw from backing out and to prohibit the in growth of bone into the 1/4-20 hole.

The Polarus Cap Screw is intended to be used in conjunction with the Polarus Rod family cleared under K920666 and K951740. Its purpose is to engage the proximal-most 5.0 interlocking screw in the rod 10 prohibit/minize backing out of that screw and to prohibit ingrowth of bone into the 1/4-20 hole. The Polarus Cap Screw is manufactured from two different materials. The cap is manufactured from a titanium alloy per ASTM F 136 and the tip portion is manufactured from medical grade polyethylene per ASTM F 648. The Polarus Cap Screw is provided sterile and is packaged in inner and outer PETG blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterility is performed using the AAMI - Method 1. Sterility assurance level is 104. We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 104.

This appears to be a 510(k) premarket notification summary for a medical device called the "Polarus Cap Screw." It explicitly states that the safety and effectiveness of the device are expected to be similar based on substantial equivalence to predicate devices, rather than on an independent study demonstrating specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving those criteria are met, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific acceptance criteria for the Polarus Cap Screw in terms of performance metrics. Instead, it relies on substantial equivalence.

2. Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned because no independent performance study is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no independent study with a test set and ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 a physical medical implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices to which the Polarus Cap Screw is deemed substantially equivalent.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding demonstrating safety and effectiveness:

• Methodology: Substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • Set screw for the Howmedica Vitallium IM Device
  • Ace Medical AIM Titanium Humeral Nail System's end cap
  • Alta IM Rod's cap screw
  • Synthes Titanium Solid Humeral Nail System's end cap
• Basis for Equivalence: Similarities in indication, intended use, material (titanium), design, and size.
• Sterilization: The device is provided sterile via a minimum of 2.5 megarads gamma radiation, with sterility verification using AAMI - Method 1 to achieve a Sterility Assurance Level (SAL) of 10^-4.
• Instrumentation Sterilization: Instrumentation is provided non-sterile but can be successfully steam sterilized under specific process parameters to achieve an SAL of 10^-4.

In conclusion, this 510(k) summary (K013616) demonstrates the device meets regulatory requirements through substantial equivalence to existing devices, not through a new performance study with defined acceptance criteria, test sets, or ground truth as typically found for diagnostic or AI-driven devices.

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The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

The Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. Each of the plate styles utilizes the same screw types and screw instruments for insertion. All of the plates and screws are manufactured from titanium and are provided non-sterile. The screws were cleared for marketing and distribution under K942340 and K942341.

The provided text describes a 510(k) premarket notification for the Acumed Congruent Bone Plate System. This is a submission demonstrating equivalence to existing devices, not a study presenting novel performance data or acceptance criteria that would typically be associated with a new device development and validation.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of regulatory submission.

Here's an explanation of what can be gleaned from the document in relation to your request:

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

• Not Applicable: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting new performance acceptance criteria through a specific study for a novel device. The "performance" is implicitly deemed acceptable if it is substantially equivalent to legally marketed predicate devices.

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: The submission does not describe a clinical or performance study with a test set of data. It relies on the established safety and effectiveness of predicate devices.

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 for a test set is mentioned.

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

• Not Applicable: No test set or adjudication method 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 a bone plate system, not an AI or imaging diagnostic device. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable: This is a medical device (bone plate), not an algorithm or AI system.

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

• Not Applicable: No ground truth is established for device performance in this document. The "ground truth" for regulatory approval in a 510(k) is the demonstrated safety and effectiveness of the identified predicate devices.

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of this 510(k) submission for a bone plate system.

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

• Not Applicable: As above, no training set or ground truth for a training set is relevant here.

Summary of Relevant Information from the Document:

While the document does not fit the typical structure for a performance study with detailed acceptance criteria, it does address the regulatory acceptance of a medical device based on substantial equivalence.

Device Description and Justification for Substantial Equivalence:

The Acumed Congruent Bone Plate System consists of bone plates and screws made from titanium, provided non-sterile. The plates are pre-bent. The screws were previously cleared under K942340 and K942341.

The justification for substantial equivalence is based on:

• Indication, Intended Use, Material, Design, and Size: The Acumed system is stated to be similar to several predicate devices.
• Predicate Devices:
  • Howmedica's Distal Humeral Plate (K890939)
  • Howmedica's Luhr Fixation System (K951415)
  • Synthes' Curved Reconstruction Plate (K913334)
  • Synthes' Modular Foot System (K001941)
  • Synthes' One-Third Tubular Curved Reconstitution Fibia Bone Plates (K912936)
  • Link's May Tibia Bone Plates

Acceptance Information (as interpreted for a 510(k) submission):

• Device Status: The device was determined to be "substantially equivalent" to legally marketed predicate devices.
• Performance Data (Limited): The document mentions that "On file at Acumed is data which shows that the instrumentation and implants can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 10-6." This is a specific performance aspect relating to sterility. However, no specific "acceptance criteria" (e.g., tensile strength, fatigue life thresholds) are explicitly stated in this public summary for the plates themselves, as these would typically be compared to predicate device performance or established standards during the engineering and testing phases, which are then summarized for the 510(k) reviewer.

In essence, the "acceptance criteria" for a 510(k) is whether the new device is as safe and effective as a legally marketed predicate device. The "study" proving this is the detailed comparison provided in the full 510(k) submission (not fully provided here, only the summary).

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Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.

The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement. It incorporates a cobalt chrome modular head, a titanium body, and a selles of the components may be mixed and matched in order to best duplicate the patient's anktomy. Several strategic holes for suturing are in the body the surgeon to tie down the greater- and lesser-tuberosities, which are frequently displaced during these types of fractures. Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire. The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head. Targeting instrumentation is provided to allow accurate of the screws through the component.

The provided text is a 510(k) summary for a medical device called the "Acumed Modular Shoulder System." This document is for a shoulder implant (prosthetic device), not an AI/ML-based device. Therefore, the questions related to AI/ML device performance (such as sample size for test sets, experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to previously approved predicate devices, primarily the Atlas Modular Shoulder (K961260) and the Select Shoulder System (K962224). The manufacturer's claim of safety and effectiveness is based on these similarities.

Here's the relevant information that can be extracted:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way typically seen for AI/ML performance. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's design, materials, and intended use being similar to existing, legally marketed devices.

2. Sample size used for the test set and the data provenance: Not applicable (this is not an AI/ML device study). The "test set" would be the device itself undergoing various engineering tests (e.g., sterilization, taper strength), but specific sample sizes for such tests are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/ML device).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" relates to engineering and biocompatibility standards. The document mentions:
* Engineering Test Data: "Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength..." (specifics not detailed).
* Sterility Verification: "Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10⁻⁶."
* Similarity to Predicate Devices: The primary "ground truth" for regulatory approval here is the demonstrable substantial equivalence to devices already proven safe and effective through their market history.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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This device is intended for anchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile.

This document is a 510(k) summary for the Acumed Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the way one would for a novel AI/software medical device.

Therefore, many of the requested categories for AI/software device evaluation are not applicable or cannot be extracted from the provided text. The document describes a traditional hardware medical device (suture anchor), not a software or AI-driven device.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document is a 510(k) summary for a hardware device, not a performance study for an AI/software device. It doesn't present performance metrics like sensitivity, specificity, or accuracy against a defined acceptance criterion.

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

Not applicable. There is no "test set" in the context of evaluating an AI or software device. The document mentions "data on file at Acumed" regarding steam sterilization validation, but this is a manufacturing process validation, not clinical performance data for a diagnostic or therapeutic AI.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, as understood in AI/software device evaluation, is not established or discussed for this hardware device.

4. Adjudication Method

Not applicable. There is no adjudication process described for a study evaluating AI or software performance.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers, which is not the subject of this 510(k).

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Acumed Suture Anchor is a physical implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable. There is no "ground truth" established in the sense of clinical diagnoses or outcomes to validate an algorithm. The 510(k) process for this device relies on demonstrating substantial equivalence to existing legally marketed predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness profiles.

8. Sample Size for the Training Set

Not applicable. There is no "training set" for a hardware medical device like this suture anchor.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or relevant for this type of device submission.

Summary of Relevant Information from the Provided Text for a Hardware Medical Device:

The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, which is the primary "study" for a 510(k) submission of this nature.

• Acceptance Criteria: The implicit acceptance criterion for a 510(k) is that the new device is "substantially equivalent" to predicate devices in terms of:
  • Indications for use.
  • Technological characteristics (e.g., material, design, sterilization).
  • Safety and effectiveness.
• Study That Proves Device Meets Acceptance Criteria (in this context): The "study" is the comparison to predicate devices.
  • Predicate Devices: Mitek GII Anchor, SuperAnchor, Linvatec Revo, and Zimmer Statak.
  • Demonstration of Equivalence:
    • Indications: The Acumed Suture Anchor has the "same indications" as the predicates (anchoring soft tissue to bone in rotator cuff repairs, and soft tissue repairs of the foot and ankle).
    • Materials: Manufactured from titanium 6AL 4V ELI per ASTM F136, similar to predicates.
    • Design: Screw-based design is "similar to the Linvatec Revo and the Zimmer Statak."
    • Surgical Techniques: "Similar surgical techniques" to the Mitek GII Anchor and SuperAnchor.
    • Sterilization: The document mentions "Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 as validated by data on file at Acumed." This is a validation of the sterilization process itself, not a comparative performance study in a clinical setting.
  • Conclusion: "Based on the similarities between the Acumed Suture Anchor and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor is expected to be similar to the predicate devices mentioned above."

Essentially, the "study" for this 510(k) is a detailed comparison and justification, rather than a clinical trial or a performance evaluation against specific numerical thresholds in a test set. This is typical for Class II hardware devices seeking market clearance via the 510(k) pathway.

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This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, non-coated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136 and is provided non-sterile.

The provided text is a 510(k) summary for the Acumed Suture Anchor, a medical device. This type of regulatory submission focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than establishing de novo performance criteria through a study with specific acceptance criteria as would be done for novel devices or those undergoing extensive clinical trials.

Therefore, the document does not contain information regarding a study designed to establish acceptance criteria and prove the device meets them in the way described in the request. Instead, the core argument for clearance is based on the similarity to predicate devices.

Here's how to address the requested information based on the provided text, and where it falls short:

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

• Information Not Found: The document does not define specific performance acceptance criteria (e.g., tensile strength, pull-out force) for the Acumed Suture Anchor, nor does it report specific performance values from a dedicated study against such criteria. The submission relies on the assumption that its performance will be "similar" to predicate devices.

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

• Information Not Found: No test set sample size or data provenance is mentioned because no performance study, in the sense of testing against acceptance criteria, is described for the Acumed Suture Anchor. The "data on file at Acumed" regarding sterilization mentions an SAL, but this is a process validation, not a device performance study.

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

• Information Not Found: This information is not applicable as no test set or expert-established ground truth is described for the device's functional performance.

4. Adjudication method for the test set

• Information Not Found: This is not applicable.

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

• Information Not Found: This is not applicable. The device is a physical bone anchor, not an AI-assisted diagnostic tool.

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

• Information Not Found: This is not applicable. The device is a physical bone anchor, not an algorithm.

7. The type of ground truth used

• Information Not Found: This is not applicable to a device clearance based on substantial equivalence to predicate devices for its functional performance. The "ground truth" here is essentially the regulatory acceptance of the predicate devices.

8. The sample size for the training set

• Information Not Found: This is not applicable. There is no mention of a "training set" as this is not a machine learning or diagnostic device.

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

• Information Not Found: This is not applicable.

Summary of Device Acceptance Criteria and Study as per the Provided Text:

The Acumed Suture Anchor's acceptance and market clearance are not based on meeting new, device-specific performance acceptance criteria established through a dedicated study. Instead, its acceptance is based on demonstrating substantial equivalence to existing predicate devices.

The arguments for substantial equivalence are:

• Identical Indications For Use: "This device is identical in indication to the Mitek GII and SuperAnchor (K953877), the Zimmer Statak (K926384), and the Linvatec Revo (K941691)." Specifically, "This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle."
• Similar Design and Manufacturing Material: "This device is most similar in design to the Zimmer Statak and the Linvatec Revo devices in that all three are based on screw designs and are manufactured from titanium alloys. The Acumed Suture Anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136."
• Similar Surgical Techniques: "The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques."
• Sterilization Validation: Acumed has identified process parameters for steam sterilization providing an SAL of 10^-6, "as validated by data on file at Acumed." (This is a process validation, not a performance study of the anchor itself).

In essence, the "study" demonstrating this device meets "acceptance criteria" is the comprehensive review by the FDA (K980103) concluding that the Acumed Suture Anchor is substantially equivalent to legally marketed predicate devices, thereby assuming similar safety and effectiveness. No specific performance study to quantify device performance (e.g., pull-out strength in tissue) against predefined numerical acceptance criteria is detailed in this 510(k) summary.

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The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine.

This washer has a post height of 2.6mm and an outer diameter of 8.0mm. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided sterile. Sterility is achieved by a minimum of 2.5 Mrads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility assurance level is 104.

I am sorry, but the provided text is a 510(k) summary for a medical device called the "Acumed Suture Washer." It describes the device's intended use, materials, and sterilization methods.

However, the text does not contain any information about acceptance criteria, study details, or performance data related to an AI/ML device. Therefore, I cannot extract the requested information to fill in the table and answer the subsequent questions.

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The Stableloc II External Fixation System is used to address Colles' fractures and distal radial osteotomies and is not intended for use in the spine.

The Stableloc II External Fixation System consists of an external fixation device and a selection of threaded guide pins. The external fixator is not intended for implantation, only as a tool in surgery. It holds in place the pins which provide fracture reduction and alignment. The Stableloc II External Fixation System is manufactured from Ultem, aluminum, stainless steel, and titanium while the guide pins are made from stainless steel per ASTM F 138. The external fixator is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 106 as validated by data on file at Acumed. The guide pins are provided sterile. Sterility is achieved by a minimum of 2.5 megarads gamına radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility level is 10th. We make no claims as to the pyrogenicity of this product. Information regarding packaging and labeling has been provided.

This document is a 510(k) summary for a medical device (Stableloc II External Fixation System) submitted in 1997. It describes the device and claims substantial equivalence to a predicate device (EBI Medical System's Orthofix Dynamic Axial Fixation System).

Based on the provided text, there is no information available about acceptance criteria, a study proving device performance against such criteria, or any of the detailed study parameters you've requested.

Here's why and what we can extract:

• Type of Submission: This is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process typically relies on comparisons to known safe and effective devices, rather than de novo clinical performance studies or specific acceptance criteria for novel performance metrics.
• Focus of the Document: The summary focuses on:
  • Device description (components, materials, intended use).
  • Comparison to a predicate device (material, intended use, design, surgical techniques).
  • Sterilization methods.
  • Claims of substantial equivalence based on these similarities.

Therefore, I cannot provide the requested information from the given text.

Explanation for each point you asked for:

1. A table of acceptance criteria and the reported device performance: Not present. The document claims "safety and effectiveness is expected to be similar" to the predicate, but provides no quantitative performance data or specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not present. No "test set" in the sense of a clinical or specific performance study is mentioned. The comparison is based on device characteristics, not a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set: Not applicable/present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable/present. This type of study is more common for diagnostic imaging AI systems, which did not exist in this context in 1997 for an external fixator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/present. This is not an AI/algorithm-driven device.
7. The type of ground truth used: Not applicable/present.
8. The sample size for the training set: Not applicable/present. There's no machine learning or AI involved.
9. How the ground truth for the training set was established: Not applicable/present.

In summary, the provided text describes a regulatory submission for a physical medical device from the late 1990s. The type of detailed performance studies and AI-related metrics you're asking for were not standard or relevant for this kind of device and submission at that time.

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The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine.

This device has a diameter of .0625" and is available in lengths of 35mm, 45mm, and 55mm. The Acumed Tension Band Pin is manufactured from 316L stainless steel and is provided pre-sterile. Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation. Validation of sterility is maintained on site. Sterility level is10.4. Information regarding packaging and labeling have been provided.

Here's a breakdown of the requested information based on the provided text for K964500:

It's important to note that the provided text is a 510(k) summary for a medical device (a surgical pin), not an AI/ML algorithm or software. Therefore, many of the questions related to performance metrics, expert reviews, and study methodologies for AI will not be directly applicable or present in this type of document. The acceptance criteria in this context are related to the physical properties and intended use of the pin, and the "study" is a comparison to predicate devices, not clinical trials in the AI sense.

K964500: Acumed Tension Band Pin

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable to this type of device submission. There isn't a "test set" in the context of an algorithm's performance. The "study" here is a substantial equivalence comparison, which relies on demonstrating similarity to already cleared predicate devices.

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

This information is not applicable. Ground truth, in the AI sense, is not established for this type of device. The assessment is primarily engineering and regulatory.

4. Adjudication Method for the Test Set

This information is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a physical surgical pin.

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

This information is not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is effectively established by:

• Material specifications: Conformance to 316L stainless steel standards.
• Dimensional accuracy: Conformance to specified diameter and lengths.
• Sterilization efficacy: Demonstrated ability to achieve and maintain a sterility assurance level (SAL).
• Predicate device characteristics: The established safety and effectiveness of the Acumed Fixation Pin and Howmedica Kirschner Wire serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" for a physical device.

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

This information is not applicable.

Summary of Device Acceptance and "Study"

The Acumed Tension Band Pin meets its "acceptance criteria" by demonstrating substantial equivalence to legally marketed predicate devices (Acumed Fixation Pin and Howmedica Kirschner Wire). The "study" proving this is a comparison of the new device's material, design, and intended use to those of the predicate devices.

The key statements proving equivalence are:

• "The Acumed Tension Band Pin is similar to the Acumed Fixation Pin and the Howmedica Kirschner Wire in material and design."
• "Like Howmedica's Kirschner Wire, the Acumed Tension Band Pin is intended to be used in tension band wiring procedures addressing malleolar, patella, and olecranon fractures."
• "Based on the similarities between the Acumed Tension Band Pin and both the Acumed Fixation Pin and Howmedica Kirschner Wire, the safety and effectiveness is expected to be similar to the Acumed Fixation Pin and Howmedica Kirschner Wire."

This type of submission relies on the premise that if a new device is sufficiently similar to one already cleared by the FDA, it can be presumed safe and effective without requiring new clinical performance studies.

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an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws. The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation.

This document is a 510(k) summary for a medical device called the "Acumed Retrograde Humeral Nail." It is a pre-market notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with acceptance criteria and a device's performance against them.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth, and study types is not available in the provided text.

The document describes the device, its material, sterilization method, and states its similarity to a predicate device ("Smith & Nephew Richards' Russell-Taylor Humeral Interlocking Nail") in design, function, indications, and surgical technique, implying that it is expected to perform as well, but it does not provide data from a study to prove this.

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