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The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.

The provided text is a 510(k) summary for a medical device called the SECURE Screw, a bone fixation fastener. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against acceptance criteria in the context of an AI/human-in-the-loop system.

Therefore, I cannot extract the acceptance criteria and study details as requested for an AI system because this document does not pertain to the evaluation of an AI-powered device.

The document describes a traditional medical device (a screw for bone fixation) and its regulatory clearance process, which relies on demonstrating substantial equivalence to an already marketed device. This process primarily involves comparing design, materials, indications for use, and performance testing against established industry standards.

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The Pegasus System is indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

The Pegasus System is a portable, disposable, rigid, video camera enabled handheld probe paired with a wireless video receiver. It is powered by internal batteries encased in a plastic handpiece/handle. The distal tip of the stainless steel probe contains a camera and LED light source for visualization. The device is provided sterile and is intended for single patient use.

The provided text describes the 510(k) premarket notification for the "Pegasus System," an arthroscope. This submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data, rather than clinical efficacy. Therefore, much of the information typically found in acceptance criteria of an AI/ML medical device (e.g., performance metrics, expert adjudication, MRMC studies) is not applicable here.

The document explicitly states: "No clinical data were required or submitted in support of this submission."

Given this, I cannot provide the full detail for all requested points as they pertain to clinical performance studies, which were not conducted for this specific device clearance.

However, I can extract the information that is present:

1. Acceptance Criteria and Reported Device Performance

Since no clinical efficacy data was submitted, the "acceptance criteria" here refer to meeting established standards for medical device safety and non-clinical performance.

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

The document does not specify a "test set" in the context of clinical data. For non-clinical performance testing (biocompatibility, electrical safety, sterilization), it states "representative samples of the device must meet." The exact sample sizes for these tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable as this was non-clinical testing.

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

Not applicable. Ground truth in the context of clinical performance (e.g., disease detection) was not established using experts, as no clinical data was submitted.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not conducted as no clinical data was required or submitted. Therefore, there is no information on how human readers might improve with or without AI assistance.

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

Not applicable. This device is an arthroscope, a piece of hardware, not an AI algorithm requiring standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on established industry standards for medical device safety and performance (e.g., ISO, IEC standards for biocompatibility, electrical safety, sterilization) and a comparison to a legally marketed predicate device (K162475). There was no clinical ground truth (e.g., expert consensus, pathology, outcomes data) as clinical data was not submitted.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.

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

Not applicable, as it's not an AI/ML device.

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The Intramedullary Fixation Device is indicated for the fixation of extra-articular fractures of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

Intramedullary Fixation Device

Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called the "A.M. Surgical Intramedullary Fixation Device." This letter does NOT contain information about acceptance criteria, study design, or performance metrics for an AI/ML device. It is a regulatory clearance for a physical medical device (an intramedullary fixation device) used for bone fixation.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance data for an AI/ML device from this document. The questions you've asked (about sample sizes, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are pertinent to studies evaluating AI/ML models, not traditional hardware medical devices like the one described in this 510(k) letter.

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The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.

• Carpal tunnel release for carpal tunnel syndrome .
• Plantar fasciotomy for plantar fasciitis .
• Lateral release of the knee for extensor mechanism malalignment .
• Forearm fasciotomy for compartment syndrome
• . Morton's neuroma for interdigital neuroma
• Gastrocnemius release for heel cord contracture (equinus) .

The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.

The provided text describes a 510(k) summary for the A.M. Surgical Mountable Endoscopic Blade. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/software device.

Here's an analysis based on the provided text for a manual surgical instrument, not an AI or software device:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
For this type of device (a manual surgical instrument), the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for algorithms. Instead, acceptance is based on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. This equivalence is established by comparing intended use, material composition, and design features, and then asserting that this similarity ensures comparable safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) relies on substantial equivalence to a predicate device (K982142), not on a new clinical study with a specific test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No "ground truth" for a test set was established in the context of a new clinical study for this device.

4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. This is a 510(k) for a manual surgical instrument, not an AI/software device that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used
Not applicable. The basis for clearance is substantial equivalence to a predicate device, not empirical ground truth data from a new study.

8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires training data.

9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device.

Summary of the Study and Conclusion:

The "study" or justification for the A.M. Surgical Mountable Endoscopic Blade is a Substantial Equivalence (SE) determination under the 510(k) pathway.

• Acceptance Criteria Met: The device met the regulatory acceptance criteria by demonstrating substantial equivalence to a previously cleared predicate device, the Mountable Endoscopic Blade (K982142). This means its intended use, material composition (stainless steel), and design features (mounts to a 4mm 30° endoscope) were found to be sufficiently similar to the predicate to ensure equivalent safety and effectiveness.
• Proof: The entire 510(k) submission, specifically section D ("Substantial Equivalence Information"), serves as the "study" or proof. It asserts that "The safety and effectiveness of Mountable Endoscopic Blade is adequately supported by the substantial equivalence information provided within this Premarket Notification." The FDA's letter concurs with this finding, stating that the device is "substantially equivalent."

In essence, for this medical device, the "study" is a regulatory comparison rather than a clinical trial or performance evaluation against specific numerical targets.

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The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist fixator made of titanium , consisting of two (distal and proximal) connecting slide sections with predetermined angled holes. Standard Kirschner wires (K-wire) are inserted through the predetermined angle holes for fracture fixation, three on the distal section and two on the proximal section. The sections can be adjusted distal to proximal and locked into place by way of a center hex screw. The device will be offered sterile and is single use.

The provided text is a 510(k) summary for a medical device (A.M. Surgical CPF Distal Radial External Cross Pin Fixation System) and a clearance letter from the FDA. It does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

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

The document primarily focuses on:

• Device Description: What the device is and its components.
• Intended Use: For what medical conditions and anatomical location the device is used.
• Predicate Device Comparison: How it compares to previously cleared devices to establish substantial equivalence.
• Regulatory Classification: Its class and product code by the FDA.
• FDA Clearance Letter: Official communication from the FDA confirming clearance.

There is no mention of any performance study, clinical trial data, or specific acceptance criteria for performance other than the device being "substantially equivalent to the predicate and is safe and effective for its intended use" based on design and intended use comparison.

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a) Carpal tunnel release / carpal tunnel syndrome
b) plantar fasciotomy/ Plantar fascitis
c) lateral release of the knee / extensor mechanism malignment
d) forearm fasciotomy / compartment syndrome
e) Mortons Neuroma/ Interdigital Neuroma

Mountable Endoscopic Knife

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Mountable Endoscopic Knife" (K982142), indicating that the device has been found substantially equivalent to a predicate device.

The letter mentions:

• Trade Name: Mountable Endoscopic Knife
• Regulatory Class: II
• Product Code: EMF
• Indications For Use: Carpal tunnel release/syndrome, plantar fasciotomy/fascitis, lateral release of the knee/extensor mechanism malignment, forearm fasciotomy/compartment syndrome, Mortons Neuroma/Interdigital Neuroma.

However, it does not specify any performance-based acceptance criteria, details of a study (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, training set details, or ground truth establishment) used to demonstrate compliance with such criteria. The substantial equivalence determination is based on the device being comparable to a legally marketed predicate device, not necessarily on a performance study against predefined acceptance criteria outlined in this document.

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