Search Results

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• . trauma (i.e., fracture or dislocation); and/or
• . tumor.

The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The HA Minuteman G3-R MIS Fusion Plate may be implanted via a minimally invasive lateral approach (L1-S1).

The HA Minuteman G3-R MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several spikes on the face of each Plate for attachment to the spinous processes. The HA Minuteman G3-R device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3-R is made from Ti6Al4V and Ti6Al4V ELI and has a hydroxyapatite coating on a portion of the implant.

The provided text describes a medical device, the HA Minuteman G3-R MIS Fusion Plate, and its submission for 510(k) clearance to the FDA. The document focuses on establishing substantial equivalence to a predicate device through technological characteristics and performance data. However, it does not contain information typically found in a study demonstrating how a device meets specific acceptance criteria based on clinical or extensive human-in-the-loop performance. Instead, it describes mechanical and simulated deployment tests.

Here's an analysis of the provided text in relation to your request, highlighting what information is available and what is not:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics like those found in a clinical study. It lists several mechanical tests performed, and for these, it states a general conclusion:

Important Note: The document lacks specific quantitative acceptance criteria (e.g., "withstanding X N-m of torque without failure") and the exact quantitative results from these tests. The statement "functioned as intended and the results observed were as expected" is a qualitative summary, implying that the device met internal design specifications or standards comparable to the predicate.

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

• Sample Size: The document does not specify sample sizes for the mechanical tests. For "Cadaveric Insertion Testing," it does not state how many cadavers were used. For "bacterial endotoxin testing," it mentions "all batches of sterile packed devices," which refers to manufacturing quality control rather than a specific test set for initial device validation.
• Data Provenance: Not mentioned. The tests appear to be conducted by the manufacturer, Spinal Simplicity. The context suggests these are internal validation tests for the 510(k) submission.

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 information is not provided. The listed tests are primarily mechanical and engineering assessments, not human interpretation tasks that would require "experts to establish ground truth" in the sense of clinical diagnosis or image labeling. The "Cadaveric Insertion Testing" would have involved medical professionals, but their specific qualifications and role in establishing "ground truth" (e.g., successful implantation, stability assessment) are not detailed.

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

Not applicable. The tests described are objective mechanical tests or simulated procedures, not subjective assessments requiring adjudication by multiple experts.

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. The HA Minuteman G3-R MIS Fusion Plate is a physical surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical tests, the "ground truth" would be the established engineering specifications, material properties, and expected mechanical responses determined through design and industry standards for spinal implants. For the "Cadaveric Insertion Testing," the "ground truth" would be the successful, unhindered placement of the device according to surgical protocol within the cadaveric anatomy. These are performance benchmarks rather than diagnostic "ground truths."

8. The sample size for the training set

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

Not applicable, as there is no training set for this type of device.

Summary of what the document implies about meeting acceptance criteria:

The document states that the device "functioned as intended and the results observed were as expected" for all mechanical and simulated deployment tests. This general statement indicates that the device met the manufacturer's performance specifications, which would have been established based on industry standards, predicate device data, and risk analysis. The purpose of this 510(k) submission is to demonstrate substantial equivalence to an already marketed predicate device, not necessarily to set new, independently validated clinical acceptance criteria using large studies. The FDA's review confirms that these internal tests, along with the device's technological characteristics, are sufficient to support the claim of substantial equivalence and do not raise new questions of safety or effectiveness.

Ask a specific question about this device

The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.

The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

The HA Minuteman G3 MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spikes at the ends of each Plate for attachment to the spinous processes. The HA Minuteman G3 device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3 is made from Ti6Al4V (per ASTM F1472) and Ti6Al4V ELI (per ASTM F136) and has a hydroxyapatite coating (per ASTM F1185) at the distal regions of the plate.

The FDA Premarket Notification (510(k)) K151741 for the Spinal Simplicity HA Minuteman G3 MIS Fusion Plate does not contain the typical information about acceptance criteria and study design for AI/Software as a Medical Device (SaMD) as requested in the prompt. This document pertains to a physical medical device (spinal implant) and focuses on demonstrating substantial equivalence to a predicate device based on material characterization and mechanical testing, not software performance.

Therefore, I cannot fulfill the request for information on acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content of the provided document.

The document discusses the following:

1. A table of acceptance criteria and the reported device performance:
This information is not presented in a table format for a "device performance" in the way one would for a diagnostic AI. Instead, the document describes characterization of the HA powder and coating, and mechanical testing.

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. This is not a study involving patient data or test sets for an AI. The testing described relates to material properties and mechanical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This document does not describe a study involving expert assessment or ground truth establishment in the context of an AI/SaMD.

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.

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 concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here would be established scientific standards for material characterization and mechanical testing.

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

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

Ask a specific question about this device

The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:
Compression Hip Screws/ IMHS

• Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
• Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
• Osteotomies for patients with diseases or deformities of the hip.
• Hip arthrodesis.
• Supracondylar fractures and distal femoral fractures using a supracondylar plate.
• Ipsilateral femoral shaft/neck fractures (long IMHS only).
  HA Coated Lag Screws are for single use only.

HA (Hydroxylapatite) Coated Lag Screws are large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture. HA Coated Lag Screws are available in various sizes made from either 316L stainless steel or Titanium-6Al-4V metal materials.

The provided text describes a 510(k) summary for HA Coated Lag Screws, which is a medical device submission seeking market clearance based on substantial equivalence to existing devices. This type of submission does not typically involve the rigorous clinical study design, acceptance criteria, and performance metrics as might be seen for devices requiring a PMA (Premarket Approval) or for AI/ML-driven diagnostic devices.

Instead, the submission focuses on demonstrating equivalence through mechanical testing, material comparison, and similarities in indications for use and design features to predicate devices. Therefore, many of the requested categories for AI/ML device studies are not applicable here.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

This 510(k) summary for HA Coated Lag Screws does not define explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI tools. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices.

Acceptance Criteria for Substantial Equivalence (Implicit from the text):
The device is considered to meet acceptance criteria if it can demonstrate:

1. Similar Indications for Use: The HA Coated Lag Screws address the same clinical uses as the predicate devices.
2. Similar Design Features: The device's design is comparable to the predicate devices.
3. Similar Operational Principles: The way the device functions is similar to the predicate devices.
4. Similar Material Composition: The materials used (316L stainless steel or Titanium-6Al-4V) are comparable to those in predicate devices.
5. Mechanical Equivalence: The device can withstand expected in vivo loading without failure, as indicated by mechanical test data, demonstrating it is "equivalent to devices currently used clinically."

Reported Device Performance:
The text states: "A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."

Details Regarding a Study for Device Performance (where applicable)

Given this is a 510(k) for a mechanical implant, the type of "study" is a mechanical test data review, not a clinical trial with human subjects in the way an AI diagnostic device would be evaluated.

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

   • Sample Size: Not specified in terms of number of screws or tests, but it refers to "mechanical test data." These tests are typically performed on a statistically relevant number of samples to ensure robust results, but the exact number isn't in the summary.
   • Data Provenance: The data is from "mechanical test data," which would be conducted in a laboratory setting by the manufacturer (Smith & Nephew, Inc. Orthopaedic Division). There is no mention of country of origin of clinical data or retrospective/prospective nature, as this is pre-market mechanical testing.

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

   • This is not applicable for mechanical testing. "Ground truth" in this context would be the physical properties and performance measured against engineering specifications and industry standards, not expert clinical consensus. The experts involved would be engineers and materials scientists interpreting the mechanical test results.

3. Adjudication method for the test set:

   • Not applicable. Mechanical testing involves objective measurements rather than adjudication of interpretations.

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

   • Not applicable. This device is a mechanical implant, not an AI-driven diagnostic or assistive tool.

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

   • Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.

6. The type of ground truth used:

   • The "ground truth" for mechanical equivalence is established through objective engineering measurements (e.g., strength, fatigue, torque, pullout force) against predefined specifications and industry standards for similar implant devices. The "equivalence" aspect also relies on comparison to the known mechanical performance of the predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires training data.

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

   • Not applicable.

Summary of Inapplicability:
It's crucial to understand that the queries primarily relate to the evaluation of AI/ML diagnostic or assistive devices. The provided document concerns a 510(k) submission for a traditional mechanical medical implant (HA Coated Lag Screws). Therefore, most of the questions regarding AI-specific evaluation methodologies (like MRMC studies, ground truth for training/test sets in an AI context, expert readers, etc.) are not relevant to this particular device submission. The device demonstrates safety and effectiveness through mechanical testing and substantial equivalence to legally marketed predicate devices.

Ask a specific question about this device

The HA PMI Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with any commercially available femoral component.

A surgeon will request a PMI device over a standard line product in order to better fill the patient's natural anatomy. For example, a Patient Matched Flanged Acetabular Component might be requested in cases of unusual anatomy or extensive bone loss. In such cases, a hemispherical acetabular component, which only has the option of screw fixation in the socket area, may not provide stability that can be obtained through additional screw fixation in the flanges.

Since each cup is matched to a particular patient, a specific device description is unavailable.

The provided text is a 510(k) summary for a medical device, specifically a hip replacement acetabular prosthesis. It states that no clinical testing was provided for this device. Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets them from the given document as no such study was conducted or provided.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Device Description: Highlighting that it's a patient-matched implant for specific anatomical needs or bone loss.
• Intended Use: Defining its purpose in hip joint reconstruction.
• Summary of Technologies: Stating material, design, sizing, and processing similarities to the predicate device.
• Non-Clinical Testing: Mentioning that "Mechanical testing and engineering analysis has justified the modifications to this device," but not providing details or acceptance criteria for these non-clinical tests.

Without clinical testing or detailed non-clinical testing reports, the requested information cannot be extracted.

Ask a specific question about this device

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.

The provided text is a 510(k) premarket notification summary for a medical device, the HA PMI Femoral Hip Stem. It states that no clinical testing was provided for this device. Therefore, a study demonstrating the device meets specific acceptance criteria, as well as information about sample sizes, ground truth establishment, expert qualifications, and adjudication methods, are not available in the provided document.

The primary method used for demonstrating safety and effectiveness for this device was non-clinical testing, specifically "Mechanical testing and engineering analysis has justified the modifications to this device." This device was approved based on substantial equivalence to a legally marketed predicate device (PMI Hip Femoral - 510(k) K923452), meaning it was deemed as safe and effective as a previously cleared device without requiring new clinical trials to prove its performance.

Since no clinical study was cited, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable as no clinical study was conducted.
2. Sample sized used for the test set and the data provenance: Not applicable.
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 for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (this is a physical hip stem, not an algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca10(PO4)6 (OH)2) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca1o(P04)s (OH)2) implants with a minimal 95 % quaranteed purity. Their porosity is 75% (pore diameter: 200-500 um). The porosity of the hydroxyapatite facilitates its colonization by fibrovascular tissue, which offers the advantages of reduced risk of infection or implant extrusion. They are available in the following diameters: 16, 17, 18, 19, 20 and 22 mm.

The provided text describes a 510(k) submission for the "HA ORBITAL IMPLANT". This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than a study designed to establish new performance criteria or conduct a comparative effectiveness study with human readers.

Therefore, many of the requested sections regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, primarily through referencing existing standards and literature for the material.

Here's an analysis of what can be extracted based on your request:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., success rates, complication rates) for the HA ORBITAL IMPLANT itself. Instead, its acceptance is based on demonstrating that its material (hydroxyapatite) meets a recognized standard and that its performance is substantially equivalent to a predicate device, supported by existing literature on hydroxyapatite orbital implants.

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

• Sample Size for Test Set: Not applicable. This submission relies on a literature review and a comparison to a predicate device, not a new clinical trial with a specific test set.
• Data Provenance: The document states that "Large and numerous studies" of hydroxyapatite were reviewed from the "literature," and "Most of these studies were performed with the predicate device." This suggests the data is retrospective, gathered from various published clinical studies, likely from multiple countries given the global nature of medical research, but specific countries are not mentioned.

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

Not applicable. No new test set with expert-established ground truth was created for this 510(k) submission. The safety and effectiveness are supported by existing medical literature and the established use of hydroxyapatite.

4. Adjudication method for the test set

Not applicable. As there was no new test set, there was no adjudication method.

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 orbital implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is based on:

• Material Standards: Conformance to ASTM F1185-88 for hydroxyapatite composition and biocompatibility.
• Established Clinical Evidence: The collective body of evidence from "large and numerous studies" in the medical literature demonstrating the "well tolerance, the improved motility and the low incidence of complications" of hydroxyapatite orbital implants, particularly the predicate device.
• Physiological/Pathological Outcomes: The literature review discusses "reduced risk of infection or implant extrusion" and comparison of complication profiles (e.g., "overlying tissue breakdown and exposure") between hydroxyapatite and other materials.

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 physical implant. The assessment relies on existing scientific knowledge and clinical experience with similar devices (the "literature" and "predicate device").

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

Not applicable for the same reason as above.

Ask a specific question about this device

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

The HA X-Series Bi-Metric® Hip Femoral Components consist of the same design and materials as the predicate devices contained in 510(k) K020580 except that the stems have been further coated with hydroxyapatitie (HA) coating. The HA coating has been added to enhance tissue adherence.

This document describes a 510(k) premarket notification for a medical device, the HA X-Series Bi-Metric® Hip Femoral Components. The application states that no clinical testing was provided for this device, as it is substantially equivalent to a legally marketed predicate device (K020580) with only the addition of a hydroxyapatite (HA) coating to enhance tissue adherence. Therefore, the required information for acceptance criteria and study details cannot be extracted from the provided text.

Specifically, the document states:
"Clinical Testing: None provided"

Without clinical testing, there are no acceptance criteria based on patient outcomes, no device performance data from a clinical trial, and no details regarding sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies. The device's approval is based on its substantial equivalence to a predicate device and non-clinical mechanical testing and engineering analysis.

Ask a specific question about this device

The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are for ) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are the same as their predicate, except for a modified profile on two of the sizes and the addition of Hydroxyapatite Coating.

The provided document is a 510(k) premarket notification for a medical device, specifically a hip implant. It primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria.

Therefore, many of the requested fields regarding acceptance criteria, study design, and performance metrics are not applicable or not provided in this type of regulatory submission. This document aims to show the new device is as safe and effective as an already legally marketed device, and typically relies on non-clinical testing for equivalence.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance Study Information

Ask a specific question about this device

The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.

The provided document describes the FDA 510(k) premarket notification for the HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem. It states very clearly that no clinical testing was provided as a basis for substantial equivalence.

Therefore, the following information cannot be extracted from the document:

• Acceptance Criteria and Reported Device Performance: This would typically be based on clinical or comparative performance data, which is explicitly stated as not having been provided.
• Sample size used for the test set and data provenance: No clinical test set was used.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established from clinical data.
• Adjudication method for the test set: Not applicable as no clinical test set was used.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as no human-in-the-loop study was conducted.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable as no ground truth based on clinical data was used.
• Sample size for the training set: Not applicable as there is no mention of a "training set" in the context of device development.
• How the ground truth for the training set was established: Not applicable.

The basis for substantial equivalence was Non-Clinical Testing, specifically "Mechanical Testing with an Engineering Justification" which determined that the components presented no new risks and were substantially equivalent to predicate devices. The predicate devices are listed as the Mallory/Head® Porous Femoral Stem (K921181) and Mallory/Head® Lateralized Press-Fit Femorals (K000538 and K003429).

This means the acceptance criteria and performance are based on engineering standards and mechanical properties, not clinical outcomes from a study involving human subjects or expert assessment of data. The document does not provide specific numerical acceptance criteria or performance metrics from this mechanical testing, only that it "determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."

Ask a specific question about this device

For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional, HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.

HA Absorbent Wound Dressing is an absorbent fibrous fleece (F) or rope (R), entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid.

Here's a breakdown of the acceptance criteria and study information for the HA Absorbent Wound Dressing, based on the provided text:

HA Absorbent Wound Dressing

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the HA Absorbent Wound Dressing and its substantial equivalence to predicate devices, but does not explicitly state quantitative acceptance criteria or provide specific device performance metrics in numerical form (e.g., absorption rate in mL/cm², healing time in days, etc.).

Instead, the "performance" is demonstrated through:

• Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) based on composition, function, and intended use.
• Biocompatibility Testing: The device passed standard toxicity tests.

Therefore, a direct table of "Acceptance Criteria" and "Reported Device Performance" as typically expected for diagnostic AI/ML devices is not present in this type of submission for a wound dressing. The "acceptance criteria" for clearance in this context are primarily demonstrating substantial equivalence and safety.

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

The provided document does not describe a "test set" in the context of an algorithm or AI system evaluation. This submission is for a physical medical device (wound dressing), and its clearance is based on substantial equivalence to predicate devices and biocompatibility testing, not on clinical performance data in a "test set" as understood for AI/ML devices. Therefore, these categories are not applicable.

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

Not applicable. As above, there is no "test set" or "ground truth" establishment for an algorithm in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

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

Not applicable. This is not an AI/ML device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is not an AI/ML device.

7. Type of Ground Truth Used:

Not applicable in the context of an algorithm. For the physical device, the "ground truth" or basis for acceptance relies on:

• Predicate Device Equivalence: The established safety and effectiveness of the legally marketed predicate devices.
• Biocompatibility Standards: Pre-defined standards for biological safety testing of medical devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary for the HA Absorbent Wound Dressing (K984388):

This submission is for a physical medical device (a wound dressing), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and "study" as typically applied to AI performance (e.g., sensitivity, specificity, F1-score on a test set) is not directly applicable.

The "study" in this context refers to biocompatibility testing and the comparison to predicate devices to demonstrate substantial equivalence and safety. The acceptance criteria for clearance were primarily based on:

• Demonstrating the HA Absorbent Wound Dressing is substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) in terms of materials, intended use, and fundamental function.
• Passing a series of biocompatibility tests to ensure the material is safe for its intended use (non-toxic, non-hemolytic, negligible irritant, non-cytotoxic, 0% sensitization potential).

The FDA's decision letter (K984388) confirms the device's substantial equivalence and outlines specific labeling limitations, which effectively become part of the modified acceptance criteria for its marketing.

Ask a specific question about this device