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The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977). Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress. Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a
The provided text is a 510(k) summary for the AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System. This document focuses on demonstrating substantial equivalence to a previously cleared device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977), rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set data) are not applicable to this type of regulatory submission.
However, I can extract information related to the device's features and safety standards, which serve as the implicit "acceptance criteria" for substantial equivalence.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
Since this is a submission for substantial equivalence, the "acceptance criteria" are not predefined performance metrics in the traditional sense. Instead, the device needs to demonstrate that it is as safe and effective as the predicate device. The performance is reported in terms of feature comparison and adherence to safety standards.
| Acceptance Criteria (Implicit: Similar to Predicate Device) | Reported Device Performance (AkroTech 4000T Kinetic Turning LAL System) |
|---|---|
| Overall System Features: | |
| On/Off Toggle Switch | On/Off Toggle |
| Modality: Firm, Float, CPR, Key Pad Lock, Alarm | Firm, Float, CPR, Key Pad Lock, Alarm |
| Data Input Control: Up/Down | Up/Down |
| Input Information (Patient Weight) | Patient Weight, Height, Rotation Angle, Time In Angle (Improved/Added features) |
| Data Feedback (Patient Time In Use, Cumulative Operating Time) | Patient Time In Use, Cumulative Operating Time |
| Air Control Zones (Six) | Six |
| Air Flow Lines (One) | One |
| ACU Features: | |
| Computer | Same as predicate |
| Hardware | Same as predicate |
| Blower | Same as predicate |
| Valves | Same as predicate |
| Materials | Same as predicate |
| Overall Dimensions | Same as predicate |
| LCD Display | Same as predicate |
| Key Pad | Same as predicate |
| Labeling | See Attachment (Implies comparable labeling) |
| Operator's Manual | See Attachment (Implies comparable manual) |
| Safety: UL544 and CSA Listed | UL544 and CSA Listed |
| Hose Connections (Locking Collet) | Quick Disconnect (Difference, but likely deemed equivalent or improved) |
| Graphic Overlay (Dynamic) | Rotational (Difference, but functional) |
| Computer Program / Software (Dynamic) | Rotational (Difference, specific to turning function) |
| Mattress Features: | |
| Air Control Zones | Same as predicate |
| Air Flow Lines | Same as predicate |
| Base | Same as predicate |
| Bottom Cover | Same as predicate |
| Top Cover | Same as predicate |
| Tie Down Straps | Same as predicate |
| Mattress Size | Same as predicate |
| Safety: California #117, UL544, and CSA Listed | California #117, UL544, and CSA Listed |
| Intermediate Comfort Cover (Zipper Closure) | Button Closure (Difference, but likely functionally equivalent) |
| CPR Deflate (Manual Release at Head End Only) | Manual Release at Both Ends (Improved feature) |
| Air Lines (Colored Extruded Air Hoses) | Clear Air Hose with Colored Spirals (Material/design difference, but likely equivalent function) |
| Air Cells (18) | 14 (Difference in number, potential impact on pressure distribution, but implicitly deemed acceptable for equivalence) |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a comparison to a predicate device based on features and specifications, not a clinical study or performance test involving a specific test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's features are compared by the engineers and regulatory reviewers.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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 medical bed system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a medical bed system, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context is the established safety and effectiveness of the predicate device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977) as determined by its previous FDA clearance. The new device demonstrates "substantial equivalence" by having similar intended use, technological characteristics, and safety/effectiveness profile, potentially with some differences that do not raise new questions of safety or effectiveness.
8. The sample size for the training set
- Not Applicable. This device is a medical bed system. There is no "training set" in the context of an algorithm. Development would involve engineering design, testing, and verification, not machine learning model training.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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JUL 1 8 1996
510(k) Summary
AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System
Lumex
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Image /page/1/Picture/0 description: The image shows the logo for Lumex, which is written in large, bold, black letters. There is a thick black line underneath the company name. Below the line, it says "A Fuqua Enterprises Company" in a smaller font. The logo is simple and professional.
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510(k) Summary
| Submitter: | Lumex Medical Products, Inc.100 Spence St.Bay Shore, NY 11706Phone (516)-273-2200Fax (516)-273-2408 |
|---|---|
| Contact Person: | Joseph ZanettiDivisional Quality Assurance Manager |
| Date Summary Prepared: | 5-22-96 |
| Classification Name: | Low air loss mattress flotation therapy - 8910Q(890.5170) |
| Common / Usual Name:: | Portable powered low air loss flotation therapymattress |
| Trade / Proprietary Name: | AkroTech 4000T Kinetic Turning Low Air Loss System |
| Establishment Registration: | 2427360 (Lumex Div. of Lumex, Inc.)1318909 (Site of manufacture) |
| Classification: | Class II |
| Performance Standards: | None established under section 514 |
| Labeling / Promotional Materials: | See attachments |
| Substantial Equivalence: | This product is similar to the AkroTech 4000product submitted by Lumex Div. of Lumex, Inc.approved by the FDA reference number K923977. |
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510(k) Summary (cont'd)
The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL)
(K923077) (K923977).
- Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU)
- The Air Floatation Mattress.
Section and the first of the first of the first of the first of the first of the first of the first of the first of the first of the first the first of the first of the first
Both Systems promote pressure reduction by redistributing patient weight over a surface
area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a
AkroTech 4000, the AirPad C AkroTech 4000, the AirBed Corporation (1240 S. Claudina St., Anaheim, CA 92805) is responsible for manufacturing the Akro Tech 4000T ACU and Lumex (CA 92805)
Bay Shore, NY 11706, 2200 in was 11 Bay Shore, NY 11706-2290) is responsible for manufacturing the 4000T air flotation mattress and marketing the product. AirBed is registered with the FDA (#2029170) as is Lumex (#2427360). AirBed Corporation operates under operator #90A (#202
15.
COMPARISON OF OVERALL FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM TO AKROTECH 4000T TURNING SYSTEM
| FEATURE | AKROTECH 4000DYNAMIC | AKROTECH 4000TTURNING |
|---|---|---|
| Switch | On / Off Toggle | On / Off Toggle |
| Modality | Firm, Float, CPR,Key Pad Lock, Alarm | Firm, Float, CPR,Key Pad Lock, Alarm |
| Data Input Control | Up / Down | Up / Down |
| Input Information | Patient Weight | Patient Weight, Height,Rotation Angle,Time In Angle |
| Data Feedback | Patient Time In Use,Cumulative Operating Time | Patient Time In Use,Cumulative Operating Time |
| Air Control Zones | Six | Six |
| Air Flow Lines | One | One |
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: ﺍﻟﻤﺮﺍﺟ ﺔ ﺑﺎﻟﻤﺎﺀ ﺑﺎﻟﻤﺎﺀ : "
COMPARISON OF ACU FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM ACU TO AKROTECH 4000T TURNING SYSTEM ACU
| ACU FEATURE | AKROTECH 4000DYNAMIC | AKROTECH 4000TTURNING |
|---|---|---|
| Computer | Same | Same |
| Hardware | Same | Same |
| Blower | Same | Same |
| Valves | Same | Same |
| Materials | Same | Same |
| Overall Dimensions | Same | Same |
| LCD Display | Same | Same |
| Key Pad | Same | Same |
| Labeling | See Attachment | See Attachment |
| Operator's Manual | See Attachment | See Attachment |
| Safety | UL544 and CSA Listed | UL544 and CSA Listed |
| Hose Connections | Locking Collet | Quick Disconnect |
| Graphic Overlay | Dynamic | Rotational |
| Computer Program /Software | Dynamic | Rotational |
COMPARISON OF MATTRESS FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM MATTRESS TO AKROTECH 4000T TURNING SYSTEM MATTRESS
| MATTRESS FEATURE | AKROTECH 4000DYNAMIC | AKROTECH 4000TTURNING |
|---|---|---|
| Air Control Zones | Same | Same |
| Air Flow Lines | Same | Same |
| Base | Same | Same |
| Bottom Cover | Same | Same |
| Top Cover | Same | Same |
| Tie Down Straps | Same | Same |
| Mattress Size | Same | Same |
| Safety | California # 117, UL544and CSA Listed | California # 117, UL544and CSA Listed |
| Intermediate Comfort Cover | Zipper Closure | Button Closure |
| CPR Deflate | Manual Release at Head EndOnly | Manual Release at BothEnds |
| Air Lines | Colored Extruded Air Hoses | Clear Air Hose withColored Spirals |
| Air Cells | 18 | 14 |
.
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.